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Asha Improving Health and Nutrition of Indian Women With AIDS and Their Children (Asha2)

Primary Purpose

HIV Infection

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Asha Support + Training
Asha Support + Food
Asha Support + Training + Food
Asha Support Only
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infection focused on measuring HIV, Women, Children, Nutrition

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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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Sites / Locations

  • All India Institute of Medical Sciences (AIIMS)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Asha Support + Training

Asha Support + Food

Asha Support + Training + Food

Asha Support Only

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in weight
Weight gain as measured in BMI (kg/m2)
Change in CD4+ T cell count
Measure of immune status in cells/mm3
Change in muscle mass
Measured by the Bioelectrical Impedance (BIA)

Secondary Outcome Measures

Change in ART adherence
Measured by visual analog scale
Change in depressive symptomatology
Measured by Center for Epidemiologic Studies Depression Scale (CES-D)
Change in internalized stigma
Measured by the Internalized Stigma Scale
Change in nutritional adequacy
Nutritional adequacy of the WLA over 18 months, measured by comparisons of vitamin, mineral and macronutrient intake, guided by dietary recommendations
Change in lipid normalization
Lipid normalization of WLA (triglycerides and cholesterol)
Change in anthropometric parameters and psychomotor development of the index children
Anthropometric parameters and psychomotor development of the index children at 6-12-, and 18-month follow-up; among those HIV-infected, we will also assess CD4 levels over time.

Full Information

First Posted
May 8, 2014
Last Updated
October 4, 2018
Sponsor
University of California, Los Angeles
Collaborators
All India Institute of Medical Sciences, New Delhi, University of California, San Francisco, University of California, Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT02136082
Brief Title
Asha Improving Health and Nutrition of Indian Women With AIDS and Their Children
Acronym
Asha2
Official Title
Asha Improving Health and Nutrition of Indian Women With AIDS and Their Children
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
All India Institute of Medical Sciences, New Delhi, University of California, San Francisco, University of California, Irvine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
HIV, Women, Children, Nutrition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Asha Support + Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Asha Support + Food
Arm Type
Experimental
Arm Description
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.
Arm Title
Asha Support + Training + Food
Arm Type
Experimental
Arm Description
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.
Arm Title
Asha Support Only
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Asha Support + Training
Intervention Type
Behavioral
Intervention Name(s)
Asha Support + Food
Intervention Type
Behavioral
Intervention Name(s)
Asha Support + Training + Food
Intervention Type
Behavioral
Intervention Name(s)
Asha Support Only
Primary Outcome Measure Information:
Title
Change in weight
Description
Weight gain as measured in BMI (kg/m2)
Time Frame
6-, 12- and 18-month followup
Title
Change in CD4+ T cell count
Description
Measure of immune status in cells/mm3
Time Frame
6-, 12- and 18-month followup
Title
Change in muscle mass
Description
Measured by the Bioelectrical Impedance (BIA)
Time Frame
6-, 12- and 18-month followup
Secondary Outcome Measure Information:
Title
Change in ART adherence
Description
Measured by visual analog scale
Time Frame
6-, 12- and 18-month followup
Title
Change in depressive symptomatology
Description
Measured by Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame
6-, 12- and 18-month followup
Title
Change in internalized stigma
Description
Measured by the Internalized Stigma Scale
Time Frame
6-, 12- and 18-month followup
Title
Change in nutritional adequacy
Description
Nutritional adequacy of the WLA over 18 months, measured by comparisons of vitamin, mineral and macronutrient intake, guided by dietary recommendations
Time Frame
6-, 12- and 18-month followup
Title
Change in lipid normalization
Description
Lipid normalization of WLA (triglycerides and cholesterol)
Time Frame
6-, 12- and 18-month followup
Title
Change in anthropometric parameters and psychomotor development of the index children
Description
Anthropometric parameters and psychomotor development of the index children at 6-12-, and 18-month follow-up; among those HIV-infected, we will also assess CD4 levels over time.
Time Frame
6-, 12- and 18-month followup

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adeline M Nyamathi, PhD
Organizational Affiliation
UCI Sue & Bill Gross School of Nursing
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria Ekstrand, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sanjeev Sinha, MD
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Principal Investigator
Facility Information:
Facility Name
All India Institute of Medical Sciences (AIIMS)
City
New Delhi
ZIP/Postal Code
110029
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
26147930
Citation
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.
Results Reference
background
PubMed Identifier
29056879
Citation
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.
Results Reference
background
PubMed Identifier
29756550
Citation
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.
Results Reference
background
PubMed Identifier
27990577
Citation
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.
Results Reference
result
PubMed Identifier
28473182
Citation
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.
Results Reference
result
PubMed Identifier
29934793
Citation
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.
Results Reference
result
PubMed Identifier
29789984
Citation
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.
Results Reference
result
PubMed Identifier
30289802
Citation
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.
Results Reference
derived

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

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