Back to resultsA Cognitive Behavioral And Structural HIV Prevention Intervention for Young Ugandan Sex Workers (ZETRA)
Primary Purpose
Sexually Transmitted Infection
Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
ZETRA cognitive behavioral structural
Sponsored by
About this trial
This is an interventional prevention trial for Sexually Transmitted Infection
Eligibility Criteria
Inclusion Criteria:
- HIV-uninfected women, aged 15-24 years, being sexually active and having engaged in any form of transactional sex at least once in the last 3 months, agreeing to participate in all intervention sessions and to all study procedures and interviews planned over 18 months of follow-up.
Exclusion Criteria:
- presence of any physical or mental condition likely to cause inability to provide consent or hinder study participation; HIV infection
Sites / Locations
- Uganda Virus Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
health literacy and technology skill building
Standard Counselling
Arm Description
ZETRA cognitive behavioral and structural
Standard of care prevention counselling
Outcomes
Primary Outcome Measures
Unprotected Sex
Secondary Outcome Measures
Full Information
NCT ID
NCT03203200
First Posted
February 24, 2017
Last Updated
March 1, 2022
Sponsor
University of California, San Francisco
Collaborators
University of Connecticut, MRC/UVRI and LSHTM Uganda Research Unit, National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT03203200
Brief Title
A Cognitive Behavioral And Structural HIV Prevention Intervention for Young Ugandan Sex Workers
Acronym
ZETRA
Official Title
A Cognitive Behavioral And Structural HIV Prevention Intervention for Young Ugandan Women Engaging in High Risk Sexual Behavior
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 24, 2015 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
University of Connecticut, MRC/UVRI and LSHTM Uganda Research Unit, National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study develops and tests a behavioural and structural intervention to prevent unprotected sex among young female sex workers. Half the participants will receive the intervention and half will receive the standard of care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
640 (Actual)
8. Arms, Groups, and Interventions
Arm Title
health literacy and technology skill building
Arm Type
Experimental
Arm Description
ZETRA cognitive behavioral and structural
Arm Title
Standard Counselling
Arm Type
No Intervention
Arm Description
Standard of care prevention counselling
Intervention Type
Behavioral
Intervention Name(s)
ZETRA cognitive behavioral structural
Intervention Description
ZETRA cognitive behavioral structural
Primary Outcome Measure Information:
Title
Unprotected Sex
Time Frame
18 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
HIV-uninfected women, aged 15-24 years, being sexually active and having engaged in any form of transactional sex at least once in the last 3 months, agreeing to participate in all intervention sessions and to all study procedures and interviews planned over 18 months of follow-up.
Exclusion Criteria:
presence of any physical or mental condition likely to cause inability to provide consent or hinder study participation; HIV infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel King, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uganda Virus Research Institute
City
Entebbe
Country
Uganda
12. IPD Sharing Statement
Citations:
PubMed Identifier
34011583
Citation
King R, Muhanguzi E, Nakitto M, Mirembe M, Kasujja FX, Bagiire D, Seeley J. Mobility study of young women who exchange sex for money or commodities using Google Maps and qualitative methods in Kampala, Uganda. BMJ Open. 2021 May 19;11(5):e043078. doi: 10.1136/bmjopen-2020-043078.
Results Reference
derived
Learn more about this trial
A Cognitive Behavioral And Structural HIV Prevention Intervention for Young Ugandan Sex Workers
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