Multicomponent Intervention to Reduce Sexual Risk and Substance Use

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.

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Key information

Conditions

HIV Chemically-Induced Disorders Communicable Diseases Disease Attributes Genital Diseases Infections Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Infections Substance Use Substance-Related Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY

New York, 10018, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MI + CBST Intervention

Behavioral

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.

Primary outcomes

Number of Unprotected Sex Acts in the Past 90 Days

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Hunter College of City University of New York

Other

Collaborators

National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start: 2013
Primary completion: 2017
Study completion: 2017
First posted: Jun 19, 2013
Registry last updated: Aug 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed