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Asha HIV Health Promotion Intervention in India

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
ASHA LIFE
USUAL Care
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 Infections

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women living with HIV
  • Ages 18-45
  • Interfacing with an Accredited Social Health Activist (ASHA)
  • Receiving ART or eligible for receiving ART
  • HIV Positive status
  • CD4 cells ≥ 100
  • Not a participant of Phase 1

Exclusion Criteria:

  • Cognitively impaired, not a participant of Phase 1

Sites / Locations

  • Indian Counsel of Medical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ASHA Life

Usual Care

Arm Description

6-session educational group discussing HIV prevention, anti-retroviral therapy (ART), coping enhancement, nutrition, parenting and life skills.

3-session educational group focusing on HIV prevention, anti-retroviral therapy (ART) and parenting.

Outcomes

Primary Outcome Measures

Conduct a randomized clinical pilot study with 70 women living with HIV in India.

Secondary Outcome Measures

Acceptability of the intervention by the women living with HIV.

Full Information

First Posted
March 11, 2009
Last Updated
September 26, 2016
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT00860769
Brief Title
Asha HIV Health Promotion Intervention in India
Official Title
ASHA HIV Health Promotion Intervention in India
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 HIV/AIDS treatment regimens, improvement in knowledge about HIV/AIDS 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 HIV/AIDS 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 HIV/AIDS and/or TB treatment regimens (HIV/AIDS/TB), b) improvement in knowledge about HIV/AIDS/TB, 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 Dal/month for the AL group vs. a basic program including 1 kg of Channa Dal/month for the UC group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASHA Life
Arm Type
Experimental
Arm Description
6-session educational group discussing HIV prevention, anti-retroviral therapy (ART), coping enhancement, nutrition, parenting and life skills.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
3-session educational group focusing on HIV prevention, anti-retroviral therapy (ART) and parenting.
Intervention Type
Behavioral
Intervention Name(s)
ASHA LIFE
Intervention Description
6-session education groups discussing HIV prevention, anti-retroviral therapy (ART), coping enhancement, nutrition, parenting and life skills
Intervention Type
Behavioral
Intervention Name(s)
USUAL Care
Intervention Description
3 session educational group focusing on HIV prevention, anti-retroviral therapy and parenting
Primary Outcome Measure Information:
Title
Conduct a randomized clinical pilot study with 70 women living with HIV in India.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Acceptability of the intervention by the women living with HIV.
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women living with HIV Ages 18-45 Interfacing with an Accredited Social Health Activist (ASHA) Receiving ART or eligible for receiving ART HIV Positive status CD4 cells ≥ 100 Not a participant of Phase 1 Exclusion Criteria: Cognitively impaired, not a participant of Phase 1
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adeline Nyamathi, PhD
Organizational Affiliation
The Regents of the University of California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indian Counsel of Medical Research
City
New Delhi
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
23539322
Citation
Nyamathi A, Ekstrand M, Salem BE, Sinha S, Ganguly KK, Leake B. Impact of Asha intervention on stigma among rural Indian women with AIDS. West J Nurs Res. 2013 Aug;35(7):867-83. doi: 10.1177/0193945913482050. Epub 2013 Mar 27.
Results Reference
result
PubMed Identifier
22872107
Citation
Nyamathi A, Hanson AY, Salem BE, Sinha S, Ganguly KK, Leake B, Yadav K, Marfisee M. Impact of a rural village women (Asha) intervention on adherence to antiretroviral therapy in southern India. Nurs Res. 2012 Sep-Oct;61(5):353-62. doi: 10.1097/NNR.0b013e31825fe3ef.
Results Reference
result
PubMed Identifier
22676466
Citation
Nyamathi A, Salem BE, Meyer V, Ganguly KK, Sinha S, Ramakrishnan P. Impact of an Asha intervention on depressive symptoms among rural women living with AIDS in India: comparison of the Asha-Life and Usual Care program. AIDS Educ Prev. 2012 Jun;24(3):280-93. doi: 10.1521/aeap.2012.24.3.280. Erratum In: AIDS Educ Prev. 2012 Aug;24(4):388.
Results Reference
result
PubMed Identifier
23370835
Citation
Nyamathi A, Sinha S, Ganguly KK, Ramakrishna P, Suresh P, Carpenter CL. Impact of protein supplementation and care and support on body composition and CD4 count among HIV-infected women living in rural India: results from a randomized pilot clinical trial. AIDS Behav. 2013 Jul;17(6):2011-21. doi: 10.1007/s10461-013-0420-5.
Results Reference
result
PubMed Identifier
22553317
Citation
Nyamathi A, Heravian A, Salem B, Suresh P, Sinha S, Ganguly K, Carpenter C, Ramakrishnan P, Marfisee M, Liu Y. Physical and mental health of rural southern Indian women living with AIDS. J Int Assoc Provid AIDS Care. 2013 Nov-Dec;12(6):391-6. doi: 10.1177/1545109712442241. Epub 2012 May 2.
Results Reference
result
PubMed Identifier
21915715
Citation
Nyamathi A, Ekstrand M, Zolt-Gilburne J, Ganguly K, Sinha S, Ramakrishnan P, Suresh P, Marfisee M, Leake B. Correlates of stigma among rural Indian women living with HIV/AIDS. AIDS Behav. 2013 Jan;17(1):329-39. doi: 10.1007/s10461-011-0041-9.
Results Reference
result
PubMed Identifier
21692578
Citation
Nyamathi A, Heravian A, Zolt-Gilburne J, Sinha S, Ganguly K, Liu E, Ramakrishnan P, Marfisee M, Leake B. Correlates of depression among rural women living with AIDS in Southern India. Issues Ment Health Nurs. 2011;32(6):385-91. doi: 10.3109/01612840.2011.577269.
Results Reference
result
PubMed Identifier
21409663
Citation
Nyamathi AM, Sinha S, Ganguly KK, William RR, Heravian A, Ramakrishnan P, Greengold B, Ekstrand M, Rao PV. Challenges experienced by rural women in India living with AIDS and implications for the delivery of HIV/AIDS care. Health Care Women Int. 2011 Apr;32(4):300-13. doi: 10.1080/07399332.2010.536282.
Results Reference
result
PubMed Identifier
21331322
Citation
Nyamathi AM, William RR, Ganguly KK, Sinha S, Heravian A, Albarran CR, Thomas A, Greengold B, Ekstrand M, Ramakrishna P, Rao PR. Perceptions of Women Living with AIDS in Rural India Related to the Engagement of HIV-Trained Accredited Social Health Activists for Care and Support. J HIV AIDS Soc Serv. 2010 Oct;9(4):385-404. doi: 10.1080/15381501.2010.525474.
Results Reference
result

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Asha HIV Health Promotion Intervention in India

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