NCT06202898

Economic Navigation and Strengthening to Research Unrestricted Services for Transgender Women (ENTRUST)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: University of Central Florida · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall hypothesis is that stabilizing transgender women financially while providing them tailored counselling will increase their odds of them linking to substance use services, PrEP services if they do not have HIV, and transgender women who are living with HIV will be more adherent to their ART treatment.

Detailed description

There continues to be a gap in the extant literature on the relationship between substance abuse and achievement of viral suppression (VS) through adherent antiretroviral treatment (ART) or PrEP uptake among transgender women which warrants further investigation. Harmful alcohol and illicit drug use associated with substance use disorders (SUD) have been independently linked to condomless sex and hinder engagement in ending the HIV epidemic (EHE) prevention initiatives, including HIV retention in care and adherence to treatment to achieve viral suppression and PrEP use. Transgender women are among the most at risk group of sexually active populations, yet least likely to be aware of and/or use preexposure prophylaxis (PrEP) to prevent HIV transmission.5 PrEP and routine HIV/STI screening, are effective approaches to reduce HIV incidence in marginalized at-risk populations and are consistent with the US National HIV/AIDS strategy.

Conditions

• Transgender Women
• Aids
• Hiv

Interventions

Type	Name	Description
OTHER	Baseline	At the baseline visits, all study participants will be complete an interviewer-assisted questionnaire using REDCap, and will also receive the SBIRT-T MI-based intervention. Participants randomized to the ENTRUST intervention group will also be assigned to a cohort for strength sessions, and they will be provided with a schedule of strength session visits
OTHER	ENTRUST	Participants randomized to the ENTRUST intervention group will also be assigned to a cohort for economic strength sessions, group-based economic training through photovoice activities and adapted screening brief intervention and treatment (SBIRT-T) adapted for transgender women delivered by a facilitator or digitally.
OTHER	Control	participants assigned to the control arm will have the option of participating in the four additional strength sessions.

Timeline

• Start date: 2023-07-11
• Primary completion: 2025-11-01
• Completion: 2027-06-01
• First posted: 2024-01-12
• Last updated: 2024-12-06

Locations

1 site across 1 country: United States