NCT02136082

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

4.8 years

First QC Date

May 8, 2014

Last Update Submit

October 4, 2018

Conditions

HIV Infection

Keywords

HIVWomenChildrenNutrition

Outcome Measures

Primary Outcomes (3)

  • Change in weight

    Weight gain as measured in BMI (kg/m2)

    6-, 12- and 18-month followup

  • Change in CD4+ T cell count

    Measure of immune status in cells/mm3

    6-, 12- and 18-month followup

  • Change in muscle mass

    Measured by the Bioelectrical Impedance (BIA)

    6-, 12- and 18-month followup

Secondary Outcomes (6)

  • Change in ART adherence

    6-, 12- and 18-month followup

  • Change in depressive symptomatology

    6-, 12- and 18-month followup

  • Change in internalized stigma

    6-, 12- and 18-month followup

  • Change in nutritional adequacy

    6-, 12- and 18-month followup

  • Change in lipid normalization

    6-, 12- and 18-month followup

  • +1 more secondary outcomes

Study Arms (4)

Asha Support + Training

EXPERIMENTAL

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

Asha Support + Food

EXPERIMENTAL

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

Asha Support + Training + Food

EXPERIMENTAL

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

Asha Support Only

ACTIVE COMPARATOR

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

Interventions

Asha Support + TrainingBEHAVIORAL
Asha Support + Training
Asha Support + FoodBEHAVIORAL
Asha Support + Food
Asha Support + Training + FoodBEHAVIORAL
Asha Support + Training + Food
Asha Support OnlyBEHAVIORAL
Asha Support Only

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All India Institute of Medical Sciences (AIIMS)

New Delhi, 110029, India

Location

Related Publications (8)

  • Nyamathi A, Ekstrand M, Srivastava N, Carpenter CL, Salem BE, Al-Harrasi S, Ramakrishnan P, Sinha S. ASHA-Life Intervention Perspectives Voiced by Rural Indian Women Living With AIDS. Health Care Women Int. 2016;37(4):412-25. doi: 10.1080/07399332.2015.1066790. Epub 2015 Jul 6.

    PMID: 26147930BACKGROUND

  • Srivastava N, Nyamathi AM, Sinha S, Carpenter C, Satyanarayana V, Ramakrishna P, Ekstrand M. Women living with AIDS in rural Southern India: Perspectives on mental health and lay health care worker support. J HIV AIDS Soc Serv. 2017;16(2):170-194. doi: 10.1080/15381501.2016.1274703. Epub 2017 Feb 23.

    PMID: 29056879BACKGROUND

  • Salem BE, Bustos Y, Shalita C, Kwon J, Ramakrishnan P, Yadav K, Ekstrand ML, Sinha S, Nyamathi AM. Chronic Disease Self-Management Challenges among Rural Women Living with HIV/AIDS in Prakasam, Andhra Pradesh, India: A Qualitative Study. J Int Assoc Provid AIDS Care. 2018 Jan-Dec;17:2325958218773768. doi: 10.1177/2325958218773768.

    PMID: 29756550BACKGROUND

  • Nyamathi A, Ekstrand M, Heylen E, Ramakrishna P, Yadav K, Sinha S, Hudson A, Carpenter CL, Arab L. Relationships Among Adherence and Physical and Mental Health Among Women Living with HIV in Rural India. AIDS Behav. 2018 Mar;22(3):867-876. doi: 10.1007/s10461-016-1631-3.

    PMID: 27990577RESULT

  • Nyamathi AM, Ekstrand M, Yadav K, Ramakrishna P, Heylen E, Carpenter C, Wall S, Oleskowicz T, Arab L, Sinha S. Quality of Life Among Women Living With HIV in Rural India. J Assoc Nurses AIDS Care. 2017 Jul-Aug;28(4):575-586. doi: 10.1016/j.jana.2017.03.004. Epub 2017 Mar 24.

    PMID: 28473182RESULT

  • Shin SS, Carpenter CL, Ekstrand ML, Yadav K, Shah SV, Ramakrishnan P, Pamujula S, Sinha S, Nyamathi AM. Household Food Insecurity as Mediator of the Association Between Internalized Stigma and Opportunistic Infections. AIDS Behav. 2018 Dec;22(12):3897-3904. doi: 10.1007/s10461-018-2193-3.

    PMID: 29934793RESULT

  • Ekstrand ML, Heylen E, Mazur A, Steward WT, Carpenter C, Yadav K, Sinha S, Nyamathi A. The Role of HIV Stigma in ART Adherence and Quality of Life Among Rural Women Living with HIV in India. AIDS Behav. 2018 Dec;22(12):3859-3868. doi: 10.1007/s10461-018-2157-7.

    PMID: 29789984RESULT

  • Nyamathi AM, Carpenter CL, Ekstrand ML, Yadav K, Garfin DR, Muniz LC, Kelley M, Sinha S. Randomized controlled trial of a community-based intervention on HIV and nutritional outcomes at 6 months among women living with HIV/AIDS in rural India. AIDS. 2018 Nov 28;32(18):2727-2737. doi: 10.1097/QAD.0000000000002016.

    PMID: 30289802DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Food

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Adeline M Nyamathi, PhD

    UCI Sue & Bill Gross School of Nursing

    PRINCIPAL INVESTIGATOR

  • Maria Ekstrand, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Sanjeev Sinha, MD

    All India Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor

Study Record Dates

First Submitted

May 8, 2014

First Posted

May 12, 2014

Study Start

August 1, 2013

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

October 9, 2018

Record last verified: 2018-10

Locations

IN(1)