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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

Tracking Information
First Submitted Date  ICMJE February 24, 2017
First Posted Date  ICMJE June 29, 2017
Last Update Posted Date October 7, 2019
Study Start Date  ICMJE August 2015
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2017)
Unprotected Sex [ Time Frame: 18 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03203200 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Cognitive Behavioral And Structural HIV Prevention Intervention for Young Ugandan Sex Workers
Official Title  ICMJE A Cognitive Behavioral And Structural HIV Prevention Intervention for Young Ugandan Women Engaging in High Risk Sexual Behavior
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Sexually Transmitted Infection
Intervention  ICMJE Behavioral: ZETRA cognitive behavioral structural
ZETRA cognitive behavioral structural
Study Arms  ICMJE
  • Experimental: health literacy and technology skill building
    ZETRA cognitive behavioral and structural
    Intervention: Behavioral: ZETRA cognitive behavioral structural
  • No Intervention: Standard Counselling
    Standard of care prevention counselling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 11, 2018)
640
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2017)
450
Estimated Study Completion Date  ICMJE April 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 15 Years to 24 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Uganda
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03203200
Other Study ID Numbers  ICMJE R01 HD085805-01
5R01MH109337-02 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE
  • University of Connecticut
  • MRC/UVRI Uganda Research Unit on Aids
  • National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Rachel King, PhD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP