The Partners Scale-Up Project

Study Overview
=================
Brief 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 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.

Official Title
-----------------
Delivery of Integrated PrEP and ART for Couples in Kenya

Conditions
-----------------
HIV-1-infection

Intervention / Treatment
-----------------
* Other: Integrated PrEP as a bridge to ART HIV-1 prevention strategy
* Drug: PrEP
* Drug: ART


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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PrEP for HIV-1 uninfected partners and ART for HIV-1 infected<br>Integrated PrEP as a bridge to ART HIV-1 prevention strategy | Other: Integrated PrEP as a bridge to ART HIV-1 prevention strategy<br>* 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<br>Drug: PrEP<br>* 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.<br>Drug: ART<br>* ART medications will be provided according to Kenya national ART policies and will come from clinic stocks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of HIV-1 infected persons whose partners are tested for HIV-1 before/after PrEP as a bridge to ART is implemented |  | up to 36 months | 
| PrEP initiation | Measure the number of HIV-1 uninfected partners initiating PrEP. | 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 | up to 6 months | 
| HIV-1 uninfected partners staying HIV-1 uninfected. |  | up to 36 months | 
| ART initiation | Number of HIV-1 infected partners newly initiating ART | up to 36 months | 
| ART adherence | Adherence measured by plasma RNA viral load. Viral load will be abstract from the HIV-infected partners records. | 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 | 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. | 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 | up to 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV-1 serodiscordant couples, PrEP as Bridge to ART