Partners PrEP Program

Study Overview
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Brief Summary
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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.

Official Title
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Integrated PrEP and ART Delivered in Ugandan Public Health Clinics to Improve HIV and ART Outcomes for HIV Serodiscordant Couples

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: PrEP
* Drug: ART


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) 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 Exclusion Criteria: - Otherwise not eligible based on the above inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV serodiscordant couples<br> | Drug: PrEP<br>* 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.<br>Drug: ART<br>* ART medication will be provided according to Uganda national guidelines for persons living with HIV.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of HIV-positive members of a discordant partnership who initiate ART | Measure ART initiation of the HIV-positive member of the couple | 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 | 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 | 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. | Up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Up to 24 months |