Scaled-Up Mobile Phone Intervention for HIV Care and Treatment: Protocol for a Facility Randomized Controlled Trial

Background: Adherence to prevention, care, and treatment recommendations among people living with HIV (PLHIV) is a critical challenge. Yet good clinical outcomes depend on consistent, high adherence to antiretroviral therapy (ART) regimens. Mobile phones offer a promising means to improve patient adherence and health outcomes. However, limited information exists on the impact that mobile phones for health (mHealth) programs have on ART adherence or the behavior change processes through which such interventions may improve patient health, particularly among ongoing clients enrolled in large public sector HIV service delivery programs and key populations such as men who have sex with men (MSM) and female sex workers (FSW). Objective: Our aim is to evaluate an mHealth intervention where text message reminders are used as supportive tools for health providers and as motivators and reminders for ART clients to adhere to treatment and remain linked to care in Ghana. Using an implementation science framework, we seek to: (1) evaluate mHealth intervention effects on patient adherence and health outcomes, (2) examine the delivery of the mHealth intervention for improving HIV care and treatment, and (3) assess the cost-effectiveness of the mHealth intervention. Methods: The 36-month study will use a facility cluster randomized controlled design (intervention vs standard of care) for evaluating the impact of mHealth on HIV care and treatment. Specifically, we will look at ART adherence, HIV viral load, retention in care, and condom use at 6 and 12-month follow-up. In addition, participant adoption and satisfaction with the program will be measured. This robust methodology will be complemented by qualitative interviews to obtain feedback on the motivational qualities of the program and benefits and challenges of delivery, especially for key populations. Cost-effectiveness will be assessed using incremental cost-effectiveness ratios, with health effects expressed in terms of viral load suppression and costs of resources used for the intervention. Results: This study and protocol was fully funded, but it was terminated prior to review from ethics boards and study implementation. Conclusions: This cluster-RCT would have provided insights into the health effects, motivational qualities, and cost-effectiveness of mHealth interventions for PLHIV in public sector settings. We are seeking funding from alternate sources to implement the trial.