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Clinical Trials/NCT02319330
NCT02319330CompletedNot Applicable

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

Yale University1 site in 1 country120 target enrollmentStarted: September 25, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
120
Locations
1
Primary Endpoint
Viral load

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

Phone counseling intervention

Experimental

Treatment as usual (TAU) plus a nurse-delivered mobile phone counseling intervention delivered at weeks 1 to 12, 14, and 16 post-randomization.

Intervention: Nurse-delivered mobile phone counseling intervention (Behavioral)

Treatment as Usual

Active Comparator

Routine HIV clinic-based counseling

Intervention: Treatment as Usual (Behavioral)

Phone counseling intervention

Experimental

Treatment as usual (TAU) plus a nurse-delivered mobile phone counseling intervention delivered at weeks 1 to 12, 14, and 16 post-randomization.

Intervention: Treatment as Usual (Behavioral)

Outcomes

Primary Outcomes

Viral load

Time Frame: 6 months post-randomization

HIV-1 RNA copies per millilitre of blood plasma

Secondary Outcomes

  • Mental health (Survey)(6 weeks post-randomization)
  • Mental health (survey)(14 weeks post-randomization)
  • Medication adherence (Self-reported)(36 weeks post-randomization)
  • Medication adherence(6 weeks post-randomization)
  • Mental health(36 weeks post-randomization)
  • Medication adherence (Self-reported)(14 weeks post-randomization)
  • Medication adherence (Self-reported)(24 weeks post-randomization)
  • Mental health(24 weeks post-randomization)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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