Transgender WomenTRUSTNCT03877497
To Reach Unrestricted Services for Transgender Women
A study testing Adapted SBIRT-T for transgender women in people with Transgender Women and Substance Abuse, run by University of Central Florida at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Transgender Women, Substance Abuse, Hiv
- What is being tested?
- Adapted SBIRT-T for transgender women
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Sep 2019to 4 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Transgender woman over the age of 18
- HIV uninfected
- no current substance abuse use according to AUDIT and SBIRT criteria
Who cannot join
- HIV infected transgender woman
- evidence of hazardous alcohol or illicit drug use
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Florida International University
Miami, Florida, 33199
University of Central Florida
Orlando, Florida, 32827
About this study
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).
Read the detailed 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.
- Conditions
- Transgender Women, Substance Abuse, Hiv
- Being tested
- Adapted SBIRT-T for transgender women
- Medical subject headings
- Substance-Related Disorders, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted SBIRT-T for transgender womenBehavioural
Also called SBIRT-T
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
| Study group | Role | What they receive |
|---|---|---|
| SBIRT-T | Experimental | The screening, brief intervention and referral to treatment (SBIRT-T) will be adapted and used as the intervention in the experimental arm Receives: Behavioral: Adapted SBIRT-T for transgender women |
| INFO-C | Active comparator | 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 Receives: Behavioral: Adapted SBIRT-T for transgender women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with substance abuse
The rate of change of substance abuse incidence for both arms
Measured: 6 months
Secondary outcomes (1)
Rate of Preexposure prophylaxis (PrEP) election
The rate of PrEP election (or new PrEP users) among study participants in both arms
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start19 Sep 2019
- Primary completion31 May 2024
- Study completion4 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transgender WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Florida International University
- Responsible party
- Principal investigator, Elena Cyrus, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877497
- Sponsor's protocol ID
- K99/R00 DA046311
- Acronym
- TRUST
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2018
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Reach Unrestricted Services for Transgender Women
- ClinicalTrials.gov ID
- NCT03877497
- Acronym / sponsor ID
- TRUST / K99/R00 DA046311
- Conditions
- Transgender Women, Substance Abuse, Hiv
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Collaborators
- Florida International University
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 4 Dec 2024 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBIRT-T | Experimental | Behavioral: Adapted SBIRT-T for transgender womenThe screening, brief intervention and referral to treatment (SBIRT-T) will be adapted and used as the intervention in the experimental arm |
| INFO-C | Active comparator | Behavioral: Adapted SBIRT-T for transgender womenThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Transgender woman over the age of 18
- HIV uninfected
- no current substance abuse use according to AUDIT and SBIRT criteria
Key exclusion criteria (2 listed)
- HIV infected transgender woman
- evidence of hazardous alcohol or illicit drug use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted SBIRT-T for transgender womenAlso: SBIRT-TTransgender 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 | Behavioural | INFO-C, SBIRT-T |
Primary outcome
Number of participants with substance abuse
Time frame: 6 months
The rate of change of substance abuse incidence for both arms
1 secondary outcome
Rate of Preexposure prophylaxis (PrEP) election
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted SBIRT-T for transgender women in people with Transgender Women and Substance Abuse, run by University of Central Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with substance abuse (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.