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Multicomponent Intervention to Reduce Sexual Risk and Substance Use

Multicomponent Intervention to Reduce Sexual Risk and Substance Use

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01880489
Enrollment
143
Registered
2013-06-19
Start date
2013-06-30
Completion date
2017-11-02
Last updated
2018-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Sexually Transmitted Infections, Substance Use

Keywords

transgender women, sexual risk, substance use, HIV prevention, behavioral intervention

Brief summary

The objective is to expand and refine an intervention for transgender women (TW) into a 7-session individual- and group-based intervention that is scalable for community settings to reduce sexual risk and substance use and to increase stigma-coping and risk-buffering behaviors among TW in NYC. The investigators will pilot test the intervention with 20 TW and subsequently, conduct a randomized controlled trial with 240 TW to compare the intervention to a wait list control condition.

Interventions

BEHAVIORALMI + CBST Intervention

The intervention focuses on exploring health goals, creating an action plan, learning about the impact stress, stigma, and substance use can have on health, improving personal growth and social support, and connecting with resources. The first two sessions will be primarily Motivational Interviewing and will explore participants' feelings about their sexual risk, substance use, non-medically monitored hormone and silicone use, and any other issues. Group sessions (Sessions 3-6) will incorporate Cognitive Behavioral Skills Training focusing barriers to physical and mental health. The last session will focus on reviewing progress toward health goals, identifying barriers to change, and generating a plan for connection to ongoing care to reach target health goals.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Hunter College of City University of New York
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 18 years of age or older * Identify as a transgender woman (assigned male at birth and currently identify as female) * Report 3 or more acts of unprotected anal or vaginal sex in the past 90 days and at least 1 in the past 30 days * Report 5 or more days of illicit drug use in the past 90 days and at least 2 in the past 30 * Provide contact information * Reside in the NYC metropolitan area * Able to complete a survey in English (Spanish-language assistance can be provided by bilingual staff) * Provide informed consent

Exclusion criteria

* Unstable, serious psychiatric symptoms * Current suicidal/homicidal ideation * Evidence of gross cognitive impairment * Currently enrolled in a drug abuse treatment or enrolled in an HIV risk or drug use intervention study

Design outcomes

Primary

MeasureTime frameDescription
Number of Unprotected Sex Acts in the Past 90 Daysevery 4 months over the course of 8 monthsDecreases from Baseline in the Number of Unprotected Sex Acts in the past 90 days at 4 and 8 months
Number of Days of Drug Use in the Past 90 Daysevery 4 months over the course of 8 monthsDecreases from Baseline in the Number of Days of Drug Use in the past 90 days at 4 and 8 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026