Multicomponent Intervention to Reduce Sexual Risk and Substance Use

Study Overview
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Brief Summary
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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.

Official Title
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Multicomponent Intervention to Reduce Sexual Risk and Substance Use

Conditions
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HIV, Sexually Transmitted Infections, Substance Use

Intervention / Treatment
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* Behavioral: MI + CBST Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MI + CBST Intervention<br>Seven sessions of Motivational Interviewing and Cognitive Behavioral Skills Training | Behavioral: MI + CBST Intervention<br>* 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.<br>|
| No Intervention: Wait List Control Condition<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Unprotected Sex Acts in the Past 90 Days | Decreases from Baseline in the Number of Unprotected Sex Acts in the past 90 days at 4 and 8 months | every 4 months over the course of 8 months | 
| Number of Days of Drug Use in the Past 90 Days | Decreases from Baseline in the Number of Days of Drug Use in the past 90 days at 4 and 8 months | every 4 months over the course of 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transgender women, sexual risk, substance use, HIV prevention, behavioral intervention