NCT02319330

Brief Summary

The overall objective of this project is to demonstrate that a low cost, cell phone-delivered intervention is a promising, feasible and acceptable way to improve the prevention and treatment outcomes of women in India who are affected by HIV and inter-related mental health and psychosocial risk factors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 18, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
Last Updated

August 17, 2020

Status Verified

August 1, 2019

Enrollment Period

3.8 years

First QC Date

July 30, 2014

Last Update Submit

August 13, 2020

Conditions

HIVDepression

Keywords

HIVAdherenceMental healthDepressionWomenMobile phone technologyeHealthIndia

Outcome Measures

Primary Outcomes (1)

  • Viral load

    HIV-1 RNA copies per millilitre of blood plasma

    6 months post-randomization

Secondary Outcomes (8)

  • Medication adherence

    6 weeks post-randomization

  • Mental health (Survey)

    6 weeks post-randomization

  • Medication adherence (Self-reported)

    14 weeks post-randomization

  • Medication adherence (Self-reported)

    24 weeks post-randomization

  • Medication adherence (Self-reported)

    36 weeks post-randomization

  • +3 more secondary outcomes

Other Outcomes (4)

  • Feasibility and acceptability (Protocol specific tools)

    6 weeks post-randomization

  • Feasibility and acceptability (Protocol specific tools)

    14 weeks post-randomization

  • Feasibility and acceptability (Protocol specific tools)

    24 weeks post-randomization

  • +1 more other outcomes

Study Arms (2)

Phone counseling intervention

EXPERIMENTAL

Treatment as usual (TAU) plus a nurse-delivered mobile phone counseling intervention delivered at weeks 1 to 12, 14, and 16 post-randomization.

Behavioral: Nurse-delivered mobile phone counseling interventionBehavioral: Treatment as Usual

Treatment as Usual

ACTIVE COMPARATOR

Routine HIV clinic-based counseling

Behavioral: Treatment as Usual

Interventions

Nurse-delivered mobile phone counseling interventionBEHAVIORAL

Multi-dimensional, patient-centered counseling approach used to build patient-provider rapport, establish sources of support, and enable and empower problem solving to address inter-related, multi-tiered barriers to care.

Phone counseling intervention
Treatment as UsualBEHAVIORAL

Routine HIV clinic-based counseling

Phone counseling interventionTreatment as Usual

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV+ women starting ART
  • Willing to be contacted by mobile phone
  • Speaks English or Hindi or Kannada
  • Screens positive for depressive symptoms or psychosocial risk factors
  • Able to provide informed consent

You may not qualify if:

  • Unable to participate in study visits
  • Any condition that, in the opinion of the site investigator, would compromise the candidate's ability to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Belgaum ART Center

Belagavi, Karnataka, India

Location

Related Publications (3)

  • Reynolds NR, Satyanarayana V, Duggal M, Varghese M, Liberti L, Singh P, Ranganathan M, Jeon S, Chandra PS. MAHILA: a protocol for evaluating a nurse-delivered mHealth intervention for women with HIV and psychosocial risk factors in India. BMC Health Serv Res. 2016 Aug 4;16(a):352. doi: 10.1186/s12913-016-1605-1.

    PMID: 27491288BACKGROUND

  • Satyanarayana VA, Duggal M, Jeon S, Singh P, Desai A, Chandra PS, Reynolds NR. Exploring the feasibility, acceptability and preliminary effects of a nurse delivered mhealth intervention for women living with HIV in South India: a pilot randomized controlled trial. Arch Womens Ment Health. 2024 Oct;27(5):751-763. doi: 10.1007/s00737-024-01462-0. Epub 2024 Apr 17.

    PMID: 38630259DERIVED

  • Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.

    PMID: 32779730DERIVED

MeSH Terms

Conditions

DepressionPsychological Well-Being

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPersonal Satisfaction

Study Officials

  • Nancy R Reynolds, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

  • Prabha Chandra, MD

    National Institute of Mental Health and Neuro Sciences (NIMHANS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2014

First Posted

December 18, 2014

Study Start

September 25, 2013

Primary Completion

July 31, 2017

Study Completion

July 31, 2017

Last Updated

August 17, 2020

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)