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Search / Trial NCT06182280

Transmaculine One-on-One and Group Empowerment for Targeted HIV Reduction

Launched by FENWAY COMMUNITY HEALTH · Dec 13, 2023

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Transgender Men Who Have Sex With Men Pre Exposure Prophylaxis Behavioral Intervention Hiv Prevention

ClinConnect Summary

The Transmaculine One-on-One and Group Empowerment for Targeted HIV Reduction trial is studying ways to help transgender masculine and gender diverse individuals who have sex with men (TMSM) better engage in HIV prevention services, specifically through a medication called PrEP. This study will look at the effects of different types of support: some participants will receive standard information about HIV prevention, while others will take part in either a one-on-one healthy lifestyle coaching session or a small group intervention tailored to their needs. Some participants will even receive both types of support. Researchers hope that these peer-led interventions will lead to more individuals starting and continuing to use PrEP compared to just receiving standard care.

To be eligible for this study, participants must be at least 18 years old, assigned female at birth, and identify as a man or a transmasculine person. They also need to have had sex with a partner assigned male at birth in the last three months and must be HIV-negative. Access to a smartphone or computer with internet is necessary, and participants must live in specific areas in the U.S. that are focusing on ending the HIV epidemic. If someone joins the study, they can expect to receive personalized support to help them understand and navigate their options for HIV prevention in a way that respects their unique experiences.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Age 18 or over
  • 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:
  • Less than age 18
  • 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

About Fenway Community Health

Fenway Community Health is a leading nonprofit organization dedicated to enhancing the health and well-being of LGBTQ+ individuals and other underserved populations through comprehensive healthcare services, research, and education. With a commitment to cultural competency and inclusivity, Fenway offers a wide range of services, including primary care, mental health services, and specialty care, while actively engaging in clinical trials that aim to advance medical knowledge and improve health outcomes. By fostering a supportive environment and prioritizing community health initiatives, Fenway Community Health strives to address health disparities and promote equitable access to quality care for all.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported