An interventional study of Adapted SBIRT-T for transgender women in Transgender Women, Substance Abuse and Hiv, sponsored by University of Central Florida. Completed at 2 sites in United States. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-10.
Sponsored by University of Central Florida · Not applicable, Interventional, and Prevention
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).
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.
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This study's enrollment of 86 is below the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.
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Exclusion Criteria:
The screening, brief intervention and referral to treatment (SBIRT-T) will be adapted and used as the intervention in the experimental arm
Behavioral: Adapted SBIRT-T for transgender women
The INFO-C group is a time-matched comparison control where information will be provided on substance use and PrEP services in a non-SBIRT-T format via printed and audio-visual study material
Behavioral: Adapted SBIRT-T for transgender women
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
Also known as: SBIRT-T
Number of participants with substance abuse
The rate of change of substance abuse incidence for both arms
Time frame: 6 months
Rate of Preexposure prophylaxis (PrEP) election
The rate of PrEP election (or new PrEP users) among study participants in both arms
Time frame: 6 months
Plan to share: Undecided
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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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University of Central Florida