Uganda PrEP and Harm Reduction Evaluation

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV-1-infection
• Intervention / Treatment: Other: Integrating PrEP delivery

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Kampala, Uganda
    • Infectious Diseases Institute, Makerere University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Participants in PrEP and MAT programs; Integrated PrEP and MAT program	Other: Integrating PrEP delivery; Integration of PrEP delivery services in NSP and MAT programs
Active Comparator: Participants in PrEP and NSP programs; Integrated PrEP and NSP program	Other: Integrating PrEP delivery; Integration of PrEP delivery services in NSP and MAT programs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of PrEP uptake	PrEP uptake will be measured through PrEP bottle inventory (bottles dispensed) in people who access NSP versus MAT.	12 months after enrollment
PrEP retention	PrEP retention will be measured through study visit attendance among those who access NSP versus MAT.	12 months after enrollment
PrEP adherence	PrEP adherence will be measured objectively through plasma tenofovir in people who access NSP versus MAT.	12 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure the impact of knowledge gained from training peers of PWUD on PrEP.	The clinic staff will train up to 50 health care providers of PWUD on PrEP service delivery using the national curriculum on PrEP services delivery. We will administer a quantitative assessment of PrEP knowledge and experiences with service provision at three time points: 1. Before the training (Baseline survey), 2. immediately after training (Post training survey), and 3. ~3 months post training (Exit survey).	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.	The clinic staff will conduct micro costing c using activity-based approaches for costs incurred (clinic wide trainings, recruitment, service delivery, lab monitoring, PrEP support, and provision of PrEP) and costs averted (health costs saved by averting incident HIV infections). Cost data will also be collected from the study budget, public health clinic budgets, published government reports, and the health economics literature. Time and motion studies will be conducted by observing visits of people who are accessing services, and staff time spent on counseling, clinical procedures, and delivering PrEP.	12 months post study enrollment

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute on Drug Abuse (NIDA); Makerere University
• Investigators: Principal Investigator: Renee Heffron, PhD, MPH, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: September 1, 2021
• First Posted (Actual): September 10, 2021

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: pre-exposure prophylaxis; substance use disorders
• Other Study ID Numbers: STUDY00012972; R01DA051796 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No