跳至主要内容
临床试验/NCT02319330
NCT02319330已完成不适用

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

Yale University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2013年9月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Viral load

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • Unable to participate in study visits
  • Any condition that, in the opinion of the site investigator, would compromise the candidate's ability to participate

结局指标

主要结局

Viral load

时间窗: 6 months post-randomization

HIV-1 RNA copies per millilitre of blood plasma

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Preventing & Treating HIV Comorbidities in India:... | 临床试验