Uganda PrEP and Harm Reduction Evaluation

Study 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.

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

Conditions
-----------------
HIV-1-infection

Intervention / Treatment
-----------------
* Other: Integrating PrEP delivery


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Participants in PrEP and MAT programs<br>Integrated PrEP and MAT program | Other: Integrating PrEP delivery<br>* Integration of PrEP delivery services in NSP and MAT programs<br>|
| Active Comparator: Participants in PrEP and NSP programs<br>Integrated PrEP and NSP program | Other: Integrating PrEP delivery<br>* Integration of PrEP delivery services in NSP and MAT programs<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pre-exposure prophylaxis, substance use disorders