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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Sexually Transmitted Infections Substance Use Behavioral: MI + CBST Intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Multicomponent Intervention to Reduce Sexual Risk and Substance Use
Actual Study Start Date : June 2013
Actual Primary Completion Date : November 2, 2017
Actual Study Completion Date : November 2, 2017
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880489


Locations
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United States, New York
Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY
New York, New York, United States, 10018
Sponsors and Collaborators
Hunter College of City University of New York
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: H. Jonathon Rendina, Ph.D. Hunter College of City University of New York
More Information
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Additional Information:

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Responsible Party: H. Jonathon Rendina, Assistant Professor, Hunter College of City University of New York
ClinicalTrials.gov Identifier: NCT01880489    
Other Study ID Numbers: R01DA034661 ( U.S. NIH Grant/Contract )
R01DA034661 ( U.S. NIH Grant/Contract )
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by H. Jonathon Rendina, Hunter College of City University of New York:
transgender women
sexual risk
substance use
HIV prevention
behavioral intervention
Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
 Communicable Diseases
Infections
Disease Attributes
Pathologic Processes