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Implementation Science at UW

Keywords: Deborah Donnell

✪ Scale up of PrEP integrated in public health HIV care clinics: a protocol for a stepped-wedge cluster-randomized rollout in Kenya

Authors:

Kenneth K. Mugwanya, Elizabeth Irungu, Elizabeth Bukusi, Nelly R. Mugo, Josephine Odoyo, Elizabeth Wamoni, Kenneth Ngure, Jennifer F. Morton, Kathryn Peebles, Sarah Masyuko, Gena Barnabee, Deborah Donnell, Ruanne Barnabas, Jessica Haberer, Gabrielle O’Malley, and Jared M. Baeten, for the Partners Scale Up Team

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: September 2018

Read the full text in the open access journal Implementation Science

Abstract:

Background

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. However, successfully bringing this integrated approach to scale requires an implementation science evaluation in public health settings.

Methods

The 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.

Discussion

Cost-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 registration

Registered with ClinicalTrials.gov on February 14, 2017:NCT03052010.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Integrated Delivery of Antiretroviral Treatment and Pre-exposure Prophylaxis to HIV-1–Serodiscordant Couples: A Prospective Implementation Study in Kenya and Uganda

Authors:

Jared M. Baeten, Renee Heffron, Lara Kidoguchi, Nelly R. Mugo, Elly Katabira, Elizabeth A. Bukusi, Stephen Asiimwe, Jessica E. Haberer, Jennifer Morton, Kenneth Ngure, Nulu Bulya, Josephine Odoyo, Edna Tindimwebwa, Craig Hendrix, Mark A. Marzinke, Norma C. Ware, Monique A. Wyatt, Susan Morrison, Harald Haugen, Andrew Mujugira, Deborah Donnell, Connie Celum, & the Partners Demonstration Project Team

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: August 2016

Read the full text in the open access journal PLOS Medicine

Abstract:

Background

Antiretroviral-based interventions for HIV-1 prevention, including antiretroviral therapy (ART) to reduce the infectiousness of HIV-1 infected persons and pre-exposure prophylaxis (PrEP) to reduce the susceptibility of HIV-1 uninfected persons, showed high efficacy for HIV-1 protection in randomized clinical trials. We conducted a prospective implementation study to understand the feasibility and effectiveness of these interventions in delivery settings.

Methods and Findings

Between November 5, 2012, and January 5, 2015, we enrolled and followed 1,013 heterosexual HIV-1-serodiscordant couples in Kenya and Uganda in a prospective implementation study. ART and PrEP were offered through a pragmatic strategy, with ART promoted for all couples and PrEP offered until 6 mo after ART initiation by the HIV-1 infected partner, permitting time to achieve virologic suppression. One thousand thirteen couples were enrolled, 78% of partnerships initiated ART, and 97% used PrEP, during a median follow-up of 0.9 years. Objective measures of adherence to both prevention strategies demonstrated high use (≥85%).

Given the low HIV-1 incidence observed in the study, an additional analysis was added to compare observed incidence to incidence estimated under a simulated counterfactual model constructed using data from a prior prospective study of HIV-1-serodiscordant couples. Counterfactual simulations predicted 39.7 HIV-1 infections would be expected in the population at an incidence of 5.2 per 100 person-years (95% CI 3.7–6.9). However, only two incident HIV-1 infections were observed, at an incidence of 0.2 per 100 person-years (95% CI 0.0–0.9, p < 0.0001 versus predicted). The use of a non-concurrent comparison of HIV-1 incidence is a potential limitation of this approach; however, it would not have been ethical to enroll a contemporaneous population not provided access to ART and PrEP.

Conclusions

Integrated delivery of time-limited PrEP until sustained ART use in African HIV-1-serodiscordant couples was feasible, demonstrated high uptake and adherence, and resulted in near elimination of HIV-1 transmission, with an observed HIV incidence of <0.5% per year compared to an expected incidence of >5% per year.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**