Uganda PrEP and Harm Reduction Evaluation

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-11

Study Completion Date

2025-12-31

Brief Summary

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This is an evaluation of programs to integrate PrEP into existing services for PWUD. PrEP will be delivered according to Uganda national guidelines and data from national monitoring and evaluation forms will be leveraged to address key outcomes. Additionally, research components will be implemented to support greater understanding of PrEP use and experiences of participants engaged with the PrEP programs.

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Detailed Description

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The first facility-based medication-assisted treatment (MAT) program (with methadone) in Kampala launched in 2020, providing opportunity to integrate pre-exposure prophylaxis(PrEP) as part of a comprehensive HIV prevention package. Additionally, a community-based needle and syringe exchange program (NSP) provides opportunity to integrate PrEP and meet priorities of PWID while building rapport between providers and end-users. With two different service models - integrating PrEP into facility-based MAT and community-based NSP - there is a great opportunity to optimize the integration of PrEP and other HIV prevention services for PWUD. By integrating PrEP into two existing programs (MAT and NSP), this study will determine uptake and persistence of PrEP use and leverage these programs to conduct costing research and budget impact analysis.

Conditions

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HIV-1-infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Participants in PrEP and MAT programs

Integrated PrEP and MAT program

Group Type ACTIVE_COMPARATOR

Integrating PrEP delivery

Intervention Type OTHER

Integration of PrEP delivery services in NSP and MAT programs

Participants in PrEP and NSP programs

Integrated PrEP and NSP program

Group Type ACTIVE_COMPARATOR

Integrating PrEP delivery

Intervention Type OTHER

Integration of PrEP delivery services in NSP and MAT programs

Interventions

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Integrating PrEP delivery

Integration of PrEP delivery services in NSP and MAT programs

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Accessing services from any of the programs implementing the integrated PrEP program described in this protocol
* Able and willing to provide informed consent
* Age ≥15 years

Exclusion Criteria

* Any clinical or chronic medical condition that in the opinion of the investigator would make the participant unsuitable for the study or unable to independently provide informed consent.

Minimum Eligible Age

15 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes