Model Consent Form

Appendix E Model Consent Form

English Version; Grade Reading Level by Flesch-Kincaid Method: 7.9

National HIV Behavioral Surveillance

Model Consent Form

The [Agency Name] and the Centers for Disease Control and Prevention (CDC) invite you to be part of a project about HIV in your community. The information I will give you can help you make a good choice about joining the project.

A. Why we are doing this project

The purpose of this project is to learn about risk for HIV. We will use this information to plan better HIV prevention and treatment programs for people in your community. This project is private which means that I will not ask for your name and no one will be able to identify you or connect your responses to you. Being in this project is voluntary.

B. What will happen

If you agree to be in this project, this is what will happen.

1. You will do an interview with a trained staff member. The questions will ask about your health, drug use, sex practices, and HIV prevention services. It will take about 40 minutes. At the end of the interview, you may be offered a chance to recruit up to 5 other people for this project.

2. If you agree to the interview, we will offer you a free HIV test. If you already know that you have HIV, we would still like to offer you an HIV test so that we can link the HIV test result with your interview responses.

3. [For sites doing blood-based testing] If you agree to an HIV test, you will also be asked to have your blood sample stored.

4. [For sites doing hepatitis testing] We will also offer you free hepatitis B and C testing.

5. [For sites doing STI testing] We will also offer you free gonorrhea and chlamydia testing. If you agree to the STD testing, you will also be asked to have your leftover STD samples stored.

[Insert a description of how testing will take place either in-person or remotely. This information should be clear and concise while including details that the participant should understand before consenting to testing, such as what options are available for them to obtain a test and whether and when a separate testing appointment will need to be scheduled.]

If you agree to the HIV test [insert names of additional tests offered, if applicable], you will have about a 10-minute prevention counseling session with a trained staff member. The session will cover the meaning of results from the HIV test [insert names of additional tests offered, if applicable]. You will also learn about how to reduce your chances of being infected with HIV and other infectious diseases. You will get referrals for additional testing and services, if needed. You will NOT get medical treatment in this project.

The HIV test will be done by rapid test.

[For sites doing one Rapid Test with local Laboratory Testing]

Rapid Test

We will [stick the tip of one of your fingers to obtain a few drops of blood/draw less than 1 tablespoon of blood]. You can get the result of your HIV test within [1 hour/maximum time for the specific test used]. If the rapid test result is reactive, or if you already know you have HIV, we will [draw less than 1 tablespoon of your blood by needle/stick the tip of one of your fingers to obtain a few drops of blood/use the blood we drew for the rapid test] for a second test to confirm your rapid test result. The result of the confirmatory test will be ready within one week. We will set up a day and time for you to get your results. [For sites that allow HIV test phone results: If you prefer, you can arrange to receive your counseling and confirmatory test results by telephone.]

[For sites doing only the one Rapid Oral Self-Test]

Rapid Test

The oral rapid HIV test will be self-collected and performed by you. [If performed during a testing appointment] A staff member will guide you in performing the test. Do not eat, drink, or use oral care products within the 30 minutes before starting the test. You will gently swipe the test swab along your upper gums once and lower gums once. You can get the result of your HIV test within 20-40 minutes.

[For sites doing the Rapid Test Algorithm]

Rapid Test Algorithm

We will [draw less than 1 tablespoon of blood/stick the tip of one of your fingers to obtain a few drops of blood]. You can get the result of your HIV test within [1 hour/maximum time for the specific test used]. If the first rapid test is reactive, we will do a second rapid test to confirm your results. For the additional rapid test, we will [use the blood we drew for the first test/stick the tip of one of your fingers to obtain a few drops of blood]. If you already know you have HIV, we may only do one rapid test. [For sites required/choosing to do laboratory confirmation in addition to the algorithm] Finally, we will use the blood to confirm your rapid test result in a laboratory. The result of the test will be ready within one week. We will set up a day and time for you to get your results. [For sites that allow HIV test phone results: If you prefer, you can arrange to receive your counseling and confirmatory test results by telephone.]

[For sites doing hepatitis B and C tests]

Hepatitis B and C tests

We will offer you free screening for hepatitis B and C infection. We will perform a rapid hepatitis C antibody test at the same time as performing the finger prick for your rapid HIV test. Additionally, we will collect a blood sample (about 2 teaspoons) with a needle from your veins. You can get the result of your rapid hepatitis C test within [20-30 minutes/maximum time for the specific test used.] If the rapid test is positive, that only tells us that you have ever been exposed to hepatitis C. Additional tests are needed to tell us whether you have hepatitis C right now and whether you have hepatitis B. The result of the additional hepatitis tests will be ready within [two weeks/maximum time for local lab to return results]. We will set up a day and time for you to get your results. [For sites that allow hepatitis test phone results: If you prefer, you can arrange to receive your counseling and test results by telephone.]

[For sites doing STI tests]

Gonorrhea and chlamydia tests

We may offer you free screening for gonorrhea and chlamydia. This STD testing involves swabbing the back of your throat and gently inserting a swab in your rectum (butt) to self-collect the samples. We will also ask you urinate into a cup. The results of the gonorrhea and chlamydia tests will be ready within two weeks. We will set up a day and time for you to get your results. [For sites that allow gonorrhea and chlamydia test phone results: If you prefer, you can arrange to receive your results by telephone.]

[Include any additional test to be offered].

Linkage

We will link your test results with your interview responses so we can learn about sexual and drug-use risk behaviors known to be connected with HIV infection. We will link your test results using the same ID assigned to the interview. Your name will not be on the test results or the interview. No one besides you will be told your test results, and neither your interview responses nor the test will be placed in any medical record.

[For sites doing Storage for Additional Tests]

Storage for Additional Tests

As part of today’s testing, we would like to store your test sample(s) that is blood [for sites offering STI testing: and other body fluids] for testing we will do in the future. We will store your sample(s) with some data about you, such as your age and race. We will not put your name on the sample(s) and there will be no way to know it is yours: thus, we will not be able to report back any results to you. We will not use your sample(s) for cloning. You can decline to let us store your sample(s) and still be in this project. If you do not wish to have us store your sample(s), your sample(s) will be destroyed after the specific testing you agree to is completed. If you agree to have us store your sample(s), we will destroy your sample(s) within 10 years.

C. Things to consider

There are minimal risks from being in this project:

1. Some of the questions in the interview are about sex and drugs and may make you feel uncomfortable.

2. [For sites conducting blood-based testing]: [The fingerstick/Drawing blood] may cause temporary discomfort from the needle stick, bruising, bleeding, light-headedness, and local infection.

3. [For sites conducting oral-based HIV testing] Collecting an oral sample may cause tingling of the gums or mouth or temporary discomfort.

3. [For sites offering STI testing] Collecting pharyngeal (throat) samples may cause gagging and temporary discomfort. Collecting rectal (butt) samples may cause temporary irritation, discomfort, and mild bleeding. Collecting a urine sample does not pose a physical risk.

4. You may feel uncomfortable finding out you might have been infected with HIV [or diseases tested for].

5. If your HIV test result [for sites offering STI testing: or STD test results] [for sites offering hepatitis testing: or hepatitis test results] is/are negative, there is a slight chance that the results are wrong and that you could still be infected.

D. Benefits

Benefits you may get from being in this project include:

1. You will receive condoms and information on HIV/AIDS and STDs.

2. You will receive free referrals to other local programs, as needed.

3. If your HIV [or additional tests offered] results are positive, you will receive counseling about ways to prevent the spread of infection and you will be able to talk about your concerns, if you wish. You will also be referred for medical care.

4. If your test results are negative, you will receive counseling on how to prevent future infections.

E. Alternatives

If you choose not to take part in the project but would like to take an HIV test [or additional tests offered], we will inform you of agencies or organizations that provide testing.

F. Compensation

For completion of the interview, you will get [interview incentive]. If you take part in the HIV test, you will get an additional [HIV test incentive]. You may also get [recruitment incentive] each for up to 5 people whom you send to us for the project. [If you take part in other tests offered, you will get (incentives for additional tests offered if applicable)].

G. Persons to Contact

This project is run by: [name of principal investigator and phone number]. You may call them with any questions about being in this project.

If you have questions about your rights as a participant or if you feel that you have been harmed, contact [IRB committee or contact name and phone number].

If you want one, you will get a copy of this form to keep.

H. Confidentiality Statement

This project is private; we will not ask your name. Your responses and test results will be labeled with a project number only. The project staff at [Agency name] and CDC will have access to the interview and testing data. Other collaborators will have access to the interview and testing data, but will not be allowed to see any information that could identify you. Your responses will be grouped with interview responses from other persons.

If you know your interviewer, you may ask for another staff member so that your answers will be fully private.

[For sites collecting contact information] We may need your phone number and/or email address to offer you easy ways to participate in the interview or testing. Contact information will be kept separate from the interview and testing data and only limited staff will have access to that information. Once the interview and testing are completed and results are returned, we will destroy your contact information. If you prefer to not provide this information, we can discuss how you might participate without providing contact information.

I. Costs

You will not be charged for counseling, the HIV test [any additional tests offered], safer sex and HIV prevention materials, referrals to appropriate agencies, or any other services provided by this project. [For sites offering remote interviews] If you use a cell phone for your interview [if applicable] or testing appointment, your phone plan might charge you for phone minutes or data use, depending on your plan. We will not reimburse you for phone minutes or data use charges you may incur during participation.

J. Right to Refuse or Withdraw

Participation in this project is completely VOLUNTARY. You are not giving up any legal claims or rights for being a part of this project. If you agree to participate, you are free to quit at any time. You may refuse to answer any question. You can choose to only do the interview and not to have an HIV test [or any additional tests offered]. You can also choose not to recruit others.

K. Agreement

Do you have any questions?

Interviewer: Answer the participant’s questions before proceeding to the next question.

You have read or had read to you the explanation of this project, you have been given a copy of this form, the opportunity to discuss any questions that you might have and the right to refuse participation. I am going to ask for your consent to participate in this project.

(Consent will be documented by the interviewer as follows:)

Do you agree to take part in the interview?

¨ Yes

¨ No

If yes:

Do you agree to HIV counseling and testing?

¨ Yes

¨ No

Do you agree to hepatitis testing (if offered)?

¨ Yes

¨ No

Do you agree to STD testing (if offered)?

¨ Yes

¨ No

Do you agree to let us store some of your test sample(s) for future testing?

¨ Yes

¨ No

If declined:

We’re interested in knowing why people do not want to do this project. Would you mind telling me which of the following best describes the reason you do not want to do this project?

You don’t have time….……………………………….……....  1

You don’t want to talk about these topics…………………  2

Some other reason……………..……………….................  3

You’d rather not say why….…………………….……...............  9

NHBS-Trans Model Surveillance Protocol E-9

Version Date: May 31, 2021