HIV Infection Clinical Trial
— Asha2Official title:
Asha Improving Health and Nutrition of Indian Women With AIDS and Their Children
NCT number | NCT02136082 |
Other study ID # | NIHMS098729 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2013 |
Est. completion date | June 2018 |
Verified date | October 2018 |
Source | University of California, Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 600 |
Est. completion date | June 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
India | All India Institute of Medical Sciences (AIIMS) | New Delhi |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles | All India Institute of Medical Sciences, New Delhi, University of California, Irvine, University of California, San Francisco |
India,
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 May 22. doi: 10.1007/s10461-018-2157-7. [Epub a — View 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/s1 — View 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. — View 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. — View 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. — View 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 Jun 22. doi: 10.100 — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in weight | Weight gain as measured in BMI (kg/m2) | 6-, 12- and 18-month followup | |
Primary | Change in CD4+ T cell count | Measure of immune status in cells/mm3 | 6-, 12- and 18-month followup | |
Primary | Change in muscle mass | Measured by the Bioelectrical Impedance (BIA) | 6-, 12- and 18-month followup | |
Secondary | Change in ART adherence | Measured by visual analog scale | 6-, 12- and 18-month followup | |
Secondary | Change in depressive symptomatology | Measured by Center for Epidemiologic Studies Depression Scale (CES-D) | 6-, 12- and 18-month followup | |
Secondary | Change in internalized stigma | Measured by the Internalized Stigma Scale | 6-, 12- and 18-month followup | |
Secondary | 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 | 6-, 12- and 18-month followup | |
Secondary | Change in lipid normalization | Lipid normalization of WLA (triglycerides and cholesterol) | 6-, 12- and 18-month followup | |
Secondary | 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. | 6-, 12- and 18-month followup |
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