Asha Improving Health and Nutrition of Indian Women With AIDS and Their Children
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      Building upon the successful qualitative Phase I of the study, Phase II commences in month
      10. The Project manager and research staff will recruit 600 women living with AIDS (WLA) and
      their oldest child between the ages of 3 and 8. The WLA will be recruited from Primary Health
      Centers (PHCs) randomly selected from 72 closest PHCs in terms of HIV prevalence in the rural
      Andhra Pradesh (AP) area of Nellore. WLA will be recruited by means of approved flyers posted
      in selected PHCs. Interested WLA will approach the research staff, stationed at the PHC to be
      screened for eligibility via a consent script. Once eligibility is determined for the WLA,
      based upon the following criteria: age, HIV and ART status (validated by ART and HIV card);
      having a child (3-8 years) and whether or not the WLA was a participant of the previous
      intervention group from the Asha pilot study, a parental consent will be obtained from the
      WLA for permission to include her oldest child in the study. The oldest child between 3-8
      years of age will be brought in to the research office or PHC (after mother speaks with the
      child at home). All children will have blood work drawn and physical health assessment on
      their first visit (total of 15 minutes). All eligible WLA will undergo a second consent for
      enrollment. General Procedure: Following informed consent, the WLA will be randomly assigned
      into one of four programs 1) Asha Support Only; 2) Asha Support + Training; 3) Asha Support +
      Food; or 4) Asha Support + Training + Food. After blood draw and physical assessment of the
      WLA, an appointment will be made for the assigned interviewer (blinded to program) to visit
      the WLA at their home preferably (or other location of choice) to conduct several 24 hour
      dietary assessments. Urine will be collected in labeled bottles on the morning after the 3rd
      day of the diet recall by the interviewer and sent directly to the lab in a cooler. Also, on
      the same day, the baseline assessment will be entered into the PC tablets; 50 minutes
      estimated with breaks). After a longer break, the WLA will then be asked to respond to
      additional questions about the sociodemographic and psychomotor development of their child
      (about 30 minutes). Interviewers will visit the WLA monthly until the end of the intervention
      (month 6) to provide individual weekly Asha Support and conduct group sessions and collect
      ongoing data, 24-hour recall, and ART pill count for WLA, and follow up questionnaires at 6-,
      12- and 18-months.
    

Detailed description: 
      Rural women living with AIDS (WLA) in India continue to face profound challenges in accessing
      and following treatment regimens, caring for family members, and maintaining positive mental
      health. Furthermore, they are generally underweight and malnourished, with adherence to
      antiretroviral therapy (ART) at levels lower than 50%. While the Indian Government's National
      Rural Health Mission utilizes a successful model to address the health needs of the rural
      population by training village women as Ashas (Accredited Social Work Activists) to enhance
      health of pregnant women and their infants, the focus on rural WLA needs to be significantly
      strengthened. U.S. and Indian collaborators recently completed an R34 pilot study which has
      demonstrated successful improvement in ART adherence, CD4 levels, and physical and mental
      health among rural Indian WLA. In total, 34 rural intervention WLA were supported by
      grant-trained, HIV-focused Ashas who provided assistance to WLA in decreasing barriers to ART
      adherence and provided protein supplementation compared to equal numbers of usual care WLA
      who received minimal protein supplementation. While very successful, our Asha pilot study
      monitored only WLA, despite the fact that many rural children are also at risk for delayed
      physical growth and psychomotor development. More importantly, we were not able to separate
      the nutritional component from the care and support component of the Asha, did not
      incorporate nutritional biomarkers, and were limited by only a six-month follow-up. In light
      of the mandate to advance both the science of nutrition and sustainability in real settings,
      our experienced team proposes to build on and extend our successful pilot work to meet this
      need, by assessing the incremental advantages of nutritional support to Asha care and support
      alone, and the impact of these programs on an index child (oldest between 3-8 years). In
      addition, we will take advantage of rural India's excellent mobile phone coverage and
      computer technology for both wireless data collection and data transfer. The proposed
      longitudinal study will use a 2x2 factorial design, specifically, 1) Asha support alone for
      WLA , vs. 2) Asha support for WLA + nutrition (food-based) training, vs. 3) Asha support for
      WLA + food supplementation, vs. 4) Asha support for WLA + nutrition training + food
      supplementation, to test the effects of nutrition training and/or food supplementation on
      primary outcomes of anthropometric parameters and immune status (CD4 levels) of the WLA at
      6-, 12- and 18-month follow-up; and secondarily on ART adherence, psychological health,
      nutritional adequacy and lipid status of the WLA over time. Based upon reviewers' comments,
      among index children, we streamlined our assessments to include anthropometric parameters and
      psychomotor development; and among those HIV positive, immune status.
    

Intervention name(s): Asha Support + Training; Asha Support + Food; Asha Support + Training + Food; Asha Support Only
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV; Women; Children; Nutrition