Multicomponent Intervention to Reduce Sexual Risk and Substance Use

Sponsor

Hunter College of City University of New York (Other)

Overall Status

Completed

CT.gov ID

NCT01880489

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

143

Enrollment

Location

Arms

53.1

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Sexually Transmitted Infections Substance Use	Behavioral: MI + CBST Intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

143 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Multicomponent Intervention to Reduce Sexual Risk and Substance Use

Actual Study Start Date :

Jun 1, 2013

Actual Primary Completion Date :

Nov 2, 2017

Actual Study Completion Date :

Nov 2, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MI + CBST Intervention Seven sessions of Motivational Interviewing and Cognitive Behavioral Skills Training	Behavioral: MI + 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.
No Intervention: Wait List Control Condition

Arm

Intervention/Treatment

Experimental: MI + CBST Intervention

Seven sessions of Motivational Interviewing and Cognitive Behavioral Skills Training

Behavioral: MI + 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.

No Intervention: Wait List Control Condition

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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