Asha HIV Health Promotion Intervention in India
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): ASHA LIFE; USUAL Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 6-session education groups 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 and parenting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention