Evaluation of short message service and peer navigation to improve engagement in HIV care in South Africa: study protocol for a three-arm cluster randomized controlled trial.

Parya Saberi,Jennifer M Gilvydis,Hailey Gilmore,Julia Dekadt,Starley B Shade,Jeri Sumitani,Mary Jane Ratlhagana,Jessica Grignon,Scott Barnhart,John Tumbo,Wayne T Steward,Emily Agnew,Sheri A Lippman

doi:10.1186/s13063-016-1190-y

Abstract

BackgroundIn countries with a high burden of HIV, such as South Africa, where the epidemic remains the world’s largest, improving early uptake of and consistent adherence to antiretroviral therapy could bring substantial HIV prevention gains. However, patients are not linked to or retained in care at rates needed to curtail the epidemic. Two strategies that have demonstrated a potential to stem losses along the HIV care cascade in the sub-Saharan African context are use of text messaging or short message service (SMS) and peer-navigation services.Methods/DesignWe designed a cluster randomized trial to assess the efficacy of an SMS intervention and a peer-navigation intervention to improve retention in care and treatment, timely linkage to care and treatment, medication adherence, and prevention behaviors in South Africa. Eighteen primary and community healthcare clinics in Rustenburg and Moses Kotane Sub-districts in the North West Province were randomized to one of three conditions: SMS intervention (n = 7), peer navigation intervention (n = 7), or standard of care (n = 4). Approximately 42 participants are being recruited at each clinic, which will result in a target of 750 participants. Eligible participants include patients accessing HIV testing or care in a study clinic, recently diagnosed with HIV, aged 18 years or older, and with access to a cellular telephone where they are willing to receive automated SMS with HIV-related messaging. Data collection includes extraction of visit information from clinical files and participant surveys at baseline, 6 months, and 12 months. Intent-to-treat (ITT) analysis will explore differences between randomization arms and the primary outcome of patient retention in care at 12 months following enrollment. We will also explore secondary outcomes including participants’ a) timely linkage to care (within 3 months of HIV diagnosis), b) adherence to treatment based on self-report and clinic’s medication dispensation dates, and c) condom-use behaviors.DiscussionThe findings will allow us to compare the efficacy of two complementary interventions, one that requires fewer resources to implement (SMS) and one (peer navigation) that offers more flexibility in terms of the patient barriers to care that it can address.Trial registrationNCT02417233, registered 12 December 2014.

Highlights

In countries with a high burden of human immunodeficiency virus (HIV), such as South Africa, where the epidemic remains the world’s largest, improving early uptake of and consistent adherence to antiretroviral therapy could bring substantial HIV prevention gains
Under the assumption that only 50 % of participants in the standard of care (SOC) clinics will remain in care [10, 38], this sample size will provide 80 % power to observe a 20 % to 23 % difference in patient retention at 12 months between the peer navigation (PN) and SOC or short message service (SMS) and SOC arms and a 17 % to 20 % difference between the PN and SMS arms. These estimates assume a two-sided alpha of 0.05 and a coefficient of variation of 0.15 to 0.20 or an intra-cluster correlation of 0.0225 to 0.04 based on a review of the recent literature around sample size estimation in large cluster randomized trials [52, 53]. This trial will determine whether the use of SMS and peer-navigation interventions in rural and peri-urban clinics can improve engagement in HIV care and prevention in South Africa, where scalable interventions are sorely needed to improve current HIV outcomes
Both interventions being explored were pilot tested and demonstrated to be feasible to implement in similar low resource clinics in one of the study sub-districts (Moses Kotane) prior to beginning the trial

Summary

Introduction

In countries with a high burden of HIV, such as South Africa, where the epidemic remains the world’s largest, improving early uptake of and consistent adherence to antiretroviral therapy could bring substantial HIV prevention gains. In countries with a high burden of disease, such as South Africa, where the epidemic remains the world’s largest with an estimated 6.4 million people living with HIV (PLHIV) [7], improving early uptake of and adherence to ART could bring substantial gains in HIV prevention. In sub-Saharan Africa, some 40 % of individuals who test positive are not successfully linked to care, and only 50 % of those who are not yet ART-eligible are retained in HIV care [10], leading to a “cascade” of losses at each stage along the care continuum [11]

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