Multicomponent Intervention to Reduce Sexual Risk and Substance Use

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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 Intervention
HIV
Sexually Transmitted Infections
Substance Use
Behavioral: MI + CBST Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Multicomponent Intervention to Reduce Sexual Risk and Substance Use

Resource links provided by NLM:


Further study details as provided by Hunter College:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 240
Study Start Date: June 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01880489

Contacts
Contact: Christopher Murphy, M.S. 212-206-7919 cmurphy@chestnyc.org
Contact: Ana Ventuneac, Ph.D. 212-206-7919 aventuneac@chestnyc.org

Locations
United States, New York
Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY Recruiting
New York, New York, United States, 10018
Contact: Christopher Murphy, M.S.    212-206-7919    cmurphy@chestnyc.org   
Contact: Ana Ventuneac, Ph.D.    212-206-7919    aventuneac@chestnyc.org   
Principal Investigator: Jeffrey T Parsons, Ph.D.         
Sponsors and Collaborators
Hunter College
Investigators
Principal Investigator: Jeffrey T. Parsons, Ph.D. Hunter College
  More Information

Additional Information:
No publications provided

Responsible Party: Jeffrey T. Parsons, Distinguished Professor, Hunter College
ClinicalTrials.gov Identifier: NCT01880489     History of Changes
Other Study ID Numbers: R01DA034661, R01DA034661
Study First Received: June 13, 2013
Last Updated: June 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Hunter College:
transgender women
sexual risk
substance use
HIV prevention
behavioral intervention

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 30, 2014