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Preventing & Treating HIV Comorbidities in India: Multi-tiered Strategy for Women (MAHILA)

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ClinicalTrials.gov Identifier: NCT02319330
Recruitment Status : Completed
First Posted : December 18, 2014
Last Update Posted : August 17, 2020
Sponsor:
Collaborators:
National Institute of Mental Health and Neuro Sciences, India
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Yale University

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.

Condition or disease Intervention/treatment Phase
HIV Depression Behavioral: Nurse-delivered mobile phone counseling intervention Behavioral: Treatment as Usual Not Applicable

Detailed Description:
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. Over the past decade there have been dramatic improvements in HIV prevention and access to life-saving antiretroviral therapy (ART). Yet, deficits in adherence to the spectrum of HIV care pose significant barriers to success. Women are at a particular disadvantage. Gender inequality, physical and situational factors place many women at increased risk for HIV acquisition and poor mental health and interrelated psychosocial co-factors (depression, gender-discrimination, violence, lack of social support, etc.) that are well established correlates of poor adherence and retention in HIV care. Recent studies have shown alarmingly high rates of loss to follow-up for these women, particularly in the transition after delivery, between PMTCT and lifelong HIV care services. Preliminary work indicates that a theory-guided adherence phone intervention that can be easily integrated and sustained as a component of routine ART Centre services is well suited for the target population, but it needs to be adapted to the sociocultural context. Following initial formative work to refine the intervention for delivery in India, clinic nurses will be trained to deliver the intervention, and the feasibility, fidelity and preliminary efficacy of the novel application of the intervention will be evaluated in a randomized trial. After baseline assessment, women (n=120) will be randomly assigned to treatment as usual (TAU) or TAU plus the phone intervention (delivered over 16 weeks) and outcomes will be evaluated at 6, 14, 24, 36 weeks post-randomization. If the promising mobile phone intervention developed and pilot tested in this project shows promise in this Phase 1 study as we expect, the efficacy and cost of the intervention will then be evaluated in a large scale, multi-site study. If successful, an extremely practical approach will be available to improve the prevention and treatment outcomes of women with HIV and co-morbid mental health problems in India.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Preventing & Treating HIV Comorbidities in India: Multi-tiered Strategy for Women
Actual Study Start Date : September 25, 2013
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : July 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Phone counseling intervention
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 intervention
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.

Behavioral: Treatment as Usual
Routine HIV clinic-based counseling

Active Comparator: Treatment as Usual
Routine HIV clinic-based counseling
Behavioral: Treatment as Usual
Routine HIV clinic-based counseling




Primary Outcome Measures :
  1. Viral load [ Time Frame: 6 months post-randomization ]
    HIV-1 RNA copies per millilitre of blood plasma


Secondary Outcome Measures :
  1. Medication adherence [ Time Frame: 6 weeks post-randomization ]
    Self-reported adherence to HIV medications

  2. Mental health (Survey) [ Time Frame: 6 weeks post-randomization ]
    Survey measures of symptoms of depression, anxiety and cognitive representation of illness

  3. Medication adherence (Self-reported) [ Time Frame: 14 weeks post-randomization ]
    Self-reported adherence to HIV medications

  4. Medication adherence (Self-reported) [ Time Frame: 24 weeks post-randomization ]
    Self-reported adherence to HIV medications

  5. Medication adherence (Self-reported) [ Time Frame: 36 weeks post-randomization ]
    Self-reported adherence to HIV medications

  6. Mental health (survey) [ Time Frame: 14 weeks post-randomization ]
    Survey measures of symptoms of depression, anxiety and cognitive representation of illness

  7. Mental health [ Time Frame: 24 weeks post-randomization ]
    Survey measures of symptoms of depression, anxiety and cognitive representation of illness

  8. Mental health [ Time Frame: 36 weeks post-randomization ]
    Survey measures of symptoms of depression, anxiety and cognitive representation of illness


Other Outcome Measures:
  1. Feasibility and acceptability (Protocol specific tools) [ Time Frame: 6 weeks post-randomization ]
    Protocol specific tools will be used to measure feasibility and user acceptability The assessment will include: 1) The ratio of eligible study participants to those enrolled; 2) Number of scheduled study visits completed at 6, 14, 24, and 36 weeks; 3) Attrition between baseline and follow-up; 4) Reason for premature drop-out; 5) Number of phone calls that were made on schedule; 6) Level of participation in intervention sessions including the total number sessions, number of sessions completed without break offs, number of break offs, length (minutes) of sessions; 7) Congruence of topic/content discussed on calls with protocol; 8) Patient and study nurse satisfaction with intervention content, mode of delivery, and protocol.

  2. Feasibility and acceptability (Protocol specific tools) [ Time Frame: 14 weeks post-randomization ]
    Protocol specific tools will be used to measure feasibility and user acceptability The assessment will include: 1) The ratio of eligible study participants to those enrolled; 2) Number of scheduled study visits completed at 6, 14, 24, and 36 weeks; 3) Attrition between baseline and follow-up; 4) Reason for premature drop-out; 5) Number of phone calls that were made on schedule; 6) Level of participation in intervention sessions including the total number sessions, number of sessions completed without break offs, number of break offs, length (minutes) of sessions; 7) Congruence of topic/content discussed on calls with protocol; 8) Patient and study nurse satisfaction with intervention content, mode of delivery, and protocol.

  3. Feasibility and acceptability (Protocol specific tools) [ Time Frame: 24 weeks post-randomization ]
    Protocol specific tools will be used to measure feasibility and user acceptability The assessment will include: 1) The ratio of eligible study participants to those enrolled; 2) Number of scheduled study visits completed at 6, 14, 24, and 36 weeks; 3) Attrition between baseline and follow-up; 4) Reason for premature drop-out; 5) Number of phone calls that were made on schedule; 6) Level of participation in intervention sessions including the total number sessions, number of sessions completed without break offs, number of break offs, length (minutes) of sessions; 7) Congruence of topic/content discussed on calls with protocol; 8) Patient and study nurse satisfaction with intervention content, mode of delivery, and protocol.

  4. Feasibility and acceptability (Protocol specific tools) [ Time Frame: 36 weeks post-randomization ]
    Protocol specific tools will be used to measure feasibility and user acceptability The assessment will include: 1) The ratio of eligible study participants to those enrolled; 2) Number of scheduled study visits completed at 6, 14, 24, and 36 weeks; 3) Attrition between baseline and follow-up; 4) Reason for premature drop-out; 5) Number of phone calls that were made on schedule; 6) Level of participation in intervention sessions including the total number sessions, number of sessions completed without break offs, number of break offs, length (minutes) of sessions; 7) Congruence of topic/content discussed on calls with protocol; 8) Patient and study nurse satisfaction with intervention content, mode of delivery, and protocol.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02319330


Locations
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India
Belgaum ART Center
Belgaum, Karnataka, India
Sponsors and Collaborators
Yale University
National Institute of Mental Health and Neuro Sciences, India
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Nancy R Reynolds, PhD Yale University
Principal Investigator: Prabha Chandra, MD National Institute of Mental Health and Neuro Sciences (NIMHANS)
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02319330    
Other Study ID Numbers: 1301011297
R21MH100939 ( U.S. NIH Grant/Contract )
First Posted: December 18, 2014    Key Record Dates
Last Update Posted: August 17, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Yale University:
HIV
Adherence
Mental health
Depression
Women
Mobile phone technology
eHealth
India
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms