HIV-1-infectionNCT05040308
Uganda PrEP and Harm Reduction Evaluation
A study testing Integrating PrEP delivery in people with HIV-1-infection, run by University of Washington at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Integrating PrEP delivery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUganda
- Study dates
- 11 Feb 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV-1-infection
- Being tested
- Integrating PrEP delivery
- Keywords
- pre-exposure prophylaxis, substance use disorders
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrating PrEP deliveryOther
Integration of PrEP delivery services in NSP and MAT programs
| Study group | Role | What they receive |
|---|---|---|
| Participants in PrEP and MAT programs | Active comparator | Integrated PrEP and MAT program Receives: Other: Integrating PrEP delivery |
| Participants in PrEP and NSP programs | Active comparator | Integrated PrEP and NSP program Receives: Other: Integrating PrEP delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of PrEP uptake
PrEP uptake will be measured through PrEP bottle inventory (bottles dispensed) in people who access NSP versus MAT.
Measured: 12 months after enrollment
PrEP retention
PrEP retention will be measured through study visit attendance among those who access NSP versus MAT.
Measured: 12 months after enrollment
PrEP adherence
PrEP adherence will be measured objectively through plasma tenofovir in people who access NSP versus MAT.
Measured: 12 months after enrollment
Secondary outcomes (2)
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).
Measured: 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.
Measured: 12 months post study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start11 Feb 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Makerere University
- Responsible party
- Principal investigator, Renee Heffron, University of Washington
- Investigators
- Renee Heffron, PhD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040308
- Sponsor's protocol ID
- STUDY00012972
- Other IDs
- R01DA051796
- Status last verified
- Apr 2024
- First submitted
- 20 May 2021
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Science Research on PrEP Delivery and Costing Within Harm Reduction Services for People Who Use Drugs in Uganda
- ClinicalTrials.gov ID
- NCT05040308
- Acronym / sponsor ID
- STUDY00012972
- Conditions
- HIV-1-infection
- Keywords
- pre-exposure prophylaxis, substance use disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Makerere University
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants in PrEP and MAT programs | Active comparator | Other: Integrating PrEP deliveryIntegrated PrEP and MAT program |
| Participants in PrEP and NSP programs | Active comparator | Other: Integrating PrEP deliveryIntegrated PrEP and NSP program |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrating PrEP deliveryIntegration of PrEP delivery services in NSP and MAT programs | Other | Participants in PrEP and MAT programs, Participants in PrEP and NSP programs |
Primary outcome
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.
PrEP retention
Time frame: 12 months after enrollment
PrEP retention will be measured through study visit attendance among those who access NSP versus MAT.
PrEP adherence
Time frame: 12 months after enrollment
PrEP adherence will be measured objectively through plasma tenofovir in people who access NSP versus MAT.
2 secondary outcomes
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
To conduct a budget impact analysis for integrating PrEP into MAT and NSP programs.
Time frame: 12 months post study enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renee Heffron, PhD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrating PrEP delivery in people with HIV-1-infection, run by University of Washington at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of PrEP uptake (time frame: 12 months after enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.