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Completed

NCT Number: NCT02136082

Asha Improving Health and Nutrition of Indian Women With AIDS and Their Children

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

All India Institute of Medical Sciences (AIIMS)

New Delhi, 110029, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1) WLA, 18-50 years of age; 2) receiving Antiretroviral Therapy (ART) for > three months; validated by an ART card given by the district hospital to all ART patients; 3) Blood Cell count > 100 validated by HIV card given by district hospital; 4) reporting to have a child aged 3-8 living with them; 5) not involved in Asha Life Intervention group of the first Asha study -

Exclusion criteria

WLA not between the ages of 18 to 50; not on Antiretroviral Therapy (ART) for at least three months and has a blood cell count of less than 100; reporting no children between the ages of 3 to 8; and a previous participant of the Asha Life Intervention group of the first Asha study.

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Treatment and study plan

Asha Support + Training

Behavioral

Asha Support + Food

Behavioral

Asha Support + Training + Food

Behavioral

Asha Support Only

Behavioral

Primary outcomes

  1. Change in weight

    Time frame: 6-, 12- and 18-month followup

    Weight gain as measured in BMI (kg/m2)

  2. Change in CD4+ T cell count

    Time frame: 6-, 12- and 18-month followup

    Measure of immune status in cells/mm3

  3. Change in muscle mass

    Time frame: 6-, 12- and 18-month followup

    Measured by the Bioelectrical Impedance (BIA)

Secondary outcomes

  1. Change in ART adherence

    Time frame: 6-, 12- and 18-month followup

    Measured by visual analog scale

  2. Change in depressive symptomatology

    Time frame: 6-, 12- and 18-month followup

    Measured by Center for Epidemiologic Studies Depression Scale (CES-D)

  3. Change in internalized stigma

    Time frame: 6-, 12- and 18-month followup

    Measured by the Internalized Stigma Scale

  4. Change in nutritional adequacy

    Time frame: 6-, 12- and 18-month followup

    Nutritional adequacy of the WLA over 18 months, measured by comparisons of vitamin, mineral and macronutrient intake, guided by dietary recommendations

  5. Change in lipid normalization

    Time frame: 6-, 12- and 18-month followup

    Lipid normalization of WLA (triglycerides and cholesterol)

  6. Change in anthropometric parameters and psychomotor development of the index children

    Time frame: 6-, 12- and 18-month followup

    Anthropometric parameters and psychomotor development of the index children at 6-12-, and 18-month follow-up; among those HIV-infected, we will also assess CD4 levels over time.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • All India Institute of Medical Sciences
  • University of California, Irvine
  • University of California, San Francisco

Registry information

Acronym: Asha2

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
May 12, 2014
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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