Integration of pre-exposure prophylaxis services into public HIV care clinics in Kenya: a pragmatic stepped-wedge randomised trial

Elizabeth M Irungu,Kenneth K Mugwanya,Nelly R Mugo,Elizabeth A Bukusi,Deborah Donnell,Josephine Odoyo,Elizabeth Wamoni,Sue Peacock,Jennifer F Morton,Kenneth Ngure,Mary Mugambi,Irene Mukui,Gabrielle O'Malley,Jared M Baeten

doi:10.1016/s2214-109x(21)00391-0

Abstract

SummaryBackgroundSuccessful and sustainable models for HIV pre-exposure prophylaxis (PrEP) delivery in public health systems in Africa are needed. We aimed to evaluate the implementation of PrEP delivery integrated in public HIV care clinics in Kenya.MethodsAs part of Kenya's national PrEP roll-out, we conducted a stepped-wedge cluster-randomised pragmatic trial to catalyse scale-up of PrEP delivery integrated in 25 public HIV care clinics. We selected high-volume clinics in these regions (ie, those with a high number of people living with HIV enrolled in HIV care and treatment). Clinics (each representing a cluster) were stratified by region and randomly assigned to the order in which clinic staff would receive PrEP training and ongoing technical support using numbered opaque balls picked from a bag. There was no masking. PrEP provision was done by clinic staff without additional financial support. Data were abstracted from records of individuals initiating PrEP. The primary outcome was the number of people initiating PrEP per clinic per month comparing intervention to control periods. Other outcomes included PrEP continuation, adherence, and incident HIV infections. This trial is registered with ClinicalTrials.gov, NCT03052010.FindingsAfter the baseline period, which started in January, 2017, every month two to six HIV care clinics crossed over from control to intervention, until August, 2017, when all clinics were implementing the intervention. Of 4898 individuals initiating PrEP (27 during the control period and 4871 during the intervention period), 2640 (54%) were women, the median age was 31 years (IQR 25–39), and 4092 (84%) reported having a partner living with HIV. The mean monthly number of PrEP initiations per clinic was 0·1 (SD 0·5) before the intervention and 7·5 (2·7) after intervention introduction (rate ratio 23·7, 95% CI 14·2–39·5, p<0·0001). PrEP continuation was 57% at 1 month, 44% at 3 months, and 34% at 6 months, and 12% of those who missed a refill returned later for PrEP re-initiation. Tenofovir diphosphate was detected in 68 (96%) of 71 blood samples collected from a randomly selected subset of participants. Six HIV infections were observed over 2531 person-years of observation (incidence 0·24 cases per 100 person-years), three of which occurred at the first visit after PrEP initiation.InterpretationWe observed high uptake, reasonable continuation with high adherence, frequent PrEP restarts, and low HIV incidence. Integration of PrEP services within public HIV care clinics in Africa is feasible.FundingNational Institute of Mental Health and Bill & Melinda Gates Foundation.

Highlights

Of the estimated 1·7 million new HIV infections in 2019, 60% occurred in the African region.[1]
In many African countries, public HIV care and treatment programmes have been very successful at scaling up antiretroviral therapy (ART) over the past 15 years and are an attractive choice for integration of pre-exposure prophylaxis (PrEP) delivery.[7,8]
Implications of all the available evidence We demonstrate that provision of PrEP services integrated in public HIV care clinics in Africa is feasible

Summary

Introduction

Of the estimated 1·7 million new HIV infections in 2019, 60% occurred in the African region.[1] Pre-exposure prophylaxis (PrEP) against HIV has the potential to reduce HIV incidence among populations at risk of HIV if it can be delivered with sufficient coverage.[2] In 2015, WHO recommended using daily oral tenofovir disoproxil fumarate (TDF), in combination with emtricitabine (FTC/TDF), as a safe and effective oral PrEP for persons at risk of HIV infection globally.[3] Many African countries have developed policies that incorporate PrEP in their HIV prevention strategies.[4]. In many African countries, public HIV care and treatment programmes have been very successful at scaling up antiretroviral therapy (ART) over the past 15 years and are an attractive choice for integration of PrEP delivery.[7,8] HIV care clinics in Africa routinely provide HIV prevention services including HIV testing services and condom distribution to uninfected partners of persons living with HIV, providing a ready PrEPeligible population.[7,9] In addition, health-care providers

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