Human Subjects Research

APPLICATION FOR APPROVAL OF HUMAN SUBJECTS RESEARCH

Please type; handwritten applications are not accepted.

This form must be completed by the Principal Investigator/Researcher for any research project that involves human participants. Submit the following items with your completed application:

• Informed consent form(s) or Exempt Research Cover Letter (please refer to instructions)

• All materials, including any survey questionnaires, or instruments, to be used;

• And copies of any fliers, advertisements, or announcements that will be used to solicit participants.

1. Principal Investigator: Suzanne M Randolph, Ph.D.

Investigator’s Affiliation with The MayaTech Corporation (Please check one):

Staff X Consultant____ Fellow____ Student ___ Outside Principal Investigator ___*

*If Outside Principal Investigator, please provide name of the organization and your affiliation with the organization under which this research will be conducted (e.g., XYZ, Inc., Evaluator; ABC, Inc., Executive Director): ________________________________________________________________

Principal Investigator Signature:____________________________________ Date: August 4, 2015

Title of Research:

Evaluation of the Office on Women’s Health Coalition for a Healthier Community Initiative

Period of Research (start and end dates) Start: August 15, 2015 End: September 30, 2017

NOTE: NO CONTACT WITH HUMAN PARTICIPANTS MAY OCCUR UNTIL THIS APPLICATION HAS BEEN APPROVED BY THE MAYATECH IRB. YOU WILL RECEIVE A NOTICE OF APPROVAL FROM THE IRB WHEN THIS OCCURS.

E-mail address to which approval should be sent: [email protected]

Applicant’s Day Time Phone: (301) 587-1600

Applicant’s E-mail Address: [email protected]

Co-Investigator(s) and email: Shelly Kowalczyk [email protected]

2. If you are a student, please provide the following:

Faculty Sponsor’s Name: Not applicable Faculty sponsor’s Phone: ______________

Faculty Sponsor’s email address: ____________________________________________

Purpose (i.e., classroom requirement, Master’s thesis): _________________________________

SUBMIT FACULTY SPONSOR RESEARCH AGREEMENT FORM WITH YOUR APPLICATION.

3. Has this research project been previously considered by the IRB?

No X Yes ___ Last approval date: _____________________

Original PI’s name: ____________________________________________________________

(If this is a renewal application and there are no substantive changes in the project complete only
through # 5.)

Original IRB Name and Federalwide Assurance No:

4. If the research is funded or conducted under contract to an agency/organization, indicate the source (for subcontracts or subawards to grants, include the parent grant or contract information as well as subcontract or subaward information, if known):

External Agency Name: U.S. Department of Health and Human Services, Office on Women’s Health

Is this funded through a___: Contract X Subcontract_____ Grant___

If yes: Contract/Subcontract/Grant Number: HHSP23320095645WC_HHSP23337006T_0002

5. Check if the following is true: (Be sure that you check all appropriate responses)

Does the research include (check all that apply):

___ minors (17 years or younger)

___ prisoners

___ pregnant women

X use of audio, video, digital recordings, or participant photos to collect subject data

___ use of protected health information

___ information that could affect the participant's employability, financial standing or reputation

___ information which deals with sensitive aspects of the participant's own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol.

___ information which would place the participant at risk of criminal or civil liability if it became

known outside the research

___ the use of educational tests (cognitive, diagnostic, aptitude, or achievement)

X survey or interview instrument

X the participants being fully informed of the research project

X voluntary participation by all participants

interviewing or surveying only elected or appointed public officials or candidates for public office

___observation of public behavior

X the collection or study of existing data, documents, records or specimens

___ procedures in which the anonymity** of the participant will be insured

**"Anonymous" refers to a study designed so as not to allow the investigator or anyone else to determine the identity of individual participants from the collected data. If codes are used, these should not be known to anyone including the PI or research staff. "Confidential" refers to a study designed so that, even if participants are identifiable to the investigator, their identity will not be revealed to anyone else.

6. Designate the category you believe describes your research:

(Applicant: Refer to MayaTech’s IRB Instructions for a detailed description of research classifications/categories)

___Exempt (If yes, indicate category # ___)

___Expedited review (If yes, indicate category# ___)

X Full Review

7. What is the objective of the study? (Be clear and concise. Do not use jargon.)

This is a multi-year evaluation of a national, federally-funded initiative, the Office on Women’s Health (OWH) Coalition for a Healthier Community (CHC) Initiative, which funded 10 grantees to implement gender-based, public health systems approaches to improve women and girls’ health in their communities over a five-year period. Process and outcome evaluation activities are included. The grantees were funded for five years during the period September 30, 2011 – September 29, 2016. The grantees are now in their fourth year of funding. The MayaTech Corporation was awarded a contract from OWH to conduct the national evaluation of the CHC initiative for the period September 27, 2012 (one year after the local grants) through September 26, 2017. Each grantee has received local IRB approval for their local evaluation activities that were funded as part of their grant. These activities include collecting data on the effects of their interventions as well as information for quarterly progress reports and end-of-year reports submitted to the OWH on their implementation activities and participant outcomes. These data are de-identified and reported in aggregate by each grantee directly to the OWH. To plan the national evaluation, MayaTech relied on these reports to determine the feasibility of proposed evaluation activities. MayaTech proposes use of these reports through document review and data abstraction for use in the national process evaluation. To address specific evaluation questions posed by OWH, MayaTech utilized community-based participatory research principles to engage OWH staff, consultants, and the grantees’ representatives in discussions about the logic model and candidate measures, indicators, and core instruments to collect data for the national evaluation (that do not reside in the local evaluation reports).

MayaTech will conduct the outcome evaluation at the systems- and community-levels (using each community as its own case and comparison over time) through a series of case studies one for each grantee). The case studies will utilize document review of the grantees’ reports to OWH over their fiver-year grant period as well as original data collection in the last year of their grants using telephone interviews and online surveys of key informants in each community. Data will be collected retrospectively on activities during grantees’ first four years of implementation and prospectively for their final year of the grants. A final wave of data will be collected from project directors at the close of their grants to collect information on additional progress, outcomes, and sustainability.

This IRB package is supplemented with a separate application to the federal government by the U.S. Department of Health and Human Services (HHS), Office on Women’s Health (the project’s funder) to the U.S. Office of Management and Budget (OMB) for its approval of the evaluation project. The OMB process is accomplished in collaboration with the OWH and will include the results of this IRB approval process.

8. What is the research design and what will be required of each participant? (Attach extra pages, if needed)

Design. This evaluation is a longitudinal, retrospective and prospective investigation of the CHC grantee communities. Data for the process evaluation and selected outcomes will be collected from review and summary analyses of secondary sources (quarterly and annual reports) provided by the grantees to OWH; and data for the outcome evaluation will be collected at three time points from grantee sites to assess participant-, coalition-, and system-level changes as well as sustainability planning. The process evaluation is being accomplished through review of grantees’ site visit reports, quarterly progress reports, and end-of-year reports that include information on implementation of gender-based and public health approaches, coalition functioning, sustainability planning, OWH performance measures, grantees’ local evaluation reports, and reports on cost-effectiveness analyses. The first time point for collection of primary data will occur in the beginning of year five (the last year) of the grantees’ funding; the second in the third quarter of year five of their grants; and the third (for collection of information on sustainability plans) at the end of year five. Each grantee will serve as its own comparison site over time by collecting retrospective data during time point one on periods prior to the currently funded CHC initiative (a period one year prior to their planning phase as well as the early years of implementation). To facilitate data collection on the years prior to implementation of the national evaluation (because grantees are now in year 4), we will use the first data collection to capture retrospective data (perspectives on the period prior to the planning phase and through the first four grantee project periods between September 2010 and September 2015). We will collect a third wave of data, at the end of year five (near the close of the grants) to collect data on additional progress, outcomes, and sustainability.

Participant requirements (description of sample and measures). There will be two sets of participants (“Key Persons” and “Coalition Participants and Community Members”) for the primary data collections. Key Persons will include individuals (described later) from each grantee site, based on their roles on the grant and/or nominations by the grantees’ project director and/or coalition chair(s). A subset of these individuals will participate in telephone interviews using a discussion guide (attached) and complete online surveys for coalition members and community leaders (attached). Coalition Participants and Community Members (up to 50 participants per grantee) will be identified by each grantee to complete an online survey for coalition participants and other community members. These telephone interviews and online surveys will provide data to supplement and triangulate against the secondary data in the grantee’s quarterly progress reports and end-of-year reports. The PDs provide Quarterly Progress Reports and (in collaboration with the local evaluator) annual end-of-year reports. As part of their local evaluations, grantees collect coalition members’ responses to a coalition functioning measure and the project director (PD) aggregates members’ responses to generate a site mean submitted in their end-of-year reports. The PD and local evaluator also complete tools annually as part of the end-of-year report on program sustainability planning and cost effectiveness analyses.

Core instruments for primary data collection and the reports used for secondary data collection are described below:

1. Discussion Guide for Grantee Key Persons’ Interviews: includes items to collect data using telephone interviews from key staff and community members familiar with the coalition on gender-based and public health systems approaches prior to the initiative and currently (i.e., at time of interview); and changes in barriers to and facilitators of improving women and girls’ health (Core Instrument for key persons’ coalition-level input)

2. Coalition Members and Community Leaders Survey: includes items to collect data via online self-administration from coalition members and community leaders on perceptions of the gender-based and public health systems approaches, changes in gender norms in the community, coalition effectiveness, and coalition impact on the community’s health (note: these individuals include members who represent their organizations or a constituency group on the local coalition; PDs and project staff also serve as coalition members for some grantee sites)(Core Instrument for members of the coalition and selected community leaders to provide coalition- and community-level input)

3. Coalition Participants and Other Community Members Survey: includes items to collect data via grantees’ distribution of online self-administered surveys to participants (individuals directly exposed to their coalition’s interventions); and other community members (indirectly exposed to their other coalition activities)on perceptions of the gender-based and public health systems approaches, changes in gender norms in the community, and impact of coalition’s programs on their own and the community’s health (note: coalition “participants” and community “members” here are different than those in #2, who are members that serve as their organization’s or constituent group’s representative on the coalition)(Core Instrument for participant- and community-level input)

4. Wilder Collaboration Factors Inventory: standard instrument in the literature adapted for the CHC and used by grantees to collect data from coalition members on perceptions of their coalition structure, membership, leadership, political climate, communications, and effectiveness (secondary analysis of coalition functioning and effectiveness)

5. Grantee Status Report on Cost-Effectiveness Analysis: used collaboratively by project directors with their local evaluator or health economist to summarize the cost elements and outcomes of their cost-effectiveness analyses (secondary analysis of cost-effectiveness)

6. Grantee Annual Report on Program Sustainability: standard instrument in the literature, the Program Sustainability Assessment Tool, used independently by the project directors and local evaluators to report on plans for sustaining their coalition in part or its entirety (secondary analysis of sustainability planning)

7. Grantee Quarterly Progress Report: grantees’ quarterly reports to OWH used by the national evaluator to abstract secondary data on progress on their gender-based analysis (GBA), their process evaluation, and program implementation—e.g., number and types of activity, numbers reached/served, frequency of coalition meetings, outreach and social media activity, professional presentations and publications, and coalition involvement in or initiation of policy changes or other systems changes (secondary analysis for process evaluation)

8. Grantee End-of-Year Report: grantees’ annual reports to OWH used by the national evaluator to abstract secondary data on the local outcome evaluations--from evaluation reports on the intervention effectiveness, cost-effectiveness analyses, outcomes from grantees’ gender-based analyses, progress on Healthy People 2020 objectives, and Government Performance and Results Act (GPRA) measures (secondary analysis for performance measurement and outcome evaluation).

Following the description of the requirements for each type of evaluation participant, Table 1 summarizes the plans for each measure and the overall evaluation.

Key Persons

The grantee will select this set of participants in collaboration with the national evaluation team at MayaTech and OWH. Upon IRB approval, MayaTech will begin the recruitment process while awaiting the federal government’s OMB determination and approval. Candidate “Key Persons” participants include:

1) the Project Director (PD) for the OWH-funded grant,

2) the Project Coordinator (PC) for the grant,

3) the Local Evaluator for the grant,

4) the Coalition Chair,

5) Coalition Co-Chair, if applicable and not one of the previous,

6) the two grant-required grassroots organizations’ representatives (who is not the chair or co-chair of the coalition),

7) other Coalition members (not serving as chair/co-chair),

8) representatives from other (non-Coalition)organizations that provide access to individuals to participate in the grantees’ programs or cooperates in other ways with the coalition, and

9) representatives of the health department (local/county or state, depending on the coalition’s reach) or other relevant health partnership in the community.

If one individual fulfills more than one of these roles, then an additional member of the coalition or a related partnering organization will be nominated and selected to increase the number of participants for that coalition.

This set of evaluation participants will participate in individual telephone interviews conducted by MayaTech staff (using Form #1--Discussion Guide for Key Persons Interviews) and individually complete the online survey (Form #2--the Coalition Members and Other Community Leaders Survey). Both the interview discussion guide and online survey will include items about participants’ perceptions of the gender-based and public health systems approaches as well as their perceived changes in community-level gender norms and gender health disparities related to the coalition’s work.

All “Key Persons” will participate in a 1- to 2-hour telephone interviews conducted by MayaTech staff during wave 1 (mid-year 5) and wave 2 (near the end of year 5). The length of time of the interview will depend on the participant’s role (2 hours for the PD, PC, and Evaluator; and 60 minutes for the other participants). An interviewer and note taker will conduct each interview. We will ask participants for permission to audio-record the interviews and produce a written transcript that will serve as the raw data. We will censor any sensitive information and inform the interviewee that we can “go off-the-record” for any sensitive comments. MayaTech will implement Wave 1 upon IRB and approval (if required) of the federal government’s IRB unit, the Office of Management and Budget [OMB]). In Wave 1, MayaTech staff will interview all “Key Persons” about their perspectives on women and girls’ health issues for the years prior to their OWH CHC funding for planning, the OWH CHC planning period, and OWH CHC project implementation through September 30, 2015.

In Wave 2, MayaTech will interview all “Key Persons” about their perspectives on changes during year 5 period and the overall project through the third quarter of year 5(through June 30, 2016). These interviews are expected to capture any perceived changes that are contributing/will contribute to improvements in women and girls’ health. In Wave 3 (at the end of year 5, prior to closeout), MayaTech will conduct interviews only with each site’s PD (or designated grantee representative) to include perspectives on sustainability planning status to determine whether processes, other aspects of the coalition, the interventions, other components, and outcomes of the grant are likely to be sustained beyond the funding period.

MayaTech will administer the Key Persons online surveys at the start of year five (pending IRB approval and any required OMB approval) at approximately the same time as the initial interviews are being conducted; and, again, in the third quarter of year five at the same time as wave 2 interview data are being collected.

Coalition Participants and Community Members

This set of participants will include up to 50 individuals in each site identified by the coalition as familiar with the coalition’s work, including past participants in their programs, staff and volunteers in coalition activities or at partnering organizations, and other community members who might have accessed coalition activities or information. This set of participants will complete only the anonymous, online surveys (Form #3--Coalition Participants and Other Community Members Survey) about their perspectives on the coalition’s work and community-level changes that are perceived to improve their own health, women and girls’ health, or the overall community’s health. These participants will complete the online survey only once, at approximately mid-year in year 5 (to allow the grantees time to identify participants and distribute the survey) via SurveyMonkey®.

A summary of the above discussion about the design appears in Table 1. All core instruments for primary data collection (forms #1-3) and secondary sources that are key sections of the quarterly and end-of-year reports (forms #s 4-6) are attached.

Table 1. Design Summary: Participant/Data Source, Measure, Method, Time to Administer, and Data Collection Points and Scope

Participant/Data Source	Measure (Form #), Method and Time to Administer	Data Collection Points and Scope
		Wave 1 Start of Yr 5* (April, 2016)	Wave 2 End of Qtr 3 Year 5 (July-August, 2016)	Wave 3 PDs only (at end of year 5) (August, 2016)
PRIMARY DATA COLLECTION from HUMAN PARTICIPANTS
“Key Persons” (PD, PC, Local Evaluator, Coalition Chair(s) and coalition members and community leaders connected to the coalition)	1--Discussion Guide for Grantee Site Interviews Telephone Interview (PD and PC--120 minutes; Others—60 minutes)	x Interviews about gender norms, gender-based approaches and public health systems approaches in community prior to planning, during the planning phase, and changes since implementation through yr4	x Interviews about same issues for changes during period from end of yr 4 through near-end of yr 5	x (PDs/grantee reps. only) Interviews about sustainability
“Key Persons” (PD, PC, Evaluator, coalition members and community leaders connected to coalition)	2--Coalition Members and Community Leaders Online Survey (20 minutes)	x Perceptions of approaches, changes in gender norms, coalition status, and coalition effects through yr4	x Perceived changes in yr 5
“Community Members” (up to 50 participants in coalition programs and other community members in each grantee community)	3--Coalition Participants and Other Community Members Online Survey (15 minutes)	x Perceived changes in gender norms and coalition effects through yr4	x Perceived changes in yr5
SECONDARY DATA ABSTRACTED from GRANTEES’ OWH REPORTS
PD Coalition Members	4--Wilder Collaboration Factors Inventory Self-administered hard-copy or Web-based distributed by each site PD: Aggregated (mean) rating of coalition members’ ratings (15 minutes) Members: 5 minutes each (5 minutes for each member; 15 minutes for PD’s mean rating)	x Coalition structure, functioning and effectiveness rated by members, aggregated by PD for national evaluator summary analyses	X National evaluator summary of changes over time
PD and Local Evaluator (joint completion)	5--Grantee Status Report on Cost- Effectiveness Analysis (joint completion and PD sends to OWH; 20 minutes)	x Document review by national evaluator to summarize selected cost elements and effectiveness indicators	x Updated review	x (Synthesis or meta-analysis of QALYs or other indicators)
PD Local Evaluator (separate completion)	6--Annual Report on Program Sustainability (adapted from “Program Sustainability Assessment Tool”) (10 minutes)	x Planning for or evidence of sustainability—national evaluator review and summary	x Updated plans for or evidence of sustainability
Grantee Progress Reports (PD)	7--Grantees’ Quarterly Progress Reports (PD sends to OWH; OWH sends to national evaluator)	x Document review by national evaluator for implementation years 2-4 for selected process and performance measures to date	x Ongoing review, changes updated for year 5	x Updated review by national evaluator
Grantee End-of-Year Report (PD and Local Evaluator)	8--Grantees’ End-of-Year Reports (inc. HP2020 Reports, GPRA Data, Evaluation Report, and GBA results) (Grantee sends to OWH; OWH sends to national evaluator)	x Document review by national evaluator for selected outcome measures (inc. HP2020 and GBA progress) to date	x Grantees submit to OWH by December 31, 2016	x Document review updated by national evaluator for selected outcome measures

9. How will the participants be selected? If you intend to recruit volunteers, please attach all advertisements and flyers. (Be specific. If students, will they be solicited from classes?)

Key Persons. As described above, the “Key Persons” will include individuals from each grantee site, based on their roles on the grant and/or nominations by the grantees’ project director and/or coalition chair(s). Key Persons will be selected from a list generated by the grantee in collaboration with the national evaluation team. Upon IRB approval, we will work with the grantee’s PD or PC to collect nominees’ contact information (email address and telephone number). We will ask the PD/PC to send a “heads up” email regarding our contacting them. MayaTech will send an email to each nominated individual explaining the purposes of the evaluation, the nature (general topics and length) of the telephone interview, and request their preference for dates/times within a two-week timeframe when they might be available for the call. We will follow up with a phone call after two email attempts. After a third attempt, we will use the list of substitute nominees for the particular role category. We will use a Web-based scheduler such as Doodle® to coordinate interview times.

MayaTech will employ both a written and an “Oral Consent Procedure” for Key Person Interviews. For the written consent, we will email the informed consent form for key persons’ interviews (attached) to the participant, ask them to sign it and either fax it to us or scan the signed form and email it to us. We will then witness the form, scan it, and send it back to the participant, prior to the call. For oral consent, as a preamble to the interview (so, just prior to initiating the discussion topics), we will read a paragraph that reviews the information on the written consent form and ask the participant for permission to proceed, including for those who provided permission in writing, verbal confirmation of permission to audio-record the interview. If either the written consent or oral consent procedure indicates that the participant declines audio-recording, we will not record the interview.

Coalition Participants and Community Members. Each coalition will identify its own set of Coalition Participants and Community Members (up to 50 in each site), described above as drawn from those familiar with the coalition’s work, including past participants in their programs, staff and volunteers in coalition activities or at partnering organizations, and other community members (personal access to the Internet is not necessary, because each site will provide access in a location convenient to its participants). The PD/PC will select up to 50 community members from their intervention and outreach lists. In sites, where participants might be resource limited with respect to Internet access, we will work with the site to ensure that a convenient location is provided (such as the program site or a library)to complete survey. Surveys will be submitted confidentially to the survey vendor site from which the national evaluator can download an Excel file for input into SPSS, the analytic software package. No email addresses will be included in the Excel or SPSS files.

There are no specific inclusion or exclusion criteria other than that participants are 18 years of age or older and have been identified by their sites as familiar with the coalition’s work. Therefore, participants will not be selected on the basis of race, gender, ethnicity, sexual orientation or other defining background descriptors. All surveys will be administered in English with a literacy/readability-tested level of eighth grade. These participants will only complete the online survey and only once. Participants will not be compensated for their participation. The informed consent for the online survey is embedded into the survey as a preamble and includes the required information for consent such as the title of the project, purpose, voluntary nature of participation, participant’s right to refuse to answer any item without penalty, minimal risks, benefit to the community, no compensation/payment, a confidentiality clause indicating confidentiality will be maintained to the extent permitted/required by law, the contact person’s name and information for questions, and a place to indicate whether they understand their rights and want to proceed or not.

10. What are the risks to the human participants (physiological, psychological)?** What are the benefits? **A participant is considered to be at risk if the possibility of physical, psychological, sociological, or other types of harm may be the consequence of an activity which goes beyond the application of established and accepted methods necessary to meet the needs of the participant, or which increases the ordinary risks of daily life, including the recognized risks inherent in a chosen occupation or field of service.

This evaluation has minimal risks to participants. For example, Key Persons or Community Members might experience some discomfort in responding to questions about how their community responded/responds to the health needs of women and girls if circumstances are perceived as poor or dire. However, no items are included about their own personal physical or mental health or that of anyone else. No sensitive questions are asked other than race/ethnicity.

Participants will not receive any direct benefits for participation in interviews or surveys, but they will be informed that their grantee agency (coalition) will receive a summary of the findings from OWH that can be used to improve the coalition’s work in their community. The coalition’s work is expected to eliminate gender disparities in health and improve women and girls’ health in their community.

11. How will confidentiality of the participants be maintained? (Is the study anonymous? Who will know the identity of the participants? If pre- and post-test, how will participants be identified?)

Key Persons. The names and affiliations of the participants will be known to the researchers in that this set of participants has specific working relationships and ties to the coalitions that are being evaluated. However, confidentiality will be maintained by assigning each participant a unique identifier so that their names are not used in labeling digital recordings or in datasets, analyses, or reports. The unique identifiers will be used to track participants’ interview responses over the two or three sets of data collection (at midyear 5, year 5-Qtr3, and (for PDs only) at Year 5-end. For online surveys, each site will be assigned a unique link and key persons will be asked to identify their category of participation. A numeric code (1 through 10) will be assigned to identify respondents’ grantee site once the Excel data from the survey vendor have been uploaded to SPSS. No names or other identifying information will be requested. Reports will only refer to categories of respondents (e.g., “PD’s indicated….”). In some instances, the individuals in these roles might change over time, and in these cases, we will assign a unique identifier to the new individual in that role. There is no expectation or requirement that an individual complete both wave 1 and wave 2 data or (in the case of PDs) waves 1-3.

Coalition Participants and Community Members. The PD/PC at each site will know the names and email addresses of their set of participants, but will not share them with others at their site, the national evaluation team, or OWH. Each site has its own IRB-approved procedures for the local evaluation and the handling of participants’ consent and data management, analysis and reporting. The sites will use the email addresses to send the online survey link that is specific to their site directly to the participants in their site. Although the completed surveys will be submitted to the online vendor’s secure database and subsequently accessed by MayaTech, the sites will not have access to the vendor dataset linking email addresses to responses; and the SPSS dataset generated by MayaTech will not contain any email addresses so that survey data at this point will be anonymous. Participants will not be asked to include their name, initials, dates of birth, or any other identifying information on these surveys. The survey datasets will be merged into one files and the results will be reported in aggregate (but can be disaggregated by site using the site’s numeric codes). MayaTech will use independent sample comparison tests to compare across sites. The surveys will only be identified by a site number (via a column added to the Excel database received from the survey vendor) and a sequential case number which is automatically generated by the online survey vendor.

12. Is there any information with regard to protocol or intention that will not be disclosed to the participant on the informed consent form? If so, what is it, and why will it not be disclosed?

No. All information will be disclosed on the informed consent form, the informed consent information on the online surveys, and in the oral consent procedures.

13. What debriefing information will be given to the participants following their participation? If any information was withheld from the participants, it must be disclosed at the debriefing.

Key Person Interviews. At the conclusion of the telephone interviews, the MayaTech staff interviewer will inform the participant of the schedule for completion of the data collection across all sites and plans for sharing the findings in an executive summary with each grantee. No information will be withheld from participants.

Online Surveys for Key Persons and Community Members. At the end of each survey form, there will be an explanation of the plans for sharing the summary of the results with each community through their project director or project coordinator. Each site will be encouraged to disseminate the findings through culturally and linguistically appropriate formats consistent with their IRB guidelines, participants’ literacy levels and languages, and the site’s community norms.

14. Specify the participant characteristics required (age, gender, etc.) and the number of participants. (Be specific).

All participants must be at least 18 years of age. There are no upper age limits. Individuals of all racial/ethnic, linguistic, socioeconomic, gender identity, religious, ability, and other backgrounds are eligible for participation. Other than meeting the age criterion and the criterion to fit one of the categories described in item #8 (“participant requirements”), there are no other inclusion or exclusion criteria.

15. How will the data be recorded and stored? (Be specific). PLEASE NOTE: All original data must be kept for a minimum of three years. Data of student researchers must be kept in a secure place in the designated faculty sponsor’s office.

Interviews. MayaTech will maintain all raw data (the digital audio recordings and written notes/transcripts) in a password-protected computer folder on the secure Local Area Network (LAN) at its headquarters in Silver Spring, MD. Each MayaTech staff member has their own username and password to access the LAN via a virtually protected network (VPN). Only the PI/PD, deputy project director (DPD), and authorized staff will have access to the area on the LAN and the data folder’s password, which will be changed every 90 days. The coded data from the interviews will be maintained in password-protected computer files on the personal computers of the PI/PD and DPD (which require a username and password for access) and the password-protected LAN described earlier. MayaTech will transfer the electronic files to password-protected portable media (e.g., CD-ROMs) or vis an encrypted portal such as a “sharepoint” for transmittal to OWH upon completion of the project. MayaTech will maintain any printed data such as transcripts in locked file cabinets of the PD or DPD and maintain the password-protected electronic files on the LAN until three years after the project. Electronic copies of the transcripts will be password-protected for transmission to OWH.

Surveys. MayaTech will maintain online survey data files (retrieved from the secure online vendor site) in password-protected computer files (Excel and SPSS) on MayaTech’s LAN immediately upon retrieval from the online vendor; and keep these files for three years beyond the end of the project. Each grantee site will adhere to their specific IRB plans for securing and storing their survey data. No names, e-mail addresses, or other identifying information will be linked to the stored data.

ATTACHMENT A

CORE INSTRUMENTS

(#1-3 from Primary Data Collection; and #4-6 from secondary sources)

1--Discussion Guide for Grantee Site Interviews*

2--Coalition Members and Community Leaders

3--Coalition Participants and Other Community Members Survey

4--Wilder Collaboration Factors Inventory

5--Grantee Status Report on Cost - Effectiveness Analysis

6—Grantee Annual Report on Program Sustainability

*Note: The informed consent form for Form #1 appears in Attachment B.

1--DISCUSSION GUIDE FOR KEY PERSONS’ INTERVIEWS

Office on Women’s Health (OWH)

Coalition for a Healthier Community (CHC)

Telephone Interview Guide for

[GRANTEE/SITE NAME]

Part I. Gender-based Approaches Retrospectively and Currently (for all interviewees)

Part II. Perspectives on the Coalition and Systems-level Changes (Non-grantee staff, coalition members who are not staff or co-chairs, and community leaders)

Part III. Perspectives on the Coalition- and Systems-level Changes (Project Directors, Project Coordinators, Evaluators)

Interview Information Sheet

Date: (Month/Day/Year): ______/______/______

Time Started: ___________Time Completed: ___________Total Time Elapsed: ___________

Community: __________________________________________________________________

Respondent: __________________________________________________________________

Organization: _________________________________________________________________

Position on OWH CHC Grant: ____________________________________________________

Position on OWH CHC Coalition: __________________________________________________

Sector Interviewee Represents on the Coalition or in Relation to the Coalition (see Sector Checklist):

____________________________________________________________________________

Years in Current Position: _______________________________________________________

Years Active in Women’s Health: __________________________________________________

Years in Community: ___________________________________________________________

Interviewer: __________________________________________________________________

Recorder: _____________________________________________________________________

Observer: _____________________________________________________________________

Additional Participant/Role: ___________________________________________________________

Additional Participant/Role: ___________________________________________________________

Additional Participant/Role: ___________________________________________________________

OFFICE ON WOMEN’S HEALTH (OWH)

COALITION FOR A HEALTHIER COMMUNITY (CHC) INITIATIVE

KEY PERSONS’ INTERVIEW GUIDE

Grantee/Site: _________________

INTERVIEWER: The MayaTech Corporation has a contract with the Office on Women’s Health (OWH) to conduct an evaluation of the Coalition for a Healthier Community (CHC) Initiative. The interview we are about to conduct consists of questions about the initiative in your community prior to the grant and over time. We are particularly interested in the activities for women and girls, but also for men and boys in [Grantee site].

ORAL CONSENT
Prior to this call, we received your signed, written consent form. You should have received the form back with our witness’ signature. Is that correct?

__YES

__NO (agree to send a copy to the participant)

Review the consents: Again, your participation is voluntary, you may withdraw or discontinue participation or refuse to answer any item without loss of any benefits to which you are otherwise entitled, and we will protect the confidentiality of your responses to the extent permitted or required by law. There are minimal risks for participation in that you might find some topics make you uncomfortable; and, if so, we can discontinue that part of the discussion. We will not ask you anything about your own or anyone else’s personal health. We expect that, although you might not benefit personally from the evaluation, that your responses will shed light on important topics that will help the coalition to improve the health in your community, particularly for women and girls.

Do you have any questions about your participation that we can answer at this point?

___NO

___YES: Briefly note nature of questions and responses.

Do you provide permission to have your interview audio-recorded?

___NO (do not audio-record)

___YES (proceed with audio-recording)

Let’s begin.

PREAMBLE: In some instances, we’re going to ask you about some of your “gender-based” programming. Are you familiar with what we mean by a gender-based program?

PROBE: If Yes, probe for their understanding, record, then provide OWH definition.

If No, provide brief scripted explanation provided (OWH definition).

By a “gender-based” program, OWH means:

“A program which is designed that addresses the roles, behaviors, activities, and biological/psychological attributes that society assigns as ‘appropriate’ for men and/or women which impact treatment, access, and overall health.” (OWH, 10/30/2014)

PART I. ALL INTERVIEEWS

PAST and CURRENT STATE OF GENDER-BASED PROGRAMMING

First let’s talk about the past state of gender-based programming in [your site] prior to 2011.

1. What were the big health issues for women and girls in [grantee site]?

[PROBE:] What groups were most affected by [health issue] in this community?

How were these groups affected?

2. Since that time what has been done to address the needs of these groups you mentioned?

[PROBE:] Are there any groups of women and girls for whom health issues are not being addressed?

[ELICIT INFORMATION REGARDING THE GROUPS MENTIONED IN RESPONSE TO QUESTION 1.]

3. How would you describe the availability of gender-based services in [the grantee site] for women and girls?

4. What significant changes were there this year in comparison to previous years in the availability of gender-based services and programs [in grantee site]?

[PROBE:] What would you say are the reasons for this?

[ASK EVEN IF NO CHANGE IS MENTIONED.]

COMMUNITY AWARENESS OF AND OPENNESS TO

Gender-based Health Programming

Let’s talk about the awareness of and openness to gender-based activities and services in [Grantee site]. As a reminder, please focus your responses on women and girls as well as men and boys.

5. How would you describe your community’s general knowledge and understanding of gender-based health programming prior to 2011? How about in the past few years?

[PROBE:] Please provide specific examples.

[PROBE:] What about the community’s knowledge of the difference between sex and gender? Would they have been generally aware of this difference?

6. What significant changes were there this year in comparison to previous years in your community’s general knowledge and understanding of gender-based health programming?

[PROBE:] What would you say are the reasons for this?

[ASK EVEN IF NO CHANGE IS MENTIONED—e.g., why no change.]

[PROBE:] What about the community’s general knowledge about the difference between sex and gender? Would you say this has change? What are the reasons for this?

Collaboration

Now let’s talk about collaboration. Collaboration refers to working together to develop and implement gender-based services and programs.

[IF NEEDED, REMIND RESPONDENT OF THE OWH DEFINITION OF GENDER-BASED PROGRAMS]

7. In general, in what ways are organizations working with each other to conduct gender-based activities and services?

8. What significant changes were there in recent years in comparison to previous years in terms of how organizations worked with each other to provide gender-based activities and services?

[PROBE:] What would you say are the reasons for this?

[ASK EVEN IF NO CHANGE IS MENTIONED.]

Coordination

Now let’s talk about coordination. Coordination refers to working together to avoid duplication and scheduling conflicts in providing gender-based services and activities.

[IF NECESSARY, REPEAT DEFINITION.]

9. In general, how do organizations plan with each other to avoid duplication of gender-based activities and services?

10. What significant changes were there this year in comparison to previous years in terms of how organizations plan with each other to avoid duplication?

[PROBE:] What would you say are the reasons for this?

[ASK EVEN IF NO CHANGE IS MENTIONED.]

PART II. Perspectives on the COALITION’S GENDER-BASED PROGRAMMING (grantee staff who are not project director or coordinator; other coalition members; and community leaders not on coalition)

(SKIP TO PART III FOR PROJECT DIRECTORS, PROJECT COORDINATORS, and EVALUATORS)

11. [Skip to PART III for project directors, project coordinators, and evaluators]: What do you know about the coalition in your community funded by the OWH Coalition for a Healthier Community Initiative?

[IF RESPONDENT SAYS THAT THEY ARE NOT FAMILIAR, ASK About this for the specific [Coalition’s Name or Grantee Organization’s Name].

[IF RESPONDENT IS NOT FAMILIAR WITH THE COALITION, SKIP TO QUESTION 30.]

12. In what ways has the [OWH CHC-funded coalition] impacted the availability of gender-based services in grantee site?

13. a) Are you familiar with the gender-based intervention, curriculum and/or training program entitled, [intervention title]? This curriculum may have been introduced by the [grantee name] [IF NOT AWARE: SKIP TO QUESTION 14.]

b) What has been the impact of the curriculum on women and girls’ health issues in [the Grantee site]?

c) What has been the impact of the curriculum on health issues in general in [the Grantee site]?

Capacity-building Assistance and Training

The next set of questions is about capacity-building assistance or training provided by OWH or [grantee name] on gender-based analysis and gender-based programs.

PHRASE, AS APPROPRIATE, FOR RESPONDENT’s ROLE:

14. a) Did your organization receive any training or capacity-building assistance from [OWH or the grantee] between 2011-2015 related to gender-based health programming?

[IF NO, SKIP TO QUESTION 19.]

b) What types?

Probe: Did you/your organization receive training on:

1. Gender analysis?

2. Gender-based Analysis (GBA)?

3. The integration of the gender-based analysis into coalition planning?

4. How frequently over the course of the grant were these trainings held?

15. a) In what ways did your organization’s capacity to address gender-based health issues improve as a result of the training received?

[IF NO IMPROVEMENT, SKIP TO QUESTION 16.]

b) How has your organization been able to maintain these improvements?

Perspectives on Coalition’s Impact

16. What has been the impact of [the coalition] on your organization?

[PROBE:] Please provide specific examples. Have you shared the training (either formally or informally) that you received from the coalition with your organization?

17. What differences has the OWH CHC funds had on [Grantee site/community]‘s overall capacity to address gender-based health issues?

[PROBE:] How has the initiative enabled [Grantee site] to address women and girls’ health needs? Needs of men and boys?

1. Programming

2. Community

3. Leadership

4. Policy changes

Probe: How have gender-based policies and regulations changed to address the health needs of women and girls in [site name]?

18. Is there any assistance that is needed by your organization to develop or implement gender-based programming, policies, or services?

Multi-sectoral Nature of the Coalition

19. [INTERVIEWER: Ask the following question, then use the checklist of sectors to indicate the sector(s) into which the respondent best fits. (Check all that apply).

    1. For which sector are you or your organization a representative in this community?

Checklist of Sectors:

__Public health departments

__Schools/Academia

__Other governmental agencies (e.g., human and social services, housing, economic development, public safety, transportation) or elected officials

__Grassroots organizations

__Organizations that serve underrepresented racial/ethnic groups or English as a Second Language participants

__Healthcare settings

__Wellness (sports club, spa, trainer, prevention specialists

__Affiliate of national health organization

__Communications and marketing

__Foundations and philanthropic organizations

__Insurance carrier/health plan

__Citizen/resident, no affiliation

__Business/industry/private entity

__Other (please specify): ______________________

Coalition Functioning [ASK ONLY OF THOSE FAMILIAR WITH THE COALITION]

20. How frequently was the coalition functioning assessed?

21. How frequently were coalition activities assessed?

22. Is there a strategic communications plan?

1. What audiences or stakeholders are reached by the plan?

23. Was there a strategic plan to guide program directions, goals, and strategies?

24. To what extent were internal support/resources effectively managed at the program and local implementation sites? Would you say:

1 2 3 4 5 6 7

Very Effectively Somewhat Not Sure Somewhat Ineffectively Very

Effectively Effectively Ineffectively Ineffectively

Please explain.

25. Were there organizations or individuals from particular sectors that should have been represented on the coalition, but were not? Please be specific.

__Public health departments

__Schools/Academia

__Other governmental agencies (e.g., human and social services, housing, economic development, public safety, transportation) or elected officials

__Grassroots organizations

__Organizations that serve underrepresented racial/ethnic groups or English as a Second Language participants

__Healthcare settings

__Wellness (sports club, spa, trainer, prevention specialists

__Affiliate of national health organization

__Communications and marketing

__Foundations and philanthropic organizations

__Insurance carrier/health plan

__Citizen/resident, no affiliation

__Business/industry/private entity

__Other (please specify): ______________________

Leveraging of Resources

26. Are you aware of ways in which the resources of the coalition have been leveraged (e.g., used to acquire additional funds) for the work of the coalition?

Probe: How did your or other organization(s) benefit from the OWH CHC to acquire new funds or other resources to support gender-based programming or policies?

Sustainability

27. Have you or your organization been involved in any discussions about the sustainability of the Coalition’s work in their community?

28. Please describe any specific examples of ways in which the coalition’s resources have been used to secure other funding, support spin-offs for gender-based programming, etc.

29. To what extent do you believe the coalition is as a whole or in part (i.e., certain aspects or components) sustainable?

ASK ALL: Conclusion

30. In your opinion, what still needs to be done to increase the availability of gender-based health services for women and girls?

    1. Probe for those not familiar with the coalition who skipped to this point:

Is there any assistance that is needed by your organization to develop or implement gender-based programming, policies, or services?

31. Is there anything else you would like to comment on about gender-based programming or women and girls’ health in [OWH CHC’s site name] community?

[END HERE FOR NON-STAFF]

[INTERVIEWER AND RECORDER PLEASE RECORD TIME ENDED.]

THANK YOU FOR YOUR PARTICIPATION IN THE EVALUATION. WE APPRECIATE YOUR HELP IN THIS IMPORTANT PROJECT AND LOOK FORWARD TO SPEAKING WITH YOU (AGAIN). WE WILL MAKE A SUMMARY OF OUR FINDINGS AVAILABLE TO OWH TO DISTRIBUTE TO THE PROJECT DIRECTOR FOR DISSEMINATION IN YOUR COMMUNITIES.

[END AUDIORECORDING AND VERBALLY RECORD UNIQUE IDENTIFIER CODE].

Time ended for PART II Participants (record here and on page 2): ________________________

PART III. Perspectives on the COALITION’S GENDER-BASED PROGRAMMING (Project Directors, Project Coordinators, and Evaluators)

1. Gender-based Approaches

This next set of questions is about your coalition’s specific gender-based approaches.

Remind interviewee that The Office on Women’s Health defines a “gender-based program” as:

“A program which is designed that addresses the roles, behaviors, activities, and biological/psychological attributes that society assigns as “appropriate” for men and/or women which impact treatment, access, and overall health.” (per OWH COR email, dtd 10/30/2014)

32. Please describe the gender-based approaches you used in your coalition’s activities.

1. What approaches were used in the evidence-based intervention?

2. What approaches were used to facilitate coalition functioning?

3. What approaches were used in community-level activities?

4. What gender-based approaches were used to effect policies or other systems-level changes?

5. Were there any approaches used to make the community in general, participants in the interventions, or coalition members aware/more aware of the significance of disease status between men and women?

33. Did your coalition conduct trainings/orientations for coalition members on:

1. Gender analysis?

2. Gender-based Analysis (GBA)?

3. The integration of the gender-based analysis into coalition planning?

4. How frequently over the course of the grant were these trainings held?

34. Has the coalition conducted another gender-based analysis or community needs assessment like the one during Phase I on which the program was based?

___a. NO:

(1) Are there plans to conduct another analysis prior to the grant’s end?

(2) What does your coalition use as the basis for assessing systems-level changes that have resulted from the coalition in terms of:

(a) Changes in community norms about women and girls?

(b) Policy changes that have resulted from coalition work?

(c) Any other changes that have resulted from the coalition’s work?

___b. YES:

1. What were the general findings related to the gender-based analysis in comparison to the previous analysis or assessment?

2. What barriers seem to have been addressed by the coalition’s work?

3. Have gender-specific community needs improved, worsened or stayed about the same?

4. Are gender-based norms and attitudes about the same, more favorable toward women and girls, or less favorable as compared to the initial assessment?

35. To what extent have data been analyzed to examine gender differences or sex differences?

    1. At the intervention level?

    2. At the coalition or community level?

2. Grantees’ Public Health Systems Approaches

This next set of questions is about the public health systems approach used in your coalition.

A public health systems approach is described as follows: “Public health systems are commonly defined as ‘all public, private, and voluntary entities that contribute to the delivery of essential public health services within a jurisdiction.’ This concept ensures that all entities’ contributions to the health and well-being of the community or state are recognized in assessing the provision of public health services.” (cdc.gov)

Political Support from Leadership

36. To what extent was there political support for the program?

a. From the [applicant organization]’s leadership (e.g., was there buy-into the program from:

(1) Senior/executive management?

(2) The Board?

b. What about the senior management or board of partnering organizations (e.g., organizations which the coalition members represented)?

c. What about grassroots organizations participating in the coalition?

d. What about local elected officials or governing bodies?

37. Were there any sectors on the coalition that were more difficult to engage or to get to provide political support than others?

Coalition Functioning

38. How frequently was the coalition functioning assessed?

39. How frequently were coalition activities assessed?

40. Is there a strategic communications plan?

2. What audiences or stakeholders are reached by the plan?

41. Was there a strategic plan to guide program directions, goals, and strategies?

42. To what extent were internal support/resources effectively managed at the program and local implementation sites? Would you say:

1 2 3 4 5 6 7

Very Effectively Somewhat Not Sure Somewhat Ineffectively Very

Effectively Effectively Ineffectively Ineffectively

Please explain.

Multi-sectoral Nature of the Coalition

43. To what extent was this initiative a multi-sectoral effort?

1—To little or no extent 2--Somewhat 3—A great deal

44. What sectors were involved? [INTERVIEWER: Please ask about the following and check all that apply and specify the name or type of partner where requested].

__Public health departments

__Schools/Academia

__Other governmental agencies (e.g., human and social services, housing, economic development, public safety) or elected officials

__Grassroots organizations

__Organizations that serve underrepresented racial/ethnic groups or English as a Second Language participants

__Healthcare settings

__Wellness (sports club, spa, trainer, prevention specialists

__Affiliate of national health organization

__Communications and marketing

__Foundations and philanthropic organizations

__Foundations and philanthropic organizations

__Insurance carrier/health plan

__Citizen/resident, no affiliation

__Business/industry/private entity

__Other (please specify): ______________________

45. Were there organizations or individuals that should have been represented on the coalition, but were not? Please be specific.

__Public health departments

__Schools/Academia

__Other governmental agencies (e.g., human and social services, housing, economic development, public safety) or elected officials

__Grassroots organizations

__Organizations that serve underrepresented racial/ethnic groups or English as a Second Language participants

__Healthcare settings

__Wellness (sports club, spa, trainer, prevention specialists

__Affiliate of national health organization

__Communications and marketing

__Foundations and philanthropic organizations

__Foundations and philanthropic organizations

__Insurance carrier/health plan

__Citizen/resident, no affiliation

__Business/industry/private entity

__Other (please specify): ______________________

46. To what extent do you believe the coalition as a whole or in part (i.e., selected aspects or components) is sustainable? Please elaborate.

 

47. Do you have recommendations for improving public health systems approaches to improving women and girls’ health? Please provide examples.

Additional Comments

48. Do you have any additional comments about or suggestions for improvement of:

1. The gender-based approach your coalition used?

2. The public health systems approach your coalition used?

3. The likelihood of sustaining the coalition or any of its activities?

4. The cost-effectiveness of the coalition’s activities?

5. The cost-benefit of the coalition’s activities?

6. Any other aspects of the initiative?

[Record End Time and thank for their participation. Explain next steps as in Part II]

2--Coalition Members and Community Leaders Online Survey

Purpose: To collect common data across grantees from coalition members and key community leaders nominated by grantees. Nominees will be surveyed on perceived gender equity in health, changes in gender norms related to health, and the extent to which the coalition is being/has been effective in implementing a gender-based, public health systems approach that is sustainable and cost-effective to improve women and girls’ health.

Data Sources: Project Directors, Key Project Staff, Coalition Members (who actively participated, past and current), Key Community Leaders (nominated by the grantee and believed to be familiar with the work of the coalition or related activities—e.g., Executive Directors of the grassroots organizations, if not represented on the coalition, partnering organizations, organizations providing supportive services to address social determinants of health, or initiatives addressing health and social determinants).

Length of time to administer: 10 minutes if not familiar with the coalition, 20 minutes if a coalition representative or individual is familiar with the coalition

Mode of administration: Online survey, self-administration; confidential

Method of data collection: Developed by MayaTech and transmitted to grantees for distribution to their email lists via online surveys set up for each site by MayaTech; submitted by respondents confidentially and directly to MayaTech via online survey vendor links; and reported confidentially

Source of items: Candidate items are from “Gender-sensitive” indicators identified in systematic review of research articles (e.g., publications produced by the United Nations, World Health Organization, Pan-American Health Organization; and the journal, Women’s Health Issues). Most of the identified items were related to economic development issues for women in developing countries; however, MayaTech has adapted the items for use in the OWH CHC national evaluation

Formatting: Will be formatted for online survey administration

Coalition Members and Community Leaders Survey

Preamble and Informed Consent: You are receiving this survey, because you have participated as a coalition member of or have been involved in a related activity in which representatives of the [Grantee’s name and Coalition OWH Name or Public Name] have been involved in your community. If you are 18 years of age or older, continue reading. Your participation is voluntary and you are free to refuse a response to any item without any penalty to you as an individual or your organization. There are minimal risks for your participation. However, please provide candid responses and as complete information as you can to assist the [local grantee] and the U. S. Department of Health and Human Services, Office on Women’s Health, which funded this initiative, in improving women and girls’ health. If you are not familiar with the coalition, the survey should take about 10 minutes; and if you are familiar with the coalition, the survey should take about 20 minutes. Do not put your name on the survey or any other identifying information (other than your sex and length of time in the community, which are asked for at the end of the survey so we can better understand the survey responses overall). We will compile your responses with dozens of others and report them so that you cannot be identified. If you would like additional information about this survey and your participation, please contact Dr. Suzanne Randolph at The MayaTech Corporation, the national evaluator, by email ([email protected]) or telephone (301-587-1600). Your local grantee contact is: [supply, name, title, contact email and/or phone].

If you agree to participate in this survey, please click “yes” below and you will be directed to the survey.

If you do not agree to participate in this survey, click “No.”

I am 18 years of age or older ___YES (CONTINUE) NO___ (send to end of survey and out)

___YES, I want to participate. (CONTINUE)

___NO, I do not want to participate. (SEND TO END AND OUT OF SURVEY)

Thank you in advance for your cooperation.

INTRODUCTION
The coalition conducted various activities through outreach and education to the larger community as well as specific intervention programs for specific groups of women and men in your community. The first two sections of the survey are about your perceptions of 1) your community’s general response to the health needs and issues of females and males; and 2) the overall health of females and males in your community. You do not need to be intimately familiar with the activities of the coalition to respond to these items. We are interested in your general perceptions of these items in your community at this point in time. Later sections solicit your perceptions on the coalition’s activities (if familiar to you) and the extent to which the ways in which women/girls ‘and men/boys' health needs are addressed in your community.

Section I. Perceptions of ways in which the community addresses the health needs of women/girls and men/boys

In this section, we are interested in your perceptions of the extent to which organizations and agencies in your community address the health needs of women/girls and men/boys and provide opportunities for their participation in health-related activities and decision-making. Please select one response which best reflects the extent to which you agree or disagree with the item.

Response set: 1—Strongly disagree 2—Disagree 3—Somewhat disagree 4—Undecided 5-Somewhat Agree 6—Agree 7—Strongly Agree 0—Don’t Know

In our community:

1. Women and men benefit about the same from health-related activities.

2. Women participate more than men in health-related activities.

3. Health activities in our community address relevant gender inequities in women's and men's roles and responsibilities.

4. Women have access to adequate resources necessary for their participation and benefit in health programs, services, and activities.

5. Health activities in our community take into account that women have gender-based needs.

6. Health-related activities are reinforcing negative gender stereotypes.

7. Organizations and agencies are working to eliminate or reduce negative gender stereotypes.

8. Organizations and agencies conduct activities that encourage community members to be more gender-sensitive so that both men and women can live healthier and happier lives.

9. Women contribute to the political decision-making in this community.

10. Women in this community get paid less than men for doing the same work.

11. Residents are knowledgeable about the difference between “sex” and “gender.”

12. Residents are knowledgeable about significant differences between men’s and women’s health.

Section II. Perceptions of Coalition Activities for those Familiar with the Coalition

This set of items is designed to gather the perceptions of those who have familiarity with the coalition’s activities and programs. Before completing this section, please answer the item below and the survey will direct you, as appropriate.

13. To what extent would you say the larger community is aware of the activities and programs of the coalition [list name, social media campaign and popular name here for reference for each grantee’s survey]?

1—Not at all aware 2—Somewhat aware 3—Aware 4—Very aware

14. How familiar are you with the activities and programs of the coalition [list name, social media campaign and popular name here for reference for each grantee’s survey]?

__1--Not at all familiar (SKIP next section and go to demographics, then submit)

__2--Somewhat familiar

__3--Familiar

__4--Very familiar

If you answered “somewhat familiar,” “familiar” or “very familiar” to item #12 above, please continue. This set of items asks about coalition activities.

For each of the following items, please provide the response that best reflects your perception for that item.

Response set: 1—Strongly disagree 2—Disagree 3—Somewhat disagree 4—Undecided 5-Somewhat Agree 6—Agree 7—Strongly Agree 0-Do not know

15. Women were included in the coalition activities as beneficiaries at all levels.

16. Women and men contribute at about the same level in implementing coalition activities.

17. Women and men benefit about the same from coalition activities.

18. There are adequate resources available to women to participate in coalition activities.

19. The coalition activities address gender inequities in women's and men's roles and responsibilities.

20. Women have access to the resources necessary for their participation and benefit in the coalition’s activities.

21. There are possible unplanned effects and outcomes that might be negative for women.

22. The coalition has adequate gender-based approaches to address the gender-based needs of women and girls.

23. The coalition’s activities are eliminating or reducing negative gender stereotypes.

24. The coalition’s activities can be easily tried out by organizations that have not been participating as partners.

25. It is easy for a man or boy to participate in coalition activities.

26. It is easy for a woman or girl to participate in coalition activities.

27. The coalition activities fit with the life circumstances of the participants/families for whom it was designed.

28. The immediate impact or benefit of the intervention program for women is visible or observable.

29. I would recommend the coalition activities to other communities for implementation.

30. The coalition’s activities are resulting in improved health for women and girls.

31. To what extent can the activities or programs of the coalition be sustained over time?

1—Not at all 2—Somewhat 3—A great extent

[FINAL TWO SECTIONS ARE ONLY FOR THOSE WHO SERVE ON THE COALITION—and is followed by DEMOGRAPHICS, ASKED OF ALL—ONLINE SURVEY WILL SEND THOSE WHO ONLY ANSWERED SECTIONS I and/or II DIRECTLY TO DEMOGRAPHICS UPON COMPLETION OF RELEVANT SECTION]

Section III. About the Coalition: For Coalition Representatives or Interested Individuals on Coalition

32. Were you a representative for your organization or did you serve as an interested individual on the [coalition name]?

__NO (SKIP and go to demographics)

__YES, as an organizational representative (including staff member)--CONTINUE

__YES, as an interested individual—CONTINUE

For each of the following, please indicate the response that best fits your perception:

Response set: 1—Strongly disagree 2—Disagree 3—Somewhat disagree 4—Undecided 5-Somewhat Agree 6—Agree 7—Strongly Agree 0-Do not know

33. Women are included as stakeholders in project identification and design meetings.

34. Women and men attend coalition meetings with about the same frequency.

35. Men and women contribute at about the same level to coalition decision making.

36. Women and men contribute at about the same level in implementing coalition activities.

37. There is an adequate number of women involved in important decision-making for the coalition.

38. The possible negative unplanned effects for women have been addressed.

39. Organizations and institutions with a gender mandate are included on the coalition.

40. Appropriate budget allocations were made to allow for the successes for men/boys.

41. Appropriate budget allocations were made to allow for the successes of women/girls.

42. The coalition disaggregates (breaks up and reports) data by sex in order to allow for ongoing analysis and improvements.

43. The coalition links its monitoring and evaluation indicators to the relevant national goals such as those set by Healthy People 2020 Objectives/topic areas.

44. The coalition is having the intended impact on the target community.

45. To what extent was there political support for the program?

Response set:

1—To little or no extent 2--Somewhat 3—A great deal

1. the applicant organization’s leadership senior/executive management?

2. the applicant organization’s leadership Board?

3. senior management or board of partnering organizations?

4. grassroot organizations participating in the coalition?

5. local elected officials or governing bodies?

46. To what extent was this initiative a multi-sectoral effort?

1—To little or no extent 2--Somewhat 3—A great deal

47. Have you or your organization leveraged the resources of the coalition or your participation in the coalition to implement gender-based activities, expand the activities of the coalition, acquire new resources, or in other ways?

___NO (skip to Section IV)

___YES: In what ways?

SECTION IV. Coalition Category

THIS SECTION IS INTENDED TO GET AT THE GENDER TRANSFORMATIVRE NATURE OF THE COALITION (CATEGORIES REFLECT POINT ALONG THE GENDER CONTINUUM)

This section asks those familiar with the coalition to check one category into which they would describe the coalition’s status.

48. Below are five categories into which coalitions doing this type of work could be grouped and a description for each. After reading each description, please check which category best describes the one in which you believe your coalition is functioning. CHECK ONLY ONE CATEGORY (THE ONE THAT BEST DESCRIBES YOUR COALITION OVERALL).

___A: Program approaches reinforce inequitable gender stereotypes, or disempower certain people in the process of achieving program goals. They can do harm by reinforcing negative behaviors and attitudes. Example: A program that reinforces women’s role as children’s caretakers by making children’s health services unfriendly toward fathers, rather than encouraging equality in parenting responsibilities.

___B: Program approaches or activities do not actively address gender stereotypes and discrimination. Such approaches at least do no harm. However, they often are less than effective because they fail to respond to gender-specific needs. EXAMPLE: Prevention messages that are not targeted to any one sex, such as “be faithful,” make no distinction between the needs of women and men.

___C: Program approaches or activities recognize and respond to the different needs and constraints of individuals based on their gender and sexuality. These activities significantly improve women’s (or men’s) access to protection, treatment, or care. However, they do not alter the balance of power between men and women; and they do little to change the larger contextual issues that lie at the root of gender inequities. EXAMPLE: Efforts to integrate screening for domestic violence with women’s annual checkups helps women access such services without fear of stigmatization; however, the needs and roles/responsibilities of males are not addressed, nor are the contextual factors that promote stigma.

___D: Program approaches or activities continuously help men and women examine societal gender expectations, stereotypes, and discrimination, and their impact on male and female health and relationships. EXAMPLE: A life skills training program, addresses healthy eating as well as broader community issues through social change activities that encourage female and male participants to question gender norms related to why they eat, cook or buy foods the way that they do; and encourages them to take responsibility to change their own norms so they can promote healthier eating in the future for themselves and others. Societal level norms are not the focus.

___E: Program approaches or activities pro-actively seek to build equitable social norms and structures in addition to individual gender-equitable behavior. EXAMPLE: An effort that both encourages groups of people to work together at the grass roots level to foster change through examining gender and sexuality and their impact on male and female health and relationships, as well as to reduce violence against women through organizing a network of people and agencies to proactively engage in political debate about the rights of vulnerable women.

PLEASE CHECK ONLY ONE OF THE ABOVE CATEGORIES BEFORE MOVING ON.

SECTION V. DEMOGRAPHICS and SECTOR REPRESENTED

49. Are you?: ___Female __Male ___Other

50. How long have you worked in this community (i.e., the general vicinity or area in which the coalition is focused/target communities). If you do not live in the specific area, but work there or have another connection which attaches you to the community, that is the length of time to which we are referring.

_______years ____months

51. Sector you represent (check all that apply)

__Public health departments

__Schools/Academia

__Other governmental agencies (e.g., human and social services, housing, economic development, public safety) or elected officials

__Grassroots organizations

__Organizations that serve underrepresented racial/ethnic groups or English as a Second Language participants

__Healthcare settings

__Wellness (sports club, spa, trainer, prevention specialists

__Affiliate of national health organization

__Communications and marketing

__Foundations and philanthropic organizations

__Foundations and philanthropic organizations

__Insurance carrier/health plan

__Citizen/resident, no affiliation

__Business/industry/private entity

__Other (please specify): ______________________

52. Please indicate for each of the following the response that best reflects what you know about the topic.

1. I am knowledgeable about the difference between “sex” and “gender.”

1—Not at all 2--Somewhat 3-Very

2. I am knowledgeable about the significant differences between men’s and women’s health.

1—Not at all 2--Somewhat 3-Very

Comments/Suggestions

53. Do you have any comments about or suggestions for improvement of programming and services to improve women and girls’ health in your community?

___NO (skip to submit)

___YES (please elaborate)

Thank you for your participation.

The Office on Women’s Health will compile the results of this survey and send the findings for our community to the Coalition’s Project Director to share with our community.

SUBMIT

3--Coalition Participants and Other Community Members Online Survey

Purpose: To collect common data across grantees from participants in grantees’ interventions or comparison activities and other community members. Respondents will be surveyed on perceived gender equity in health, changes in gender norms related to health, and the extent to which the coalition is being/has been effective in implementing a gender-based, public health systems approach that is improving women and girls’ health.

Data Sources: participants in grantees’ interventions or comparison activities and other community members

Length of time to administer: 10 minutes if not familiar with the coalition, 15 minutes if a participant was in the coalition’s intervention or comparison group

Mode of administration: Hard-copy or online survey, self-administration; confidential

Method of data collection: Developed by MayaTech and transmitted to grantees for distribution to their participants via email lists maintained by grantee, links for each site to online survey set up by MayaTech; submitted by respondents confidentially directly to MayaTech via online survey vendor links; and reported anonymously

Source of items: Candidate items are from “Gender-sensitive” indicators identified in systematic review of research articles (e.g., publications produced on gender norms and health outcomes effects). Most items identified were for intimate partner violence in developing countries; however, MayaTech has adapted the items for use in the OWH CHC national evaluation

Formatting: Will be formatted for online survey administration

Coalition Participants and Other Community Members

Preamble: You are receiving this survey, because you have participated in or were provided with health information from the [Grantee’s name/Coalition’s Public Name] in your community. If you are 18 years of age or older, you are eligible to participate in the survey. Your participation is voluntary and you are free to refuse a response to any item without any penalty to you as an individual or your organization. There are minimal risks for your participation. There are no individual benefits, but your community will receive information to improve health programs and services. So, please provide candid responses and as complete information as you can to assist the [Coalition/local grantee] and the U. S. Department of Health and Human Services, Office on Women’s Health, which funded this initiative, in improving women and girls’ health. The survey will take between 10-20 minutes to complete. Do not put your name on the survey or any other identifying information (other than your sex/gender and length of time in the community, which are asked for at the end of the survey). We will compile your responses with dozens of others and report them so that you cannot be identified. If you would like additional information about this survey and your participation, please contact Dr. Suzanne Randolph at The MayaTech Corporation, the national evaluator, by email ([email protected]) or telephone (301-587-1600). Your local coalition contact is: [supply, name, title, contact email and/or phone].

If you agree to participate in this survey, please click “yes” below and you will be directed to the survey.

If you do not agree to participate in this survey, click “No.”

I am 18 years of age ___YES (continue) ___NO (send to end of survey and out)

___YES, I agree to participate in the survey. (continue)

___NO, I do not agree to participate in the survey. (Send to end and out)

Thank you in advance for your cooperation.

Section I. Views on ways in which the community addresses the health needs of women/girls and men/boys

We are interested in your views on the extent to which organizations and agencies in your community address the health needs of women/girls and men/boys and provide opportunities for their participation in health-related activities and decision-making. Please select one response which best reflects the extent to which you agree or disagree with the item.

Response set: 1—Strongly disagree 2—Disagree 3—Somewhat disagree 4—Undecided 5-Somewhat Agree 6—Agree 7—Strongly Agree 0—Don’t Know

In our community:

1. Women and men benefit about the same from health-related activities.

2. Women participate more than men in health-related activities.

3. Health activities in our community address relevant gender inequities in women's and men's roles and responsibilities.

4. Women have access to adequate resources necessary for their participation and benefit in health programs, services, and activities.

5. Health activities in our community take into account that women have gender-based needs.

6. Health-related activities are reinforcing negative gender stereotypes.

7. Organizations and agencies are working to eliminate or reduce negative gender stereotypes.

8. Organizations and agencies conduct activities that encourage community members to be more gender-sensitive so that both men and women can live healthier and happier lives.

9. Women contribute to the political decision-making in this community.

10. Women in this community get paid less than men for doing the same work.

11. Residents are aware of the difference between “sex” and “gender.”

12. Residents are knowledgeable about significant differences between men’s and women’s health.

[NOTE: THE NEXT SECTION IS FOR THOSE WHO PARTICIPATED IN THE INTERVENTION OR COMPARISON GROUP OR ARE OTHERWISE FAMILIAR WITH THE COALITION]

Section II. Views on Coalition Activities (for those Familiar with the Coalition)

This set of items is designed to gather your views on the coalition’s activities and programs. Before completing this section, please answer the item below and the survey will direct you, as appropriate.

13. Are you aware of any of the following coalition initiatives [each coalition provides list, including social media or campaign messages]—CHECK ALL THAT APPLY

14. Did you participate in any of the coalition’s activities or programs [such as list name, social media campaign and popular name here for reference for each grantee’s survey]?

___NO

___NOT SURE

___YES: Which one(s)?

15. If you answered “Yes” to #12, do you feel improved in any area of your health as a result of participation in the coalition’s programs?

___NO (skip to 27)

___YES: In which areas of your health?

16. How familiar are you with the activities and programs of the coalition?

__1--Not at all familiar (SKIP next section and go to demographics, then submit)

__2--Somewhat familiar

__3--Familiar

__4--Very familiar

[NOTE: If participant answered “somewhat familiar,” “familiar” or “very familiar” to item above, they will be directed to continue to the next set of items that asks about coalition activities].

17. To what extent would you say the larger community is aware of the activities and programs of the coalition?

1—Not at all aware 2—Somewhat aware 3—Unsure 4--Aware 5—Very aware

18. To what extent is the coalition making a difference in improving women and girls’ health in your community?

1—No difference at all 2—A little difference 3—Unsure 4—Somewhat of a difference 5—A great deal of difference

For each of the following items, please provide the response that best reflects your view for that item.

Response set: 1—Strongly disagree 2—Disagree 3—Somewhat disagree 4—Undecided 5-Somewhat Agree 6—Agree 7—Strongly Agree 0-Do not know

19. Females were included in the coalition activities.

20. Males were included in the coalition activities.

21. The coalition’s activities are eliminating or reducing negative gender stereotypes.

22. Males and females benefit about the same from coalition activities.

23. There are adequate resources available to women and girls to participate in coalition activities.

24. Both females and males have fair access to the resources necessary to participate in the coalition activities.

25. There are possible negative effects of participation for females.

26. The coalition has adequate approaches to address the needs of women and girls.

27. Females benefit more than males from the coalition’s activities.

Provide the response that best reflects your views on each of the next items.

Response set: 1—Strongly disagree 2—Disagree 3—Somewhat disagree 4—Undecided
5-Somewhat Agree 6—Agree 7—Strongly Agree 0-Do not know

28. The coalition’s activities can be easily tried out by others that have not yet participated.

29. It is easy for a man or boy to participate in coalition activities.

30. It is easy for a woman or girl to participate in coalition activities.

31. The coalition activities fit with the life circumstances of the participants/families for whom it was designed.

32. The immediate benefit of the intervention program for females is visible or observable.

33. I would recommend the coalition activities to other community residents for participation.

34. Others can see the difference that the coalition is making in improving women and girls’ health in our community.

35. Others can see the difference that the coalition is making in reducing negative stereotypes about women and girls.

SECTION III. DEMOGRAPHICS and HEALTH

36. Are you?: ___Female __Male __Other

37. Are you Hispanic or Latino/Latina? ___Yes ___No

38. What is your race? (Check all that apply):

__American Indian or Alaska Native

__Asian

__Black or African American

__Native Hawaiian or Other Pacific Islander

__White

39. How long have you lived in this community (that is, the general vicinity or area in which the coalition activities are located)? If you do not live in the specific area, but work there or have another connection which attaches you to the community, that is the length of time to which we are referring.

____ Years ____ Months

40. How would you rate your health today?

__1—Excellent 2—Very Good 3—Good 4--Fair 5—Poor

41. Now thinking about your physical health, which includes physical illness and injury, for how many days during the past 30 days was your physical health not good?

____ Number of days

42. Now thinking about your mental health, which includes stress, depression, and problems with emotions, for how many days during the past 30 days was your mental health not good?

____ Number of days

43. During the past 30 days, for about how many days did poor physical or mental health keep you from doing your usual activities, such as self-care, work, or recreation?

____ Number of days

44. Compared to three years ago, would you say that your health has:

1—Declined 2—Stayed about the same, still unhealthy

3—Stayed about the same, still healthy 4—Improved

45. Please indicate for each of the following the response that best reflects what you know about the topic.

3. I am knowledgeable about the difference between “sex” and “gender.”

1—Not at all 2--Somewhat 3-Very

4. I am knowledgeable about the significant differences between men’s and women’s health.

1—Not at all 2--Somewhat 3-Very

Thank you for your cooperation. Office on Women’s Health will provide a summary of the results for our community to the project director of the coalition to share with in our community.

SUBMIT

4--The Wilder Collaboration Factors Inventory: Project Directors and Coalition Members

Distributed annually by Project Directors (PDs) programs to individual members, average for the coalition for each item submitted by PD as part of their annual reporting

Source: Collaboration: What Makes it Work 2nd Ed. by Mattessich et al. Copyright 2001, Fieldstone Alliance. All rights reserved, used with permission. www.FieldstoneAlliance.org

______________________________________________________________________

Name of Collaboration Completion Date

Please indicate the degree to which you agree/disagree with each of the following statements about [Your Collaborative Group]:

Factor	Statement	Strongly Disagree	Disagree	Neutral, No Opinion	Agree	Strongly Agree
History of collaboration or cooperation in the community	1. Agencies in our community have a history of working together	1	2	3	4	5
	2. Trying to solve problems through collaboration has been common in this community. It’s been done a lot before.	1	2	3	4	5
Collaborative group seen as a legitimate leader in the community	3. Leaders in this community who are not part of our collaborative group seem hopeful about what we can accomplish.	1	2	3	4	5
	4. Others (in this community) who are not a part of this collaboration would generally agree that the organizations involved in this collaborative project are the “right” organizations to make this work.	1	2	3	4	5
Favorable political and social climate	5. The political and social climate seems to be “right” for starting a collaborative project like this one.	1	2	3	4	5
	6. The time is right for this collaborative project.	1	2	3	4	5
Mutual respect, understanding, and trust	7. People involved in our collaboration always trust one another.	1	2	3	4	5
	8. I have a lot of respect for the other people involved in this collaboration.	1	2	3	4	5
Appropriate cross section of members	9. The people involved in our collaboration represent a cross section of those who have a stake in what we are trying to accomplish.	1	2	3	4	5
	10. All the organizations that we need to be members of this collaborative group have become members of the group.	1	2	3	4	5
Members see collaboration as in their self-interest	11. My organization will benefit from being involved in this collaboration.	1	2	3	4	5
Ability to compromise	12. People involved in our collaboration are willing to compromise on important aspects of our project.	1	2	3	4	5
Members share a stake in both process and outcome	13. The organizations that belong to our collaborative group invest the right amount of time in our collaborative efforts.	1	2	3	4	5
	14. Everyone who is a member of our collaborative group wants this project to succeed.	1	2	3	4	5
	15. The level of commitment among the collaboration participants is high.	1	2	3	4	5
Multiple layers of participation	16. When the collaborative group makes major decisions, there is always enough time for members to take information back to their organizations to confer with colleagues about what the decision should be.	1	2	3	4	5
	17. Each of the people who participate in decisions in this collaborative group can speak for the entire organization they represent, not just a part.	1	2	3	4	5
Flexibility	18. There is a lot of flexibility when decisions are made; people are open to discussing different options.	1	2	3	4	5
	19. People in this collaborative group are open to different approaches to how we can do our work. They are willing to consider different ways of working.	1	2	3	4	5
Development of clear roles and policy guidelines	20. People in this collaborative group have a clear sense of their roles and responsibilities.	1	2	3	4	5
	21. There is a clear process for making decisions among the partners in this collaboration.	1	2	3	4	5
Adaptability	22. This collaboration is able to adapt to changing conditions, such as fewer funds than expected, changing political climate, or change in leadership.	1	2	3	4	5
	23. This group has the ability to survive even if it had to make major changes in its plans or add some new members in order to reach its goals.	1	2	3	4	5
Appropriate pace of development	24. This collaborative group has tried to take on the right amount of work at the right pace.	1	2	3	4	5
	25. We are currently able to keep up with the work necessary to coordinate all the people, organizations, and activities related to this collaborative project.	1	2	3	4	5
Open and frequent communication	26. People in this collaboration communicate openly with one another.	1	2	3	4	5
	27. I am informed as often as I should be about what goes on in the collaboration.
	28. The people who lead this collaborative group communicate well with the members.	1	2	3	4	5
Established informal relationships and communication links	29. Communication among the people in this collaborative group happens both at formal meetings and in informal ways.	1	2	3	4	5
	30. I personally have informal conversations about the project with others who are involved in this collaborative group.	1	2	3	4	5
Concrete, attainable goals and objectives	31. I have a clear understanding of what our collaboration is trying to accomplish.	1	2	3	4	5
	32. People in our collaborative group know and understand our goals.	1	2	3	4	5
	33. People in our collaborative group have established reasonable goals.	1	2	3	4	5
Shared vision	34. The people in this collaborative group are dedicated to the idea that we can make this project work.	1	2	3	4	5
	35. My ideas about what we want to accomplish with this collaboration seem to be the same as the ideas of others.	1	2	3	4	5
Unique purpose	36. What we are trying to accomplish with our collaborative project would be difficult for any single organization to accomplish by itself.	1	2	3	4	5
	37. No other organization in the community is trying to do exactly what we are trying to do.	1	2	3	4	5
Sufficient funds, staff, materials, and time	38. Our collaborative group had adequate funds to do what it wants to accomplish.	1	2	3	4	5
	39. Our collaborative group has adequate “people power” to do what it wants to accomplish.	1	2	3	4	5
Skilled leadership	40. The people in leadership positions for this collaboration have good skills for working with other people and organizations.	1	2	3	4	5

Suggested open-ended questions:

41. What is working well in the collaboration?

42. What needs improvement in the collaboration?

5—Grantee Status Report on Cost-Effectiveness Analysis

Office on Women’s Health (OWH)

Coalition for a Healthier Community (CHC) Initiative

Project Directors Use in collaboration with Evaluators/Health Economists to Report Annually

PLEASE PUT YOUR GRANTEE NAME IN THE TABLE (FIRST ROW)—It will appear on subsequent sheets.

Person completing report: _______________________________

Role/Title on CHC Grant: _____________________________

Date: __________________________

GUIDANCE: The OWH is interested in the question of “What is the cost effectiveness of offering a gender-based approach in women’s health programming?” In addition, OWH would like to capture any information on the cost-benefits of such approaches. This form is designed to capture the status of your cost-effectiveness and/or cost-benefit analyses. Please consult your health economist or economic evaluation resource person, if available, to assist with completion of this form.

1. In Table 1, please report on:

   1. Whether you have or are collecting data for each indicator

   2. Any actual data or statistical results for the elements that are requested

   3. The time period over which/or for which data were collected (the shaded rows); and

   4. As applicable and available, the analytic/time horizon for your analysis.

Table 1. Program costs, cost-benefit analysis and cost-effectiveness indicators/measures

GRANTEE NAME:
INDICATOR/MEASURE	GRANTEE’S REPORT ON WHETHER DATA ARE COLLECTED AND ANY STATISTICAL DATA AVAILABLE
Program Planning Annual cost per participant for program planning	Cost for start-up period of Phase II grant (do not include Phase I) Grant-funded cost: In-kind or other sources: Total cost: Number of participants in the phase II evidence-based interventions and comparison groups (see measure #3, should have the same number of participants) Intervention group Comparison group Total number combined: (DO NOT INCLUDE OUTREACH OR SOCIAL MEDIA NUMBERS)
Time period:	The time period for which planning costs were calculated (from start up through end of planning period for Phase II grant [do not include Phase I; just the start of the Phase II grant]):
Program Implementation for Overall Program Annual cost per participant for program implementation--Overall (includes all costs for coalition, outreach, social media, intervention and comparison activities)	Cost for implementation of the project From start of implementation of any activities (do not include planning cost above)—include costs for outreach, social media, and intervention and comparison group activity through the end of the implementation of all activities at the time of your economic analysis Grant-funded: In-kind or other sources: Total: Number of total participants reached Intervention Group(s) Comparison Group(s) Total for all other activities (other than in intervention and comparison groups) Total (1+2+3) =
Time period	Start date of implementation activities: End date of implementation activities (end of implementation of all activities, not just the intervention, at the time of the economic analysis): What is the total duration of the implementation period in years and/or months? (e.g., 2 years; 2 years and 4 months)
Intervention Cost per Participant (include cost for those in the intervention group separately from those in the comparison group; also include the numbers of participants in each group)	The cost for implementing the evidence-based intervention (intervention group only) Grant-funded cost: In-kind or other sources: Total: The cost for implementing the comparison group activities Grant funded cost: In-kind or other sources: Total: Number of participants in the evidence-based intervention group Number of participants in the comparison group Total number combined of intervention and comparison group
Time period (this period might be the same as for the overall implementation; however, consider that you might have started outreach activities at a time prior to actual implementation of anyone into the intervention or comparison groups; the latter is what is requested here)	Duration of the intervention implementation Date of start of first session for first intervention group/participant: End date of last session for last group/participant in the intervention: What is the duration in years and months over which the intervention implementation took place (e.g., 3 years 2 months)?
Direct Medical Care Cost Avoided (Averted)	Actual or Estimated medical care costs (can use average price for specific costs such as those in “b” below [e.g., cost of an ER visit] for your geographic area; ideally, report on or capture actual costs to the extent you can have them or can get them) The number of participants in the program who are using ambulatory, ER, inpatient and outpatient care, rehabilitation/counseling services, etc. [medical care items might vary based on your HP 2020 priority areas: At baseline At post-test Are you collecting these from/on program participants? Indicate whether you are using: ___Questionnaires? ___Electronic medical records? ___Other methods to gather the data? (please specify)
Direct Non-Medical Costs Avoided (averted)	Are you collecting any data on these or other non-medical costs? At baseline? ___Transportation ___Childcare ___Waiting time costs ___Other non-medical costs (please specify) At post-test? ___Transportation ___Childcare ___Waiting time costs ___Other non-medical costs (please specify) NOTE: This should be calculated per participant in the program to examine participants receiving services at baseline compared to post-test
Time period	Do you have data for a baseline? ____Yes: What data and when collected? ____No: Do you have a way to establish a baseline? ___Yes ___No ___Not sure/Don’t know Do you have data for at least one follow up point? __Yes: Please indicate follow up point(s)—e.g., 6 and 12 months after program __No: Do you have a plan to capture follow up data? ___Yes: At which point(s)? ___No ___Not sure
Indirect Morbidity Costs Avoided (Averted) (productivity gain)	Do you collect any data for this measure—e.g., # of disability days and hours of work taken by women with the condition; hourly wage rate by women with the condition? __Yes: If so, what are you collecting? __No Are you collecting a Quality of Life (QoL) Measure? If so, what QoL instrument are you using (e.g., SF12)? Did you use this measure at both baseline and post-test(s)?
Time period	How frequently are you collecting: Indirect morbidity costs data (other than quality of life) Data using the Quality of Life measure you are using:
Quality Adjusted Life Years (QALYs)- OWH expects that each grantee will use a health economist or other economic evaluation resource person to generate this measure, as applicable for their HP 2020 priority area(s).	Is your project collecting data or using existing literature to generate QALYs? ____YES: What measure are you using? ____NO: What is your plan to generate these? ____NOT SURE/DON’T KNOW
Gender- based costs	Do you have a way to estimate the cost for the specific gender-based approach (es) incorporated into your overall coalition, the intervention(s), outreach activities, or social media activities? ___YES: Please describe your method. ___NO ___NOT SURE/DON’T KNOW
Other (specify):	Please describe any other cost measures you are collecting or plan to collect and analyze.
Time period

2. Does your project have a health economist or other economic evaluation resource person that is assisting with the economic evaluation?

___Yes: Name and Affiliation _______________________________________________

___No:

2. What is the status of your cost-effectiveness analysis (CEA)?

1. Have you established a time horizon/analytic horizon for your analysis?

___Yes: Please state the horizon and describe how you established your horizon.

___No: When might you have this information?

2. Are you conducting a cost-benefit analysis?

__Yes: Have you established a time horizon/analytic horizon for your analysis?

___Yes: Please state the horizon and describe how you established your horizon.

___No

__No

__Not Sure/Don’t Know

2. Additional comments about your economic evaluation.

Thank you for your participation.

6--Annual Report on Program Sustainability*

Office on Women’s Health/ Coalition for a Healthier Community

Please insert the grantee’s name and project year below. Check one response for each item based on your overall OWH CHC coalition activities in the past project year. Please submit each year at the end of the project year with your Annual Report.

Grantee Name:

Project/Coalition Title:

Project Year: 201__ - 201___

In the following questions, you will rate your program across a range of specific factors that affect sustainability. Please respond to as many items as possible. If you truly feel you are not able to answer an item, you may select “NA” (not able to answer). For each statement, circle the number that best indicates the extent to which your program has or does the following things.

Subscale and Items			1- To Little or No Extent			2		3		4				5	6	7 To a very great extent	NA Not able to answer
Environmental Support: Internal and external political environments that support your program
1. Environmental champions advocate for the program.
2. The program has strong champions with the ability to garner resources.
3. The program has political support within the larger organization.
4. The program has political support from outside of the organization.
5. The program has strong advocacy support.
Funding Stability: Establishing a consistent financial base for your program
6. The program exists in a supportive state economic climate.
7. The program implements policies to help ensure sustained funding.
8. The program is funded through a variety of sources.
9. The program has a combination of stable and flexible funding.
10. The program has sustained funding.
Partnerships: Cultivating connections between your program and its stakeholders
11. Diverse community organizations are invested in the success of the program.
12. The program communicates with community leaders.
13. Community leaders are involved with the program.
14. Community members are passionately committed to the program.
15. The community is engaged in the development of program goals.
Organizational Capacity: Having the internal support and resources needed to effectively manage your program
16. The program is well integrated into the operations of the organization.
17. Organizational systems are in place to support the various program needs.
18. Leadership effectively articulates the vision of the program to external partners.
19. Leadership efficiently manages staff and other resources.
20. The program has adequate staff to complete the program’s goals.
Program Evaluation: Assessing your program to inform planning and document results
21. The program has the capacity for quality program evaluation.
22. The program reports short-term and intermediate outcomes.
23. Evaluation results inform program planning and implementation.
24. Program evaluation results are used to demonstrate successes to funders and other key stakeholders.
25. The program provides strong evidence to the public that the program works.
Program Adaptation: Taking actions that adapt your program to ensure its ongoing effectiveness
26. The program periodically reviews the evidence base.
27. The program adapts strategies as needed.
28. The program adapts to new science.
29. The program proactively adapts to changes in the environment.
30. The program makes decisions about which components are ineffective and should not continue.
Communications: Strategic communication with stakeholders and the public about your program
31. The program has communication strategies to secure and maintain public support.
32. Program staff members communicate the need for the program to the public.
33. The program is marketed in a way that generates interest.
34. The program increases community awareness of the issue.
35. The program demonstrates its value to the public.
Strategic Planning: Using processes that guide your program’s directions, goals, and strategies
36. The program plans for future resource needs.
37. The program has a long-term financial plan.
38. The program has a sustainability plan.
39. The program’s goals are understood by all stakeholders.
40. The program clearly outlines roles and responsibilities for all stakeholders.

*Source: https://sustaintool.org/ and http://www.cdc.gov/pcd/issues/2014/13_0184.htm

ATTACHMENT B

INFORMED CONSENT FORM FOR KEY PERSONS

(TELEPHONE INTERVIEWS for Form #1)

INFORMED CONSENT FORM FOR KEY PERSONS’ INTERVIEWS

TITLE OF PROJECT: Evaluation of the Office on Women’s Health Coalition for a Healthier Community Initiative

PRINCIPAL INVESTIGATOR: Suzanne M. Randolph Ph.D. PHONE: (301) 587-1600

Purpose of the Study:

This study is designed to evaluate the United States Department of Health and Human Services, Office on Women’s Health, Coalition for a Healthier Community Initiative across the ten grantee sites funded by the initiative. This aspect of the evaluation is designed to collect information from key persons who have been directly involved as staff, coalition representatives, or in other ways as a community partner with the coalition in your community. All information will be examined in connection with data collected from others such as participants and other community members to determine the effectiveness of the initiative in improving women’s and girls’ health.

Procedures:

As a key person in your coalition, you will be asked to complete or participate in three data collections: 1) a key persons’ telephone interview; 2) a key persons’ online survey; and 3) a coalition members’ collaborations survey. For the interviews, the MayaTech Corporation, the national evaluator, will contact participants twice between September 1, 2015 and September 29, 2016, approximately 3-6 months apart) to conduct a telephone interview. The interview should take about 60 minutes if you are not the project director, project coordinator, or local evaluator and 120 minutes if you do have one of these roles. MayaTech will contact you using an electronic scheduler to set up each interview at your convenience. Each interview will be conducted by a trained interviewer who will be assisted by a note taker. The interview will take place by telephone using the Discussion Guide for Key Persons Interviews. Discussion topics are designed to collect your perceptions on the coalition’s activities, approaches, and possible impacts on policy changes and other changes that have addressed gender-based problems, improved women’s and girls’ health, and/or improved the overall health of your community. Your permission is being requested to audio-record the interview for the purposes of accurately capturing your perceptions for later coding. Your name will not be attached to specific quotes. Information will only be used to identify themes among the responses of the various participants. No sensitive information about your own or other specific individuals’ health will be requested.

You are also requested to complete an online survey twice (approximately the same times as the interviews) about your perceptions on these topics. We will use SurveyMonkey to distribute the Coalition Members and Community Leaders Survey to you. Again, your name is not requested and will not be tied to specific comments you make on the online survey. For the collaborations survey, your project director will distribute the Collaborations Factors Inventory at about these same times that you will complete on your own and return to your project director. The form requests ratings of various aspects of your coalition. Your name will not be requested, and your individual scores will not be known to us. All forms will be pooled by the project director to generate average scores for your coalition.

You will also be asked at the time of the interview to orally consent to the interview; and at the time of the online survey, to indicate on the survey that you are willing to participate. If you are a project director, and still available, at the end of the grant, MayaTech will also contact me for a one-hour interview about similar topics and the sustainability of the project.

Risks/Discomfort: There are no known risks associated with participation in the study. Should the interview become distressing to you, it will be terminated immediately.

Benefits: There are no personal benefits to you. It is hoped that the results of this study will have beneficial effects for the public health systems in your community and that the information gathered and the recommendations provided can be used by your coalition as well as groups across the nation to improve women and girls’ health.

Alternatives to Participation: Participation in this study is voluntary. You are free to withdraw or discontinue participation at any time. Refusal to participate in this study will in no way affect your participation in the coalition or any services received by you from the grantee or participating organizations.

Cost Compensation: Participation in this study will involve no costs or payments to you.

Confidentiality: All information collected during the study period will be kept strictly confidential. You will be identified through identification numbers. No publications or reports from this project will include personally identifying information on any participant. Because you are a key person in your coalition, others might be aware of the pool of individuals from which participants were drawn. However, we will not publish names in our reports on the national evaluation.

PERMISSIONS AND SIGNATURES

If you agree to join this study, please initial and sign your name below.

Permission to audio-record: Do you give permission to audio-record your interview? Digital recordings will be maintained in password-protected files for three years after completion of the project as suggested by the Institutional Review Board. The recordings will not be used for purposes unrelated to this evaluation.

_____YES Initials: ______

_____NO: Initials: ______

Signatures:

I have read this form and/or had it read, had the information explained to me, and I understand its contents. I have had all of my questions answered. I understand that by signing below, I am agreeing to participate in this evaluation project with my rights protected as described above.

_____________________________________________ ____________________

Subject's Signature Date

_____________________________________________

Subject’s Printed Name

_____________________________________________ ____________________

Witness to Consent Procedures** Date

____________________________________________

Witness’ Printed Name

_____________________________________________ ____________________

Principal Investigator Date

**If investigator is not the person who will witness participant's signature, then the person administering the informed consent should write his/her name and title on the "witness" line.

If you have any questions regarding this study, please email Dr. Suzanne Randolph ([email protected]) at The MayaTech Corporation or Ms. Valerie Spencer ([email protected]), President and Institutional Review Board Manager at MayaTech. Both also can be reached at The MayaTech Corporation, 8401 Colesville Road, Suite 430, Silver Spring, MD 20910; or by phone at (301) 587-1600.

THIS PROJECT HAS BEEN REVIEWED BY THE INSTITUTIONAL REVIEW BOARD FOR THE PROTECTION OF HUMAN PARTICIPANTS AT THE MAYATECH CORPORATION, SILVER SPRING, MD.

Application for Approval of Human Subjects Research 15