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

NCT ID: NCT03203200

Last Updated: 2022-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

640 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-24

Study Completion Date

2021-10-31

Brief Summary

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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

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Conditions

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Sexually Transmitted Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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health literacy and technology skill building

ZETRA cognitive behavioral and structural

Group Type EXPERIMENTAL

ZETRA cognitive behavioral structural

Intervention Type BEHAVIORAL

ZETRA cognitive behavioral structural

Standard Counselling

Standard of care prevention counselling

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ZETRA cognitive behavioral structural

ZETRA cognitive behavioral structural

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

24 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Connecticut

OTHER

Sponsor Role collaborator

MRC/UVRI and LSHTM Uganda Research Unit

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rachel King, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Uganda Virus Research Institute

Entebbe, , Uganda

Site Status

Countries

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Uganda

References

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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.

Reference Type DERIVED
PMID: 34011583 (View on PubMed)

Other Identifiers

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5R01MH109337-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01 HD085805-01

Identifier Type: -

Identifier Source: org_study_id

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