MAHILA: A protocol for evaluating a nurse-delivered mHealth intervention for women with HIV and psychosocial risk factors in India

Abstract

Background: Women living with HIV are vulnerable to a variety of psychosocial barriers that limit access and adherence to treatment. There is little evidence supporting interventions for improving access and treatment adherence among vulnerable groups of women in low- and middle-income countries. The M obile Phone-Based A pproach for H ealth I mprovement, L iteracy and A dherence (MAHILA) trial is assessing the feasibility, acceptability and preliminary efficacy of a novel, theory-guided mobile health intervention delivered by nurses for enhancing self-care and treatment adherence among HIV-infected women in India. Methods/Design: Women (n = 120) with HIV infection who screen positive for depressive symptoms and/or other psychosocial vulnerabilities are randomly assigned in equal numbers to one of two treatment arms: treatment as usual plus the mobile phone intervention (experimental group) or treatment as usual (control group). In addition to treatment as usual, the experimental group receives nurse-delivered self-care counselling via mobile phone at fixed intervals over 16 weeks. Outcome measures are collected at baseline and at 4, 12, 24 and 36 weeks post-baseline. Outcomes include antiretroviral treatment adherence, HIV-1 RNA, depressive symptoms, illness perceptions, internalized stigma and quality of life. Discussion: The MAHILA trial will provide information about how a mobile health counselling intervention delivered by non specialist nurses may improve access to care and support the adherence and clinical outcomes of women with HIV infection living in low- and middle-income countries such as India. Trial registration: NCT02319330 (First received: July 30, 2014; Last verified: January 2016)