Strategies to Prevent HIV Acquisition Among Transgender Men Who Have Sex With Men (TMSM)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- PrEP uptake
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: PrEP4T (Behavioral)
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.
干预措施: LS4TM (Behavioral)
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.
干预措施: PrEP4T (Behavioral)
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.
干预措施: LS4TM (Behavioral)
Condition A: Standard of Care (SOC)
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.
结局指标
主要结局
PrEP uptake
时间窗: 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.
次要结局
- PrEP adherence and persistence(18 months)
研究者
Sari Reisner, ScD
Principal Investigator
Fenway Community Health