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

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.

Conditions

• HIV Infection

Interventions

BEHAVIORAL

Asha Support + Training

BEHAVIORAL

Asha Support + Food

BEHAVIORAL

Asha Support + Training + Food

BEHAVIORAL

Asha Support Only

Sponsors & Collaborators

• All India Institute of Medical Sciences

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• University of California, Irvine

  collaborator OTHER

• University of California, Los Angeles

  lead OTHER

Principal Investigators

• Adeline M Nyamathi, PhD · UCI Sue & Bill Gross School of Nursing

• Maria Ekstrand, PhD · University of California, San Francisco

• Sanjeev Sinha, MD · All India Institute of Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-08-31

Primary Completion

2018-06-30

Completion

2018-06-30

Countries

• India

Study Locations