Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03877497 |
| Other study ID # |
K99/R00 DA046311 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 19, 2019 |
| Est. completion date |
June 30, 2024 |
Study information
| Verified date |
December 2023 |
| Source |
University of Central Florida |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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).
Description:
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.
