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Multicomponent Intervention to Reduce Sexual Risk and Substance Use

Primary Purpose

HIV, Sexually Transmitted Infections, Substance Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MI + CBST Intervention
Sponsored by
Hunter College of City University of New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring transgender women, sexual risk, substance use, HIV prevention, behavioral intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MI + CBST Intervention

Wait List Control Condition

Arm Description

Seven sessions of Motivational Interviewing and Cognitive Behavioral Skills Training

Outcomes

Primary Outcome Measures

Number of Unprotected Sex Acts in the Past 90 Days
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
Decreases from Baseline in the Number of Days of Drug Use in the past 90 days at 4 and 8 months

Secondary Outcome Measures

Full Information

First Posted
June 13, 2013
Last Updated
August 3, 2018
Sponsor
Hunter College of City University of New York
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01880489
Brief Title
Multicomponent Intervention to Reduce Sexual Risk and Substance Use
Official Title
Multicomponent Intervention to Reduce Sexual Risk and Substance Use
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 2013 (Actual)
Primary Completion Date
November 2, 2017 (Actual)
Study Completion Date
November 2, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hunter College of City University of New York
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Sexually Transmitted Infections, Substance Use
Keywords
transgender women, sexual risk, substance use, HIV prevention, behavioral intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MI + CBST Intervention
Arm Type
Experimental
Arm Description
Seven sessions of Motivational Interviewing and Cognitive Behavioral Skills Training
Arm Title
Wait List Control Condition
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
MI + CBST Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Unprotected Sex Acts in the Past 90 Days
Description
Decreases from Baseline in the Number of Unprotected Sex Acts in the past 90 days at 4 and 8 months
Time Frame
every 4 months over the course of 8 months
Title
Number of Days of Drug Use in the Past 90 Days
Description
Decreases from Baseline in the Number of Days of Drug Use in the past 90 days at 4 and 8 months
Time Frame
every 4 months over the course of 8 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H. Jonathon Rendina, Ph.D.
Organizational Affiliation
Hunter College of City University of New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY
City
New York
State/Province
New York
ZIP/Postal Code
10018
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://chestnyc.org/
Description
Center for HIV/AIDS Educational Studies and Training website

Learn more about this trial

Multicomponent Intervention to Reduce Sexual Risk and Substance Use

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