Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 29, 2019
Open Peer Review Period: Aug 1, 2019 - Sep 26, 2019
Date Accepted: Feb 4, 2020
(closed for review but you can still tweet)
Improving Retention in Care and Promoting Adherence to HIV Treatment: A Protocol for a Multi-site Randomized Controlled Trial of Mobile Phone Text Messaging
ABSTRACT
Background The objective of this trial is to assess whether sending weekly motivational text messages (SMS) through mobile phones versus no text messaging will improve retention in care and promote adherence to treatment and health outcomes among patients receiving HIV treatment in Fako Division of Cameroon. Materials and Methods This is a multi-site randomized controlled single-blinded trial. Computer generated random block sizes shall be used to produce a randomization list. Participants shall be randomly allocated into the intervention and control groups determined by serially numbered sealed opaque envelopes. The 156 participants will either receive the mobile phone text message or usual standard of care. We hypothesize that sending weekly motivational SMS reminders will produce a change in behavior to enhance retention, treatment adherence and hence health outcomes. Participants shall be evaluated and data collected at baseline, and then at 2, 4 and 6 months after the launch of the intervention. Text messages shall be sent out and delivery recorded. Primary outcome measures are retention in care and adherence to treatment. Secondary outcomes are clinical (weight, body mass index), Biological (virologic suppression, Tuberculosis co-infection), quality of life, treatment discontinuation and mortality. Analysis shall be by intention-to-treat. Analysis of covariates shall be performed to determine factors influencing outcomes. Ethics and dissemination Approval was received from the Institutional Review Board of the Faculty of Health Sciences of the University of Buea in Cameroon (Reference number: 2018/147/UB/SG/IRB/FHS). Administrative authorization was obtained from the Regional Delegation of the Ministry of Public Health for the South West Region. Findings will be communicated and disseminated through scientific publications. A summary of the findings will be made available to participants. Trial Registration: Pan African Clinical Trial Registry in South Africa with unique identification number PACTR201802003035922.
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