Asha HIV Health Promotion Intervention in India - Full Text View

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Behavioral: ASHA LIFE Behavioral: USUAL Care	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention
Official Title:	ASHA HIV Health Promotion Intervention in India

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Adeline Nyamathi, PhD, University of California, Los Angeles:

Primary Outcome Measures:

Conduct a randomized clinical pilot study with 70 women living with HIV in India. [ Time Frame: 2 years ]

Secondary Outcome Measures:

Acceptability of the intervention by the women living with HIV. [ Time Frame: 2 years ]


Enrollment:	68
Study Start Date:	September 2008
Study Completion Date:	June 2012
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ASHA Life 6-session educational group discussing HIV prevention, anti-retroviral therapy (ART), coping enhancement, nutrition, parenting and life skills.	Behavioral: ASHA LIFE 6-session education groups discussing HIV prevention, anti-retroviral therapy (ART), coping enhancement, nutrition, parenting and life skills
Active Comparator: Usual Care 3-session educational group focusing on HIV prevention, anti-retroviral therapy (ART) and parenting.	Behavioral: USUAL Care 3 session educational group focusing on HIV prevention, anti-retroviral therapy and parenting

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.

Eligibility


Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860769

Locations


India
Indian Counsel of Medical Research
New Delhi, India

Sponsors and Collaborators

University of California, Los Angeles

Investigators


Principal Investigator:	Adeline Nyamathi, PhD	The Regents of the University of California

More Information

Publications:

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.

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.

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.

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.

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.

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.

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.

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.

Nyamathi AM, William RR, Ganguly KK, Sinha S, Heravian A, Albarrán 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.


Responsible Party:	Adeline Nyamathi, PhD, Distinguished Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00860769 History of Changes
Other Study ID Numbers:	G071208102 1 R34 MH082662:01R
Study First Received:	March 11, 2009
Last Updated:	September 26, 2016

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

ClinicalTrials.gov processed this record on August 22, 2017