A randomized blinded controlled trial of mobile phone reminders on the follow-up medical care of HIV-exposed and HIV-infected children in Cameroon: study protocol (MORE CARE).

BACKGROUND

In Cameroon, only two-thirds of children with HIV exposure or infection receive appropriate HIV-directed medical care. Mortality, antiretroviral therapy resistance and suboptimal virological response are strongly related to missed opportunities for treatment, and, more specifically, to skipped scheduled medical appointments. The present trial, MORE CARE (Mobile Reminders for Cameroonian Children Requiring HIV Care) seeks to determine if reminders sent by text message (SMS), phone call, or concomitant SMS and phone calls most increase the presence at medical appointments of HIV-infected or -exposed children (efficacy), and which is the most efficient related to working time and financial cost (efficiency).

METHODS/DESIGN: We will carry out a multicenter single-blind, randomized, factorial controlled trial. A randomization list will be electronically generated using random block sizes. Central allocation will be determined by sequentially numbered. A total of 224 subjects will be randomized into four groups (SMS, Call, SMS + Call, and Control) with an allocation ratio of 1:1:1:1. SMS and calls will be sent between 48 and 72 hours before the scheduled appointment. A medical assistant will send out text messages and will call participants. Our primary outcome is appointment measured by efficacy and efficiency of interventions. We hypothesize that two reminders (concomitant use of SMS and phone calls) as an appointment reminder is more effective to improve appointment compared to one reminder (only SMS or only call), and that the most efficient is use of only SMS. The analysis will be intention to treat.

DISCUSSION

This trial investigates the potential of SMS and phone calls as motivational reminders to improve children's adherence to medical appointments for HIV-related care in Cameroon. The intervention will act to end missed appointment due to forgetfulness.

TRIAL REGISTRATION

Pan African Clinical Trials Registry: PACTR201304000528276.