NCT05040308

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 10, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

February 11, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 15, 2025

Status Verified

April 1, 2024

Enrollment Period

3.9 years

First QC Date

May 20, 2021

Last Update Submit

April 10, 2025

Conditions

HIV-1-infection

Keywords

pre-exposure prophylaxissubstance use disorders

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • To measure the impact of knowledge gained from training peers of PWUD on PrEP.

    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.

    12 months post study enrollment

Study Arms (2)

Participants in PrEP and MAT programs

ACTIVE COMPARATOR

Integrated PrEP and MAT program

Other: Integrating PrEP delivery

Participants in PrEP and NSP programs

ACTIVE COMPARATOR

Integrated PrEP and NSP program

Other: Integrating PrEP delivery

Interventions

Integrating PrEP deliveryOTHER

Integration of PrEP delivery services in NSP and MAT programs

Participants in PrEP and MAT programsParticipants in PrEP and NSP programs

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Infectious Diseases Institute, Makerere University

Kampala, Uganda

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Renee Heffron, PhD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 20, 2021

First Posted

September 10, 2021

Study Start

February 11, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 15, 2025

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

UG(1)