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Asha HIV Health Promotion Intervention in India

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Adeline Nyamathi, PhD, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00860769
First received: March 11, 2009
Last updated: September 26, 2016
Last verified: September 2016

March 11, 2009
September 26, 2016
September 2008
March 2011   (final data collection date for primary outcome measure)
Conduct a randomized clinical pilot study with 70 women living with HIV in India. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00860769 on ClinicalTrials.gov Archive Site
Acceptability of the intervention by the women living with HIV. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Asha HIV Health Promotion Intervention in India
ASHA HIV Health Promotion Intervention in India
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.

This Community health study was conducted in two phases:

Phase I was initiated with the establishment of a Community Advisory Board (CAB) composed of 10 persons including WLA, Ashas, and health care providers consisting of Nurse Midwives, HIV and TB experts selected from a Primary Care Clinic in Nellore, Andhra Pradesh. The CAB considered issues related to stigma, disclosure, and psycho-socio-cultural factors affecting the health-seeking behaviors of WLA. They also analyzed the strategies that Asha could employ to support WLA in optimizing their health and well-being and that of their families. This was followed by focus groups conducted separately with the same type of participants. Eligibility criteria included WLA who were currently on ART, were 16-45 years of age, and were able to provide informed consent.

Phase II: A randomized control trial-pilot study was completed in Year 3. We assessed the outcomes of 34 WLA who participated in the AL program at six-month follow-up, as compared with 34 WLA in the Usual Care (UC) Program; in terms of: a) compliance with HIV/AIDS and/or TB treatment regimens (HIV/AIDS/TB), b) improvement in knowledge about HIV/AIDS/TB, c) improvement in psychological distress, d) reduction in stigma, e) reduction in number of opportunistic infections (OIs), f) increase in CD4 levels, and g) completion of the program. The intervention incorporated a comprehensive education and skills program to which we added high protein supplements (1 kg of Black Gram and 1 kg of Toor Dal/month for the AL group vs. a basic program including 1 kg of Channa Dal/month for the UC group.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
  • Behavioral: ASHA LIFE
    6-session education groups discussing HIV prevention, anti-retroviral therapy (ART), coping enhancement, nutrition, parenting and life skills
  • Behavioral: USUAL Care
    3 session educational group focusing on HIV prevention, anti-retroviral therapy and parenting
  • Experimental: ASHA Life
    6-session educational group discussing HIV prevention, anti-retroviral therapy (ART), coping enhancement, nutrition, parenting and life skills.
    Intervention: Behavioral: ASHA LIFE
  • Active Comparator: Usual Care
    3-session educational group focusing on HIV prevention, anti-retroviral therapy (ART) and parenting.
    Intervention: Behavioral: USUAL Care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
June 2012
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women living with HIV
  • Ages 18-45
  • Interfacing with an Accredited Social Health Activist (ASHA)
  • Receiving ART or eligible for receiving ART
  • HIV Positive status
  • CD4 cells ≥ 100
  • Not a participant of Phase 1

Exclusion Criteria:

  • Cognitively impaired, not a participant of Phase 1
Female
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00860769
G071208102, 1 R34 MH082662:01R
No
Not Provided
Not Provided
Adeline Nyamathi, PhD, University of California, Los Angeles
University of California, Los Angeles
Not Provided
Principal Investigator: Adeline Nyamathi, PhD The Regents of the University of California
University of California, Los Angeles
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP