Adherence, Medication, HIV Infections
Conditions
Keywords
Transgender, Men who have sex with men, pre-exposure prophylaxis, behavioral intervention, HIV prevention
Brief 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. 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.
Interventions
BEHAVIORALPrEP4T
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.
BEHAVIORALLS4TM
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.
Sponsors
Fenway Community Health
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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 * 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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP uptake | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP adherence and persistence | 18 months | Measurement of PrEP use or disuse across the intervention and follow-up periods as measured by biomarker sampling collected by dried blood spots. |
Countries
United States
Outcome results
None listed