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NCT03203200 Clinical Trial

A Cognitive Behavioral And Structural HIV Prevention Intervention for Young Ugandan Sex Workers

Sexually Transmitted Infection Clinical Trial

— ZETRA  

Official title:
A Cognitive Behavioral And Structural HIV Prevention Intervention for Young Ugandan Women Engaging in High Risk Sexual Behavior

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03203200
Other study ID # R01 HD085805-01
Secondary ID 5R01MH109337-02
Status Completed
Phase N/A
First received
Last updated
Start date August 24, 2015
Est. completion date October 31, 2021

Study information
Verified date March 2022
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 640
Est. completion date October 31, 2021
Est. primary completion date October 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 24 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• ZETRA cognitive behavioral structural
ZETRA cognitive behavioral structural

Locations
Country Name City State
Uganda Uganda Virus Research Institute Entebbe

Sponsors (4)
Lead Sponsor Collaborator
University of California, San Francisco MRC/UVRI and LSHTM Uganda Research Unit, National Institute of Mental Health (NIMH), University of Connecticut

Country where clinical trial is conducted

Uganda, 

Outcome
Type Measure Description Time frame Safety issue
Primary Unprotected Sex 18 months
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