- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02136082
Asha Improving Health and Nutrition of Indian Women With AIDS and Their Children (Asha2)
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New Delhi, India, 110029
- All India Institute of Medical Sciences (AIIMS)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Asha Support + Training
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.
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Experimental: Asha Support + Food
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.
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Experimental: Asha Support + Training + Food
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.
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Active Comparator: Asha Support Only
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in weight
Time Frame: 6-, 12- and 18-month followup
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Weight gain as measured in BMI (kg/m2)
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6-, 12- and 18-month followup
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Change in CD4+ T cell count
Time Frame: 6-, 12- and 18-month followup
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Measure of immune status in cells/mm3
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6-, 12- and 18-month followup
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Change in muscle mass
Time Frame: 6-, 12- and 18-month followup
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Measured by the Bioelectrical Impedance (BIA)
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6-, 12- and 18-month followup
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in ART adherence
Time Frame: 6-, 12- and 18-month followup
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Measured by visual analog scale
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6-, 12- and 18-month followup
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Change in depressive symptomatology
Time Frame: 6-, 12- and 18-month followup
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Measured by Center for Epidemiologic Studies Depression Scale (CES-D)
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6-, 12- and 18-month followup
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Change in internalized stigma
Time Frame: 6-, 12- and 18-month followup
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Measured by the Internalized Stigma Scale
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6-, 12- and 18-month followup
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Change in nutritional adequacy
Time Frame: 6-, 12- and 18-month followup
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Nutritional adequacy of the WLA over 18 months, measured by comparisons of vitamin, mineral and macronutrient intake, guided by dietary recommendations
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6-, 12- and 18-month followup
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Change in lipid normalization
Time Frame: 6-, 12- and 18-month followup
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Lipid normalization of WLA (triglycerides and cholesterol)
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6-, 12- and 18-month followup
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Change in anthropometric parameters and psychomotor development of the index children
Time Frame: 6-, 12- and 18-month followup
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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.
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6-, 12- and 18-month followup
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Adeline M Nyamathi, PhD, UCI Sue & Bill Gross School of Nursing
- Principal Investigator: Sanjeev Sinha, MD, All India Institute of Medical Sciences, New Delhi
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIHMS098729
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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