The effect of weekly short message service communication on patient retention in care in the first year after HIV diagnosis: study protocol for a randomised controlled trial (WelTel Retain).

INTRODUCTION: Interventions to improve retention in care after HIV diagnosis are necessary to optimise the timely initiation of antiretroviral therapy (ART) and HIV/AIDS control outcomes. Widespread mobile phone use presents new opportunities to engage patients in care. A randomised controlled trial (RCT), WelTel Kenya1, demonstrated that weekly text messages led to improved ART adherence and viral load suppression among those initiating ART. The aim of this study was to determine whether the WelTel intervention is an effective and cost-effective method of improving retention in care in the first year of care following HIV diagnosis.

METHODS AND ANALYSIS: WelTel Retain is an open, parallel group RCT that will be conducted at the Kibera Community Health Centre in Nairobi, Kenya. Over a 1-year period, we aim to recruit 686 individuals newly diagnosed with HIV who will be randomly allocated to an intervention or control arm (standard care) at a 1:1 ratio. Intervention arm participants will receive the weekly WelTel SMS 'check-in' to which they will be instructed to respond within 48 h. An HIV clinician will follow-up and triage any problems that are identified. Participants will be followed for 1 year, with a primary endpoint of retention in care at 12 months. Secondary outcomes include retention in stage 1 HIV care (patients return to the clinic to receive their first CD4 results) and timely ART initiation. Cost-effectiveness will be analysed through decision-analytic modelling.

ETHICS AND DISSEMINATION: Ethical approval has been obtained from the University of British Columbia and the African Medical and Research Foundation. This trial will test the effectiveness and cost-effectiveness of the WelTel intervention to engage patients during the first year of HIV care. Trial results and economic evaluation will help inform policy and practice on the use of WelTel in the early stages of HIV care.

TRIAL REGISTRATION: ClinicalTrials.gov NCT01630304.