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Multicomponent Intervention to Reduce Sexual Risk and Substance Use

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ClinicalTrials.gov Identifier: NCT01880489
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
H. Jonathon Rendina, Hunter College of City University of New York

Tracking Information
First Submitted Date  ICMJE June 13, 2013
First Posted Date  ICMJE June 19, 2013
Last Update Posted Date August 7, 2018
Actual Study Start Date  ICMJE June 2013
Actual Primary Completion Date November 2, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2013)
  • Number of Unprotected Sex Acts in the Past 90 Days [ Time Frame: 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 [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01880489 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multicomponent Intervention to Reduce Sexual Risk and Substance Use
Official Title  ICMJE Multicomponent Intervention to Reduce Sexual Risk and Substance Use
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • HIV
  • Sexually Transmitted Infections
  • Substance Use
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 3, 2018)
143
Original Estimated Enrollment  ICMJE
 (submitted: June 14, 2013)
240
Actual Study Completion Date  ICMJE November 2, 2017
Actual Primary Completion Date November 2, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01880489
Other Study ID Numbers  ICMJE R01DA034661( U.S. NIH Grant/Contract )
R01DA034661 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party H. Jonathon Rendina, Hunter College of City University of New York
Study Sponsor  ICMJE Hunter College of City University of New York
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: H. Jonathon Rendina, Ph.D. Hunter College of City University of New York
PRS Account Hunter College of City University of New York
Verification Date August 2018

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