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NCT Number: NCT06202898

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baseline

Other

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

ENTRUST

Other

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.

Control

Other

participants assigned to the control arm will have the option of participating in the four additional strength sessions.

Primary outcomes

  1. Number of participants with substance abuse

    Time frame: 1 year

    The rate of change of substance abuse incidence for both arms

Secondary outcomes

  1. Rate of substance use in transgender women

    Time frame: 1 year

    The rate of stabilizing transgender women financially while providing them tailored counselling to increase their odds of them linking to substance use services, pre-exposure prophylaxis (PrEP) services if they do not have HIV, and transgender women who are living with HIV to be more adherent to their antiretroviral therapy (ART) treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Amoy Fraser, PhD, CCRP, PMP

CONTACT

[email protected]

4072668742

Elena Cyrus, PhD

CONTACT

[email protected]

4072661507

Sponsors and collaborators

Lead sponsor

University of Central Florida

Other

Collaborators

  • 26Health
  • National Institute of Drug Abuse
  • Sunserve
  • Survivor's Pathway

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Jan 12, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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