CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 600 enrolled
Drug / intervention
Asha Support + Training +3 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02136082
NCT02136082N/ACompleted

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

University of California, Los Angeles·interventional·Posted May 12, 2014·Updated Oct 9, 2018

In Brief

A clinical study evaluating Asha Support + Training, Asha Support + Food, and 2 other interventions for HIV Infection. Completed, enrolled 600 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infection
CountriesIndia

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 12, 2014
Enrollment StartAug 1, 2013
Primary CompletionJun 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 12.1 years ago

Interventions

Asha Support + Trainingbehavioral

Asha Support + Foodbehavioral

Asha Support + Training + Foodbehavioral

Asha Support Onlybehavioral