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OpenTrials
Completed

NCT Number: NCT03877497

To Reach Unrestricted Services for Transgender Women

Florida has the fifth largest transgender population in the United States. Transgender women, particularly those of color, in the southern part of Florida are a marginalized population who are impacted by co-morbidities of substance abuse and HIV in their communities. The overall objective of the study is to use a vetted adapted brief intervention to stem the development of substance abuse in at-risk transgender women, and thereby increase primary and secondary prevention methods such as routine HIV screening, uptake of pre-exposure prophylaxis (PrEP) and use of non-occupational post-exposure prophylaxis (nPEP).

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Key information

About this study

Background: Transgender women are disproportionally affected by substance abuse and HIV. Evidence-based interventions that can address both issues simultaneously may efficiently improve the overall health of transgender women and reduce burdensome health and societal costs associated with substance abuse and HIV. In South Florida, the majority of transgender women identify as Black or Latina, or transgender women of color (TWOC). TWOC are at highest risk for substance abuse and HIV acquisition, due to multiple external stressors arising as a consequence of being a gender minority, and also a racial/ethnic minority. Studies have demonstrated Screening, Brief Intervention, and Referral to Treatment (SBIRT) to be effective in mitigating development of substance use disorders (SUD) in other at-risk, marginalized populations. An adapted culturally-tailored SBIRT focused on linkage to substance use services and HIV pre- and post-exposure prophylaxis (PrEP and nPEP) may effectively reduce the odds of individuals in this special population developing a SUD and also facilitate their voluntary election of HIV screening and use of PrEP/nPEP for HIV prevention. Objectives: K99 -In preparation for the independent phase, the career development phase will include training in qualitative research methods and intervention development. R00 - In the independent phase, the study objectives will be to (a) use a mixed-methods approach to obtain formative data among 40 transgender women that will aid in adapting and developing an adapted culturally tailored SBIRT intervention (SBIRT-A), (b) pre-test and refine SBIRT-A in 15 transgender women based on formative work and, (c) pilot test SBIRT-A in a sample of 76 transgender to assess feasibility and acceptability. Pilot Design: Randomized trial among 76 adult (18 years or older) HIV uninfected transgender women at moderate risk for developing a substance use disorder who will be randomized to either SBIRT-A or the control condition (INFO-C). The INFO-C group will be a time-matched comparison control where information will be provided on substance use and PrEP services in a non-SBIRT format via printed and audio-visual study material. There will be a follow-up visit in three months to assess linkage, and barriers and facilitators to substance use services and PrEP/nPEP. Analysis: Bivariate difference tests (chi square and t-tests) will be used to test differences between SBIRT-A and INFO-C participants for the primary outcome measures (linkage to substance use services, PrEP, and nPEP) at the three-month visit. Multivariate binary logistic regressions (post- and pre-intervention) will be used to determine substance use as a predictor of (1) HIV/STI screening in the past three months and (2&3) PrEP and nPEP uptake in the past three months. Significance: Results derived from this study will help elucidate the relationship between substance use and HIV among transgender women, including TWOC, in South Florida, and will provide evidence for a larger study that can test the efficacy of SBIRT-A to reduce prevalence of substance abuse and HIV in this special population. The aims of this study are parallel to the NIH/National Institute on Drug Abuse (NIDA) strategic plan to decrease HIV/AIDS health disparities, prevent HIV transmission, and better understand the interaction of drug abuse and HIV/AIDS.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Transgender woman over the age of 18
  • HIV uninfected
  • no current substance abuse use according to AUDIT and SBIRT criteria

Exclusion criteria

  • HIV infected transgender woman
  • evidence of hazardous alcohol or illicit drug use

Treatment and study plan

Adapted SBIRT-T for transgender women

Behavioral

Transgender women will be screened for substance use. Those at moderate risk or less will be randomized into the study into either the intervention arm (SBIRT-A) or the control arm (CONTROL-C). Those at higher risk will be ineligible for the study and referred for substance use treatment services

Other names: SBIRT-T

Primary outcomes

  1. Number of participants with substance abuse

    Time frame: 6 months

    The rate of change of substance abuse incidence for both arms

Secondary outcomes

  1. Rate of Preexposure prophylaxis (PrEP) election

    Time frame: 6 months

    The rate of PrEP election (or new PrEP users) among study participants in both arms

Sponsors and collaborators

Lead sponsor

University of Central Florida

Other

Collaborators

  • Florida International University

Registry information

Acronym: TRUST

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Mar 15, 2019
Registry last updated
Dec 10, 2024

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

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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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