Antiretroviral Adherence and Quality-of-life Support for HIV+ Patients in India With Twice-daily Interactive Voice Response (IVR) Calls With Health and Mental Health Messaging Compared to Weekly IVR Survey Only Control Condition: The Mobile-messaging Adherence and Support for Health Study, India.

Summary

The purpose of this study is to test whether twice-daily Interactive Voice Response (IVR) calls made at the estimated times of patients' antiretroviral (ART) medication dosing and three reminder calls for monthly clinic appointments, will result in improvements in ART adherence, appointment attendance, health indicators (CD4 cell counts), coping skills, social support, depressive symptoms, and other quality-of-life indicators, compared to a control group receiving one IVR assessment call each week, over six months.

This is a randomized controlled trial of the IVR intervention with n=400 PLH taking first line ART in India on a twice-a-day dosing schedule. The research is supported by an Indo-U.S. Bilateral review and funding collaboration between NIH and ICMR. The research is being implemented in Kolkata by Drs. Smarajit Jana (PI, India) and Protim Ray (Project Director) at Durbar, a community-based organization providing HIV/STD prevention and community development programs with sex workers and other at-risk communities.

This is Phase 2 of a two-phase pilot project. Phase 1 was a one-month no-control pilot (n=46) for feasibility, acceptability, and patient feedback on preferences for messaging content. Phase 2 has two sites, described as Phases 2A and 2b, which will occur simultaneously and differ only in their recruitment sites and corresponding sampling strategy (sample size, gender ratio, eligibility criteria) based on site population characteristics.

* Phase 2A will recruit n=80 women and n=20 men from Durbar's Mamata Care and Treatment Center (MCTC) (providing HIV testing and treatment linkage and support) and associated Mamata Network of Positive Women (MNPW), which focus on HIV+ sex workers and their male partners and networks.
* Phase 2B will recruit n=100 women and n=200 men from the ART Centre at the Calcutta School of Tropical Medicine (STM), which hosts the largest ART center in the Northeast Region of India and has over 3,000 active patients on first line ART.

The sampling plan reflects the gender distribution of clients and patients at the two sites.

Participants will be randomized within each site and gender sub-sample to receive:

* The IVR Intervention: consisting of two (2) automated voice calls ("intervention messages") each day for six months, PLUS one IVR assessment call (consisting of four \[4\] questions) every week for 6 months; OR,
* The Control Condition: consisting of standard care, PLUS one IVR assessment call (consisting of four \[4\] questions) every week for 6 months.

All participants will be interviewed in-person by a research team member at baseline and followed-up at 2- 4- and 6-months using structured questionnaires and recording information from the participant's personal medical record (i.e., their "ART Card") to assess background characteristics and intervention impacts on ART adherence, health quality-of-life (i.e., depressive symptoms, social support). All participants will receive one IVR assessment phone call (consisting of four (4) questions during each week of the 6 month study. Each once-a-week IVR assessment will ask about missed medication and the participant's health/quality of life, and participants will respond by keying in a 1 (yes) or 2 (no) on their mobile phone.

Conditions

• HIV/AIDS

Interventions

BEHAVIORAL

Daily IVR Calls Intervention

BEHAVIORAL

Weekly IVR Survey Only

Sponsors & Collaborators

• Indian Council of Medical Research

  collaborator OTHER_GOV

• Durbar Mahila Samanwaya Committee

  collaborator UNKNOWN

• Calcutta School of Tropical Medicine

  collaborator OTHER

• Dimagi Inc.

  collaborator INDUSTRY

• University of California, Los Angeles

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-04-30

Primary Completion

2015-03-31

Completion

2015-03-31

Countries

• India

Study Locations