Asha HIV Health Promotion Intervention in India

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by University of California, Los Angeles.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00860769
First received: March 11, 2009
Last updated: April 10, 2009
Last verified: April 2009
  Purpose

In this study, village women in India, living with HIV (WLH), along with researchers from the US, HIV and TB experts from the Indian Council for Medical Research and the AII India Institute of Medical Sciences will plan an intervention designed to support women who are receiving treatment and care for HIV and TB, and to help promote their adjustment to illness and improve their health as it relates to their coping and behavioral responses and physical health outcomes. This intervention, delivered by specially trained village women (ASHAs), will then be tested with WLH to assess how acceptable and effective the intervention might be compared to WLH who receive usual care. The women will be recruited from four villages which have high rates of HIV/AIDS in rural Andhra Pradesh (AP), India, where ASHAs are providing general health services. Two of the four selected villages will have ASHAs trained in the intervention strategies. The remaining two will be usual care. The investigators anticipate this three-year study will lead to a culturally tailored intervention that will be tested in a larger study.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: ASHA HIV Health Promotion Intervention in India

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acceptability of the intervention by the women living with HIV. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: September 2008
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 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:

In India, an estimated 5.7 million people are infected with HIV; of whom 2.5 million are women. While access to antiretroviral therapy (ART) is expanding for people living with AIDS, most of the treatment centers are located in urban areas. However, nearly half of the HIV infected population live in rural areas plagued with poor public health infrastructure. In India, rural women are the hardest hit by HIV/AIDS; they bear the brunt of stigma, have little autonomy or decision-making power, are illiterate, rarely employed, and lack basic knowledge of HIV transmission. These women living with HIV (WLH) face profound challenges in accessing and following treatment regimens, caring for family members, and maintaining positive mental health. Complicating the HIV/AIDS scenario is Mycobacterium Tuberculosis (TB). It is estimated that there are over 2 million cases of HIV/TB co-infection in India; over 60% of persons with AIDS have developed TB. To address the health needs of the rural population, the Government of India has promoted the ASHA (Accredited Social Health Activist); a health advocate who resides in rural communities and promotes the health of women and children in the areas of hygiene and nutrition. However, the expansion of the ASHAs' role to address the needs of a marginalized community of WLH is an innovative strategy that is timely and of societal relevance. A research team that possesses extensive experience in community-based qualitative and longitudinal HIV prevention and behavioral change research in the US and in India are well poised to design and pilot test a novel intervention for rural WLH to improve adherence behavior and enhance their mental health and social well-being. Along with US researchers, key HIV and TB researchers from the Indian Council for Medical Research and the All India Institute of Medical Sciences plan a descriptive Phase I followed by an exploratory randomized clinical trial pilot study in Phase II, to assess the acceptability and effectiveness of an intervention program, delivered by ASHAs, and focused on enhancing TB and/or HIV treatment and care, and promoting psychological adjustment to illness, and HIV-related social, cognitive, behavioral, psychological and treatment outcomes of WLH. Participants will be recruited from four high prevalent HIV/AIDS villages in rural Andhra Pradesh (AP), India, where ASHAs are providing general health services. Two of the four randomly selected villages will have ASHAs trained in the intervention strategies. The remaining two will be usual care. The planned program will be designed, in significant part, by our community partners composed of WLH, ASHAs, and health care experts. We anticipate this three-year study will lead to a culturally tailored intervention that will lead to a larger clinical trial.

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women living with HIV
  • Ages 16-45
  • Interfacing with an Accredited Social Health Activist (ASHA)
  • Receiving ART or eligible for receiving ART
  • HIV Positive status
  • CD4 cells >200
  • 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

No publications provided

Responsible Party: Dr. Adeline Nyamathi, The Regents of the University of California
ClinicalTrials.gov Identifier: NCT00860769     History of Changes
Other Study ID Numbers: G071208102, 1 R34 MH082662:01R
Study First Received: March 11, 2009
Last Updated: April 10, 2009
Health Authority: India: Indian Council of Medical Research
India: All India Institute of Medical Sciences (AIIMS)

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 30, 2014