To Reach Unrestricted Services for Transgender Women

NCT03877497 | Completed DMC

• 1 other identifier: K99/R00 DA046311
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Transgender Women; Substance Abuse; Hiv

Outcome Measures

Primary Outcomes (1)

• Number of participants with substance abuse

  The rate of change of substance abuse incidence for both arms

  6 months

Secondary Outcomes (1)

• Rate of Preexposure prophylaxis (PrEP) election

  6 months

Study Arms (2)

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

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

Behavioral: Adapted SBIRT-T for transgender women

Interventions

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

Also known as: SBIRT-T

INFO-C; SBIRT-T

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Transgender women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Central Florida: lead
• Florida International University: collaborator

Study Sites (2)

Florida International University

Miami, Florida, 33199, United States

Location

University of Central Florida

Orlando, Florida, 32827, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: March 15, 2019
• Study Start: September 19, 2019
• Primary Completion: May 31, 2024
• Study Completion: December 4, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

US (2)