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Clinical Trials/NCT05040308
NCT05040308
Active, not recruiting
Not Applicable

Implementation Science Research on PrEP Delivery and Costing Within Harm Reduction Services for People Who Use Drugs in Uganda

University of Washington1 site in 1 country300 target enrollmentFebruary 11, 2022
ConditionsHIV-1-infection

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV-1-infection
Sponsor
University of Washington
Enrollment
300
Locations
1
Primary Endpoint
Rate of PrEP uptake
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 11, 2022
End Date
December 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Renee Heffron

Associate Professor

University of Washington

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Rate of PrEP uptake

Time Frame: 12 months after enrollment

PrEP uptake will be measured through PrEP bottle inventory (bottles dispensed) in people who access NSP versus MAT.

PrEP retention

Time Frame: 12 months after enrollment

PrEP retention will be measured through study visit attendance among those who access NSP versus MAT.

PrEP adherence

Time Frame: 12 months after enrollment

PrEP adherence will be measured objectively through plasma tenofovir in people who access NSP versus MAT.

Secondary Outcomes

  • To measure the impact of knowledge gained from training peers of PWUD on PrEP.(Baseline (pre-training), immediately after training, and 3 months post training)
  • To conduct a budget impact analysis for integrating PrEP into MAT and NSP programs.(12 months post study enrollment)

Study Sites (1)

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