Asha HIV Health Promotion Intervention in India
|ClinicalTrials.gov Identifier: NCT00860769|
Recruitment Status : Completed
First Posted : March 12, 2009
Last Update Posted : September 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Behavioral: ASHA LIFE Behavioral: USUAL Care||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||ASHA HIV Health Promotion Intervention in India|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||June 2012|
Experimental: ASHA Life
6-session educational group discussing HIV prevention, anti-retroviral therapy (ART), coping enhancement, nutrition, parenting and life skills.
Behavioral: ASHA LIFE
6-session education groups discussing HIV prevention, anti-retroviral therapy (ART), coping enhancement, nutrition, parenting and life skills
Active Comparator: Usual Care
3-session educational group focusing on HIV prevention, anti-retroviral therapy (ART) and parenting.
Behavioral: USUAL Care
3 session educational group focusing on HIV prevention, anti-retroviral therapy and parenting
- Conduct a randomized clinical pilot study with 70 women living with HIV in India. [ Time Frame: 2 years ]
- Acceptability of the intervention by the women living with HIV. [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00860769
|Indian Counsel of Medical Research|
|New Delhi, India|
|Principal Investigator:||Adeline Nyamathi, PhD||The Regents of the University of California|