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Uganda PrEP and Harm Reduction Evaluation

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University of Washington

Status

Active, not recruiting

Conditions

HIV-1-infection

Treatments

Other: Integrating PrEP delivery

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05040308
STUDY00012972
R01DA051796 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

15 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

300 participants in 2 patient groups

Participants in PrEP and MAT programs
Active Comparator group
Description:
Integrated PrEP and MAT program
Treatment:
Other: Integrating PrEP delivery
Participants in PrEP and NSP programs
Active Comparator group
Description:
Integrated PrEP and NSP program
Treatment:
Other: Integrating PrEP delivery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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