Overview

This trial is active, not recruiting.

Condition hiv infections
Treatments asha life, usual care
Phase phase 1/phase 2
Sponsor University of California, Los Angeles
Start date September 2008
End date June 2011
Trial size 70 participants
Trial identifier NCT00860769, 1 R34 MH082662:01R, G071208102

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
6-session educational group discussing HIV prevention, anti-retroviral therapy (ART), coping enhancement, nutrition, parenting and life skills.
asha life
6-session education groups discussing HIV prevention, anti-retroviral therapy (ART), coping enhancement, nutrition, parenting and life skills
(Active Comparator)
3-session educational group focusing on HIV prevention, anti-retroviral therapy (ART) and parenting.
usual care
3 session educational group focusing on HIV prevention, anti-retroviral therapy and parenting

Primary Outcomes

Measure
Conduct a randomized clinical pilot study with 70 women living with HIV in India.
time frame: 2 years

Secondary Outcomes

Measure
Acceptability of the intervention by the women living with HIV.
time frame: 2 years

Eligibility Criteria

Female participants from 16 years up to 45 years old.

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

Additional Information

Official title ASHA HIV Health Promotion Intervention in India
Principal investigator Adeline Nyamathi, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2009.
Information provided to ClinicalTrials.gov by University of California, Los Angeles.