NCT03203200

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
640

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 24, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 29, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

6.2 years

First QC Date

February 24, 2017

Last Update Submit

March 1, 2022

Conditions

Sexually Transmitted Infection

Outcome Measures

Primary Outcomes (1)

  • Unprotected Sex

    18 months

Study Arms (2)

health literacy and technology skill building

EXPERIMENTAL

ZETRA cognitive behavioral and structural

Behavioral: ZETRA cognitive behavioral structural

Standard Counselling

NO INTERVENTION

Standard of care prevention counselling

Interventions

ZETRA cognitive behavioral structuralBEHAVIORAL

ZETRA cognitive behavioral structural

health literacy and technology skill building

Eligibility Criteria

Age15 Years - 24 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • presence of any physical or mental condition likely to cause inability to provide consent or hinder study participation; HIV infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uganda Virus Research Institute

Entebbe, Uganda

Location

Related Publications (1)

  • 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.

    PMID: 34011583DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rachel King, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2017

First Posted

June 29, 2017

Study Start

August 24, 2015

Primary Completion

October 31, 2021

Study Completion

October 31, 2021

Last Updated

March 16, 2022

Record last verified: 2022-03

Locations

UG(1)