Multicomponent Intervention to Reduce Sexual Risk and Substance Use

This study is currently recruiting participants.
Verified June 2013 by Hunter College
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeffrey T. Parsons, Hunter College
ClinicalTrials.gov Identifier:
NCT01880489
First received: June 13, 2013
Last updated: June 14, 2013
Last verified: June 2013

June 13, 2013
June 14, 2013
June 2013
January 2017   (final data collection date for primary outcome measure)
  • Number of Unprotected Sex Acts in the Past 90 Days [ Time Frame: every 4 months over the course of 8 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Decreases from Baseline in the Number of Days of Drug Use in the past 90 days at 4 and 8 months
Same as current
Complete list of historical versions of study NCT01880489 on ClinicalTrials.gov Archive Site
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Multicomponent Intervention to Reduce Sexual Risk and Substance Use
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • HIV
  • Sexually Transmitted Infections
  • Substance Use
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.
  • Experimental: MI + CBST Intervention
    Seven sessions of Motivational Interviewing and Cognitive Behavioral Skills Training
    Intervention: Behavioral: MI + CBST Intervention
  • No Intervention: Wait List Control Condition
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
January 2017
January 2017   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact: Christopher Murphy, M.S. 212-206-7919 cmurphy@chestnyc.org
Contact: Ana Ventuneac, Ph.D. 212-206-7919 aventuneac@chestnyc.org
United States
 
NCT01880489
R01DA034661, R01DA034661
Yes
Jeffrey T. Parsons, Hunter College
Hunter College
National Institute on Drug Abuse (NIDA)
Principal Investigator: Jeffrey T. Parsons, Ph.D. Hunter College
Hunter College
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP