Clinical trial NCT02319330: Preventing & Treating HIV Comorbidities in India: Multi-tiered Strategy for Women
Official title: Preventing & Treating HIV Comorbidities in India: Multi-tiered Strategy for Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Depression
Keywords: HIV
Adherence
Mental health
Depression
Women
Mobile phone technology
eHealth
India
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health and Neuro Sciences, India
name: National Institute of Mental Health (NIMH)
First posted: 2014-12-18
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Viral load
timeFrame: 6 months post-randomization
Secondary outcomes:
measure: Medication adherence
timeFrame: 6 weeks post-randomization
measure: Mental health (Survey)
timeFrame: 6 weeks post-randomization
measure: Medication adherence (Self-reported)
timeFrame: 14 weeks post-randomization
measure: Medication adherence (Self-reported)
timeFrame: 24 weeks post-randomization
measure: Medication adherence (Self-reported)
timeFrame: 36 weeks post-randomization
measure: Mental health (survey)
timeFrame: 14 weeks post-randomization
measure: Mental health
timeFrame: 24 weeks post-randomization
measure: Mental health
timeFrame: 36 weeks post-randomization
Other outcomes:
measure: Feasibility and acceptability (Protocol specific tools)
timeFrame: 6 weeks post-randomization
measure: Feasibility and acceptability (Protocol specific tools)
timeFrame: 14 weeks post-randomization
measure: Feasibility and acceptability (Protocol specific tools)
timeFrame: 24 weeks post-randomization
measure: Feasibility and acceptability (Protocol specific tools)
timeFrame: 36 weeks post-randomization
Locations:
city: Belgaum
country: India
facility: Belgaum ART Center
state: Karnataka
Study officials:
affiliation: Yale University
name: Nancy R Reynolds, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Mental Health and Neuro Sciences (NIMHANS)
name: Prabha Chandra, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.