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

Study Overview
=================
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.

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

Conditions
-----------------
HIV, Depression

Intervention / Treatment
-----------------
* Behavioral: Nurse-delivered mobile phone counseling intervention
* Behavioral: Treatment as Usual


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phone counseling intervention<br>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<br>* 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.<br>Behavioral: Treatment as Usual<br>* Routine HIV clinic-based counseling<br>|
| Active Comparator: Treatment as Usual<br>Routine HIV clinic-based counseling | Behavioral: Treatment as Usual<br>* Routine HIV clinic-based counseling<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral load | HIV-1 RNA copies per millilitre of blood plasma | 6 months post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication adherence | Self-reported adherence to HIV medications | 6 weeks post-randomization | 
| Mental health (Survey) | Survey measures of symptoms of depression, anxiety and cognitive representation of illness | 6 weeks post-randomization | 
| Medication adherence (Self-reported) | Self-reported adherence to HIV medications | 14 weeks post-randomization | 
| Medication adherence (Self-reported) | Self-reported adherence to HIV medications | 24 weeks post-randomization | 
| Medication adherence (Self-reported) | Self-reported adherence to HIV medications | 36 weeks post-randomization | 
| Mental health (survey) | Survey measures of symptoms of depression, anxiety and cognitive representation of illness | 14 weeks post-randomization | 
| Mental health | Survey measures of symptoms of depression, anxiety and cognitive representation of illness | 24 weeks post-randomization | 
| Mental health | Survey measures of symptoms of depression, anxiety and cognitive representation of illness | 36 weeks post-randomization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Adherence, Mental health, Depression, Women, Mobile phone technology, eHealth, India