Abstract
BackgroundAntiretroviral therapy (ART) for HIV-infected persons and pre-exposure prophylaxis (PrEP) for uninfected persons are extraordinarily effective strategies for HIV prevention. In Africa, the region which shoulders the highest HIV burden, HIV care is principally delivered through public health HIV care clinics, offering an existing platform to incorporate PrEP delivery and maximize ART and PrEP synergies. However, successfully bringing this integrated approach to scale requires an implementation science evaluation in public health settings.MethodsThe Partners Scale Up Project is a prospective, pragmatic implementation evaluation, designed as a stepped-wedge, cluster-randomized trial, operating at 24 clinics in Kenya. In collaboration with the Kenya Ministry of Health, we are catalyzing scaled implementation of PrEP delivery integrated in HIV care clinics. The intervention package includes staff training, clinic streamlined access to PrEP commodity from the Kenya Medical Supply Authority, and ongoing intensive technical assistance to rigorously assess how PrEP delivery is implemented. PrEP service delivery including retention efforts are conducted by the clinic staff with no additional resources from the project. Guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework and Consolidated Framework for Implementation Science Research, project progress and learning are documented through ongoing monitoring and process evaluations, including chart abstraction and individual and key informant interviews, to evaluate pragmatic rollout and understand barriers and facilitators for successful PrEP delivery in this setting. In this staged rollout design, each step provides data for both pre-implementation (baseline) and implementation periods, and we will compare time points across steps in the baseline versus implementation periods.DiscussionCost-effective delivery models are urgently needed to maximize the public health impact of PrEP and ART. The Partners Scale Up Project will set the stage for full-scale PrEP implementation fully run and owned by the Kenya Ministry of Health. The work combines nationally sponsored PrEP delivery with technical support and implementation science from academic partners, defining a new but sustainable paradigm for public health collaboration.Trial registrationRegistered with ClinicalTrials.gov on February 14, 2017:NCT03052010.
Highlights
Antiretroviral therapy (ART) for Human immunodeficiency virus (HIV)-infected persons and pre-exposure prophylaxis (PrEP) for uninfected persons are extraordinarily effective strategies for HIV prevention
The specific aims are: 1) Facilitate delivery of PrEP integrated into ART care for HIV-serodiscordant couples at scale in public HIV care centers in Kenya and evaluate program impact; 2) Assess facilitators and barriers to (a) implementation of PrEP within ART delivery settings and (b) optimized PrEP adherence in public health context with limited measurement capacity; 3) Determine efficiency, cost, and cost-effectiveness of integrated PrEP and ART when delivered in public health clinics; and
For novel HIV prevention interventions, like PrEP, the potential pathway for this transition to implementation has been defined as follows: clinical trials are followed by open label extensions, which provide first access to the product in the trial population, demonstration projects that “road test” the intervention among individuals who had not been in the clinical trials and using strategies to mimic real-world delivery, and product introduction, which leads the intervention to scale through integration into existing health systems [33]
Summary
Antiretroviral therapy (ART) for HIV-infected persons and pre-exposure prophylaxis (PrEP) for uninfected persons are extraordinarily effective strategies for HIV prevention. In Africa, the region which shoulders the highest HIV burden, HIV care is principally delivered through public health HIV care clinics, offering an existing platform to incorporate PrEP delivery and maximize ART and PrEP synergies. Successfully bringing this integrated approach to scale requires an implementation science evaluation in public health settings. Pivotal clinical trials demonstrated very high efficacy for HIV prevention strategies in couples [12], including antiretroviral therapy (ART) for HIV-infected partners [13] and pre-exposure prophylaxis (PrEP) for HIV-uninfected partners [12]. Priority persons for HIV prevention include HIV-uninfected members of serodiscordant couples, those couples in which the HIV-infected partner is not yet taking ART or has not achieved viral suppression on ART
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