Uganda PrEP and Harm Reduction Evaluation

April 10, 2025 updated by: Renee Heffron, University of Washington

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 months after enrollment
PrEP retention
Time Frame: 12 months after enrollment
PrEP retention will be measured through study visit attendance among those who access NSP versus MAT.
12 months after enrollment
PrEP adherence
Time Frame: 12 months after enrollment
PrEP adherence will be measured objectively through plasma tenofovir in people who access NSP versus MAT.
12 months after enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To measure the impact of knowledge gained from training peers of PWUD on PrEP.
Time Frame: Baseline (pre-training), immediately after training, and 3 months post training
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.
Time Frame: 12 months post study enrollment
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)
Makerere University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Renee Heffron, PhD, MPH, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 11, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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