HIV-1-infectionPhase 4NCT03052010
The Partners Scale-Up Project
A Phase 4 study testing Integrated PrEP as a bridge to ART HIV-1 prevention strategy, PrEP and ART in people with HIV-1-infection, run by University of Washington at 2 sites in Kenya.
Trial summary
An implementation project to scale-up delivery of antiretroviral-based HIV-1 prevention methods to Kenyan HIV-1 serodiscordant couples in HIV-1 care centers. Pre-exposure prophylaxis (PrEP) as a bridge to antiretroviral therapy (ART) HIV-1 prevention strategy will be introduced into 24 public HIV-1 care centers in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Integrated PrEP as a bridge to ART HIV-1 prevention strategy, PrEP and ART
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,898 participants
- Where
- 2 sitesKenya
- Study dates
- 6 Feb 2017to 30 Apr 2021
- Phase
- Phase 4
- 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
Who may be able to join
- For HIV-1 uninfected members of the couple
- Age ≥18
- Able and willing to provide consent for follow-up in the cohort
- HIV-1 uninfected based on negative HIV-1 tests, per Kenya national guidelines
- Not currently using PrEP
- For HIV-1 infected members of the couple
Show all 15Show fewer
- Age ≥18
- Able and willing to provide consent for follow-up in the cohort
- HIV-1 infected based on positive HIV-1 tests, per Kenya national guidelines
- Not currently using ART
- For both members of the couple - Meet criteria for initiating PrEP as per Kenya national guidelines, including:
- HIV-1 infected member not currently using ART, on ART <6 months, or on ART but not virally suppressed based on a viral load test done at the clinic as per Kenya national guidelines or
- Trying to conceive
- For key delivery informants
- Able and willing to provide consent
Who cannot join
- Otherwise not eligible based on the above inclusion criteria
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Delivery of Integrated PrEP and ART for Couples in Kenya
An implementation project to scale-up delivery of antiretroviral-based HIV-1 prevention methods to Kenyan HIV-1 serodiscordant couples in HIV-1 care centers. Pre-exposure prophylaxis (PrEP) as a bridge to antiretroviral therapy (ART) HIV-1 prevention strategy will be introduced into 24 public HIV-1 care centers in central and western Kenya according to national guidelines using a stepped wedge design, stratified by region.
Read the detailed description
PrEP as a bridge to ART strategy will be introduced into 24 Kenyan public HIV-1 care centers according to national guidelines, in staged fashion, stratified by region (a stepped wedge design). Monitoring and evaluation activities will identify implementation barriers and solutions, characterize costs, and provide best practices for further scale-up. A research component will establish prospective open cohorts of couples at each clinic (up to 200) to study how the program is effectively implemented. Follow-up in the cohorts will be for up to 36 months at each care center and will evaluate impact, costs, and facilitators and barriers to implementation at patient, provider and health system levels.
- Conditions
- HIV-1-infection
- Being tested
- Integrated PrEP as a bridge to ART HIV-1 prevention strategy, PrEP, ART
- Keywords
- HIV-1 serodiscordant couples, PrEP as Bridge to ART
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated PrEP as a bridge to ART HIV-1 prevention strategyOther
The PrEP as a bridge to ART intervention will be introduced into clinics according to Kenya national guidelines using a stepped wedge design, stratified by region. The components of the intervention are: a) Couples' HIV-1 counseling and testing; 2) PrEP as a bridge to ART: PrEP offered prior to ART initiation in couples in which the HIV-1 infected partner is not on ART due to refusal/delay, during the first 6 months after ART start during viral decline, and then discontinuation; 3) ART at any CD4 count, offered to all HIV-1 infected partners, with ongoing promotion/counseling for those delaying/declining;4) Standard of care HIV-1 prevention services
PrEPDrug
A fixed-dose, oral co-formulation of emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) is the approved and preferred regimen for HIV-1 prevention in Kenya and the United States. The World Health Organization (WHO) recommends TDF-containing medications as PrEP, which includes TDF combined with FTC as well as potentially TDF alone and TDF combined with lamivudine (or 3TC, a medication closely related to FTC). Any TDF-containing medications that align with WHO and Kenya national guidelines for PrEP will be used. PrEP medication will come from clinic stocks.
ARTDrug
ART medications will be provided according to Kenya national ART policies and will come from clinic stocks.
| Study group | Role | What they receive |
|---|---|---|
| PrEP for HIV-1 uninfected partners and ART for HIV-1 infected | Other | Integrated PrEP as a bridge to ART HIV-1 prevention strategy Receives: Other: Integrated PrEP as a bridge to ART HIV-1 prevention strategy; Drug: PrEP; Drug: ART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of HIV-1 infected persons whose partners are tested for HIV-1 before/after PrEP as a bridge to ART is implemented
Measured: up to 36 months
PrEP initiation
Measure the number of HIV-1 uninfected partners initiating PrEP.
Measured: up to 36 months
PrEP adherence
Adherence by HIV-1 uninfected partners until their HIV-1 infected partners initiate ART and sustain use for six months. Adherence will be measured by self reported and random dry blood spot for tenofovir levels
Measured: up to 6 months
HIV-1 uninfected partners staying HIV-1 uninfected.
Measured: up to 36 months
ART initiation
Number of HIV-1 infected partners newly initiating ART
Measured: up to 36 months
ART adherence
Adherence measured by plasma RNA viral load. Viral load will be abstract from the HIV-infected partners records.
Measured: up to 6 months
Facilitators and barriers to implementation of integrated PrEP and ART
Mixed methods assessment of how integrated PrEP and ART is implemented at the level of provider, health center, and health systems
Measured: up to 36 months
PrEP delivery operational tools
Training manual on deliver of integrated PrEP and ART HIV prevention strategy for couples will be developed.
Measured: 24 months
Cost and cost-effectiveness of the integrated PrEP and ART when delivered in public health clinics.
Time and motions to define the cost and cost-effectiveness of intervention summarized in terms of HIV infections averted, disability-adjusted life years saved, and incremental cost-effectiveness over routine HIV-1 care
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start6 Feb 2017
- Primary completion15 Dec 2020
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4,898 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute, Kenya National AIDS & STI Control Programme, National Institute of Mental Health (NIMH), Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Jared Baeten, University of Washington
- Investigators
- Jared Baeten, MD, PhD, Principal investigator, University of WashingtonKenneth K. Mugwanya, MBChB, MS, PhD, Study director, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052010
- Sponsor's protocol ID
- STUDY00002183
- Other IDs
- 2R01MH095507
- Status last verified
- Oct 2021
- First submitted
- 5 Feb 2017
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from the Partners Scale-Up Project will be available at end of the Project by contacting the International Clinical Research Center at the University of Washington (icrc@uw.edu)
Publications
Irungu EM, Mugwanya KK, Mugo NR, Bukusi EA, Donnell D, Odoyo J, Wamoni E, Peacock S, Morton JF, Ngure K, Mugambi M, Mukui I, O'Malley G, Baeten JM; Partners Scale-Up Project Team. Integration of pre-exposure prophylaxis services into public HIV care clinics in Kenya: a pragmatic stepped-wedge randomised trial. Lancet Glob Health. 2021 Dec;9(12):e1730-e1739. doi: 10.1016/S2214-109X(21)00391-0.
PubMed 34798031Irungu EM, Odoyo J, Wamoni E, Bukusi EA, Mugo NR, Ngure K, Morton JF, Mugwanya KK, Baeten JM, O'Malley G; Partners Scale-Up Project Team. Process evaluation of PrEP implementation in Kenya: adaptation of practices and contextual modifications in public HIV care clinics. J Int AIDS Soc. 2021 Sep;24(9):e25799. doi: 10.1002/jia2.25799.
PubMed 34496148Peebles K, Mugwanya KK, Irungu E, Odoyo J, Wamoni E, Morton JF, Ngure K, Bukusi EA, Mugo NR, Masyuko S, Mukui I, Baeten JM, Barnabas RV; Partners Scale-Up Project Team. Low costs and opportunities for efficiency: a cost analysis of the first year of programmatic PrEP delivery in Kenya's public sector. BMC Health Serv Res. 2021 Aug 16;21(1):823. doi: 10.1186/s12913-021-06832-3.
PubMed 34399736Irungu EM, Ngure K, Mugwanya K, Mugo N, Bukusi E, Wamoni E, Odoyo J, Morton JF, Bernabee G, Mambo B, Masyuko S, Mukui I, O'Malley G, Baeten JM. Training health care providers to provide PrEP for HIV serodiscordant couples attending public health facilities in Kenya. Glob Public Health. 2019 Oct;14(10):1524-1534. doi: 10.1080/17441692.2019.1588908. Epub 2019 Mar 14.
PubMed 30871413Mugwanya KK, Irungu E, Bukusi E, Mugo NR, Odoyo J, Wamoni E, Ngure K, Morton JF, Peebles K, Masyuko S, Barnabee G, Donnell D, Barnabas R, Haberer J, O'Malley G, Baeten JM; Partners Scale Up Team. Scale up of PrEP integrated in public health HIV care clinics: a protocol for a stepped-wedge cluster-randomized rollout in Kenya. Implement Sci. 2018 Sep 4;13(1):118. doi: 10.1186/s13012-018-0809-7.
PubMed 30180860
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivery of Integrated PrEP and ART for Couples in Kenya
- ClinicalTrials.gov ID
- NCT03052010
- Acronym / sponsor ID
- STUDY00002183
- Conditions
- HIV-1-infection
- Keywords
- HIV-1 serodiscordant couples, PrEP as Bridge to ART
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,898 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute, Kenya National AIDS & STI Control Programme, National Institute of Mental Health (NIMH), Bill and Melinda Gates Foundation
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 14 Feb 2017 (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.
An implementation project to scale-up delivery of antiretroviral-based HIV-1 prevention methods to Kenyan HIV-1 serodiscordant couples in HIV-1 care centers. Pre-exposure prophylaxis (PrEP) as a bridge to antiretroviral therapy (ART) HIV-1 prevention strategy will be introduced into 24 public HIV-1 care centers in central and western Kenya according to national guidelines using a stepped wedge design, stratified by region.
Detailed description
PrEP as a bridge to ART strategy will be introduced into 24 Kenyan public HIV-1 care centers according to national guidelines, in staged fashion, stratified by region (a stepped wedge design). Monitoring and evaluation activities will identify implementation barriers and solutions, characterize costs, and provide best practices for further scale-up. A research component will establish prospective open cohorts of couples at each clinic (up to 200) to study how the program is effectively implemented. Follow-up in the cohorts will be for up to 36 months at each care center and will evaluate impact, costs, and facilitators and barriers to implementation at patient, provider and health system levels.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PrEP for HIV-1 uninfected partners and ART for HIV-1 infected | Other | Other: Integrated PrEP as a bridge to ART HIV-1 prevention strategy, Drug: PrEP, Drug: ARTIntegrated PrEP as a bridge to ART HIV-1 prevention strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- For HIV-1 uninfected members of the couple
- Age ≥18
- Able and willing to provide consent for follow-up in the cohort
- HIV-1 uninfected based on negative HIV-1 tests, per Kenya national guidelines
- Not currently using PrEP
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 |
|---|---|---|
| Integrated PrEP as a bridge to ART HIV-1 prevention strategyThe PrEP as a bridge to ART intervention will be introduced into clinics according to Kenya national guidelines using a stepped wedge design, stratified by region. The components of the intervention are: a) Couples' HIV-1 counseling and testing; 2) PrEP as a bridge to ART: PrEP offered prior to ART initiation in couples in which the HIV-1 infected partner is not on ART due to refusal/delay, during the first 6 months after ART start during viral decline, and then discontinuation; 3) ART at any CD4 count, offered to all HIV-1 infected partners, with ongoing promotion/counseling for those delaying/declining;4) Standard of care HIV-1 prevention services | Other | PrEP for HIV-1 uninfected partners and ART for HIV-1 infected |
| PrEPA fixed-dose, oral co-formulation of emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) is the approved and preferred regimen for HIV-1 prevention in Kenya and the United States. The World Health Organization (WHO) recommends TDF-containing medications as PrEP, which includes TDF combined with FTC as well as potentially TDF alone and TDF combined with lamivudine (or 3TC, a medication closely related to FTC). Any TDF-containing medications that align with WHO and Kenya national guidelines for PrEP will be used. PrEP medication will come from clinic stocks. | Drug | PrEP for HIV-1 uninfected partners and ART for HIV-1 infected |
| ARTART medications will be provided according to Kenya national ART policies and will come from clinic stocks. | Drug | PrEP for HIV-1 uninfected partners and ART for HIV-1 infected |
Primary outcome
Number of HIV-1 infected persons whose partners are tested for HIV-1 before/after PrEP as a bridge to ART is implemented
Time frame: up to 36 months
PrEP initiation
Time frame: up to 36 months
Measure the number of HIV-1 uninfected partners initiating PrEP.
PrEP adherence
Time frame: up to 6 months
Adherence by HIV-1 uninfected partners until their HIV-1 infected partners initiate ART and sustain use for six months. Adherence will be measured by self reported and random dry blood spot for tenofovir levels
HIV-1 uninfected partners staying HIV-1 uninfected.
Time frame: up to 36 months
ART initiation
Time frame: up to 36 months
Number of HIV-1 infected partners newly initiating ART
ART adherence
Time frame: up to 6 months
Adherence measured by plasma RNA viral load. Viral load will be abstract from the HIV-infected partners records.
Facilitators and barriers to implementation of integrated PrEP and ART
Time frame: up to 36 months
Mixed methods assessment of how integrated PrEP and ART is implemented at the level of provider, health center, and health systems
PrEP delivery operational tools
Time frame: 24 months
Training manual on deliver of integrated PrEP and ART HIV prevention strategy for couples will be developed.
Cost and cost-effectiveness of the integrated PrEP and ART when delivered in public health clinics.
Time frame: up to 36 months
Time and motions to define the cost and cost-effectiveness of intervention summarized in terms of HIV infections averted, disability-adjusted life years saved, and incremental cost-effectiveness over routine HIV-1 care
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 19 Oct 2021.
- Derived from this study: PubMed 34798031Irungu EM, Mugwanya KK, Mugo NR, Bukusi EA, Donnell D, Odoyo J, Wamoni E, Peacock S, Morton JF, Ngure K, Mugambi M, Mukui I, O'Malley G, Baeten JM; Partners Scale-Up Project Team. Integration of pre-exposure prophylaxis services into public HIV care clinics in Kenya: a pragmatic stepped-wedge randomised trial. Lancet Glob Health. 2021 Dec;9(12):e1730-e1739. doi: 10.1016/S2214-109X(21)00391-0.
- Derived from this study: PubMed 34496148Irungu EM, Odoyo J, Wamoni E, Bukusi EA, Mugo NR, Ngure K, Morton JF, Mugwanya KK, Baeten JM, O'Malley G; Partners Scale-Up Project Team. Process evaluation of PrEP implementation in Kenya: adaptation of practices and contextual modifications in public HIV care clinics. J Int AIDS Soc. 2021 Sep;24(9):e25799. doi: 10.1002/jia2.25799.
- Derived from this study: PubMed 34399736Peebles K, Mugwanya KK, Irungu E, Odoyo J, Wamoni E, Morton JF, Ngure K, Bukusi EA, Mugo NR, Masyuko S, Mukui I, Baeten JM, Barnabas RV; Partners Scale-Up Project Team. Low costs and opportunities for efficiency: a cost analysis of the first year of programmatic PrEP delivery in Kenya's public sector. BMC Health Serv Res. 2021 Aug 16;21(1):823. doi: 10.1186/s12913-021-06832-3.
- Derived from this study: PubMed 30871413Irungu EM, Ngure K, Mugwanya K, Mugo N, Bukusi E, Wamoni E, Odoyo J, Morton JF, Bernabee G, Mambo B, Masyuko S, Mukui I, O'Malley G, Baeten JM. Training health care providers to provide PrEP for HIV serodiscordant couples attending public health facilities in Kenya. Glob Public Health. 2019 Oct;14(10):1524-1534. doi: 10.1080/17441692.2019.1588908. Epub 2019 Mar 14.
- Derived from this study: PubMed 30180860Mugwanya KK, Irungu E, Bukusi E, Mugo NR, Odoyo J, Wamoni E, Ngure K, Morton JF, Peebles K, Masyuko S, Barnabee G, Donnell D, Barnabas R, Haberer J, O'Malley G, Baeten JM; Partners Scale Up Team. Scale up of PrEP integrated in public health HIV care clinics: a protocol for a stepped-wedge cluster-randomized rollout in Kenya. Implement Sci. 2018 Sep 4;13(1):118. doi: 10.1186/s13012-018-0809-7.
- Individual participant dataSharing planned: Yes. Data from the Partners Scale-Up Project will be available at end of the Project by contacting the International Clinical Research Center at the University of Washington (icrc@uw.edu)
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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.
Jared Baeten, MD, PhD principal investigator
University of Washington
Kenneth K. Mugwanya, MBChB, MS, PhD study director
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Integrated PrEP as a bridge to ART HIV-1 prevention strategy, PrEP and ART in people with HIV-1-infection, run by University of Washington at 2 sites in Kenya.
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 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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-1 infected persons whose partners are tested for HIV-1 before/after PrEP as a bridge to ART is implemented (time frame: up to 36 months). The study lists 9 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 NCT03052010, which also lists 5 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 19 Oct 2021.