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. (MASHIndia)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of California, Los Angeles
Sponsor:
Collaborators:
Indian Council of Medical Research
Durbar Mahila Samanwaya Committee
Calcutta School of Tropical Medicine
Dimagi Inc.
Information provided by (Responsible Party):
Dallas Swendeman, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT02118454
First received: April 15, 2014
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
HIV/AIDS
Behavioral: Daily IVR Calls Intervention
Behavioral: Weekly IVR Survey Only

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: ART Adherence Behaviour and Practices Among HIV Positives in Kolkata, India-a Pilot Project

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Change in antiretroviral medication adherence measured by AIDS Clinical Trials Group (ACTG) self-report measure. [ Time Frame: Change from baseline to 2-, 4-, and 6-months prospective ] [ Designated as safety issue: No ]
  • Change in antiretroviral medication adherence as measured by weekly IVR surveys [ Time Frame: Change over 6 months prospective ] [ Designated as safety issue: No ]
  • Change in antiretroviral medication adherence as measured by pill counts at monthly medical appointments recorded in medical charts [ Time Frame: Change from 6 months prior to baseline to 6-months prospective ] [ Designated as safety issue: No ]
  • Change in antiretrovial medication adherence as indicated by changes in CD4 cell counts as recorded in patients' medical charts [ Time Frame: Change from up to 18 months before baseline to 6 months prospective ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in ART clinic appointment non-adherence resulting in lack of ART, as measured by self-report [ Time Frame: Change from Baseline to 2-, 4-, and 6-months prospective ] [ Designated as safety issue: No ]
  • Change in depressive symptoms as measured by the depression subscale of the HADS self-report measure [ Time Frame: Change from baseline to 2-, 4-, and 6-months prospective ] [ Designated as safety issue: No ]
  • Change in coping skills in 8 domains applied to HIV/AIDS and ART as measured by the Brief Cope self-report measure [ Time Frame: Change from baseline to 2-, 4-, and 6-months prospective ] [ Designated as safety issue: No ]
  • Change in social support as measured by MOS Social Support Survey Brief 8-item self-report measure [ Time Frame: Change from baseline to 2-, 4-, and 6-months prospective ] [ Designated as safety issue: No ]
  • Change in ART attitudes and adherence expectations as measured by self-report items from the ACTG measure [ Time Frame: Change from baseline to 2-, 4-, and 6-months prospective ] [ Designated as safety issue: No ]
  • Change in preferences for IVR messaging as measured by self-report [ Time Frame: 2-, 4-, and 6-months prospective ] [ Designated as safety issue: No ]
    As a pilot study, preferences and acceptability are important aims.

  • Change in depressive symptoms as measured 2 questions in weekly IVR surveys [ Time Frame: Change over 6-months prospective ] [ Designated as safety issue: No ]
  • Change in preferences for IVR messaging as measured IVR call log data [ Time Frame: Change over 6 months prospective ] [ Designated as safety issue: No ]
    IVR systems automatically log call information including if answered, call duration, and early termination (indicating low preference for message).

  • Change in preferences for IVR messaging as measured by responses to an IVR survey at the end of each IVR message [ Time Frame: Change over 6 months prospective ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change in physical symptoms or side effects as measured by self-report in the ACTG adherence measure. [ Time Frame: Change from baseline to 2-, 4-, and 6-months prospective, and weekly over 6 months ] [ Designated as safety issue: No ]
    Symptom reports may indicate treatment success or failure potentially linked to adherence, and conversely, side effects may indicate medication use but also precipitate non-adherence.

  • Change in disclosures of HIV status as measured by self-report [ Time Frame: Change from Baseline to 2-, 4-, and 6-months prospective ] [ Designated as safety issue: Yes ]
    IVR calls may result in active, passive, and inadvertent HIV+ status disclosures, which may result in improved social support or discrimination

  • Change in stigma related to HIV/AIDS as measured by self-report [ Time Frame: Change from Baseline to 2-, 4-, and 6-months prospective ] [ Designated as safety issue: No ]
  • Change in condom Use as measured by self-report [ Time Frame: Change from Baseline to 2-, 4-, and 6-months prospective ] [ Designated as safety issue: No ]
    Condom use is not directly targeted in the current intervention but was an original proposed study aim and may be implemented if participants request sexual health messages.

  • Change in alcohol consumption as measured AUDIT-C 3-item alcohol screen. [ Time Frame: Chagne from Baseline to 2-, 4-, and 6-months prospective ] [ Designated as safety issue: No ]
    Alcohol abuse is not directly targeted in the current intervention but was an original proposed study aim and may be implemented if participants request alcohol related messages.

  • Change in physical symptoms or side effects as measured by one question in weekly IVR surveys. [ Time Frame: Change over 6 months prospective ] [ Designated as safety issue: No ]
    Symptom reports may indicate treatment success or failure potentially linked to adherence, and conversely, side effects may indicate medication use but also precipitate non-adherence.


Estimated Enrollment: 400
Study Start Date: April 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Daily IVR calls
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
Active Comparator: Weekly IVR Survey Only
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02118454

Contacts
Contact: Dallas T Swe, PhD, MPH 3108041806 dswendeman@mednet.ucla.edu

Locations
India
Calcutta School of Tropical Medicine ART Centre Recruiting
Kokata, West Bengal, India, 700073
Contact: Nandita Basu, MD       Stmkolkatadirector@gmail.com   
Durbar Mahila Samanwaya Committee (MCTC & MNPW) Recruiting
Kolkata, West Bengal, India, 700006
Contact: Protim Ray, MD    913325303148    Ray.protim@gmail.com   
Contact: Smarajit Jana, MD    913325303148    smarajitjana@gmail.com   
Principal Investigator: Smarajit Jana, MD         
Sponsors and Collaborators
University of California, Los Angeles
Indian Council of Medical Research
Durbar Mahila Samanwaya Committee
Calcutta School of Tropical Medicine
Dimagi Inc.
  More Information

No publications provided

Responsible Party: Dallas Swendeman, Assistant Professor-in-Residence, Center Co-Director, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02118454     History of Changes
Other Study ID Numbers: 1R21AI094666, INDO-US/86/9/20 1O-ECD-II
Study First Received: April 15, 2014
Last Updated: April 29, 2014
Health Authority: United States: UCLA SGIRB
United States: National Institutes of Health (NIH), National Institute of Allergy & Infectious Diseases (NIAID)
India: Indian Council of Medical Research (ICMR)
India: Durbar Ethical Review Committee

Keywords provided by University of California, Los Angeles:
Medication adherence
Self-management
Depression
Coping
Social support
Mobile health
Antiretroviral treatment

ClinicalTrials.gov processed this record on August 21, 2014