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Clinical Trials/NCT01880489
NCT01880489
Completed
Not Applicable

Multicomponent Intervention to Reduce Sexual Risk and Substance Use

Hunter College of City University of New York1 site in 1 country143 target enrollmentJune 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV
Sponsor
Hunter College of City University of New York
Enrollment
143
Locations
1
Primary Endpoint
Number of Unprotected Sex Acts in the Past 90 Days
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
November 2, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Hunter College of City University of New York
Responsible Party
Principal Investigator
Principal Investigator

H. Jonathon Rendina

Assistant Professor

Hunter College of City University of New York

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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