Malawi ERB Protocol
Attach 3 QDRL-ERB-VACS Malawi - approved by ERB 1219 2012.doc
NCHS Questionnaire Design Research Laboratory
Malawi ERB Protocol
OMB: 0920-0222
Attachment 3 – QDRL NCHS ERB approved package 12/19/2012
NCHS Cover Sheet for Submitting Human
Research
Protocols and Related Documentation
The CDC Human Research Protection Office (HRPO) provides the forms for submitting and tracking human research protocols at CDC. Please see HRPO Guide: Overview for further details. Use this cover sheet when submitting HRPO forms to the NCHS Human Subjects Contact. When submitting materials with these forms, please consecutively number ALL pages beginning with the protocol title page and followed by consent form(s) and ancillary documents.
1Protocol identifiers
Leave protocol ID blank if not yet assigned. Leave amendment number and amendment title blank if not requesting a review of changes to an ERB-approved protocol.
CDC protocol ID: 2010-19
Protocol title: NCHS Laboratory-Based Questionnaire Design
Amendment number:
Amendment title: Evaluation of Violence Against Children Survey (VACS) - Malawi
2CDC primary contact
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Name and degrees |
User ID |
Telephone # |
CDC unit |
Primary contact |
Kristen Miller, Ph.D. |
KTM8 |
301-458-4625 |
NCHS/ORM/IRCLS |
3Forms submitted with this cover sheet
Check all that apply.
Requests for ERB review Requests for exempted protocols
0.1250 Initial Review 0.1250X Initial Review for Exemption
0.1251 Continuing Review of Approved Protocol 0.1251X Continuing Review of Exempted Protocol
0.1252 Review of Changes to Approved Protocol 0.1252X Review of Changes to Exempted Protocol
0.1253 End of Human Research Review 0.1253 End of Human Research Review
Tracking CDC’s research partners Managing incidents and adverse events
0.1370 CDC’s Research Partners 0.1254 Incident Report
(supplement to 0.1250–0.1252X) 0.1254S Supplemental Report on Adverse Events
Alternative review arrangements
0.1371 Request to Rely on a Non-CDC IRB
4Additional comments
5Approvals/Signatures
As principal investigator, I hereby accept responsibility for conducting this CDC-sponsored research project in an ethical manner, consistent with the policies and procedures contained in CDC's "Procedures for Protection of Human Research Participants" and to abide by the principles outlined in 45 CFR 46, "Protection of Human Subjects."
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Principal Investigator:
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As a supervisor of the principal investigator, I hereby accept responsibility for ensuring that this CDC-sponsored research project is conducted in an ethical manner, consistent with the policies and procedures contained in CDC's "Procedures for Protection of Human Research Participants" and with the principles outlined in 45 CFR 46, "Protection of Human Subjects."
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Date |
Remarks |
Branch Chief:
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Check if PI is Branch Chief: |
Division Director:
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Check if PI is Division Director: |
I concur that this CDC-sponsored research project is consistent with the policies and procedures contained in CDC's "Procedures for Protection of Human Research Participants" and with other applicable CDC and NCHS policies.
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Remarks |
Human Subjects Contact:
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NCHS Confidentiality Officer:
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6OMB Reminder
Please note that the principal investigator is responsible for obtaining OMB clearance on federally sponsored information collections. Approval by or exemption from the NCHS Research ERB is unrelated to OMB clearance requirements under the Paperwork Reduction Act. For more information on whether your study requires OMB clearance, please contact your OMB coordinator or OPPE clearance staff.
Request for Review of Changes to
IRB-Approved Protocol
Use this form to seek approval for changes to a protocol that has received approval by a CDC or non-CDC IRB. [See 45 CFR 46.103(b)(4)(iii).] See HRPO Guide: IRB Review Cycle for further details on how to complete this form.
1Protocol identifiers
CDC protocol ID: 2010-19 Protocol version number version date
Protocol title: NCHS Laboratory-Based Questionnaire Design
Amendment number:
Amendment title or brief descriptor (optional): Evaluation of Violence Against Children Survey (VACS) - Malawi
No change in keywords. If no change, please skip to section 2.
Suggested keywords (optional). Enter each term in a separate cell:
2Key CDC personnel
No change in key CDC personnel. If no changes, please list only the primary contact and principal investigator.
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Name and degrees |
User ID |
SEV # |
CDC NC/division |
Primary contact |
Kristen Miller, Ph.D. |
KTM8 |
10504 |
NCHS/ORM/IRCLS |
Principal investigator |
Kristen Miller, Ph.D. |
KTM8 |
10504 |
NCHS/ORM/IRCLS |
Investigator 2 |
Karen Whitaker, B.S. |
KRS0 |
1012 |
NCHS/ORM/IRCLS |
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SEV # is CDC’s Scientific Ethics Verification Number. CDC NC/division is the national center (or equivalent) and division (or equivalent), or coordinating center or office if submitted at that level.
List all other CDC investigators, if any. Include name and degrees, user ID, SEV #, CDC NC/division:
3CDC’s role in project
Check yes or no for each of the following.
y n CDC employees or agents will obtain data by intervening or interacting with participants.
y n CDC employees or agents will obtain or use identifiable (including coded) private data or biological specimens.
y n CDC employees or agents will obtain or use anonymous or unlinked data or biological specimens.
y n CDC employees will provide substantial technical assistance or oversight.
y n CDC employees will participate as co-authors in presentation(s) or publication(s).
“Agents” includes on-site contractors, fellows, and others appointed or retained to work at a CDC facility conducting activities under the auspices of CDC.
4CDC’s research partners
Research partners include all direct and indirect recipients of CDC funding (e.g., grants, cooperative agreements, contracts, subcontracts, purchase orders) and other CDC support (e.g., identifiable private information, supplies, products, drugs, or other tangible support) for this research activity, as well as collaborators who do not receive such support. On review of changes, HRPO needs current information on partners that have been added or dropped since the last review. See HRPO Guide: CDC’s Research Partners for further details. Check one of the following.
No research partners have been added since the last review.
Research partners have been added and are listed on form 0.1370, which accompanies this form.
5Study participants—planned demographic frequencies
No change in planned demographic frequencies. If no change, please skip to section 6.
Report estimated counts (rather than percentages). Include participants at domestic and foreign sites. See HRPO Guide: IRB Review Cycle for definitions.
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Number of participants
20
Location of participants
Participating at domestic sites
0
participating at foreign sites
20
Sex/Gender of participants
Female
0
Male
0
Sex/gender not available
0
Ethnicity of participants
Hispanic or Latino
0
Not Hispanic or Latino
0
Ethnicity not available
0
Race of participants
American Indian or Alaska Native
0
Asian
0
Black or African American
0
Native Hawaiian or Other Pacific Islander
0
White
0
More than one race
0
Race not available
0
Comments on demographics
The goal is to conduct as many as twenty cognitive interviews with 13-24 year old English speaking males and females living in Zomba recruited through the Center for Social Research through flyers.
6Regulation and policy
6.1Mode of IRB review on CDC’s behalf
Location of IRB (check one):
CDC IRB
Non-CDC IRB through IRB authorization agreement [submit form 0.1371 if this is a new request]
Institution or organization providing IRB review:
IRB registration number (if known):
Federalwide assurance number (if any):
Suggested level of risk to subjects (check one):
Minimal
Greater than minimal
Suggested level of IRB review for the modified protocol (check one):
See HRPO Worksheet for Expedited Review for detailed assistance. If relying on a non-CDC IRB, please indicate the level of review that you think is appropriate under human research regulations.
Convened-board is suggested
Not eligible for expedited review. For example, poses greater than minimal risk and changes are substantial; involves use of drug, biologic, or device under IND or IDE; involves collection of large amount of blood; use of x-rays or microwaves; anesthesia; or physically invasive procedures
Other specified reason:
Expedited review is suggested, under the following categories (check all that apply):
Proposed changes to protocol are minor
1a Study of drugs not requiring Investigational New Drug exemption from FDA
1b Study of medical devices not requiring Investigational Device Exemption from FDA
2a Collection of blood from healthy, nonpregnant adults; below volume limit, minimally invasive
2b Collection of blood from other adults and children; below volume limit, minimally invasive
3 Prospective noninvasive collection of biological specimens for research purposes
4 Collection of data through routine, noninvasive procedures, involving no general anesthesia, sedation, x-rays, or microwaves
5 Research that uses previously collected materials
6 Collection of data from voice, video, digital, or image recordings made for research purposes
7 Research that uses interview, program evaluation, human factors, or quality assurance methods
6.2Vulnerable populations
Check one of the following:
No change in vulnerable populations (added or dropped). If no change, please skip to section 6.3.
There is a proposed change in the intention to include or exclude a group of potentially vulnerable subjects, such as pregnant women or fetuses, children, or prisoners.
Please summarize and justify the proposed change, including which groups are affected and where the change is described in the protocol.
In order to conduct a study to better understand violence against children for the purposes of prevention, it is important to select a population that most closely approximates the age of interest. A precedent has been set in many parts of the world for interviewing adolescent and preadolescent children on the topic of violence victimization. For example, the national violence against children surveys previously implemented by CDC and in-country partners in developing countries, including Swaziland, Tanzania, Kenya, Zimbabwe, and Haiti included respondents 13-24 years of age. The Global School-Based Student Health Survey (GSHS), which has been conducted in over 50 countries around the world asks questions about violence to children as young as 13. In Tanzania this survey asked a question regarding sexual violence among school aged children as young as 11 years old. The Health Behavior in School-aged Children (HBSC) survey, initiated in 1982, focuses on preadolescents beginning at age 11. The HBSC, which has been conducted in over 40 countries, includes questions on sexual behavior and violence. In the US, there have also been studies in which children as young as 10 years of age have been interviewed about sexual violence; these studies have been extremely effective in mobilizing key entities into taking action to prevent violence against children.
6.3Free and informed consent
Check one of the following:
No change in consent process, forms, or approved waivers. If no change, please skip to section 6.4.
There are proposed changes in consent process, forms, or approved waivers.
Please summarize and justify the proposed changes in the consent/assent/permission process (e.g., recruitment, scripts) or in the documentation of consent/assent/permission (e.g., consent forms), including where the changes are described in the protocol. Include any changes related to the HIPAA Privacy Rule. Also describe how it is shown that the modified consent process and documentation are in understandable language (e.g., reading level, comprehension tool, short form, translation).
The QDRL is requesting a waiver of signed informed assent/consent for the following: 1) child assent of youth 13-17 years of age; 2) parental consent of youth 13-17 years of age; and 3) consent of participants 18-24 years of age. This research study involves no more than minimal risk of harm to children/young adults and involves no procedures for which written consent is normally required outside the research context. Available data indicate that 19 percent of women and 11 percent of men have no education. As such, it would be inappropriate to expect those who are illiterate to read and sign a consent form. In addition, a signed informed consent would be the only document linking a respondent to the study. Consequently, each respondent will be read the consent form that addresses their rights and welfare as a respondent in the study and given time to ask questions and then will provide verbal consent if they agree to participate in the study.
The QDRL is also requesting a waiver of the requirement to inform parents of youth 13-17 years of age of the purpose of the research. This is justified because:
The Malawi National Committee for Research in Social Sciences and Humanities has approved this protocol, agreeing that the waiver is appropriate given circumstances presented below and within the context of Malawi.
The waiver of alteration will not adversely affect the rights and welfare of the subjects. The Malawi National Committee for Research in Social Sciences and Humanities believes the need to initially describe the study in general terms and purposefully not disclose that the survey is on violence is critical for adhering to WHO ethical and safety guidelines for research on domestic violence against women. Although the proposed survey is not solely on women and domestic violence, the Malawi National Committee for Research in Social Sciences and Humanities believes that these guidelines are important since a perpetrator of sexual, physical, or emotional violence may be a household member including a parent/primary caregiver who may be asked to grant assent. For the cognitive study, the parent/caregiver will have an opportunity to provide permission as part of the consent process. WHO guidelines recommend that the only person in a household who should be aware of the nature and contents of the survey is the selected respondent. Accordingly, for the protection and safety of the participants, parents/caregivers will be informed that the study concerns young peoples’ health, educational, and life experiences and only mentions “community violence” as part of a list of broad topics, such as access to health services and education, that are included in the survey in order to obtain permission to speak with the study participant.
The research could not practicably be carried out without the waiver
It is critical to the success of this cognitive testing project that informed consent procedures exactly replicate the survey administration process and adhere to the WHO ethical and safety guidelines for participants 13 to 17 years of age. The need to initially describe the study in general terms and purposefully not disclose that the survey is on violence is critical for adhering to WHO ethical and safety guidelines for research on domestic violence against women. Although the proposed survey is not specifically on women and domestic violence, we believe that these guidelines are important since a perpetrator of sexual, physical, or emotional violence may be a household member including a parent/primary caregiver who may be asked to grant consent.
Note that full disclosure of the study objectives will be revealed to study 13-17 year old participants during QDRL’s administration of the child assent. Youth 13-17 will be told that if they choose to participate that information about their sexual activity, HIV, and their experiences with physical, emotional and sexual violence will be asked.
6.4Other regulation and policy considerations
Check one of the following:
No change in other regulation and policy considerations. If no change, please skip to section 6.5.
There are proposed changes in other regulation and policy considerations.
Please describe and justify changes to any of the following regulation and policy considerations, including where the changes are described in the protocol:
Exception to PHS policy regarding notification of HIV test results
Human genetic testing
Inclusion of a registrable clinical trial or change in registration status
Plans for long-term storage of identifiable biological specimens
Involvement of drug, biologic, or device, including Investigational New Drug or Investigational Device Exemption status (See HRPO Worksheet to Determine FDA Regulatory Coverage for guidance on whether or not FDA regulations apply.)
6.5Confidentiality protections
Check one of the following:
No change in confidentiality protections (e.g., granted, applied for, denied). If no change, please skip to section 7.
There are proposed changes in confidentiality protections.
Please describe and justify changes to confidentiality protections under a Certificate of Confidentiality (301(d)) or Assurance of Confidentiality (308(d)) or other formal confidentiality protections, including whether requests for these protections are granted, pending, or denied and where these requests are described in the protocol:
Deborah Weimer Tress, CDC Principal Senior Attorney has asserted that 308(d) and CIPSEA apply to the collected data, including for the limited time it would be in the host country.
7Summary of proposed changes
Describe and justify proposed modifications to the protocol, except for modifications justified above. Include page numbers in reference to clean copy (and marked copy if possible). Continue summary in supplemental document if necessary.
Modification 1. Description and reason for proposed modification to the protocol
Our protocol (2010-19) is generic, and covers the overall work done by our staff in general terms. This amendment provides for us to
evaluate the Violence Against Children Survey for the Malawi Center for Social Research (CSR) and the CDC's Office of Global Health.
Modification 2. Description and reason for proposed modification to the protocol
The questionnaire to be evaluated is included as Appendix 2. Only Malawi specific changes have been made to the instrument.
Modification 3. Description and reason for proposed modification to the protocol
The flyer to be used for recruiting respondents in this study is included as Appendix 3. Only Malawi specific changes have been made to the flyer.
Modification 4. Description and reason for proposed modification to the protocol
The eligibility screener to be used for verifying eligibility of those who respond to the flyer is included as Appendix 4. Only Malawi specific changes have been made to the eligibility screener.
Modification 5. Description and reason for proposed modification to the protocol
The parental consent form is included as Appendix 5. The child 13-17 assent consent form and 18-24 year old informed consent form are included as Appendix 6. Only Malawi specific changes have been made to the forms.
Modification 6. Description and reason for proposed modification to the protocol
The referral form to be used for this study appears as Appendix 7.
Modification 7. Description and reason for proposed modification to the protocol
The contact numbers for support services appear as Appendix 8.
8Material submitted with this form
Check all that apply. Describe additional material in the comments section. Clean and marked copies are required for modified materials. Entire documents may not be needed if there is enough context to enable a meaningful review. Optional items may be requested by HRPO or the IRB.
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Clean
Marked
Complete protocol
Consent, assent, and permission documents or scripts
Other information for recruits or participants (e.g., ads, brochures, flyers, scripts)
Data collection instruments (e.g., questionnaires, interview scripts, record abstraction tools)
Certification of IRB approval or exemption for research partners being added
9Additional comments
Appendix 1
Overview of Procedure for Evaluation of Violence Against Children Survey (VACS) - Malawi
The staff of the Questionnaire Design Research Laboratory (QDRL) is requesting ERB approval to evaluate the Violence Against Children Survey (VACS) in Malawi. Plans are to conduct cognitive testing of the VACS January 5-12. A Multi-Sectoral Task Force, comprised of Ministries to the Government of Malawi and national and international agencies and non-governmental organizations, assembled for their expertise on the topic of violence against children and community involvement, have provided input into the development of this protocol. There has been communication between CDC, UNICEF Malawi, and the Center for Social Research to discuss materials, human subjects protections planning, logistics, and other critical topics. In-country IRB approval was received from the National Committee for Research in Social Sciences and Humanities for the Study of Violence Against Children and Young Women in Malawi on October 18, 2012. See Appendix 9.
The VACS questionnaire for the cognitive interview was altered in both length and ordering from the original fielded questionnaire so that the QDRL could fully explore stakeholders’ issues within the time frame and the structure of the cognitive interview. The VACS cognitive interview questionnaire submitted as part of this protocol is the same questionnaire that was submitted as part of the Evaluation of Violence Against Children Survey (VACS) – Philippines submitted under Amendment 23 and approved by the ERB on August 15, 2012 with the exception that references to Philippines have been changed to Malawi denoted struck and highlighted text. See Appendix 2. The QDRL is currently analyzing the data from the Philippines interviews (question-by-question) which will take up to several months. Based on the analysis, the questions may be altered by stakeholders, hopefully, in time for January Malawi testing. However, the topics covered in the questionnaire will not change. In the case that an updated questionnaire is finalized prior to the Malawi testing dates, the QDRL will send the updated questionnaire to the ERB for their files.
Several of the Appendices included in this protocol were approved by the ERB on August 15, 2012 as part of the Philippines VACS, and have only been updated to refer to Malawi vs. the Philippines and to delete references to recording of interviews. The QDRL will not be recording the cognitive interviews. Strikeout and highlighted text denote updates to the approved forms. These forms include: Appendix 3, flyer; Appendix 4, eligibility screener; Appendix 5, parental consent; Appendix 6, child assent/adult consent.
VACS Background and Rationale
Violence against children and young women is a major human rights violation and health problem throughout the world. Generally, this abuse is divided into three major categories: physical, emotional, and sexual, all of which can have significant short- and long-term health consequences for children and young women. These include injury, sexual and reproductive health problems, unintended pregnancy, increased risk of HIV, mental health issues, alcohol and drug abuse, social ostracism, and increased incidence of chronic disease in adulthood. Victims of childhood violence are more likely to engage in risk behaviors as adolescents and adults, and may be more likely to become perpetrators themselves.
Malawi is of particular importance in the study of violence against children and young women. Throughout the last several decades, Malawi has consistently had some of the poorest development indicators in sub-Saharan Africa and has consistently experienced widespread poverty, food insecurity, and high prevalence of HIV, all of which have the potential to increase the vulnerability of all children and young women. In addition, there is a large population of children who are orphans, work in agricultural or domestic settings, and/or do not attend school, which constitute an unusually large proportion of children who may be particularly vulnerable to violence. Although there have been no nationally representative data on violence against children in Malawi to date, available studies have uncovered high rates of physical and sexual violence experienced in childhood, particularly among girls and very young children.
The findings from the VACS will be used primarily to better understand the magnitude of violence against children and young women, especially sexual violence, and its underlying risk and protective factors in order to make recommendations to relevant Ministries to the Government of Malawi and national and international agencies and non-governmental organizations on developing strategies to identify, treat, and prevent violence against children and young women. In addition to the primary use mentioned above, the findings of the survey may also serve as a foundation for future research on violence.
Cognitive Testing Rationale
Prior to the actual VACS being conducted in Malawi the instrument will undergo cognitive testing and evaluation. QDRL Staff will obtain information about the processes study participants use to answer survey questions, identify what current questions measure and pinpoint any potential problems in the questions, e.g. questions which are vague or ambiguous, questions that cannot be answered readily or accurately by the respondent or otherwise contribute to the non-sampling errors of the survey. The VACS survey instrument will be evaluated for optimal design and also provide documentation supporting the validity of survey data. The documentation will guide the redesign of questions and also serve data users, allowing them to be critical users in their approach and application of the data.
As determined by all partners, the analytic purpose of the cognitive interviewing study is to provide understanding regarding:
Feasibility of collecting such data given the sensitivity and age suitability of the questions
Assurance that meaning of terms and concepts are understood
Length of the questionnaire
Ordering of sections
Length of section introductions
Ability of respondents to distinguish between types of violence
Ability of respondents to distinguish specific events
Feasibility of collecting VACS data is an important research goal. The cognitive interviewer, an experienced QDRL staff person, will conduct the interview with this goal in mind. If it becomes apparent, in the interview, that the respondent does not understand terms or concepts, subsequent questions pertaining to those topics will not be asked. Similarly, if at any time in the interview, it becomes apparent that a respondent does not want to answer such questions because of sensitivity or because of past experiences, subsequent questions will not be asked. This type of respondent reaction, alone, provides important information about feasibility.
As in all QDRL studies that involve highly sensitive topics, the emphasis of this interview will not pertain to respondents’ specific answers to questions. Rather, focus will pertain to aspects of the question response process.
Informed Consent/Assent
The QDRL is requesting a waiver of signed informed assent/consent for the following: 1) child assent of youth 13-17 years of age; 2) parental consent of youth 13-17 years of age; and 3) consent of participants 18-24 years of age. This research study involves no more than minimal risk of harm to children/young adults and involves no procedures for which written consent is normally required outside the research context. Available data indicate that 19 percent of women and 11 percent of men have no education. As such, it would be inappropriate to expect those who are illiterate to read and sign a consent form. In addition, a signed informed consent would be the only document linking a respondent to the study. Consequently, each respondent will be read the consent form that addresses their rights and welfare as a respondent in the study and given time to ask questions and then will provide verbal consent if they agree to participate in the study (Appendix 6).
The QDRL is also requesting a waiver of the requirement to inform parents of youth 13-17 years of age of the purpose of the research. This is justified because:
The Malawi National Committee for Research in Social Sciences and Humanities has approved this protocol, agreeing that the waiver is appropriate given circumstances presented below and within the context of Malawi.
The waiver of alteration will not adversely affect the rights and welfare of the subjects. The Malawi National Committee for Research in Social Sciences and Humanities believes the need to initially describe the study in general terms and purposefully not disclose that the survey is on violence is critical for adhering to WHO ethical and safety guidelines for research on domestic violence against women. Although the proposed survey is not solely on women and domestic violence, the Malawi National Committee for Research in Social Sciences and Humanities believes that these guidelines are important since a perpetrator of sexual, physical, or emotional violence may be a household member including a parent/primary caregiver who may be asked to grant assent. For the cognitive study, the parent/caregiver will have an opportunity to provide permission as part of the consent process. WHO guidelines recommend that the only person in a household who should be aware of the nature and contents of the survey is the selected respondent. Accordingly, for the protection and safety of the participants, parents/caregivers will be informed that the study concerns young peoples’ health, educational, and life experiences and only mentions “community violence” as part of a list of broad topics, such as access to health services and education, that are included in the survey in order to obtain permission to speak with the study participant.
The research could not practicably be carried out without the waiver
It is critical to the success of this cognitive testing project that informed consent procedures exactly replicate the survey administration process and adhere to the WHO ethical and safety guidelines for participants 13 to 17 years of age. The need to initially describe the study in general terms and purposefully not disclose that the survey is on violence is critical for adhering to WHO ethical and safety guidelines for research on domestic violence against women. Although the proposed survey is not specifically on women and domestic violence, we believe that these guidelines are important since a perpetrator of sexual, physical, or emotional violence may be a household member including a parent/primary caregiver who may be asked to grant consent.
Note that full disclosure of the study objectives will be revealed to study 13-17 year old participants during QDRL’s administration of the child assent. Youth 13-17 will be told that if they choose to participate that information about their sexual activity, HIV, and their experiences with physical, emotional and sexual violence will be asked.
Conduct of the Cognitive Interview
The Center for Social Research will recruit males and females living in Zomba who are 13 to 24 years of age for the study. There are no other specific selection criteria other than age, language, and residency status. The Center for Social Research will work with primary school, secondary school and chancellor collage in Zomba town and its surroundings for recruitment of 13-24 year old males and females. Flyers will be distributed to these organizations for recruitment (Appendix 3). The Center for Social Research will recruit study participants/respondents, determine eligibility, and schedule the interviews. Contact names and phone numbers will be collected from study participants/respondents for the purpose of scheduling interviews, making reminder calls, and backfilling for no shows. Names and phone numbers will be destroyed at the completion of the study or interview. During the eligibility process, study participants considered minors (13-17 years old) will be informed that their parent/primary caregiver must accompany them to the scheduled interview location, and provide permission in-person for them to participate in the study.
Twenty interviews will be conducted by NCHS/QDRL staff members in a private room arranged by The Center for Social Research with an individual participant for approximately 90 minutes each. The study will be conducted anonymously. The completed questionnaire will not contain any identifying information. No personal data (names, addresses, and phone numbers) will be collected or recorded on a questionnaire. A unique identifier which cannot be linked to the individual will be assigned. Interviews will not be recorded. Study participants will be remunerated $50.00 USD to cover for the study participants’ transportation and token for their participation.
As mentioned previously, study participants considered minors will require the accompaniment and permission of the parent/primary caregiver in order to participate in the cognitive testing. NCHS/QDRL staff will read the contents of a verbal consent form/Information and Consent Form (Appendix 5) to the parent/primary caregiver. The “Information and Consent Form” will inform the parent/primary caregiver that the survey is an opportunity to learn more about “young peoples’ health, educational, and life experiences” and only mentions “community violence” as part of a list of broad topics, such as access to health services and education. The Malawi National Committee for Research in Social Sciences and Humanities believes the need to initially describe the study in general terms and purposefully not disclose that the survey is on violence is critical for adhering to WHO ethical and safety guidelines for research on domestic violence against women. Although the proposed survey is not solely on women and domestic violence, the Malawi National Committee for Research in Social Sciences and Humanities believes that these guidelines are important since a perpetrator of sexual, physical, or emotional violence may be a household member including a parent/primary caregiver who may be asked to grant assent. Parents/primary caregivers will be also informed that the study is voluntary and that the information shared during the interview is confidential and they will not be permitted access to any data collected in their child’s interview. Once parent/primary caregivers grant permission NCHS/QDRL staff will administer the “Initial Information Form & Consent/Assent Form” (Appendix 6) to the study participants/respondents. This form will inform the respondents that information they provide will be anonymous, and that their decision regarding participation is voluntary and confidential. Full disclosure of the study objectives will be revealed to study participants during this time, and for study participants who choose to participate, information about their sexual activity, HIV, and their experiences with physical, emotional and sexual violence will be asked. Informed verbal assent will be obtained from each study participant/respondent using the “Initial Information Form & Consent/Assent Form.” Respondents that are willing to participate will be read the questions and asked to supply verbal responses.
Emancipated minors and children living in child-headed households will be excluded from participation.
For study participants considered adults (18-24 years old), a similar consent process will be used as described above except that the parental/caregiver consent will not be necessary. These study participants/respondents will still be administered the “Initial Information Form & Consent/Assent Form” described above.
Participants will be informed before the start of the interview that if they are uncomfortable answering any question, they can skip them or they can stop the interview at any time. In regards to the possibility that someone may learn about the interview, this risk will be minimized by efforts to ensure the interview is conducted in a safe, private place and the consent process which will further ensure that other individuals are not aware that the survey is specific to sexual violence.
The interview will begin with a brief introduction about the VACS. Interviewers will explain how the cognitive testing is aimed to gain an understanding of how respondents answer questions – what thought process they use, how they comprehend questions, and how they calculate dates and numbers of events to reach their chosen responses and that the objective of the study does not focus on what study participants/respondents answer.
Contact numbers for support services in their area will be provided. These contact numbers will be represented in a child-friendly format and distributed at the beginning of the interview. They will include a list of a range of services for children’s health and well-being in their area (Appendix 8).
Cognitive Interview Response Plan
Note: The Cognitive Interview Response Plan outlined below is the same plan approved by the ERB on August 15, 2012 for the VACS Philippines with the exception of item #4 of the respondent requests referral section, and references to Malawi support services and personnel versus Philippines support services and personnel. See highlighted text for changes.
Because of the nature of the study, it is possible that children or adult respondents could disclose that they are (or have been) victims of violence. Regardless of whether or not such circumstances are disclosed in the interview, respondents could experience psychological discomfort given the subject matter of the questionnaire. Given both of these scenarios, a response plan which includes a referral process has been put in place.
At the beginning of each interview, respondents will receive detailed information regarding the interview process and told of the interview’s primary purpose: to test the survey questions, not to collect data regarding their experiences. Respondents will receive consent instructions that are detailed in the consent protocol. At this time, child-respondents (under 18 years of age) will also be notified that, should information regarding imminent danger be disclosed, the interviewer must report this information to the Center for Social Research (CSR) and will coordinate with appropriate agencies for needed case management interventions.
There are no specific questions in the protocol that are pre-determined as triggers. Rather, the interviewer will be aware that, at all times during the interview, a respondent could experience psychological discomfort which may or may not stem from current or past victimization. Interviewers are trained to be alert at all points during the interview for signs of distress. Aside from the respondent openly acknowledging distress, other signs include nonverbal cues such as silence, subtle withdrawal, anxiousness or sadness, or unusual patterns in responding. If these cues arise at any time during the interview, interviewers will:
Acknowledge such behaviors in a sensitive manner to the respondent and express concern that the respondent might be uncomfortable with the questions;
Reassure the respondent that such reactions are understandable responses;
Remind the respondent that questions may be skipped or the interview stopped;
Assess whether the interview should end regardless of whether or not the respondent chooses to do so;
Assess whether the respondent is an “at risk” case or an “emergency” case in need of immediate assistance.
During the interview, child respondents may be identified as being “emergency case” respondents or “at risk” respondents. “At risk” respondents are differentiated from “emergency case” respondents based upon the level of threat or danger that the respondent reports. Respondents deemed “at risk” include:
Those who becomes upset (e.g. crying, withdrawing, becoming angry) during the interview
Those indicating that they experienced any form of abuse in the past 12 months
Those deemed “emergency cases” are under the age of 18 and include:
Those in need of immediate medical attention because of bruises, broken bones, cuts or other serious medical conditions
Those in need of immediate psychological attention because their behavior is erratic, their speech is incoherent or they indicate potential for suicide
Those reporting recurrent sexual abuse in the home or sexual abuse within last 72 hours
The child-respondent’s companion or guardian is the alleged perpetrator
Those who indicate that they do not feel safe in their current living situation.
Protocol for Emergency Cases: If a respondent is deemed to be an emergency case the interviewer will immediately contact the CSR Response Coordinator, Mr. Sidon Kanyani, while still in the presence of the respondent.
When the respondent is safely in the care of the CSR Response Coordinator, the QDRL interviewer is no longer involved in the intervention.
The CSR Response Coordinator will talk to the respondent and explain the existing roles and responsibilities of agencies in dealing with disclosures such as:
The requirement by law to report to the District Social Welfare Officer (DSWO) for respondents aged younger than 16.
Any information will be handled in strict confidentiality within the child protection team
Family will be assured of the safety of the respondent and update them on the progress of interventions.
After assessing the situation, the CSR Response Coordinator will contact Mr. Joseph Kalero, the District Social Welfare Officer for Zomba who will be on stand-by to assist respondent on needed course of action. Depending on the assessment, those actions may include:
Medical care, including emergency treatment or care. The District Social Welfare Officer will accompany the respondent to treatment via CSR office vehicle to the nearest hospital or medical facility.
Further counseling. The Social Worker will be the case manager and will facilitate the needed case management interventions of the respondent.
Additional services (e.g. non-emergency medical services, legal services). The District Social Welfare Officer will also provide the respondent with information on how to access these services.
Protocol for “At Risk” Cases: At the end of the interview, if a respondent is deemed “at risk,” he/she will be verbally asked by the interviewer if they wish to receive psychosocial, medical or other follow up support services. Flyers that contain listing and contact of social welfare and justices agencies in Zomba will be given to the respondent. The respondent has the option of requesting or refusing support.
Although emergency and at risk cases are defined as child-respondents, adult respondents who also appear at risk will receive an option of referral.
Respondent Requests Referral: If a respondent requests a referral, the following procedures will be implemented:
The interviewer will complete a referral form (Appendix 7). In order to fill out the form, the interviewer will ask the respondent to provide as much contact information as the respondent is comfortable with, for example: name, mobile number, and when and where they would prefer to meet to receive services (e.g. a nearby school).
The interviewer will immediately contact the CSR Response Coordinator while still in the presence of the respondent and relay requested meeting time for the response.
When the respondent is safely in the care of the CSR Response Coordinator, the QDRL interviewer is no longer involved in the response plan.
Depending on the respondent request for referral, a referral form will be completed for the respondent. Potential referral service providers such as Zomba One Stop Centers (which provides medical and psychosocial support for survivors of violence), Police Victims Support Unit at Zomba Police Stations, Yoneco (Youth Network and Counseling which provides psychosocial support and toll-free helpline) and Zomba Social Welfare Office will be informed and be on standby to accept referrals from CSR Response Coordinator. Inter-agency referral system for survivors of violence, abuse and exploitation is already in place in Zomba and regular case conferences are held at Zomba Regional Hospital. Cases referred from the CSR Response Coordinator will form part of the existing caseload for case management by Zomba inter-agency team.
Any unanticipated problems involving risks to participants or others, serious or continuing noncompliance, or any other incident that is reportable to IRB per protocol or per IRB will be reported immediately to the Malawi National Committee for Research in Social Sciences and Humanities and the CDC/NCHS/QDRL IRB. Both IRB’s will consider available resources and develop a plan to best meet the needs of study participants.
Safeguarding of Data
All data, including questionnaires, interviewer’s notes, and any other information collected as part of this study, will be stored in secure travel cases while in route to the NCHS/QDRL at which point they will be transferred to secured locked storage cabinets. All data, including questionnaires, interviewer’s notes, and any other information collected as part of this study, will remain the property of the CDC/NCHS/QDRL.
Appendix 2 – VACS Questionnaire to be cognitively tested
Note to ERB reviewers: This questionnaire is the same questionnaire that was submitted as part of the VACS Philippines protocol and approved by the ERB on August 15, 2012 with the exception of the word “Malawi” replacing the words “the Philippines”. The QDRL is currently analyzing the data from the Philippines interviews (question-by-question) which will take up to several months. Based on the analysis, the questions may be altered by stakeholders, hopefully, in time for January Malawi testing. However, the topics covered in the questionnaire will not change. In the case that an updated questionnaire is finalized prior to the Malawi testing dates, the QDRL will send the updated questionnaire to the ERB for their files.
VIOLENCE AGAINST CHILDREN SURVEY - Malawi: Age13-24Years
F1 |
RECORD THE TIME THE INTERVIEW BEGAN (00:00):
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F2 |
The first questions are about yourself:
How old were you on your last birthday? |
y
don’T know/declined................................................. |
99 |
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F3
|
EDUCATION:
Have you ever attended school? |
Y NO...................................................................................... DON’T KNOW/DECLINED……………………………. |
1 2 99 |
F10 |
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F4
|
Are you currently attending school? |
YES.................................................................................... NO..................................................................................... DON’T KNOW/DECLINED……………………………. |
1 2 99 |
F7 |
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F5
|
How would you describe your grades in school? Excellent, very good, good, fair, or poor?
How is R determining this? |
EXCELLENT................................................................... VERY GOOD.................................................................. GOOD.............................................................................. FAIR................................................................................. POOR............................................................................... DON’T KNOW/DECLINED……………………………. |
1 2 3 4 5 99 |
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F6
|
How do you travel to school on most days? (Interviewer, respondent should provide only one answer)
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SCHOOL BUS.................................................................. CAR.................................................................................. PUBLIC TRANSPORTATION........................................ WALKING ALONE......................................................... WALKING WITH siblings/friends........................ BICYCLE.......................................................................... I BOARD AT SCHOOL................................................... OTHER (SPECIFY) : ___________________________ DON’T KNOW/DECLINED……………………………. |
1 2 3 4 5 6 7 88 99 |
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F7
|
What is the highest level of schooling you have completed?
How many years was R in school? |
less than primary................................................... pRIMARY......................................................................... elementary…………………………………………. sECONDARY................................................................... hIGHER THAN SECONDARY……………….……….. DON’T KNOW/DECLINED……………………………. |
1 2 3 4 5 99 |
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F8
|
How close do you feel to other students at your school? Very close, somewhat close, not too close, not close at all?
How is R determining this? |
Very close........................................................ Somewhat Close....................................................... Not Too close............................................................. Not cloes at all................................................. DON’T KNOW/DECLINED……………………………. |
1 2 3 4 99 |
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F9
|
How much do you feel that your teachers care about you? A lot, A little, Not very much, Not at all?
How is R determining this? (Interviewer prompt if necessary: Do you strongly agree, agree, disagree or strongly disagree?) |
A Lot........................................................ A LITTLE....................................................... Not very much.......................................................... Not at all................................................. DON’T KNOW/DECLINED……………………………. |
1 2 3 4 99 |
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F10
|
WORK:
Have you ever worked for money or any other form of payment? |
YES................................................................................... NO..................................................................................... don’t know / DECLINED…………………………. |
1 2 99 |
F15 |
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F12 |
What was this type of work? |
MINING…………………................................................. QUARRYING..................................................................... PYROTECHNICS PRODUCTION................................... FISHING………................................................................ DOMESTIC WORK……………...................................... CONSTRUCTION.............................................................. OTHER (SPECIFY) : ___________________________ DON’T KNOW/DECLINED……………………………. |
1 2 3 4 5 6 88 99 |
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F15 |
GENDER ATTITUDES: Sometimes a husband is annoyed or angered by things his wife does. Do you believe that it is acceptable for a man to hit or beat his wife: (Read categories below)
INTERVIEWER: PLEASE CIRCLE THE APPROPRIATE RESPONSE FOR QUESTION A THROUGH E |
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F16 |
Sometimes men and women have different ideas about having sex. Do you agree or disagree with the following statements: (Read categories below)
INTERVIEWER: PLEASE CIRCLE THE APPROPRIATE RESPONSE FOR QUESTION A THROUGH E |
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F231 |
PV4: WITNESSING PHYSICAL VIOLENCE
The following questions are about physical violence by strangers or people you know well in the home or the community. |
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F232 |
WITNESSING AT HOME
Have you seen any adults in your home hit, kick, slap, punch, or hurt each other intentionally: never, once, a few times, many times?
(Determine if these specific acts are being considered or if other acts are also included) |
A)
Never... Once..... few....... many.... Dk/dta. |
1 2 3 4
9 |
F233
F233 |
B) How old were you when this first happened: 0-5, 6-11, 12-17, 18 or older?
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C) How old were you the most recent time this happened?
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D) Did this happen in the last 12 months?
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0 to 5 years...... 6 to 11 years.... 12 to 17 years.. 18 or older....... Don’t know/ DECLINED …….. |
1 2 3 4
99 |
0 to 5 years......... 6 to 11 years....... 12 to 17 years..... 18 or older.......... DON’t KNOW/ DECLINED.............. |
1 2 3 4
99 |
YES.............. NO................ DK/DTA...... |
1 2 99 |
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ears
old:
ES
PHYSICAL VIOLENCE
F153 |
pv2: PARENTS AND OTHER RELATIVES (Ask highlighted questions in this section, and then probe for accuracy of answers)
Now let us discuss parents and other relatives.
PV2A: Has a parent or other relative punched, kicked, whipped, or beat you with an object: never, once, a few times, many times?
(Determine if these specific acts are being considered or if other acts are also included: Punched, kicked, whipped, choked, smothered, drowned, weapon)
|
Never.......................................................... Once............................................................ few............................................................... many........................................................... DON’T KNOW/DECLINED…................... |
1
2 3 4
9 |
F166 F160
F166 |
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F154 |
PV2A: MOST RECENT TIME
How old were you the most recent time this happened? |
0 to 5 years............................................. 6 to 11 years........................................... 12 to 17 years......................................... 18 or older............................................. DON’T KNOW/DECLINED…................... |
1 2 3 4 99 |
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F155 |
What was your relationship to the relative who did this to you this most recent time?
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F156 |
Was this relative older than you, younger than you, or about the same age? |
older........................................................ younger.................................................. about same age.................................. don’t know/DECLINED...................... |
1 2 3 99 |
f158
|
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F157 |
Would you say this relative was more than 10 years older than you, 5-10 years older or less than 5 years older? |
more than 10 years older…........... 5-10 YEARS OLDER……………………… less than 5 years older…............... don’t know/DECLINED........................ |
1 2 3 99 |
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F158 |
Did this happen in the last 12 months? |
YES…....................….....….....…................. NO................................................................. DON’t KNOW/DECLINED……..……….. |
1 2 99 |
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F159 |
As a result of this most recent time when a relative punched, kicked, whipped, or beat you with an object, did you experience?
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F160 |
PV2A: FIRST TIME
How old were you the first time this happened? |
0 to 5 years.............................................. 6 to 11 years............................................ 12 to 17 years…...................................... 18 or older.............................................. DON’T KNOW/DECLINED….................... |
1 2 3 4 99 |
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F161 |
What was your relationship to the relative who did this to you the first time?
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F162 |
Was the relative than older you, younger than you, or about the same age? |
older........................................................ younger.................................................. about same age.................................. don’t know/DECLINED...................... |
1 2 3 99 |
f164
|
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F163 |
Would you say this relative more than 10 years older than you, 5-10 years older, or less than 5 years older? |
more than 10 years older............. 5-10 YEARS OLDER………………..……... less than 5 years older.................. don’t know/DECLINED........................ |
1 2 3 99 |
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F164 |
Did this happen in the last 12 months? |
YES............................................................... NO................................................................. DON’t KNOW/DECLINED……..……….. |
1 2 99 |
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F165 |
As a result of this first time when a relative punched, kicked, whipped, or beat you with an object, did you experience?
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F166 |
PV2B:
Has a parent or any other relative choked, smothered, tried to drown, burned or scalded you intentionally: never, once, a few times, many times? |
Never......................................................... Once............................................................ few.............................................................. many.......................................................... DON’T KNOW/DECLINED......................... |
1
2 3 4
9 |
f179 f173
f179 |
F179 |
PV2C:
Has a parent or other relative used or threatened to use a knife or other weapon against you: never, once, a few times, many times?
|
Never......................................................... Once........................................................... few.............................................................. many......................................................... DON’T KNOW/DECLINED…................... |
1
2 3 4
9 |
f192 f186
f192 |
F300 |
EMOTIONAL VIOLENCE
EV1
Has/did a parent or primary caregiver ever say that you were not loved, or did not deserve to be loved, or that they wished you had never been born or were dead, or has a parent or primary caregiver ever ridiculed you or put you down (for example say that you were stupid or useless): never, once, a few times, or many times? |
Never............................................................ Once.............................................................. few................................................................. many............................................................. DON’T KNOW/DECLINED…...................... |
1
2 3 4
9 |
F400 F306
F400 |
F1021 |
PERPETRATION (Ask highlighted questions in this section, and then probe for accuracy of answers)
Have you slapped or pushed a current or previous partner/husband: never, once, a few times, many times? By partner I mean a boyfriend, romantic partner, fiancé, live-in partner, or husband. |
Never................................................................................. Once................................................................................... few...................................................................................... many.................................................................................. DON’T KNOW/DECLINED.............................................. |
1 2 3 4 99 |
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F1022 |
Have you punched, kicked, whipped, or beat with an object a current or previous partner/husband: never, once, a few times, many times? |
Never................................................................................. Once................................................................................... few...................................................................................... many.................................................................................. DON’T KNOW/DECLINED.............................................. |
1 2 3 4 99 |
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F1023 |
Have you choked, smothered, tried to drown, or intentionally burned or scalded a current or previous partner/husband: never, once, a few times, many times? |
Never................................................................................. Once................................................................................... few...................................................................................... many.................................................................................. DON’T KNOW/DECLINED.............................................. |
1 2 3 4 99 |
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F1024 |
Have you used or threatened to use a knife or other weapon against a current or previous partner/husband: never, once, a few times, many times? |
Never................................................................................. Once................................................................................... few...................................................................................... many.................................................................................. DON’T KNOW/DECLINED.............................................. |
1 2 3 4 99 |
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F1025 |
Have you forced a current or previous partner/husband to have sexual intercourse or perform any other sex acts with you when they did not want to: never, once, a few times, many times? |
Never................................................................................. Once................................................................................... few...................................................................................... many.................................................................................. DON’T KNOW/DECLINED.............................................. |
1 2 3 4 99 |
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F1026 |
Have you forced someone who was not your husband or partner at the time to have sexual intercourse or perform any other sex acts with you when they did not want to: never, once, a few times, many times? |
Never................................................................................. Once................................................................................... few...................................................................................... many.................................................................................. DON’T KNOW/DECLINED.............................................. |
1 2 3 4 99 |
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F400 |
SEXUAL BEHAVIOR:
(Ask highlighted questions in this section, and then probe for accuracy of answers)
The next set of questions is about your sexual activity and practices. Some of these questions are personal but keep in mind that your name is not on the survey and no one else will know your answers. There are no right or wrong answers, and remember that you can skip any question that you don’t feel comfortable answering.
Have you ever had sexual intercourse whether this was something you wanted to do at the time or something you did not want to do? |
YES.......................................................................... NO............................................................................ DON’T KNOW/DECLINED…………………… |
1 2 99 |
F500 |
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F401 |
How old were you when you had sexual intercourse for the very first time? |
DON’T KNOW/DECLINED…………………… |
99 |
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F402 |
The first time you had sexual intercourse, would you say that you had it because you wanted to, or because you were made to have it without your permission? |
wanted to......................................................... made to............................................................... DON’T KNOW/DECLINED……………………... |
1 2 99 |
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F406 |
SEX HISTORY AND RISK TAKING:
In your life, how many sexual partners have you ever had? A sexual partner is any person with whom you have had sexual intercourse whether this was something you wanted to do at the time or something you did not want to do.
|
(Interviewers: 0 is not an acceptable answer for this question, if respondent says 0 then refer back to F400 and correct if necessary)
DON’T KNOW/DECLINED……………………………………. |
99 |
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F407 |
Have you had sexual intercourse in the past 12 months?
|
Y NO................................................................................................... DON’T KNOW/DECLINED……………………………………. |
1 2 99
|
F500 |
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F408 |
How many partners have you had sexual intercourse with in the past 12 months? |
NUMBER of PARTNERS
DON’T KNOW/DECLINED…………………………………… |
99 |
|
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F409 |
INTERVIEWER: CONTINUE DOWN THE COLUMN, ASKING ALL THE QUESTIONS FOR PARTNER 1 BEFORE CONTINUING TO PARTNER 2 AND PARTNER 3. |
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F410 |
(Refer back to F406; are answers to this question consistent? The point is to assess whether R is counting all partners or only certain relationships) |
PARTNER 1 MOST RECENT
What is/was your relationship to the most recent person with whom you had sexual intercourse? |
PARTNER 2 SECOND MOST RECENT
Now think back to the partner you had sexual intercourse with before the partner we just talked about.
What is/was your relationship to the person with whom you had sexual intercourse? |
PARTNER 3 THIRD MOST RECENT
Now think back to the partner you had sexual intercourse with before the partner we just talked about.
What is/was your relationship to the person with whom you had sexual intercourse? |
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HUSBAND..................... LIVE-IN PARTNER...... BOYFRIEND NOT LIVING WITH YOU...... SOMEONE YOU PAID FOR SEX……………… SOMEONE WHO PAID YOU FOR SEX............... CASUAL ACQUINTANCE............ FRIEND.......................... OTHER(SPECIFY)________________________ DK/DTA......................... |
1 2
3
4
5
6 7
88 99 |
HUSBAND..................... LIVE-IN PARTNER....... BOYFRIEND NOT LIVING WITH YOU...... SOMEONE YOU PAID FOR SEX………………. SOMEONE WHO PAID YOU FOR SEX............... CASUAL ACQUINTANCE............ FRIEND.......................... OTHER(SPECIFY)_________________________ DK/DTA......................... |
1 2
3
4
5
6 7
88 99 |
HUSBAND..................... LIVE-IN PARTNER....... BOYFRIEND NOT LIVING WITH YOU...... SOMEONE YOU PAID FOR SEX………………. SOMEONE WHO PAID YOU FOR SEX............... CASUAL ACQUINTANCE............ FRIEND........................... OTHER(SPECIFY)__________________________ DK/DTA........................... |
1 2
3
4
5
6 7
88 99 |
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F411 |
In the past 12 months, how often did you or this partner use a condom during sexual intercourse? Would you say always, sometimes, or never? |
ALWAYS........................ SOMETIMES.................. NEVER........................... DON’T KNOW / DECLINED..................... |
1 2 3
99 |
ALWAYS........................ SOMETIMES.................. NEVER........................... DON’T KNOW / DECLINED...................... |
1 2 3
99 |
ALWAYS........................ SOMETIMES.................. NEVER........................... DON’T KNOW / DECLINED.................... |
1 2 3
99 |
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F412 |
INTERVIEWER: CHECK NUMBER OF PARTNERS REPORTED IN F408 |
I
I
|
|
I
I PARTNER 3
|
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GO TO F500 |
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F403 |
(Ask highlighted questions in this section, and then probe for accuracy of answers)
ASK PREGNANCY QUESTIONS ONLY OF FEMALES 13-24 YEARS OF AGE.
PREGNANCY: The next questions are about pregnancy.
Have you ever been pregnant? |
Y NO.................................................................................................... DON’T KNOW/DECLINED……………………………………. |
1 2 99 |
F406 |
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F404 |
How old were you the first time that you got pregnant? |
YEARS OLd:
DON’T KNOW/DECLINED……………………………………. |
99 |
|
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F405 |
Have you ever had a pregnancy that did not end in a live birth? |
YES................................................................................................. NO.................................................................................................. DON’T KNOW/DECLINED……………………………………. |
1 2 99 |
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ES
F
F408=1 F500
ES
F500 |
SEXUAL VIOLENCE : NON-CONTACT SEXUAL VIOLENCE/EXPLOITATION
The next set of questions is about different kinds of sexual violence. Some of these questions are personal but keep in mind that your name is not on the survey and no one else will know your answers. There are no right or wrong answers, and remember that you can skip any question that you don’t feel comfortable answering. |
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F501 |
NON CONTACT SEXUAL VIOLENCE
Has anyone ever made you upset by speaking to you in a sexual way or writing sexual things about you?
(Ensure that R is not limiting answer to certain types of relationships) |
A)
YES.... 1 N DK/ F502 DTA.... 99
|
B) How old were you when this first happened: 0-5, 6-11, 12-17, 18 or older? |
C) How old were you the most recent time this happened?
|
D) Did this happen in the last 12 months?
|
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0 to 5 years...... 6 to 11 years.... 12 to 17 years.. 18 or older...... DON’T KNOW / DECLINED……... |
1 2 3 4
99 |
0 to 5 years...... 6 to 11 years.... 12 to 17 years.. 18 or older...... DON’T KNOW / DECLINED……... |
1 2 3 4
99 |
YES.................... NO...................... DON’t KNOW/ DECLINED........ |
1 2
99 |
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E) How well did you know the person who did this to you? |
not at all…………...…………. not very well………………... very well……………………… don’t KNOW/DECLINED……… |
1 2 3 99 |
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F502 |
Has anyone made you witness sexual activities or sexual abuse, even without making you participate (e.g. images/photos, videos, online)? |
A)
YES.... 1 N DK/ F503 DTA.... 99
|
B) How old were you when this first happened: 0-5, 6-11, 12-17, 18 or older? |
C) How old were you the most recent time this happened? |
D) Did this happen in the last 12 months?
|
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0 to 5 years...... 6 to 11 years.... 12 to 17 years.. 18 or older...... DON’T KNOW / DECLINED……... |
1 2 3 4
99 |
0 to 5 years...... 6 to 11 years.... 12 to 17 years.. 18 or older...... DON’T KNOW / DECLINED……... |
1 2 3 4
99 |
YES.................... NO...................... DON’t KNOW/ DECLINED........ |
1 2
99 |
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E) How well did you know the person who did this to you? |
not at all………………....…. not very well…………..….. very well………………….… don’t KNOW/DECLINED…..... |
1 2 3 99 |
|||||||||||||||||
F503 |
Has anyone made you participate in a sex video or in sexual photos? |
A)
YES.... 1 N DK/ F504 DTA.... 99
|
B) How old were you when this first happened: 0-5, 6-11, 12-17, 18 or older? |
C) How old were you the most recent time this happened? |
D) Did this happen in the last 12 months?
|
||||||||||||||
0 to 5 years...... 6 to 11 years.... 12 to 17 years.. 18 or older...... DON’T KNOW / DECLINED……... |
1 2 3 4
99 |
0 to 5 years...... 6 to 11 years.... 12 to 17 years.. 18 or older...... DON’T KNOW / DECLINED……... |
1 2 3 4
99 |
YES.................... NO...................... DON’t KNOW/ DECLINED........ |
1 2
99 |
||||||||||||||
E) How well did you know the person who did this to you? |
not at all………………....…. not very well…………..….. very well………………….… don’t KNOW/DECLINED…..... |
1 2 3 99 |
|||||||||||||||||
F504 |
Has anyone made you look at their sexual body parts or made you show them yours? |
A)
YES.... 1 N DK/ F505 DTA.... 99
|
B) How old were you when this first happened: 0-5, 6-11, 12-17, 18 or older? |
C) How old were you the most recent time this happened? |
D) Did this happen in the last 12 months?
|
||||||||||||||
0 to 5 years...... 6 to 11 years.... 12 to 17 years.. 18 or older...... DON’T KNOW / DECLINED……... |
1 2 3 4
99 |
0 to 5 years...... 6 to 11 years.... 12 to 17 years.. 18 or older...... DON’T KNOW / DECLINED……... |
1 2 3 4
99 |
YES.................... NO...................... DON’t KNOW/ DECLINED........ |
1 2
99 |
||||||||||||||
E) How well did you know the person who did this to you? |
not at all…………...………. not very well…………….. very well…………………… don’t KNOW/DECLINED…… |
1 2 3 99 |
|||||||||||||||||
F505 |
SEXUAL VIOLENCE : MONEY, GOODS OR FAVORS EXCHANGED FOR SEX/EXPLOITATION
Has anyone ever given you money, food, gifts, or any favors to have sexual intercourse or perform any other sexual acts with them? |
Y NO.................................................................................. DON’T KNOW / DECLINED....................................... |
1 2 99 |
F600 |
|||||||||||||||
O.....
2
ES
F600 |
SEXUAL VIOLENCE: SEXUAL ABUSE (Ask highlighted questions in this section, and then probe for accuracy of answers)
SV1: TOUCHING WITHOUT PERMISSION- LIFETIME
How many times in your life has anyone touched you in a sexual way without your permission, but did not try and force you to have sex of any kind? Touching without permission includes being fondled, pinched, grabbed, or touched without your permission |
0.................................................................. 1..................................................................
don’t know/DECLINED.....................
|
0
1
9 |
F700 F613
F601
F700 |
||
F601 |
SV1A: TOUCHING – MOST RECENT
How old were you the most recent time this happened? |
don’t know/DECLINED................................................... |
99 |
|
||
F602 |
This most recent time, did more than one person touch you in a sexual way without your permission?
|
y no, one person only...................................................... don’t know/DECLINED................................................... |
1 2 99 |
F605 |
||
F603 |
This most recent time, how many people touched you in a sexual way without your permission?
|
don’t know/DECLINED................................................... |
99 |
|
||
F604 |
Of these people who touched you in a sexual way without your permission this most recent time, think of the person you know the best for the following questions: |
|||||
9
es...........................................................................................
UMBER
OF PEOPLE:
F605 |
What was your relationship to the person who did this to you? |
||||||
Male BoyFRIEND/ROMANTIC Partner…………... Husband…………………………………………. father…………………......................................... STEP FATHER……………………………………... brother………………………………………….. STEP BROTHER………………………………… uncle……………………………………………... OTHER RELATIVE (SPECIFY)_______________ Male Teacher...................................................... Male POlice.......................................................... Male SECURITY PERSON................................... Male Employer................................................... Male in my neighborhood………………... Male COMMUNITY LEADER………………….. Male Religious Leader.................................. Male Friend…………………………………….. Male Stranger………………………………... OTHER Male (SPECIFY) ___________________ |
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 |
Female Girlfriend/Romantic Partner………………………. wife……………………………………………………………. mother……………………………………………………….. STEP MOTHER………………………………………………... sister………………................................................................. STEP SISTER…………………………………………………... aunt…………………………………………………………… OTHER RELATIVE (SPECIFY)________________________ FEMale Teacher................................................................... fEMale POlice........................................................................ FEMale SECURITY PERSON…............................................ FEMale Employer................................................................ FEMale in my neighborhood………………................. FEMale COMMUNITY LEADER…………………………… FEMale Religious Leader................................................ FEMale Friend……………………………………………... FEMale Stranger………………………………................ OTHER FEMALE (SPECIFY) __________________________ |
19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 |
||||
Wearing Mask/It was dark/Couldn’t see…..……88 Don’t Know/DECLINED …………………………………99 |
|||||||
F606 |
Was the person older than you, younger than you, or about the same age? |
older............................................................................. younger...................................................................... about same age....................................................... don’t know/DECLINED............................... |
1 2 3 99 |
F608 |
|||
F607 |
Would you say this person was more than 10 years older than you, 5-10 years older or less than 5 years older? |
more than 10 years older................................ 5-10 YEARS OLDER…………………………………. less than 5 years older..................................... don’t know/DECLINED.......................................... |
1 2 3 99 |
|
||||
F608
|
Where were you when this happened to you? |
MY HOME………................................... PERPETRATOR’S HOME…………….. SOMEONE ELSE’S HOME…………… ON A ROAD/STREET…….…………… MARKET/SHOP/MALL……………….. SCHOOL………………………………... |
1 2 3 4 5 6 |
INSIDE A CAR/BUS......................................... LAKE, RIVER, OTHER BODY OF WATER... FIELD OR OTHER OUTDOOR AREA……… Bar/Restaurant/Disco/Club………… OTHER LOCATION (SPECIFY):__________ don’t know/DECLINED............................. |
7 8 9 10 88 99 |
|||
F609 |
About what time of day did this happen? |
MORNING (SUNRISE TO NOON)............................. AFTERNOON (noon to sunset).......................... EVENING (SUNSET TO MIDNIGHT)....................... LATE AT NIGHT (Midnight to sunrise).......... don’t know/DECLINED......................................... |
1 2 3 4 99 |
|
||||
F610 |
Was the person that did this to you drunk or on any illegal drugs when the touching happened? |
YES................................................................................. NO.................................................................................. don’t know/DECLINED......................................... |
1 2 99 |
|
||||
F611 |
Were you drinking, drunk, high, drugged, passed out or on any illegal drug when someone touched you without your permission this most recent time? |
YES................................................................................. NO.................................................................................. don’t know/DECLINED......................................... |
1 2 99 |
|
||||
F612 |
Did this happen to you within the past 12 months? |
YES................................................................................. NO.................................................................................. don’t know/DECLINED......................................... |
1 2 99 |
|
||||
F700 |
SV2: ATTEMPTED SEX- LIFETIME
How many times in your life has anyone tried to make you have sexual intercourse of any kind without your permission, but did not succeed? |
0............................................................................................ 1............................................................................................
don’t know/DECLINED............................................... |
0
1
9 |
F800 F713
F701
F800 |
rite
number if
9
F800 |
SV3: PRESSURED INTO SEX- LIFETIME
Have you ever had sexual intercourse of any kind with anyone, male or female, after they pressured you by doing things like telling you lies, making promises about the future they knew were untrue, threatening to end your relationship, or threatening to spread rumors about you? |
yes....................................................................... no........................................................................ don’t know/DECLINED................................ |
1 2 99 |
|
F801 |
Have you ever had unwanted sexual intercourse of any kind with anyone, male or female, after they pressured you by repeatedly asking for sex, or showing they were unhappy? |
yes....................................................................... no………………………..................................... don’t know / Declined………………...... |
1 2 99 |
|
F802 |
Have you ever had unwanted sexual intercourse of any kind with anyone, male or female, after they pressured you using their influence or authority over you, for example, saying they will give you bad grades, that they will fire you, or that they will arrest you? |
yes....................................................................... no………………………..................................... don’t know / Declined………………..... |
1 2 99 |
|
F900 |
SV4: PHYSICALLY FORCED SEX- LIFETIME
How many times in your life have you been physically forced to have sexual intercourse of any kind regardless of whether you did or did not fight back? By physical force, we mean things like being pinned or held down or use of violence like pulling your hair, pushing, shoving, punching, using or threatening to use a weapon, or threatening to physically harm you or a loved one. |
0......................................................................... 1.........................................................................
write number if
2
don’t know/declined............................
|
0 1
9 |
F931 F916
F901
F931
|
times or more:
F931 |
I
I |
|||||||
F932 |
SV: HELP-SEEKING AND REPORTING
I would like you to think back to all the sexual experiences that happened without your permission. These experiences may include: unwanted sexual touching, attempted sex, pressured sex, or physically forced sex. |
|
|
|
||||
Did you ever tell anybody about any of these experiences of unwanted touching, attempted sex, pressured sex, or physically forced sex? |
YES.....................................................................................
N DON’T KNOW/DECLINED............................................. |
1 2 99
|
F934
|
|||||
F933 |
Were there any sexual experiences that you did not tell anyone about? |
YES.....................................................................................
N DON’T KNOW/DECLINED............................................. |
1 2 99 |
F935 |
||||
F934 |
Why didn’t you tell anyone about these experiences?
(Circle all mentioned) |
AFRAID OF GETTING INTO TROUBLE....... embarrassed FOR SELF/FAMILY........... DEPENDENT ON PERPETRATOR................. PERPETRATOR THREATENED ME.............. DIDN’T THINK IT WAS A PROBLEM........... FELT IT WAS MY FAULT............................... |
A B C D E F |
Didn’t want abuser to get in trouble AFRAID OF BEING ABANDONED....................... OTHER REASON (SPECIFY):________________ __________________________________________ DON’T KNOW/DECLINED...................................... |
G H
X Z |
|||
F
F600=1 or more 
O.......................................................................................F935 |
SV SERVICES
Did you talk to or receive services from:
|
other person/place (specify):_______________________________
|
||||||||||||||||||||||||||
F936 |
skip
i if
f935a and f935b and f935c and f935d aND F935E=2/99
|
|||||||||||||||||||||||||||
F937 |
What was the main reason you did not talk to or receive services? |
did not know where to go……………………..… aFRAID OF causing more violence or GETTING IN TROUBLE …………………………............. embarrassed FOR SELF OR my FAMILY................. DID NOT WANT ABUSER TO GET IN TROUBLE........... TOO FAR TO SERVICES..................................................... AFRAID OF BEING ABANDONED.................................... did not think it was a problem............................ COULD NOT AFFORD TRANSPORT................................ COULD NOT AFFORD SERVICE FEES............................. DID NOT NEED/WANT SERVICES................................... NO ONE TO HELP ME......................................................... Felt it was useless………………………………….. Other (specify):______________________________ DON’t know/DECLINED................................................. |
1
2 3 4 5 6 7 8 9 10 11 12 88 99 |
|
||||||||||||||||||||||||
f
f935a or f935b or f935c or f935d OR F935E=1
SKIP to f938
F938 |
Were there any professional services that you would have wanted but were not available? |
Y No................................................................................... DON’t know/DECLINED......................................... |
1 2 99 |
F940 |
||||
F939 |
What services would you have wanted? (Circle all mentioned) |
COUNSELING SERVICES......................... MEDICAL SERVICES................................ LEGAL COUNSEL..................................... TRADITIONAL HEALER SERVICES...... POLICE SERVICES.................................... EDUCATIONAL PROGRAMS………… |
A B C D E F |
SHELTER…………………………………... OTHER (SPECIFY):__________________ DON’T KNOW/DECLINED.........................
|
G X Z |
|||
ES.................................................................................F940 |
Was there anyone else that you spoke to regarding any sexual experiences that happened without your permission? (Circle all mentioned)
|
|||||||||||||||||||||||||||||||||||||||||||||||
MOTHER………………………………………… Father…………………………………………. SISTER…………………………………………… BROTHER……………………………………….. other relative……………………………... HUSBAND………………………………………. bOYFRIEND/rOMANTIC PARTNER………… friend…………………………………………... NEIGHBOR………………………………………. |
A B C D E F G H I |
TRADITIONAL HEALER……………………………... HOTLINE………………………………………………. NGO WORKER………………………………………... Teacher……………………………………………… employer……………………………………………. community leader…………………………….... religious leader……………………………….... OTHER (SPECIFY)____________________________ don’t know/declined………………………….. |
L M N O P Q R X Z |
|||||||||||||||||||||||||||||||||||||||||||||
F941 |
Have any of these incidents caused you to do any of the following: (Read categories below)
|
Yes
No
DK/ DTA
A) STOP GOING TO
SCHOOL?
1
2
99
B) DECREASE THE AMOUNT
OF TIME YOU SPEND IN SCHOOL?
1
2
99
C) SPEND LESS TIME AT
HOME?
1
2
99
D) SPEND MORE TIME AT
HOME?
1
2
99
E) SPEND MORE TIME
ALONE?
1
2
99
F) AVOID GOING OUTSIDE
AT NIGHT?
1
2
99
G) STOP GOING TO WORK?
1
2
99
H) DECREASE THE HOURS
YOU ARE ABLE TO WORK?
1
2
99
I) NOT SEEK HEALTH
SERVICES THAT YOU NEEDED?
1
2
99
J) OTHER
1
2
99 OTHER (SPECIFY):_________________________________ |
||||||||||||||||||||||||||||||||||||||||||||||
F1031 |
The next two questions ask about things that have ever happened to you.
Have you ever had thoughts of ending your life? |
YES................................................................................. N DON’T KNOW / DECLINED....................................... |
1 2 99 |
F1033 |
F1034 |
Have you ever been tested for HIV? |
YES................................................................................. NO.................................................................................. DON’T KNOW / DECLINED....................................... |
1 2
9 |
F1036 F1036 |
F1035 |
What is the main reason you have never been tested? |
N DON’T KNOW WHERE TO GET HIV TEST……... test costs too much........................................... transport to test site is too much............ test site too far awaY...................................... afraid others will know about test/test results.................................................. don’t need test/Low risk................................. don’t want to know if I have the aids virus............................................................................ can’t get treatment if i have Aids............. other(specify)____________________________ DON’T KNOW / DECLINED....................................... |
1 2 3 4 5
6 7
8 9 88 99 |
F1038 |
F1038 |
Have you ever had a sexually transmitted infection? |
YES................................................................................. NO................................................................................... DON’T KNOW/DECLINED......................................... |
1 2 99 |
|
O
O
KNOWLEDGE ABOUT HIV TEST.......................
DEBRIEFING:
Do you feel that the time you took to answer these questions was worthwhile and will be useful to Malawi in addressing the problem of violence? Did you find it upsetting or stressful to answer any of these questions? Which questions did you find upsetting or stressful to answer? The questions on physical violence, emotional violence, sexual violence, or other questions? How has talking about these things made you feel?
RESPONSE PLAN CHECKLIST: DID RESPONDENT REPORT ANY VIOLENCE IN THE PAST 12 MONTHS?
DID THE RESPONDENT BECOME VISIBLLY UPSET AT ANY POINT DURING THE INTERVIEW?
DID THE RESPODENT REPORT FEELING UNSAFE IN CURRENT LIVING SITUATION AT ANY POINT DURING INTERVEW?
IF NO WAS SELECTED FOR ALL OF THE ABOVE AND THE RESPONDENT DID NOT DISCLOSE ANY VIOLENCE, CONTINUE TO FINISH OPTION 1. IF NO WAS SELECTED FOR ALL OF THE ABOVE BUT THE RESPONDENT DISCLOSED VIOLENCE, CONTINUE TO FINISH OPTION 2. IF YES WAS SELECTED FOR ANY OF THE ABOVE, CONTINUE TO FINISH OPTION 3.
FINISH OPTION 1: RESPONDENT DID NOT DISCLOSE ANY VIOLENCE
I would like to thank you very much for helping me. I appreciate the time that you have taken. I realize that these questions may have been difficult for you to answer, but it is only by hearing from [girls and young women/boys and young men] like you that we can really understand about [women’s/men’s health] and life experiences in Malawi.
Here is a list of organizations that provide various types of services that may be of interest to you. Please contact them if you need help.
FINISH OPTION 2: RESPONDENT DISCLOSED VIOLENCE BUT DID NOT MEET THE CRITERIA LISTED ABOVE
I would like to thank you very much for helping us. I appreciate the time that you have taken. I realize that these questions may have been difficult for you to answer, but it is only by hearing from [girls and young women/boys and young men] like you that that we can really understand about health and experiences of violence in Malawi
From what you have told me, I can tell that you have had some very difficult times in your life. No one has the right to treat someone else in that way. However, from what you have told me I can see also that you are strong, and have survived through these difficult circumstances.
Here is a list of organizations that provide support to people like you who may have experienced violence. Please contact them if you would like to talk over your situation with anyone. You can go whenever you feel ready, either soon or later on.
FINISH OPTION 3: OFFER RESPONSE PLAN TO RESPONDENT I would like to thank you very much for helping us. I appreciate the time that you have taken. I realize that these questions may have been difficult for you to answer, but it is only by hearing from [girls and young women/boys and young men] like you that that we can really understand about health and experiences of violence in Malawi.
From what you have told me, I can tell that you have had some very difficult times in your life. No one has the right to treat someone else in that way. However, from what you have told me I can see also that you are strong, and have survived through these difficult circumstances.
I wanted to offer you some more immediate help if this would be something you need and want. A counselor can talk to you about the things that have happened to you and/or connect you to other services that might be helpful. If you decide that you would like to talk to a counselor, I would only share the information that you want me to share. As I told you in the beginning, your answers are confidential and I will not share these with the counselor. Would you like to speak with a counselor?
It is fine that you do not want to speak with a counselor now. I wanted to give you this list of organizations that provide support, legal advice and counseling services to people like you who may have experiences of violence. If you change your mind in the future, please contact them if you would like to talk over your situation with someone. You can go whenever you feel ready, either soon or later on. |
YES
Appendix 3 – Flyer
Note to ERB reviewers: This flyer is the same flyer that was submitted as part of the VACS Philippines protocol and approved by the ERB on August 15, 2012 with the exception that Malawi specific information replaces the Philippines specific information.
13-24 year olds
Wanted for Study
We are looking for youth 13-24 years of age to help us learn how to ask questions for a national survey about young peoples’ health and life experiences.
Participants receive: MK3500
To participate, you will take part in an interview that contains questions about:
your experiences in school
health risk behaviors
safety and violence
your relationships with friends, family and community members
FOR MORE INFORMATION,
Please call: CSR phone #
Study Sponsors: The Center for Social Research (CSR) in partnership with UNICEF and the US Centers for Disease Control and Prevention (CDC)
Appendix 4 – Eligibility screener
Note to ERB reviewers: This eligibility screener is the same eligibility screener that was submitted as part of the VACS Philippines protocol and approved by the ERB on August 15, 2012 with the exception that Malawi specific information replaces the Philippines specific information and recording of the interview has been removed.
Eligibility screener – Targeted: Males & females, 13-24 years old, fluent in English, residing in Zomba recruited through flyers, and word-of-mouth
Recruited by CSR through flyer or word-of-mouth and respondent has phoned the contact number on flyer to speak with a live person or the respondent has left a phone message on an answering machine
Recruited through response to flyer/word-of-mouth respondent “live” call-in:
...Hello, my name is [fill] with the CSR. I understand that you are interested in participating in the research study about young peoples’ health and life experiences? Is that correct? Wait for acknowledgement. The survey topics include such things as experience in school, health risk behaviors, safety and violence, experience accessing professional medical and social services, and relationships with friends, family and community members.
...In order to determine if you are eligible for our study, I’ll need a few minutes of your time to ask some background questions. Answering these questions is completely voluntary. We are required by law to use your information for statistical research only and to keep it confidential. The law prohibits us from giving anyone any information that may identify you without your consent.
Wait for acknowledgment, such as, “Okay.” Continue and go to screener question 1.
1. How old are you? [If under age 13 or over age 24, go to exit script 1]
2. Are you male or female?
Male
Female
3. Do you speak English fluently?
Yes
No
4. Do you live in Zomba?
Yes
No
[If quota has been met, go to exit script 2.]
Entry Script:
...Based on your answers to the questions so far, we would like you to take part in our study. For this study we’d like you to come to [fill location]. For teens 13-17. In order for you to participate in the study, your parent/primary caregiver must be present at the time of the scheduled interview to give permission for you to participate. The interview will last approximately 90 minutes and you will receive $11.00 USD. An interviewer will ask you questions about your experience in school, health risk behaviors, safety and violence, experience accessing professional medical and social services, and relationships with friends, family and community members. Then the interviewer will ask you to explain what you were thinking and how you came up with your answers. Your answers will help us find out if the survey questions make sense, are easy to answer, and that everyone understands the questions the same way. Everything you say will be kept private.
Do you have any questions at this point? Pause to answer questions. If (not/you have no other questions), then let’s get you on the schedule, ok? We will be interviewing (Day, Month/Date) through (Day, Month/Date) from 8 a.m. to 6 p.m. Looking at your schedule, when would you be available to participate? Schedule. [If date/times not available go to exit script 3.]
A reminder call will be made to you a few days in advance. Should you have any questions or need to change your appointment, please feel free to contact me [name] at [phone number]. Thank you for responding to our ad, and I look forward to seeing you here at (DATE/TIME) Get respondent to cite date & time if possible.
---------------------------------------------------------
Exit script 1: I’m sorry, you have to be between the ages of 13 and 24 to take part in this study and therefore we won’t be able to use you at this time.
Exit script2: Based upon your answers, it seems that we may already have a number of volunteers with very similar answers to yours. At this point we need to talk with people with some different characteristics. However, if we have cancellations or other slots open up, I may wish to call you back. Would it be okay if I kept your name, telephone number, and the information you provided in response to the eligibility questions until the end of this study? If yes, make notation. If no, We will not keep any of the information you gave me.
Exit script 3: I see...ok, we were hoping to complete this particular study between (Month/Date) and (Month/Date), so it looks like we won’t be able to schedule you at this time.
Recruited through flyer or word-of-mouth and respondent has left a phone message on the CSR answering machine:
Dial respondent’s telephone number [hereafter referred to as R] as indicated on audiotape recording.
Note: Speak only to R. If the number is answered by an answering machine, call back at another time.
CSR: Good morning/afternoon, may I speak to (name)?
If R is not available or not at home, say, “Thank you” and try again at another time.
If the person who answered the phone (NOT R) asks, “Who is calling?” or “What’s this about?” say, “I am returning their call to me. I’ll try to reach them at another time.
If R has been successfully contacted, continue...
...Hello, my name is [fill] with the CSR. You may remember that you responded to a flyer looking for teens and young adults aged 13-24 to participate in the research study about young peoples’ health and life experiences? Wait for acknowledgement. The survey topics include such things as experience in school, health risk behaviors, safety and violence, experience accessing professional medical and social services, and relationships with friends, family and community members.
...In order to determine if you are eligible for our study, I’ll need a few minutes of your time to ask some background questions. Answering these questions is completely voluntary. We are required by law to use your information for statistical research only and to keep it confidential. The law prohibits us from giving anyone any information that may identify you without your consent.
Wait for acknowledgment, such as, “Okay.” Continue and go to screener question 1.
1. How old are you? [If under age 13 or over age 24, go to exit script 1]
2. Are you male or female?
Male
Female
3. Do you speak English fluently?
Yes
No
4. Do you live in Zomba?
Yes
No
[If quota has been met, go to exit script 2.]
Entry Script:
...Based on your answers to the questions so far, we would like you to take part in our study. For this study we’d like you to come to [fill location]. For teens 13-17. In order for you to participate in the study, your parent/primary caregiver must be present at the time of the scheduled interview to give permission for you to participate. The interview will last approximately 90 minutes and you will receive $11.00 USD. An interviewer will ask you questions about your experience in school, health risk behaviors, safety and violence, experience accessing professional medical and social services, and relationships with friends, family and community members. Then the interviewer will ask you to explain what you were thinking and how you came up with your answers. Your answers will help us find out if the survey questions make sense, are easy to answer, and that everyone understands the questions the same way. Everything you say will be kept private.
Do you have any questions at this point? Pause to answer questions. If (not/you have no other questions), then let’s get you on the schedule, ok? We will be interviewing (Day, Month/Date) through (Day, Month/Date) from 8 a.m. to 6 p.m. Looking at your schedule, when would you be available to participate? Schedule. [If date/times not available go to exit script 3.]
A reminder call will be made to you a few days in advance. Should you have any questions or need to change your appointment, please feel free to contact me [name] at [phone number]. Thank you for responding to our ad, and I look forward to seeing you here at (DATE/TIME) Get respondent to cite date & time if possible.
---------------------------------------------------------
Exit script 1: I’m sorry, you have to be between the ages of 13 and 24 to take part in this study and therefore we won’t be able to use you at this time.
Exit script2: Based upon your answers, it seems that we may already have a number of volunteers with very similar answers to yours. At this point we need to talk with people with some different characteristics. However, if we have cancellations or other slots open up, I may wish to call you back. Would it be okay if I kept your name, telephone number, and the information you provided in response to the eligibility questions until the end of this study? If yes, make notation. If no, We will not keep any of the information you gave me.
Exit script 3: I see...ok, we were hoping to complete this particular study between (Month/Date) and (Month/Date), so it looks like we won’t be able to schedule you at this time.
Appendix 5 – Parental/Primary Caregiver Consent for Minors 13-17 years of age
Note to ERB reviewers: This parental/primary caregiver consent is the same consent form that was submitted as part of the VACS Philippines protocol and approved by the ERB on August 15, 2012 with the exception that Malawi specific information replaces the Philippines specific information and recording of the interview has been removed.
PURPOSE OF THE RESEARCH
Hello, my name is _____. I am from the US Centers for Disease Control and Prevention. We are working in partnership with the Malawi Center for Social Research. Your child has expressed interest in participating in a research study testing questions for a national survey that is going to be conducted in Malawi to learn about young peoples’ health and life experiences. The data collected through this national survey will help to develop programs aimed at improving the health and healthcare of children and young adults. The survey topics include such things as experience in school, health risk behaviors, safety and violence, experience accessing professional medical and social services, and relationships with friends, family and community members.
PROCEDURES
Your child’s interview will show us how to improve the questions for the national survey by ensuring that the questions make sense, are easy to answer and that everyone understands the questions the same way. If you allow your child to take part in this study we will ask your child to answer the survey questions and then we will ask your child to explain what he/she was thinking and how he/she came up with their answers.
All respondents may choose not to answer any question for any reason, if he/she does not want to answer a question he/she can say so and the interviewers will move on to the next one.
BENEFITS & RISKS
There is little or no risk to participating in this study. Again some questions in the survey ask about your child’s health and life experiences. Again, if the questions are upsetting or difficult to answer, we can stop the interview at any time or we can skip those questions.
We are only interviewing girls/boys and young women/men in your area who are between 13 and 24 years old. The interview will last approximately 90 minutes and each participant will receive MK3500/approximately $11.00USD.
Would you allow me to ask the (girl/young woman OR boy/young man) who is interested in participating as a study participant some questions about health, educational, and life experiences?
NOTE WHETHER THE PARENT/PRIMARY CAREGIVER AGREES TO ALLOW YOU TO SPEAK WITH THE RESPONDENT:
Does not agree to
allow you to speak to the respondent
agrees to
Allow you to speak with the RESPONDENT
NAME OF NCHS/QDRL STAFF OBTAINING VERBAL CONSENT:______________________________________
SIGNATURE OF NCHS/QDRL STAFF: _________________________________
DATE: ____/____/_______
Appendix 6 – Child Assent 13-17 years of age and Adult Consent 18-24 years of age
Note to ERB reviewers: This child assent/adult consent is the same assent/consent form that was submitted as part of the VACS Philippines protocol and approved by the ERB on August 15, 2012 with the exception that Malawi specific information replaces the Philippines specific information and recording of the interview has been removed.
PURPOSE OF THE RESEARCH
Hello, my name is _____. I am from the US Centers for Disease Control and Prevention. We are working in partnership with the Malawi Center for Social Research testing questions for a national survey that is going to be conducted in Malawi to learn about young peoples’ health and life experiences. The data collected through this national survey will help to develop programs aimed at improving the health and healthcare of children and young adults. The survey topics include such things as experience in school, health risk behaviors, safety and violence, experience accessing professional medical and social services, and relationships with friends, family and community members.
I understand you are between the ages of 13 and 24. Is that correct? INTERVIEWER, TICK THE APPROPRIATE RESPONSE
Y
es
No
If yes, fill age ________
Today we are testing these questions with other children/youth to see if they make sense, and to see how other children/youth understand the questions. The goal of this study is to improve the survey questions before they are asked on the actual survey. The information from the actual survey will be used to help make decisions about young people’s health and life experiences and help make health programs for young people in Malawi better.
PROCEDURES
If you agree to participate in this survey, I will ask you to answer the survey questions and then I will ask you to explain what you were thinking and how you came up with your answers. I will ask you questions about your family, school, and community relationships. In addition I will be asking about your sexual activity, HIV, and your experiences with physical, emotional and sexual violence. I know that these are sensitive and sometimes difficult things to talk about, but your answers will help us improve the questions on the upcoming national survey.
RISKS & BENEFITS
There is little or no risk to participating in this study. Again some questions in the survey ask about your health and life experiences. Several questions will be asked whether anyone has committed harm or violence against you. Answering questions like this can be difficult. Again, if the questions are upsetting or difficult to answer, we can stop the interview at any time or we can skip those questions.
You may benefit from being in the study by learning more about services available for those who have experienced violence. The interview will last approximately 90 minutes and each participant will receive MK3500/approximately $11.00USD.
QUESTIONS OR CONCERNS
There are people you can contact if you have any questions or concerns. If you have questions about participating in this study, you can ask me. If you have questions about your rights as a person in this study, you may talk to Alister C. Munthali at 0 888 822 004.
CONFIDENTIALITY
Your answers to the questions, what you say about the survey questions will be kept private. Only the people who work on this study will be able to look at my notes. Your name will not appear on any documents. No one will be able to look at the documents and know that it was about you. Any information you share with us is confidential and will not be shared with anyone.
For children 13-17 years of age - Your parent(s) have not been told about the questions we will be asking in the interview. If you would like, you may tell your parents about the questions. This is your decision.
If you are under 18 years of age, however, and it becomes apparent that you are in danger, I must disclose this information to the District Social Welfare Officer (DSWO) and to the Center for Social Research (CSR) so that you can receive the necessary help to make you safe.
Deciding to participate in this study is up to you. There will be no change in the health care that you get and there will be no effect on your family. Only the people who are conducting this study will know whether you are in the study. They will not tell anyone else your answers. You have the right not to be in this survey or to stop being in the survey at any time.
Are you willing to be in this study? (Tick the Appropriate Box)
YES NO
NAME OF NCHS/QDRL STAFF OBTAINING VERBAL CONSENT:______________________________________
SIGNATURE OF NCHS/QDRL STAFF: _________________________________
DATE: ____/____/_______
Appendix 7 – Referral Form for Support Services
There are services available if you want to talk to someone more about violence or any of the experiences we have talked about today. If you are feeling upset about the things we have talked about or you currently don’t feel safe, we can help put you in touch with someone who can provide support, legal advice and listening and social work services. Is this something you would like us to do?
We will need to note down your contact information, including your name and a safe place (e.g. at school, a pagoda, health center, a friend’s house etc.) where a social worker can find you. They will contact you within one week. However, we would not give them any of the information you have shared with us during the interview, unless you would like us to do so. There is no way for you to be connected with this interview. The research team will not keep your contact information.
CONTACT INFORMATION
Name: ______________________________________________
What is the best and safest way for a social worker to find or contact you? _________________________
____________________________________________________________________________________
Phone number: _______________________________
Best time of day to call: ____________________________
Location
Region: _____________________________
District: ___________________________
Village: ____________________________
Nearby Landmark (e.g. pagoda, school, health center): ___________________________________________
Information to be shared: _________________________________________________________________
_____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
TO BE COMPLETED BY THE INTERVIEWER
I CERTIFY THAT I HAVE READ THE ABOVE PROCEDURE FOR OFFERING TO PUT THE PARTICIPANT IN CONTACT WITH DIRECT COUNSELING SERVICES AND THE PARTICIPANT HAS GIVEN ME PERMISSION TO SHARE THE ABOVE CONTACT INFORMATION WITH A SERVICE PROVIDER.
INITIALS OF THE INTERVIEWER:________
Appendix 8 – List of Services with Contact Information
Growing up is a
challenging time! Sometimes young people and their family need extra
help. Below are some of the services that are available in Zomba
district that can help you and your family deal with the various
health and life experiences of young people. You are welcome to
contact any of these organizations for advice and assistance. If they
are unable to provide support directly, they can help you to identify
another organization that could help.
Zomba One Stop
Center
The One Stop Center at Zomba Hospital
provides medical, psychosocial and legal aid services for women and
children who have experienced physical, sexual and emotional abuse.
The Zomba One Stop Center is located in Zomba Central Hospital. If
you want more information about One Stop Center in Zomba and the
services they can provide you can visit Zomba One Stop
Center
Address: Along Zomba-Blantyre Road with Zomba
Central Hospital Campus.
Name and title: Mr Francis Futu (Social
Worker),
Telephone number: +265 88 838 9777
YONECO
ChildHelp Line
YONECO Child help line also provides
provide advice by phone or at their drop in centers on a range of
issues affecting children and youth. They can also support you to
make referrals to other services. You can always call YONECO Child
help line free of charge if you need help at the following telephone
number
Address: Along Zomba-Blantyre Main Road at
Skinala in Zomba
Telephone: Hughes T. Munthali (999027690),
Project Officer for Helpline
Child Helpline Freephone Number:
116
Police Victim Support Unit
Police
Victim Support Unit provides legal aid and psychosocial support for
women and children survivors of violence, abuse and exploitation and
for children suspected of committing crime. The Police Victim Support
Unit also provide referral services for women and children survivors
of violence, abuse and exploitation.
Name and title:
Mr N. Chibondo (Police Victim Support Unit Coordinator)
Address:
Opposite, University of Malawi Buildings in Zomba.
Telephone:
+265 88 833 7262
District Social Welfare
Office
District Social Welfare Office is
responsible for coordinating all child protections issues in the
districts. It implements also implemental central level plans related
to children, gender, community development and adult literacy.
Name
and title: Mr Kalelo (District Social Welfare Officer)
Address:
Zomba District Commissioner’s Office building, next to only
Traffic Lights in
Zomba.
Telephone: +265 99 993 1029
Page
| File Type | application/msword |
| File Title | New Protocol, Request for IRB Review |
| Author | zfk9 |
| Last Modified By | CDC User |
| File Modified | 2012-12-19 |
| File Created | 2012-12-19 |
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