Transmaculine One-on-One and Group Empowerment for Targeted HIV Reduction
NCT ID: NCT06182280
Last Updated: 2023-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
375 participants
INTERVENTIONAL
2024-01-31
2027-06-30
Brief Summary
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Detailed Description
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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 (BIPOC and white) and Movement Advancement Project state 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.49 Blinding will occur at the statistician and investigator levels, 50 but is not possible for participants or staff in the intervention. Participants will be followed for 18 months.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
DOUBLE
Study Groups
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Condition A: Standard of Care (SOC)
SOC will include linkage to the CDC's 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, UCSF Center for Excellence in Trans Health, and National LGBTQIA+ Health Education Center, among other sources.
No interventions assigned to this group
Condition B: Online one-on-one peer navigation (SOC + PrEP4T)
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.
PrEP4T
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.
Condition C: Online peer-delivered small group-based behavioral intervention (SOC + LS4TM)
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.
LS4TM
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.
Condition D: Peer-delivered and group-based intervention (SOC + PrEP4T + LS4TM)
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.
PrEP4T
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.
LS4TM
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.
Interventions
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PrEP4T
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.
LS4TM
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.
Eligibility Criteria
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Inclusion Criteria
* Assigned female sex at birth
* 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
* 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
Exclusion Criteria
* Not assigned female sex at birth
* 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
18 Years
FEMALE
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Fenway Community Health
OTHER
Responsible Party
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Sari Reisner, ScD
Principal Investigator
Locations
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Fenway Community Health
Boston, Massachusetts, United States
Countries
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Facility Contacts
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Sari Reisner, ScD
Role: primary
Kevin Smith, PhD
Role: backup
References
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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.
Other Identifiers
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