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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Number of participants with substance abuse [Time frame: 1 year]

Secondary outcome measures (1)

• Rate of substance use in transgender women [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

• Aged ≥18 years
• Male at birth
• Identify as a woman/transgender woman
• Should not be consistently using PrEP (less than four doses per week)
• Should not have any known allergy or adverse reaction to PrEP or the active drug tenofovir in ART. One of the goals of the study is to move more people into a PrEP program
• Be able to speak and understand spoken English and/or Spanish (including persons who cannot read or write)
• Have a smart phone that can take pictures

Exclusion criteria

• Unwilling to adhere to study procedures
• Participation in an HIV vaccine trial
• Have a life-threatening SUD\*
• Any condition, that in the opinion of the study staff, would make participation in the study unsafe, or interfere with achieving the study objective such as medical conditions which prevents the use of PrEP
• Unable to provide consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• University of Central Florida — Orlando

Identifiers

NCT: NCT06202898 · STUDY00005488

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗