Multicomponent Intervention to Reduce Sexual Risk and Substance Use

HIV Clinical Trial

Official title:

Multicomponent Intervention to Reduce Sexual Risk and Substance Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01880489
• Other study ID #: R01DA034661
• Secondary ID: R01DA034661
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: November 2, 2017

Study information

• Verified date: August 2018
• Source: Hunter College of City University of New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: November 2, 2017
• Est. primary completion date: November 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV
• Sexually Transmitted Diseases
• Sexually Transmitted Infections
• Substance Use

Intervention

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.

Locations

Country	Name	City	State
United States	Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY	New York	New York

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   Center for HIV/AIDS Educational Studies and Training website