HIV InfectionsTOGETHRNCT06182280
Transmasculine One-on-One and Group Empowerment for Targeted HIV Reduction
A study testing PrEP4T and LS4TM in people with HIV Infections and Adherence, Medication, run by Fenway Community Health at 1 site in United States.
Trial summary
Transgender masculine and gender diverse people who have sex with men (TMSM) have an increased risk of human immunodeficiency virus (HIV) and face unique barriers engaging in prevention services. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Adherence, Medication
- What is being tested?
- PrEP4T and LS4TM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or over
- Identifies as a man, trans man, or another transmasculine identity
- Has had sex with a partner assigned male sex at birth with a flesh penis in the last 3 months
- Has access to a smartphone or computer with internet access
- Is HIV-uninfected
- Resides in one of the Ending the Epidemic targeted geographic hotspots in the United States
Show all 11Show fewer
- Willing and able to provide informed consent in English
- Meets CDC guidelines for PrEP indications in the last 3 months (adapted for TMSM) including:
- Condomless receptive vaginal/frontal or anal sex with a partner assigned male at birth with a flesh penis
- Sharing needles or syringes for illicit drug use and/or hormones
- Self-reported anogenital sexually transmitted infection diagnosis
Who cannot join
- Less than age 18
- Does not identify as a man, trans man, or another transmasculine identity
- Does not have access to a smartphone or computer
- Is living with HIV (HIV positive)
- Does not reside in one of the Ending the Epidemic geographic hotspots in the United States
- Will not or cannot provide written informed consent in English
- Does not meet the trans-adapted CDC guidelines for PrEP indications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strategies to Prevent HIV Acquisition Among Transgender Men Who Have Sex With Men (TMSM)
Transgender masculine and gender diverse people who have sex with men (TMSM) have an increased risk of human immunodeficiency virus (HIV) and face unique barriers engaging in prevention services. Digitally delivered support interventions addressing HIV prevention barriers delivered by peers in one-on-one or small-group settings may be effective at increasing pre-exposure prophylaxis (PrEP) engagement for HIV prevention. This study examines the independent and combined effects of individual and group-based peer-support interventions on PrEP outcomes. Participants will be randomly assigned to receive: (i) standard-of-care HIV prevention information, (ii) a one-on-one healthy lifestyle intervention tailored for transgender masculine people, (iii) a peer-group based healthy lifestyle intervention for transgender masculine people, or (iv) both the one-on-one and group-based interventions delivered together. The hypotheses are that the individual group-based interventions will result in higher PrEP uptake and persistence than the standard of care and that the combined interventions will be more effective than receiving one individual intervention.
Read the detailed description
This study will comprise a digitally delivered, open-label randomized 2x2 factorial trial (1:1:1:1 randomization) of peer-delivered HIV prevention strategies. The 2x2 factorial design has two actors: individualized, one-on-one peer navigation (PrEP for Transgender Men and Transmasculine People [PrEP4T] vs none) (Condition B) and group-based behavioral intervention (LifeSkills for Men [LS4TM] vs none) (Condition C). The trial will compare the efficacy of the interventions to increase PrEP uptake.
Participants in Conditions B and C will receive 6 weeks of their assigned intervention in addition to SOC. Participants in Condition D will be assigned to receive both interventions which may not occur simultaneously. Follow-up will continue another 15 months after the intervention ends to assess effects. In the final 6 months of this 5 years study, PrEP4T and LS4TM will be offered to all participants, regardless of study group assignment. We will ask which intervention participants prefer and gather implementation data.
Randomization and intervention allocation will be automated and computer-generated through an electronic system; the allocation sequence will be concealed. Stratified randomization by race/ethnicity (Black, Indigenous, and People of Color [BIPOC] and White) and Movement Advancement Project state lesbian, gay, bisexual, transgender, and queer (LGBTQ) equality policy tally (high, medium, or fair overall policy tally as of October 2023, and low or negative overall policy tally as of October 2023) will ensure balance across groups and allow subgroup analyses. Blinding will occur at the statistician and investigator levels, but is not possible for participants or staff in the intervention. Participants will be followed for 18 months.
- Conditions
- HIV Infections, Adherence, Medication
- Being tested
- PrEP4T, LS4TM
- Keywords
- Transgender, Men who have sex with men, pre-exposure prophylaxis, behavioral intervention, HIV prevention
- Medical subject headings
- HIV Infections, Medication Adherence, Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEP4TBehavioural
PrEP4T is an individualized TMSM-specific intervention adapted from The Fenway Model. PrEP4T consists of online one-on-one sessions between a peer and a participant using a strengths-based case management manualized curriculum. Peer navigators (PNs) share transmasculine community membership with participants and are trained to provide linkages. They use an individualized approach to navigate barriers, apply an assets-based frame to promote resiliencies, and pragmatically leverage these to improve biomedical HIV prevention outcomes. PNs utilize techniques from established behavior change models (e.g., Motivational Interviewing; Transtheoretical Model) in PrEP decision-making.
LS4TMBehavioural
LS4TM is a theory-based peer-delivered small group-based behavioral intervention to reduce HIV risk and address mental health-related effects of stigma for TMSM. Groups will be led by trained peer navigator staff and comprise no more than 10 participants per cohort.
| Study group | Role | What they receive |
|---|---|---|
| Condition A: Standard of Care (SOC) | No intervention | SOC will include linkage to the Centers for Disease Control and Prevention's (CDC) HIV Prevention Services Locator, a US directory of HIV testing and PrEP services. A Digital Library of HIV prevention, sexual health, and anti-stigma materials (written and video media) will be provided. This content is curated from CDC, Gate Trans Men \& HIV Project, the University of California, San Francisco's (UCSF) Center for Excellence in Trans Health, and National LGBTQIA+ Health Education Center, among other sources. |
| Condition B: Online one-on-one peer navigation (SOC + PrEP4T) | Experimental | PrEP4T is an individualized TMSM-specific intervention consisting of online one-on-one sessions between a peer and a participant. PrEP4T has 9 hours of content: 6 1.5-hour sessions conducted weekly for 6 weeks. Participants will also receive access to the SOC materials. Receives: Behavioral: PrEP4T |
| Condition C: Online peer-delivered small group-based behavioral intervention (SOC + LS4TM) | Experimental | LS4TM is a theory-based peer-delivered small group-based behavioral intervention. The LS4TM manualized intervention is comprised of 9 hours of content: 6 2-hour small-group sessions with up to 12 participants per group delivered weekly for 6 weeks. Participants will also receive access to the SOC materials. Receives: Behavioral: LS4TM |
| Condition D: Peer-delivered and group-based intervention (SOC + PrEP4T + LS4TM) | Experimental | Both PrEP4T and LS4TM will be delivered to participants. Group D will receive 21 hours of content: 6 2-hour LS4TM sessions and 6 1.5-hour PrEP4T sessions. Group D participants may not receive both interventions simultaneously within 6 weeks. Receives: Behavioral: PrEP4T; Behavioral: LS4TM |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP uptake
Uptake of new PrEP prescriptions during the study intervention and follow-up period as measured by biomarker sampling collected by dried blood spots.
Measured: 18 months
Secondary outcomes (1)
PrEP adherence and persistence
Measurement of PrEP use or disuse across the intervention and follow-up periods as measured by biomarker sampling collected by dried blood spots.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start1 Apr 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The 2x2 factorial design has two actors: individualized, one-on-one peer navigation (PrEP4T vs none) and group-based behavioral intervention (LS4TM vs none). The comparator is standard-of-care information and resources on HIV prevention and linkage to care.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fenway Community Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Sari Reisner, ScD, Fenway Community Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182280
- Sponsor's protocol ID
- 1R01MH129175-01A1
- Acronym
- TOGETHR
- Status last verified
- Aug 2026
- First submitted
- 13 Dec 2023
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reisner SL, Scheim AI, Cole SW, Wirtz AL, Poteat T, Mimiaga MJ, Marzinke MA, Meyer AI, Smith K, Pletta DR, Mayer KH. Transgender Men and Transmasculine One-on-One and Group-Delivered Empowerment for Targeted HIV Reduction (TOGETHR) Study: Protocol for a Digital Factorial Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 20;14:e76831. doi: 10.2196/76831.
PubMed 41115262
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies to Prevent HIV Acquisition Among Transgender Men Who Have Sex With Men (TMSM)
- ClinicalTrials.gov ID
- NCT06182280
- Acronym / sponsor ID
- TOGETHR / 1R01MH129175-01A1
- Conditions
- HIV Infections, Adherence, Medication
- Keywords
- Transgender, Men who have sex with men, pre-exposure prophylaxis, behavioral intervention, HIV prevention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Fenway Community HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 26 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Transgender masculine and gender diverse people who have sex with men (TMSM) have an increased risk of human immunodeficiency virus (HIV) and face unique barriers engaging in prevention services. Digitally delivered support interventions addressing HIV prevention barriers delivered by peers in one-on-one or small-group settings may be effective at increasing pre-exposure prophylaxis (PrEP) engagement for HIV prevention. This study examines the independent and combined effects of individual and group-based peer-support interventions on PrEP outcomes. Participants will be randomly assigned to receive: (i) standard-of-care HIV prevention information, (ii) a one-on-one healthy lifestyle intervention tailored for transgender masculine people, (iii) a peer-group based healthy lifestyle intervention for transgender masculine people, or (iv) both the one-on-one and group-based interventions delivered together. The hypotheses are that the individual group-based interventions will result in higher PrEP uptake and persistence than the standard of care and that the combined interventions will be more effective than receiving one individual intervention.
Detailed description
This study will comprise a digitally delivered, open-label randomized 2x2 factorial trial (1:1:1:1 randomization) of peer-delivered HIV prevention strategies. The 2x2 factorial design has two actors: individualized, one-on-one peer navigation (PrEP for Transgender Men and Transmasculine People [PrEP4T] vs none) (Condition B) and group-based behavioral intervention (LifeSkills for Men [LS4TM] vs none) (Condition C). The trial will compare the efficacy of the interventions to increase PrEP uptake.
Participants in Conditions B and C will receive 6 weeks of their assigned intervention in addition to SOC. Participants in Condition D will be assigned to receive both interventions which may not occur simultaneously. Follow-up will continue another 15 months after the intervention ends to assess effects. In the final 6 months of this 5 years study, PrEP4T and LS4TM will be offered to all participants, regardless of study group assignment. We will ask which intervention participants prefer and gather implementation data.
Randomization and intervention allocation will be automated and computer-generated through an electronic system; the allocation sequence will be concealed. Stratified randomization by race/ethnicity (Black, Indigenous, and People of Color [BIPOC] and White) and Movement Advancement Project state lesbian, gay, bisexual, transgender, and queer (LGBTQ) equality policy tally (high, medium, or fair overall policy tally as of October 2023, and low or negative overall policy tally as of October 2023) will ensure balance across groups and allow subgroup analyses. Blinding will occur at the statistician and investigator levels, but is not possible for participants or staff in the intervention. Participants will be followed for 18 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The 2x2 factorial design has two actors: individualized, one-on-one peer navigation (PrEP4T vs none) and group-based behavioral intervention (LS4TM vs none). The comparator is standard-of-care information and resources on HIV prevention and linkage to care.
| Arm | Type | Receives |
|---|---|---|
| Condition A: Standard of Care (SOC) | No intervention | –SOC will include linkage to the Centers for Disease Control and Prevention's (CDC) HIV Prevention Services Locator, a US directory of HIV testing and PrEP services. A Digital Library of HIV prevention, sexual health, and anti-stigma materials (written and video media) will be provided. This content is curated from CDC, Gate Trans Men \& HIV Project, the University of California, San Francisco's (UCSF) Center for Excellence in Trans Health, and National LGBTQIA+ Health Education Center, among other sources. |
| Condition B: Online one-on-one peer navigation (SOC + PrEP4T) | Experimental | Behavioral: PrEP4TPrEP4T is an individualized TMSM-specific intervention consisting of online one-on-one sessions between a peer and a participant. PrEP4T has 9 hours of content: 6 1.5-hour sessions conducted weekly for 6 weeks. Participants will also receive access to the SOC materials. |
| Condition C: Online peer-delivered small group-based behavioral intervention (SOC + LS4TM) | Experimental | Behavioral: LS4TMLS4TM is a theory-based peer-delivered small group-based behavioral intervention. The LS4TM manualized intervention is comprised of 9 hours of content: 6 2-hour small-group sessions with up to 12 participants per group delivered weekly for 6 weeks. Participants will also receive access to the SOC materials. |
| Condition D: Peer-delivered and group-based intervention (SOC + PrEP4T + LS4TM) | Experimental | Behavioral: PrEP4T, Behavioral: LS4TMBoth PrEP4T and LS4TM will be delivered to participants. Group D will receive 21 hours of content: 6 2-hour LS4TM sessions and 6 1.5-hour PrEP4T sessions. Group D participants may not receive both interventions simultaneously within 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 or over
- Identifies as a man, trans man, or another transmasculine identity
- Has had sex with a partner assigned male sex at birth with a flesh penis in the last 3 months
- Has access to a smartphone or computer with internet access
- Is HIV-uninfected
Key exclusion criteria (7 listed)
- Less than age 18
- Does not identify as a man, trans man, or another transmasculine identity
- Does not have access to a smartphone or computer
- Is living with HIV (HIV positive)
- Does not reside in one of the Ending the Epidemic geographic hotspots in the United States
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrEP4TPrEP4T is an individualized TMSM-specific intervention adapted from The Fenway Model. PrEP4T consists of online one-on-one sessions between a peer and a participant using a strengths-based case management manualized curriculum. Peer navigators (PNs) share transmasculine community membership with participants and are trained to provide linkages. They use an individualized approach to navigate barriers, apply an assets-based frame to promote resiliencies, and pragmatically leverage these to improve biomedical HIV prevention outcomes. PNs utilize techniques from established behavior change models (e.g., Motivational Interviewing; Transtheoretical Model) in PrEP decision-making. | Behavioural | Condition B: Online one-on-one peer navigation (SOC + PrEP4T), Condition D: Peer-delivered and group-based intervention (SOC + PrEP4T + LS4TM) |
| LS4TMLS4TM is a theory-based peer-delivered small group-based behavioral intervention to reduce HIV risk and address mental health-related effects of stigma for TMSM. Groups will be led by trained peer navigator staff and comprise no more than 10 participants per cohort. | Behavioural | Condition C: Online peer-delivered small group-based behavioral intervention (SOC + LS4TM), Condition D: Peer-delivered and group-based intervention (SOC + PrEP4T + LS4TM) |
Primary outcome
PrEP uptake
Time frame: 18 months
Uptake of new PrEP prescriptions during the study intervention and follow-up period as measured by biomarker sampling collected by dried blood spots.
1 secondary outcome
PrEP adherence and persistence
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Derived from this study: PubMed 41115262Reisner SL, Scheim AI, Cole SW, Wirtz AL, Poteat T, Mimiaga MJ, Marzinke MA, Meyer AI, Smith K, Pletta DR, Mayer KH. Transgender Men and Transmasculine One-on-One and Group-Delivered Empowerment for Targeted HIV Reduction (TOGETHR) Study: Protocol for a Digital Factorial Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 20;14:e76831. doi: 10.2196/76831.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrEP4T and LS4TM in people with HIV Infections and Adherence, Medication, run by Fenway Community Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP uptake (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06182280, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.