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.

NCT02118454 | Completed

• 2 other identifiers: 1R21AI094666INDO-US/86/9/20 1O-ECD-II
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Medication adherence; Self-management; Depression; Coping; Social support; Mobile health; Antiretroviral treatment

Outcome Measures

Primary Outcomes (4)

• Change in antiretroviral medication adherence measured by AIDS Clinical Trials Group (ACTG) self-report measure.

  Change from baseline to 2-, 4-, and 6-months prospective

• Change in antiretroviral medication adherence as measured by weekly IVR surveys

  Change over 6 months prospective

• Change in antiretroviral medication adherence as measured by pill counts at monthly medical appointments recorded in medical charts

  Change from 6 months prior to baseline to 6-months prospective

• Change in antiretrovial medication adherence as indicated by changes in CD4 cell counts as recorded in patients' medical charts

  Change from up to 18 months before baseline to 6 months prospective

Secondary Outcomes (9)

• Change in ART clinic appointment non-adherence resulting in lack of ART, as measured by self-report

  Change from Baseline to 2-, 4-, and 6-months prospective

• Change in depressive symptoms as measured by the depression subscale of the HADS self-report measure

  Change from baseline to 2-, 4-, and 6-months prospective

• Change in coping skills in 8 domains applied to HIV/AIDS and ART as measured by the Brief Cope self-report measure

  Change from baseline to 2-, 4-, and 6-months prospective

• Change in social support as measured by MOS Social Support Survey Brief 8-item self-report measure

  Change from baseline to 2-, 4-, and 6-months prospective

• Change in ART attitudes and adherence expectations as measured by self-report items from the ACTG measure

  Change from baseline to 2-, 4-, and 6-months prospective

Other Outcomes (6)

• Change in physical symptoms or side effects as measured by self-report in the ACTG adherence measure.

  Change from baseline to 2-, 4-, and 6-months prospective, and weekly over 6 months

• Change in disclosures of HIV status as measured by self-report

  Change from Baseline to 2-, 4-, and 6-months prospective

• Change in stigma related to HIV/AIDS as measured by self-report

  Change from Baseline to 2-, 4-, and 6-months prospective

Study Arms (2)

Daily IVR calls

EXPERIMENTAL

The Daily IVR Calls 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

Behavioral: Daily IVR Calls Intervention

Weekly IVR Survey Only

ACTIVE COMPARATOR

The Weekly IVR Survey Only control condition: consisting of standard care, PLUS one IVR assessment call (consisting of four \[4\] questions) every week for 6 months.

Behavioral: Weekly IVR Survey Only

Interventions

Daily IVR Calls Intervention BEHAVIORAL

Daily IVR calls

Weekly IVR Survey Only BEHAVIORAL

Weekly IVR Survey Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• HIV+
• Taking 1st-line ART 6 months or longer
• Missed taking any ART dose in the previous 6 months
• Able to speak and understand Bengali, Hindi, or English\*
• Willing to receive health-related IVR messages on mobile phones. (If participant will use personal cell phone and is currently registered on the "National Do Not Call" (NDNC) registry, the participant must be willing to be removed from the registry for the duration of the study.)
• Able to provide informed consent
• Phase 2A - Client at MCTC or member of MNPW, or peer referral of MCTC client or MNPW member,
• Phase 2A - Received a CD4 count result in the prior two months\*\*
• Phase 2B - Patient at Calcutta School of Tropical Medicine ART Centre, or peer referral of a patient,
• Phase 2B - Received

You may not qualify if:

• Less than age 18
• Not HIV+
• Not taking 1st-line ART for 6 months or longer
• Does not report missing an ART dose in the prior 6 months
• Not able to speak and understand Bengali, Hindi, or English
• Is not willing to receive health-related IVR messages on mobile phones. (If participant will use personal cell phone and is currently registered on the "National Do Not Call" (NDNC) registry, the participant is NOT willing to be removed from the registry for the duration of the study.)
• Unable to provide informed consent.
• Phase 2A - Not client at MCTC or Member of MNPW, or peer referral of MCTC client or MNPW member
• Phase 2A - Not received a CD4 count result in the prior two months
• Phase 2B - Not patient at Calcutta School of Tropical Medicine ART Centre, or peer referral of a patient,
• Phase 2B - Not received a CD4 count result in the prior month.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Indian Council of Medical Research: collaborator
• Durbar Mahila Samanwaya Committee: collaborator
• Calcutta School of Tropical Medicine: collaborator
• Dimagi Inc.: collaborator

Study Sites (2)

Calcutta School of Tropical Medicine ART Centre

Kokata, West Bengal, 700073, India

Location

Durbar Mahila Samanwaya Committee (MCTC & MNPW)

Kolkata, West Bengal, 700006, India

Location

Related Publications (2)

• Swendeman D, Fehrenbacher AE, Roy S, Ray P, Sumstine S, Scheffler A, Das R, Jana S. A pilot randomized controlled trial (RCT) of daily versus weekly interactive voice response calls to support adherence among antiretroviral treatment patients in India. Mhealth. 2020 Oct 5;6:35. doi: 10.21037/mhealth-19-248a. eCollection 2020.

  PMID: 33437832 DERIVED

• Swendeman D, Fehrenbacher AE, Roy S, Das R, Ray P, Sumstine S, Ghose T, Jana S. Gender disparities in depression severity and coping among people living with HIV/AIDS in Kolkata, India. PLoS One. 2018 Nov 21;13(11):e0207055. doi: 10.1371/journal.pone.0207055. eCollection 2018.

  PMID: 30462688 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Medication Adherence; Depression

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Behavioral Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor-in-Residence, Center Co-Director

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: April 21, 2014
• Study Start: April 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: June 8, 2015

Record last verified: 2015-06

Locations

IN (2)