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Completed

NCT Number: NCT02319330

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

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.

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Key information

Conditions

HIV Behavior Behavioral Symptoms Depression Personal Satisfaction Psychological Well-Being

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Belgaum ART Center

Belagavi, Karnataka, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nurse-delivered mobile phone counseling intervention

Behavioral

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.

Treatment as Usual

Behavioral

Routine HIV clinic-based counseling

Primary outcomes

  1. Viral load

    Time frame: 6 months post-randomization

    HIV-1 RNA copies per millilitre of blood plasma

Secondary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • National Institute of Mental Health and Neuro Sciences, India

Registry information

Acronym: MAHILA

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Dec 18, 2014
Registry last updated
Aug 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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