Ignite Creation Date:
2024-05-05 @ 9:22 PM
Last Modification Date:
2024-10-26 @ 10:02 AM
Study NCT ID:
NCT00860769
Status:
COMPLETED
Last Update Posted:
2016-09-28
First Post:
2009-03-11
Brief Title:
Asha HIV Health Promotion Intervention in India
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
ASHA HIV Health Promotion Intervention in India
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this randomized pilot study was to conduct an intervention with 68 rural women living with AIDS to compare the effectiveness of two different programs on compliance with HIVAIDS treatment regimens improvement in knowledge about HIVAIDS and TB improvement in psychological distress reduction in stigma satisfaction with care provided to family members reduction in number of opportunistic infections increase in CD4 levels and completion of the designed Asha-Life AL program The trial was designed to assess the impact of the Asha-Life AL intervention engaging with an HIV-trained village woman Asha Accredited Social Health Activist to participate in the care of women living with AIDS WLA along with other health care providers compared to a Usual Care group Two high prevalence HIVAIDS villages in rural Andhra Pradesh which were demographically alike and served by distinct Public Health Centers were selected randomly from a total of 16 villages
Detailed Description:
This Community health study was conducted in two phases
Phase I was initiated with the establishment of a Community Advisory Board CAB composed of 10 persons including WLA Ashas and health care providers consisting of Nurse Midwives HIV and TB experts selected from a Primary Care Clinic in Nellore Andhra Pradesh The CAB considered issues related to stigma disclosure and psycho-socio-cultural factors affecting the health-seeking behaviors of WLA They also analyzed the strategies that Asha could employ to support WLA in optimizing their health and well-being and that of their families This was followed by focus groups conducted separately with the same type of participants Eligibility criteria included WLA who were currently on ART were 16-45 years of age and were able to provide informed consent
Phase II A randomized control trial-pilot study was completed in Year 3 We assessed the outcomes of 34 WLA who participated in the AL program at six-month follow-up as compared with 34 WLA in the Usual Care UC Program in terms of a compliance with HIVAIDS andor TB treatment regimens HIVAIDSTB b improvement in knowledge about HIVAIDSTB c improvement in psychological distress d reduction in stigma e reduction in number of opportunistic infections OIs f increase in CD4 levels and g completion of the program The intervention incorporated a comprehensive education and skills program to which we added high protein supplements 1 kg of Black Gram and 1 kg of Toor Dalmonth for the AL group vs a basic program including 1 kg of Channa Dalmonth for the UC group
Phase I was initiated with the establishment of a Community Advisory Board CAB composed of 10 persons including WLA Ashas and health care providers consisting of Nurse Midwives HIV and TB experts selected from a Primary Care Clinic in Nellore Andhra Pradesh The CAB considered issues related to stigma disclosure and psycho-socio-cultural factors affecting the health-seeking behaviors of WLA They also analyzed the strategies that Asha could employ to support WLA in optimizing their health and well-being and that of their families This was followed by focus groups conducted separately with the same type of participants Eligibility criteria included WLA who were currently on ART were 16-45 years of age and were able to provide informed consent
Phase II A randomized control trial-pilot study was completed in Year 3 We assessed the outcomes of 34 WLA who participated in the AL program at six-month follow-up as compared with 34 WLA in the Usual Care UC Program in terms of a compliance with HIVAIDS andor TB treatment regimens HIVAIDSTB b improvement in knowledge about HIVAIDSTB c improvement in psychological distress d reduction in stigma e reduction in number of opportunistic infections OIs f increase in CD4 levels and g completion of the program The intervention incorporated a comprehensive education and skills program to which we added high protein supplements 1 kg of Black Gram and 1 kg of Toor Dalmonth for the AL group vs a basic program including 1 kg of Channa Dalmonth for the UC group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1 R34 MH08266201R | None | None | None |