Protocol No: ECCT/18/03/01 Date of Protocol: 14-02-2018

Study Title:

HIV self-testing to improve the efficiency of PrEP delivery.

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Study Objectives:

Aim 1:          In a randomized trial, we will test the use of HIV-1 self-testing to decrease the frequency and burden of clinic visits for PrEP while resulting in equivalent adherence and testing.  

Aim 2:          We will conduct mixed-methods work to understand user and provider experiences, preferences, barriers, and facilitators related to HIV-1 self-testing. 

Aim 3:          We will assess costs and cost-effectiveness of HIV-1 self-testing to optimize PrEP delivery. 

 

Laymans Summary:

Like PrEP, HIV-1 self-testing is a recent innovation and its opportunities to improve HIV-1 prevention have not been fully realized.  We hypothesize that HIV-1 self-testing can streamline PrEP delivery – through decreasing the frequency of PrEP clinic visits by having self-tests at home replace clinic-based testing.  Both oral fluid and new finger stick blood-based HIV-1 self-tests could be used, and these two modalities might have different costs or preferences. 

In May 2017, Kenya announced national scale-up of PrEP for persons at risk for HIV-1, prioritizing HIV-1 serodiscordant couples, women at risk, and other priority groups, and also the prioritization of HIV-1 self-testing in the country.  This project proposes to address key access and cost of delivery challenges for PrEP by integrating the new modality of HIV-1 self-testing.

Abstract of Study:

Maximizing access and minimizing costs of delivery are key challenges for optimizing the public health impact of pre-exposure prophylaxis (PrEP) for HIV-1 prevention, particularly for resource-constrained settings.  PrEP is highly effective and safe when taken as prescribed, and demonstration studies are showing how PrEP can be delivered in clinical settings.  In Africa, PrEP will be added to an already-burdened health infrastructure and the ability of public health systems to afford PrEP will necessitate making its delivery cost-effective and time-efficient.  PrEP delivery programs will need to be cost-sensitive to staffing needs (e.g., frequent clinic visits); moreover, patients may not continue PrEP if their costs (e.g., travel to / waiting in clinics) are high.  HIV-1 testing is central to PrEP: testing must occur prior to initiation and ongoing HIV-1 testing is essential for delivery.  Like PrEP, HIV-1 self-testing is a recent innovation and its opportunities to improve HIV-1 prevention have not been fully realized.  We hypothesize that HIV-1 self-testing can streamline PrEP delivery – through decreasing the frequency of PrEP clinic visits by having self-tests at home replace clinic-based testing.  Both oral fluid and new finger stick blood-based HIV-1 self-tests could be used, and these two modalities might have different costs or preferences. 

In May 2017, Kenya announced national scale-up of PrEP for persons at risk for HIV-1, prioritizing HIV-1 serodiscordant couples, women at risk, and other priority groups, and also the prioritization of HIV-1 self-testing in the country.  This project proposes to address key access and cost of delivery challenges for PrEP by integrating the new modality of HIV-1 self-testing.

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