An interventional study of Baseline and ENTRUST in Transgender Women, Aids and Hiv, sponsored by University of Central Florida. Recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by University of Central Florida · Not applicable, Interventional, and Prevention
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.
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.
2,099 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 273 are open to participants now.
This study's planned enrollment of 110 is close to the median of 104 across 1,590 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →University of Central Florida is the lead sponsor of 104 studies on the registry; 43 are open to participants now.
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Exclusion Criteria:
The proposed intervention 'ENTRUST' will address structural disparities transgender women encounter by providing skills to aid with economic navigation while simultaneously strengthening and improving social cohesion to increase the odds of them linking to care that is available to them.
Other: Baseline · Other: ENTRUST
Comparison control group.
Other: Baseline · Other: Control
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
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.
participants assigned to the control arm will have the option of participating in the four additional strength sessions.
Number of participants with substance abuse
The rate of change of substance abuse incidence for both arms
Time frame: 1 year
Rate of substance use in transgender women
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.
Time frame: 1 year
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Acquired Immunodeficiency Syndrome →
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