Clinical trial NCT05040308: Uganda PrEP and Harm Reduction Evaluation
Official title: Implementation Science Research on PrEP Delivery and Costing Within Harm Reduction Services for People Who Use Drugs in Uganda
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV-1-infection
Keywords: pre-exposure prophylaxis
substance use disorders
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Makerere University
First posted: 2021-09-10
Enrollment: 300
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Rate of PrEP uptake
timeFrame: 12 months after enrollment
measure: PrEP retention
timeFrame: 12 months after enrollment
measure: PrEP adherence
timeFrame: 12 months after enrollment
Secondary outcomes:
measure: To measure the impact of knowledge gained from training peers of PWUD on PrEP.
timeFrame: Baseline (pre-training), immediately after training, and 3 months post training
measure: To conduct a budget impact analysis for integrating PrEP into MAT and NSP programs.
timeFrame: 12 months post study enrollment
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Infectious Diseases Institute, Makerere University
Study officials:
affiliation: University of Washington
name: Renee Heffron, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: