HIV InfectionsPPPNCT03586128
Partners PrEP Program
An observational study of HIV Infections, run by University of Washington at 1 site in Uganda.
Trial summary
Through close collaboration with the Ugandan Ministry of Health, the investigators plan to provide PrEP for HIV-negative members of HIV serodiscordant couples by launching PrEP delivery within 12 public ART clinics in Kampala, Uganda. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- PrEP and ART
- How many people
- 1,381 participants
- Where
- 1 siteUganda
- Study dates
- 8 Jun 2018to 19 Nov 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: HIV serodiscordant couples from the Kampala, Uganda area
Who may be able to join
- For both members of the couple
- Age ≥18 years
- Able and willing to provide informed consent
- Sexually active with each other
- Willing to engage with the clinic system as a couple
- For HIV-positive members of the couples (index participants)
Show all 15Show fewer
- HIV-positive, according to national HIV testing algorithm
- Recent diagnosis as a member in an HIV serodiscordant couple
- Not currently enrolled in an HIV treatment clinical trial
- For HIV-negative members of the couples (partner participants)
- HIV-negative, according to national HIV testing algorithm
- Recent diagnosis as a member in an HIV serodiscordant couple
- Not currently enrolled in an HIV treatment clinical trial
- Not currently using PrEP
- Eligible for PrEP, according to WHO or Ugandan national guidelines
Who cannot join
- Otherwise not eligible based on the above inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrated PrEP and ART Delivered in Ugandan Public Health Clinics to Improve HIV and ART Outcomes for HIV Serodiscordant Couples
Through close collaboration with the Ugandan Ministry of Health, the investigators plan to provide PrEP for HIV-negative members of HIV serodiscordant couples by launching PrEP delivery within 12 public ART clinics in Kampala, Uganda. Intervention delivery will be launched in a staggered fashion among clinics through a stepped wedge cluster randomized trial providing a rigorous research opportunity to measure the effect of the intervention on PrEP and ART initiation and adherence. To measure these outcomes using clinic records and biomarkers, the program will enroll approximately 1440 HIV serodiscordant couples. Additionally, the program will collect qualitative and quantitative data to determine if PrEP-taking is a modeled behavior that facilitates ART use and characterize the way that PrEP and ART use interact within couples and estimate the programmatic costs of the integrated PrEP and ART strategy.
- Conditions
- HIV Infections
- Being tested
- PrEP, ART
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEPDrug
PrEP will be introduced into clinics according to Uganda national guidelines using a stepped wedge design. Uganda guidelines recommend any tenofovir disoproxil fumarate (TDF) containing medication be used for PrEP; this includes emtricitabine (FTC)/TDF, lamivudine (3TC)/TDF or TDF alone.
ARTDrug
ART medication will be provided according to Uganda national guidelines for persons living with HIV.
| Study group | Role | What they receive |
|---|---|---|
| HIV serodiscordant couples | Not described Receives: Drug: PrEP; Drug: ART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of HIV-positive members of a discordant partnership who initiate ART
Measure ART initiation of the HIV-positive member of the couple
Measured: Up to 24 months
HIV viral load suppression of HIV-positive members of a discordant partnership
ART adherence by measuring HIV viral load of the HIV-positive member of the couple
Measured: Up to 24 months
Number of HIV-negative members of a discordant partnership who initiate PrEP
Measure PrEP initiation of the HIV-negative member of the couple
Measured: Up to 24 months
PrEP adherence of HIV-negative members of a discordant partnership
Measure PrEP adherence, among HIV-negative members of a discordant partnership who initiated PrEP, by self-report and tenofovir drug level testing.
Measured: Up to 24 months
Secondary outcomes (3)
PrEP-taking as a modeled behavior
Measure the degree to which PrEP-taking behavior is modeled by HIV-negative partners and the degree to which it is witnessed by HIV-positive partners using questionnaires developed for this purpose.
Measured: Up to 24 months
Facilitators and barriers to use of ART and PrEP
Mixed methods assessment of how integrated PrEP and ART is 1) used among couples and 2) implemented by health care providers using qualitative interviews and questionnaires. These data will be aggregated to understand the facilitators and barriers to use of ART and PrEP.
Measured: Up to 24 months
Programmatic costs of providing integrated PrEP and ART to HIV serodiscordant couples
Conduct micro-costing, cost-effectiveness, and budget impact analyses to estimate the programmatic costs of providing integrated PrEP and ART to HIV serodiscordant couples.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start8 Jun 2018
- Primary completion19 Nov 2021
- Study completion19 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,381 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University, 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
- NCT03586128
- Sponsor's protocol ID
- STUDY00000320
- Acronym
- PPP
- Status last verified
- Dec 2021
- First submitted
- 19 Jun 2018
- Last updated
- 6 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Wyatt MA, Pisarski EE, Nalumansi A, Kasiita V, Kamusiime B, Nalukwago GK, Thomas D, Muwonge TR, Mujugira A, Heffron R, Ware NC; Partners PrEP Program Study Team. How PrEP delivery was integrated into public ART clinics in central Uganda: A qualitative analysis of implementation processes. PLOS Glob Public Health. 2024 Mar 7;4(3):e0002916. doi: 10.1371/journal.pgph.0002916. eCollection 2024.
PubMed 38452111Heffron R, Muwonge TR, Thomas KK, Nambi F, Nakabugo L, Kibuuka J, Thomas D, Feutz E, Meisner A, Ware NC, Wyatt MA, Simoni JM, Katz IT, Kadama H, Baeten JM, Mujugira A; Partners PrEP Program Team. PrEP uptake and HIV viral suppression when PrEP is integrated into Ugandan ART clinics for HIV-negative members of HIV-serodifferent couples: A stepped wedge cluster randomized trial. EClinicalMedicine. 2022 Aug 11;52:101611. doi: 10.1016/j.eclinm.2022.101611. eCollection 2022 Oct.
PubMed 35990584
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated PrEP and ART Delivered in Ugandan Public Health Clinics to Improve HIV and ART Outcomes for HIV Serodiscordant Couples
- ClinicalTrials.gov ID
- NCT03586128
- Acronym / sponsor ID
- PPP / STUDY00000320
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,381 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Harvard University, Makerere University
- Study start
- 8 Jun 2018 (actual)
- Primary completion
- 19 Nov 2021 (actual)
- Study completion
- 19 Nov 2021 (actual)
- First posted
- 13 Jul 2018 (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.
Through close collaboration with the Ugandan Ministry of Health, the investigators plan to provide PrEP for HIV-negative members of HIV serodiscordant couples by launching PrEP delivery within 12 public ART clinics in Kampala, Uganda. Intervention delivery will be launched in a staggered fashion among clinics through a stepped wedge cluster randomized trial providing a rigorous research opportunity to measure the effect of the intervention on PrEP and ART initiation and adherence. To measure these outcomes using clinic records and biomarkers, the program will enroll approximately 1440 HIV serodiscordant couples. Additionally, the program will collect qualitative and quantitative data to determine if PrEP-taking is a modeled behavior that facilitates ART use and characterize the way that PrEP and ART use interact within couples and estimate the programmatic costs of the integrated PrEP and ART strategy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV serodiscordant couples | – | Drug: PrEP, Drug: ART |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HIV serodiscordant couples from the Kampala, Uganda area
Key inclusion criteria (15 listed)
- For both members of the couple
- Age ≥18 years
- Able and willing to provide informed consent
- Sexually active with each other
- Willing to engage with the clinic system as a couple
Key exclusion criteria (1 listed)
- Otherwise not eligible based on the above inclusion criteria
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 |
|---|---|---|
| PrEPPrEP will be introduced into clinics according to Uganda national guidelines using a stepped wedge design. Uganda guidelines recommend any tenofovir disoproxil fumarate (TDF) containing medication be used for PrEP; this includes emtricitabine (FTC)/TDF, lamivudine (3TC)/TDF or TDF alone. | Drug | HIV serodiscordant couples |
| ARTART medication will be provided according to Uganda national guidelines for persons living with HIV. | Drug | HIV serodiscordant couples |
Primary outcome
Number of HIV-positive members of a discordant partnership who initiate ART
Time frame: Up to 24 months
Measure ART initiation of the HIV-positive member of the couple
HIV viral load suppression of HIV-positive members of a discordant partnership
Time frame: Up to 24 months
ART adherence by measuring HIV viral load of the HIV-positive member of the couple
Number of HIV-negative members of a discordant partnership who initiate PrEP
Time frame: Up to 24 months
Measure PrEP initiation of the HIV-negative member of the couple
PrEP adherence of HIV-negative members of a discordant partnership
Time frame: Up to 24 months
Measure PrEP adherence, among HIV-negative members of a discordant partnership who initiated PrEP, by self-report and tenofovir drug level testing.
3 secondary outcomes
PrEP-taking as a modeled behavior
Time frame: Up to 24 months
Facilitators and barriers to use of ART and PrEP
Time frame: Up to 24 months
Programmatic costs of providing integrated PrEP and ART to HIV serodiscordant couples
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Derived from this study: PubMed 38452111Wyatt MA, Pisarski EE, Nalumansi A, Kasiita V, Kamusiime B, Nalukwago GK, Thomas D, Muwonge TR, Mujugira A, Heffron R, Ware NC; Partners PrEP Program Study Team. How PrEP delivery was integrated into public ART clinics in central Uganda: A qualitative analysis of implementation processes. PLOS Glob Public Health. 2024 Mar 7;4(3):e0002916. doi: 10.1371/journal.pgph.0002916. eCollection 2024.
- Derived from this study: PubMed 35990584Heffron R, Muwonge TR, Thomas KK, Nambi F, Nakabugo L, Kibuuka J, Thomas D, Feutz E, Meisner A, Ware NC, Wyatt MA, Simoni JM, Katz IT, Kadama H, Baeten JM, Mujugira A; Partners PrEP Program Team. PrEP uptake and HIV viral suppression when PrEP is integrated into Ugandan ART clinics for HIV-negative members of HIV-serodifferent couples: A stepped wedge cluster randomized trial. EClinicalMedicine. 2022 Aug 11;52:101611. doi: 10.1016/j.eclinm.2022.101611. eCollection 2022 Oct.
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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?
An observational study of HIV Infections, 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 15 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: finished, as of the sponsor's last update on 6 Dec 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of HIV-positive members of a discordant partnership who initiate ART (time frame: Up to 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03586128, which also lists 2 linked publications.
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 6 Dec 2021.