You will be paid for your participation in this research study. We will pay you:

• $30 each time you complete a full-length survey at baseline, 3, 6, 12, and 18 months.  
• $10 each time you complete a short survey at 9 months and 15 months.
• $20 for each HIV test kit you complete and return.  
• $10 for each intervention session (virtual peer navigation and/or virtual peer support group) you attend.  
• $50 if you are selected for an interview and you choose to participate.

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Depending on what group you are randomly assigned to, you may be asked to complete no intervention sessions, 6 intervention sessions, or 12 intervention sessions. If you are asked to repeat the baseline survey and home test kit, you will be paid again. You may or may not be asked to participate in the 9-month interview. You will not be paid for the optional intervention sessions in months 12-18 of the study.

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You will receive payment in the form of a pre-paid gift card called ClinCard. You will receive the physical card in the mail at your preferred address. Your payment will be loaded onto the card shortly after each of your visits. We will pay you using the same card throughout the entire study, so we suggest keeping it in a safe location. If your card is lost, stolen, or damaged please contact one of the study staff members and we will mail you another card. Any balance you had on the original card will automatically transfer to the new card. However, we cannot replace money that was spent on a lost or stolen card.

Participation in the study can last up to 18 months (about 1.5 years). Below is a summary of the study activities. All study activities will be done online digitally through a platform like Zoom. All sample collections (HIV testing) will be done from your home.

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Study activities include:

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Online survey (about 30 minutes):  

We will ask you to complete an online survey. The survey will ask questions about your background, health, sex life, mood, stressors, attitudes, alcohol/drug use, and other experiences. It will include questions about experiences of discrimination or mistreatment. You will complete online surveys at your first visit (baseline) and 3, 6, 12, and 18 months. Though all the same topics will be covered, the baseline and 6-month surveys will be slightly different. In the first survey, we will want to see what information you may already know before one of the interventions. In the 6-month survey, we will ask about your experiences with the intervention you were assigned to. These surveys will be sent to you by email.

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Short online survey (approximately 15 minutes):  

We will ask you to complete a short survey to monitor PrEP use. You will complete these surveys at months 9 and 15. These will be sent to you through your preferred method of contact.

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Blood sample collection (about 15 minutes):  

You will receive a discrete blood sample collection kit in the mail from Molecular Testing Labs (MTL), using the name and mailing address that you provide. You should receive the kit through the US Postal Service within 2-3 days of the order being placed by study staff. Your first (baseline) kit should be returned within 1 week of the delivery date. Additionally, all samples should be shipped to the lab within 5 days of collection to make sure the sample is testable. We encourage you to mail your kit the same day you complete it.

The kit includes:

• Materials and instructions to prick your finger and collect drops of your blood on a storage card.
• A pre-paid envelope for free return shipping to the lab.  

Once you collect your sample, you will mail the card to the laboratory in the pre-paid envelope. You can return the sealed package to any mailbox or a post office location near you. After you mail your kit, the lab will receive it within 2-3 days. The lab will screen all returned samples for HIV and test for the level of PrEP in your blood. All of the materials you send to MTL and the results they release will be identified by your study ID number or a kit ID number. Your name will only be on the mailing materials, not on the lab report.

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HIV results delivery:  

Each blood collection kit you complete will be tested for HIV. Results are typically returned within 7 days. When your results are ready, study staff will contact you at your preferred phone number. The kit will also be tested for PrEP medication (presence of the medication in your blood). The PrEP levels testing process is different and does not generate results to deliver.

A note about this kind of HIV testing: If the sample tests positive for HIV antigens and antibodies, it does not mean you have been diagnosed with HIV. Another test is needed to confirm that result. Should this occur, study staff will help connect you to testing services near you. Once connected, you will schedule the additional test with the testing site. Based on those results, your healthcare team will help you plan for any needed care. The clinic or other testing site is required to report a positive result to your state health department. They do this so that public health officials can monitor what’s happening with the HIV epidemic in your city and state. Many states and some cities have partner-notification laws. These laws require someone who tests positive for HIV (or their healthcare provider) to tell their sex or needle-sharing partner(s). A positive HIV diagnosis ends your study participation, but we will keep your study data that we have already collected.  

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Intervention:  

You will be randomly assigned to 1 of 4 study groups. Intervention activities range from none to 3.5 hours per week for 6 weeks, depending on the study group you are assigned to. These activities may include one-on-one peer navigation, group discussions, both, or neither. Everyone will also have access to a website with information about HIV services and PrEP.

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Study Schedule:

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First (baseline) study visit (total time 45 minutes):

• Online survey – must be completed within 1 week of visit
• Blood sample collection – must be completed within 1 week of delivery date and within 5 days of collection date

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HIV test results and randomization (total time 20 minutes):

• When we deliver your HIV test result and you are confirmed to be HIV-negative, we will randomly assign you to one of the 4 study groups. You will be assigned by chance (like the flip of a coin, or the drawing of a lottery). We do not have any control over which group you are assigned to.  
• As a reminder, the groups are:

• Group A (total time varies): Access to a website with information about HIV services and PrEP. You will have the option of reviewing the provided materials as often as you want.
• Group B (9 hours over 6 weeks): One-on-one peer support and access to the website. There will be one (1) one-on-one peer session that lasts 90 minutes once a week for 6 weeks.  

• Group C (12 hours over 6 weeks): Small group-based support and access to the website. There will be one (1) small-group peer session that lasts 2 hours once a week for 6 weeks. You may have to wait for a group to form. If your group hasn’t begun before your 6-month follow-up, you will be asked to complete a new baseline survey and DBS kit. If this happens, you will be compensated for your second baseline survey and home test kit.
• Group D (18 hours over 6-12 weeks): One-on-one peer support, small group-based support, and a website with information about HIV services and PrEP. You will be asked to complete all of the sessions described for Groups B and C. You may have to wait for a group to form so you may not participate in both interventions at the same time.

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Month 3 (total time 45 minutes):

• Online survey

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Months 6, 12, and 18 (total time 45 minutes each):

• Online survey
• Blood sample collection  

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Months 9 and 15 (total time 15 minutes each):

• Short online survey

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Month 9 interview (total time 1-1.5 hours):  

• We plan to ask some participants to complete an interview. Interview selection will not be random, but instead based on certain study characteristics. We will select both participants who are taking PrEP and participants who aren’t taking PrEP from each study group.
• During the interview, we will ask questions about the materials you were given and your thoughts on HIV prevention and PrEP use. The interview will take place online. The audio will be recorded and transcribed using Zoom’s automated audio transcription feature so that the study staff can remember what is said.  
• Not everyone who participates in the study will be asked to interview.

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Months 12-18 optional peer and small-group sessions (total time varies):

• After you complete your study assigned group strategy, you can choose to take part in one-on-one peer navigation sessions, small-group sessions, or both. This is so that you can have a chance to learn and experience the same things as other participants in the study. These sessions will cover the same material and take the same amount of time as described above.  

• You do not need to take part in these optional sessions to take part in the study. These optional sessions are not compensated.

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Missed Activities:

• You will be asked to complete online surveys every 3-6 months while in the study. If necessary, you may complete a survey up to 3 months before or 3 months after the due date for your next follow-up. This excludes the baseline survey, which must be completed within 1 week.
• You may be assigned to participate in small-group sessions. If you cannot attend a session, you will receive a summary sheet summarizing the missed session. The summary will be sent through your preferred contact method.

If you are interested in participating, study staff will check whether you live in an EHE priority hotspot when you complete the screener to check eligibility.  

If you would like to check ahead of time, you can consult the CDC’s list of EHE priority hotspots here.

To participate in the TOGETHR study, you must meet the following requirements:

• Are 18 years or older.
• Are a transgender man or transmasculine (ex. nonbinary, genderqueer, genderfluid, etc.) and assigned a female sex at birth.  
• Are sexually active with one or more partners who have a penis and were assigned a male sex at birth.
• Have access to a smartphone or computer with internet access.
• Are HIV-negative.
• Have had certain kinds of sex, shared injection supplies, and/or been diagnosed with a sexually transmitted infection in the last 3 months.
• Live in an Ending the HIV Epidemic (EHE) priority hotspot.  
• Are comfortable reading and conversing in English.

The transgender community is well represented in the TOGETHR study staff, with trans researchers working in various roles on the team, including as staff and three of the study investigators. The TOGETHR study also has a Community Advisory Board (CAB) of community members who use their lived experience to provide ongoing guidance and feedback to the project.

The purpose of the study is to learn more about how effective different peer-to-peer strategies are at preventing HIV and supporting pre-exposure prophylaxis (PrEP) access in transgender men and transmasculine people. PrEP is a prescription medication that reduces the risk of acquiring HIV.

We will use what we learn from this study to create better tools to help support the sexual health and well-being of transgender men and transmasculine people.

This study is for transgender men and transmasculine people (ex. nonbinary, genderqueer, genderfluid, etc. and assigned a female sex at birth) who are sexually active with one or more partners who have a penis and were assigned a male sex at birth.