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✪ 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**

✪ An integrated community health worker intervention in rural Nepal: A type 2 hybrid effectiveness-implementation study protocol

Authors:

Sheela Maru, Isha Nirola, Aradhana Thapa, Poshan Thapa, Lal Kunwar, Wan-Ju Wu, Scott Halliday, David Citrin, Ryan Schwarz, Indira Basnett, Naresh KC, Khem Karki, Pushpa Chaudhari and Duncan Maru

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: March 2018

Read the full text in the open access journal Implementation Science

Abstract:

Background

Evidence-based medicines, technologies, and protocols exist to prevent many of the annual 300,000 maternal, 2.7 million neonatal, and 9 million child deaths, but they are not being effectively implemented and utilized in rural areas. Nepal, one of South Asia’s poorest countries with over 80% of its population living in rural areas, exemplifies this challenge.
Community health workers are an important cadre in low-income countries where human resources for health and health care infrastructure are limited. As local women, they are uniquely positioned to understand and successfully navigate barriers to health care access. Recent case studies of large community health worker programs have highlighted the
importance of training, both initial and ongoing, and accountability through structured management, salaries, and ongoing monitoring and evaluation. A gap in the evidence regarding whether such community health worker systems can change health outcomes, as well as be sustainably adopted at scale, remains. In this study, we plan to evaluate a community
health worker system delivering an evidence-based integrated reproductive, maternal, newborn, and child health intervention as it is scaled up in rural Nepal.

Methods

We will conduct a type 2 hybrid effectiveness-implementation study to test both the effect of an integrated reproductive, maternal, newborn, and child health intervention and the implementation process via a professional community health worker system. The intervention integrates five evidence-based approaches: (1) home-based antenatal care and post-natal
care counseling and care coordination; (2) continuous surveillance of all reproductive age women, pregnancies, and children under age 2 years via a mobile application; (3) Community-Based Integrated Management of Newborn and Childhood Illness; (4) group antenatal and postnatal care; and 5) the Balanced Counseling Strategy to post-partum
contraception. We will evaluate effectiveness using a pre-post quasi-experimental design with stepped implementation and implementation using the RE-AIM framework.

Discussion

This is the first hybrid effectiveness-implementation study of an integrated reproductive, maternal, newborn, and child health intervention in rural Nepal that we are aware of. As Nepal takes steps towards achieving the Sustainable Development Goals, the data from this three-year study will be useful in the detailed planning of a professionalized
community health worker cadre delivering evidence-based reproductive, maternal, newborn, and child health interventions to the country’s rural population.

Trial registration

ClinicalTrials.gov Identifier: NCT03371186, registered 04 December 2017, retrospectively registered.

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

✪ Enhance®Fitness Dissemination and Implementation: 2010–2015: A Scoping Review

Authors:

Miruna G. Petrescu-Prahova, Thomas J. Eagen, Sarah L. Fishleder, Basia Belza

University of Washington affiliated authors are displayed in bold.

Published: February 2017

Read the full text in the open access journal American Journal of Preventive Medicine

Abstract:

Introduction

Physical activity has many benefits for older adult physical and mental health. Enhance®Fitness (EF) is an evidence-based group exercise program delivered by community-based organizations. The purpose of this study was to review recent evidence on the dissemination and implementation of EF.

Methods

A scoping review of qualitative and quantitative studies with EF as main focus was conducted. CINAHL, PubMed, PubMed Central, SCOPUS, Web of Science, PsycINFO, and Google Scholar were searched between October and November 2015 for data-based studies on EF published in 2010–2015. Two team members abstracted each paper independently using a data abstraction tool. Results were summarized using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.

Results

Seventeen publications met inclusion criteria. EF has reached and is effective across a broad population base, including individuals with low SES and diverse ethnic/racial backgrounds. EF participation may be associated with reduced risk for falls requiring medical care, and is associated with fewer hospital admissions. Analyses of medical cost savings from EF participation and program implementation costs suggest economic benefits of EF implementation for communities. Organization-level maintenance is facilitated by program-specific and organizational factors, such as instructor training and funding. Individual-level maintenance is facilitated by program structure, absence of pain, and increased quality of life.

Conclusions

More-rigorous evidence is needed about the association between participation in EF and conditions such as falls. Evaluation of program fidelity, adaptations, and sustainability is limited; more-systematic examination across population groups and types of organizations would help ensure older adults continue to benefit from EF participation.

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