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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of California, Los Angeles
Sponsor:
Collaborator:
All India Institute of Medical Sciences, New Delhi
Information provided by (Responsible Party):
Adeline Nyamathi, PhD, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT02136082
First received: May 8, 2014
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

Building upon a successful qualitative Phase I of the Asha Nutrition study, Phase II commences in month 10 of the study. 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 following informed consent. 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 Asha-Life 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) and informed child of a "food health" study. 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 trained 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.


Condition Intervention Phase
HIV Infection
Behavioral: Asha Support + Training
Behavioral: Asha Support + Food
Behavioral: Asha Support + Training + Food
Behavioral: Asha Support Only
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Asha Improving Health and Nutrition of Indian Women With AIDS and Their Children

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Number of women living with HIV and their oldest child in India. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: August 2013
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Asha Support + Training
Asha Support + Training: 1) Group discussions delivered over a six month period that cover four main categories a) Staying Healthy; b) Caregiving; c) Staying Upbeat; and d) Healthy Eating for Self and Family; 2) Referral for Life Skills Classes to teach women about selling fruit and vegetables and dried fish, sewing and embroidery and computer skills; 3) Asha Support. Women are visited by an Asha to discuss the group sessions, any difficulties the women may be experiencing with staying on ART, and ways to help women stay on the regimen.
Behavioral: Asha Support + Training
Experimental: Asha Support + Food
Asha Support + Food 1) Group discussions delivered over a six month period that cover three main categories a) Staying Healthy; b) Caregiving; and c) Staying Upbeat; 2) Referral for Life Skills Classes to teach women about selling fruit and vegetables and dried fish, sewing and embroidery and computer skills; 3) Asha Support. Women are visited by an Asha to discuss the group sessions, any difficulties the women may be experiencing with staying on ART, and ways to help women stay on the regimen; 4) Food supplementation of high protein food such as urad dal or tur dal.
Behavioral: Asha Support + Food
Experimental: Asha Support + Training + Food
Asha Support + Training + Food: 1) Group discussions delivered over a six month period that cover four main categories a) Staying Healthy; b) Caregiving; c) Staying Upbeat; and d) Healthy Eating for Self and Family; 2) Referral for Life Skills Classes to teach women about selling fruit and vegetables and dried fish, sewing and embroidery and computer skills; 3) Asha Support. Women are visited by an Asha to discuss the group sessions, any difficulties the women may be experiencing with staying on ART, and ways to help women stay on the regimen; 4) Food supplementation of high protein food such as urad dal or tur dal.
Behavioral: Asha Support + Training + Food
Active Comparator: Asha Support Only
Asha Support Only 1) Group discussions delivered over a six month period that cover three main categories a) Staying Healthy; b) Caregiving; c) Staying Upbeat; 2) Referral for Life Skills Classes to teach women about selling fruit and vegetables and dried fish, sewing and embroidery and computer skills; 3) Asha Support. Women are visited by an Asha to discuss the group sessions, any difficulties the women may be experiencing with staying on ART, and ways to help women stay on the regimen.
Behavioral: Asha Support Only

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02136082

Locations
India
All India Institute of Medical Sciences (AIIMS) Recruiting
New Delhi, India, 110029
Contact: Sanjeev Sinha, MD       drsanjeevsinha@gmail.com   
Principal Investigator: Sanjeev Sinha, MD         
Sponsors and Collaborators
University of California, Los Angeles
All India Institute of Medical Sciences, New Delhi
  More Information

No publications provided

Responsible Party: Adeline Nyamathi, PhD, Distinguished Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02136082     History of Changes
Other Study ID Numbers: NIHMS098729
Study First Received: May 8, 2014
Last Updated: May 9, 2014
Health Authority: India: Indian Council of Medical Research (ICMR)
India: Health Ministry Screening Committee (HMSC)

Keywords provided by University of California, Los Angeles:
HIV
Women
Children
Nutrition

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 18, 2014