Multicomponent Intervention to Reduce Sexual Risk and Substance Use

Not Applicable

Completed

• Conditions: Sexually Transmitted Infections; Substance Use; HIV
• Interventions: Behavioral: MI + CBST Intervention

• Registration Number: NCT01880489
• Lead Sponsor: Hunter College of City University of New York

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-13
• Study First Submitted QC: 2013-06-14
• Study First Posted: 2013-06-19
• Primary Completion: 2017-11-02
• Study Completion: 2017-11-02
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-03
• Last Update Posted: 2018-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 143

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MI + CBST Intervention	MI + CBST Intervention	Seven sessions of Motivational Interviewing and Cognitive Behavioral Skills Training

Primary Outcome Measures

Name	Time	Method
Number of Unprotected Sex Acts in the Past 90 Days	every 4 months over the course of 8 months	Decreases 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 Days	every 4 months over the course of 8 months	Decreases from Baseline in the Number of Days of Drug Use in the past 90 days at 4 and 8 months

Trial Locations

Locations (1)

Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY; 🇺🇸 New York, New York, United States