title: MAHILA: a protocol for evaluating a nurse-delivered mHealth intervention for women with HIV and psychosocial risk factors in India.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  NCT02319330 (First received: July 30, 2014; Last verified: January 2016).
authors.affiliation: Division of Acute Care/Health Systems, School of Nursing, Yale University, 400 West Campus Drive, West Haven, CT, 06516, USA. nancy.reynolds@yale.edu.
authors.forename: Nancy R
authors.initials: NR
authors.lastname: Reynolds
authors.affiliation: Department of Clinical Psychology, National Institute of Mental Health and Neuro Sciences, Bengaluru, 560029, India.
authors.forename: Veena
authors.initials: V
authors.lastname: Satyanarayana
authors.affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh, India.
authors.forename: Mona
authors.initials: M
authors.lastname: Duggal
authors.affiliation: Department of Psychiatry, National Institute of Mental Health and Neuro Sciences, Hosur Road, Bengaluru, 560029, India.
authors.forename: Meiya
authors.initials: M
authors.lastname: Varghese
authors.affiliation: Division of Acute Care/Health Systems, School of Nursing, Yale University, 400 West Campus Drive, West Haven, CT, 06516, USA.
authors.forename: Lauren
authors.initials: L
authors.lastname: Liberti
authors.affiliation: Indraprastha Institute of Information Technology (IIIT-D), B-304, Academic Block, Okhla Phase III, New Delhi, 110020, India.
authors.forename: Pushpendra
authors.initials: P
authors.lastname: Singh
authors.affiliation: Department of Psychiatry, Yale University, School of Medicine, 300 George Street, New Haven, CT, 06511, USA.
authors.forename: Mohini
authors.initials: M
authors.lastname: Ranganathan
authors.affiliation: Division of Acute Care/Health Systems, School of Nursing, Yale University, 400 West Campus Drive, West Haven, CT, 06516, USA.
authors.forename: Sangchoon
authors.initials: S
authors.lastname: Jeon
authors.affiliation: Department of Psychiatry, National Institute of Mental Health and Neuro Sciences, Hosur Road, Bengaluru, 560029, India. chandra@nimhans.ac.in.
authors.forename: Prabha S
authors.initials: PS
authors.lastname: Chandra
mesh_terms: D000328:Adult; D002985:Clinical Protocols; D036861:Delivery, Obstetric; D005240:Feasibility Studies; D005260:Female; D015658:HIV Infections / Q000188:drug therapy / Q000451:nursing* / Q000523:psychology*; D015497:HIV-1 / Q000302:isolation & purification; D006801:Humans; D007194:India; D055118:Medication Adherence; D009732:Nursing Care / Q000592:standards*; D017063:Outcome Assessment, Health Care; D011247:Pregnancy; D011788:Quality of Life; D012307:Risk Factors; D012648:Self Care; D057545:Social Stigma; D017216:Telemedicine
keywords: Antiretroviral adherence; HIV; LMIC; Mental health; Women; mHealth