Multicomponent Intervention to Reduce Sexual Risk and Substance Use

NCT01880489 | Completed DMC

• 1 other identifier: R01DA034661
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Sexually Transmitted Infections; Substance Use

Keywords

transgender women; sexual risk; substance use; HIV prevention; behavioral intervention

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

MI + CBST Intervention

EXPERIMENTAL

Seven sessions of Motivational Interviewing and Cognitive Behavioral Skills Training

Behavioral: MI + CBST Intervention

Wait List Control Condition

NO INTERVENTION

Interventions

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.

MI + CBST Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hunter College of City University of New York: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

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

New York, New York, 10018, United States

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders; Mental Disorders

Study Officials

• H. Jonathon Rendina, Ph.D.

  Hunter College of City University of New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 13, 2013
• First Posted: June 19, 2013
• Study Start: June 1, 2013
• Primary Completion: November 2, 2017
• Study Completion: November 2, 2017
• Last Updated: August 7, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)