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

Not Applicable

Completed

• Conditions: HIV; Depression
• Interventions: Behavioral: Treatment as Usual; Behavioral: Nurse-delivered mobile phone counseling intervention

• Registration Number: NCT02319330
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2013-09-25
• Study First Submitted: 2014-07-30
• Study First Submitted QC: 2014-12-17
• Study First Posted: 2014-12-18
• Primary Completion: 2017-07-31
• Study Completion: 2017-07-31
• Status Verified: 2019-08
• Last Update Submitted: 2020-08-13
• Last Update Posted: 2020-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment as Usual	Treatment as Usual	Routine HIV clinic-based counseling
Phone counseling intervention	Nurse-delivered mobile 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.
Phone counseling intervention	Treatment as Usual	Treatment as usual (TAU) plus a nurse-delivered mobile phone counseling intervention delivered at weeks 1 to 12, 14, and 16 post-randomization.

Primary Outcome Measures

Name	Time	Method
Viral load	6 months post-randomization	HIV-1 RNA copies per millilitre of blood plasma

Secondary Outcome Measures

Name	Time	Method
Mental health (survey)	14 weeks post-randomization	Survey measures of symptoms of depression, anxiety and cognitive representation of illness
Medication adherence (Self-reported)	36 weeks post-randomization	Self-reported adherence to HIV medications
Mental health (Survey)	6 weeks post-randomization	Survey measures of symptoms of depression, anxiety and cognitive representation of illness
Medication adherence	6 weeks post-randomization	Self-reported adherence to HIV medications
Mental health	36 weeks post-randomization	Survey measures of symptoms of depression, anxiety and cognitive representation of illness

Trial Locations

Locations (1)

Belgaum ART Center; 🇮🇳 Belgaum, Karnataka, India