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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03203200
Recruitment Status : Active, not recruiting
First Posted : June 29, 2017
Last Update Posted : October 7, 2019
Sponsor:
Collaborators:
University of Connecticut
MRC/UVRI Uganda Research Unit on Aids
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Sexually Transmitted Infection Behavioral: ZETRA cognitive behavioral structural Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 640 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Cognitive Behavioral And Structural HIV Prevention Intervention for Young Ugandan Women Engaging in High Risk Sexual Behavior
Study Start Date : August 2015
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: health literacy and technology skill building
ZETRA cognitive behavioral and structural
Behavioral: ZETRA cognitive behavioral structural
ZETRA cognitive behavioral structural

No Intervention: Standard Counselling
Standard of care prevention counselling



Primary Outcome Measures :
  1. Unprotected Sex [ Time Frame: 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03203200


Locations
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Uganda
Uganda Virus Research Institute
Entebbe, Uganda
Sponsors and Collaborators
University of California, San Francisco
University of Connecticut
MRC/UVRI Uganda Research Unit on Aids
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Rachel King, PhD University of California, San Francisco

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03203200     History of Changes
Other Study ID Numbers: R01 HD085805-01
5R01MH109337-02 ( U.S. NIH Grant/Contract )
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female