HIV Infections Clinical Trial
Official title:
Utilization of Decentralized HIV Testing and Care Services in Rural Maharashtra, India
This community-based clinical trial based in two districts of rural Maharashtra, India compares utilization of an intervention model of "fully-decentralized," or rural primary clinic-based, HIV testing and care services, with a control model of the Indian government's partially-decentralized HIV services, offering rural referral clinic testing and urban-based HIV care.
India has one of the highest estimated number of HIV cases globally. Sixty percent of its
HIV cases occur in rural residents, yet there is no system of HIV testing or care services
for them. Preliminary studies have identified very low HIV testing utilization among men and
recently pregnant women in rural Maharashtra, even though these are, by government policy,
high-priority target groups for rural HIV testing, diagnosis, and prevention.
This study will compare two models of rural HIV testing and care services in two districts
of Maharashtra, India. The "Control" model is the Indian government's current strategy of
"partially decentralized" rural-based HIV testing services at a secondary-level Community
Health Center clinic, which serves a village group population of 30,000. HIV care including
antiretroviral therapy is provided a the rural district headquarters in the district urban
center. The "Intervention" model is a novel model of "fully decentralized" rural-based HIV
testing which will be offered at the Community Health Center, two Primary Health Centers,
and eight village-level sub-center clinics, and HIV care offered at a rural-based clinic.
The primary outcomes of this trial are to assess and compare utilization rates for these two
types of HIV services models among rural adult men age 18-49 and pregnant women age 18 and
older. Additionally, the secondary outcomes include comparing HIV clinical and behavioral
risk characteristics of services utilizers in each model, and characteristics of utilizers
versus non-utilizers between and within each model. Clinical care outcomes include WHO
Clinical stage at time of HIV diagnosis and at first clinical care visit, and birth outcomes
for HIV-infected pregnant women.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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