Multicomponent Intervention to Reduce Sexual Risk and Substance Use
August 3, 2018 updated by: H. Jonathon Rendina, Hunter College of City University of New York
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
143
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
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New York, New York, United States, 10018
- Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MI + CBST Intervention
Seven sessions of Motivational Interviewing and Cognitive Behavioral Skills Training
|
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.
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No Intervention: Wait List Control Condition
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
every 4 months over the course of 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
|
every 4 months over the course of 8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: H. Jonathon Rendina, Ph.D., Hunter College of City University of New York
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2013
Primary Completion (Actual)
November 2, 2017
Study Completion (Actual)
November 2, 2017
Study Registration Dates
First Submitted
June 13, 2013
First Submitted That Met QC Criteria
June 14, 2013
First Posted (Estimate)
June 19, 2013
Study Record Updates
Last Update Posted (Actual)
August 7, 2018
Last Update Submitted That Met QC Criteria
August 3, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01DA034661 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.