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

  • United States
    • New York
      • New York, New York, United States, 10018
        • Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY

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
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

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.

Sponsor

Hunter College of City University of New York

Collaborators

National Institute on Drug Abuse (NIDA)

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.

Helpful Links

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

Keywords

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.

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