CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 68 enrolled
Drug / intervention
ASHA LIFE +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00860769
NCT00860769Phase 2Completed

ASHA HIV Health Promotion Intervention in India

University of California, Los Angeles·interventional·Posted Mar 12, 2009·Updated Sep 28, 2016

In Brief

A Phase 2 clinical trial evaluating ASHA LIFE and USUAL Care for HIV Infections. Completed, enrolled 68 participants across 1 site.

Detailed Summary

The purpose of this randomized pilot study was to conduct an intervention with 68 rural women living with AIDS to compare the effectiveness of two different programs on compliance with HIV/AIDS treatment regimens, improvement in knowledge about HIV/AIDS and TB, improvement in psychological distress, reduction in stigma; satisfaction with care provided to family members, reduction in number of opportunistic infections, increase in CD4 levels and completion of the designed Asha-Life (AL) program. The trial was designed to assess the impact of the Asha-Life (AL) intervention engaging with an HIV-trained village woman, Asha (Accredited Social Health Activist), to participate in the care of women living with AIDS (WLA), along with other health care providers compared to a Usual Care group. Two high prevalence HIV/AIDS villages in rural Andhra Pradesh, which were demographically alike and served by distinct Public Health Centers, were selected randomly from a total of 16 villages.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesIndia
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 12, 2009
Enrollment StartSep 1, 2008
Primary CompletionMar 1, 2011
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 17.3 years ago

Interventions

ASHA LIFEbehavioral

6-session education groups discussing HIV prevention, anti-retroviral therapy (ART), coping enhancement, nutrition, parenting and life skills

USUAL Carebehavioral

3 session educational group focusing on HIV prevention, anti-retroviral therapy and parenting