Ignite Creation Date:
2024-05-06 @ 2:48 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02136082
Status:
COMPLETED
Last Update Posted:
2018-10-09
First Post:
2014-05-08
Brief Title:
Asha Improving Health and Nutrition of Indian Women With AIDS and Their Children
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Asha Improving Health and Nutrition of Indian Women With AIDS and Their Children
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Asha2
Brief 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 Governments 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 US 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 Indias 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None