Utilization of HIV Clinical Services in Rural India

Institute of Health Management, Pachod, India

Status and phase: Completed; Phase 3

Conditions: Sexually Transmitted Infections; HIV Infections

Treatments: Behavioral: HIV Testing and Care Services

Study type: Interventional

Funder types: Other

Identifiers

NCT00554567

VCTUtilizationStudy2007

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,300 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult Male Age 18 - 49 or Pregnant Female age 18 and older
• Capacity to give written informed consent

Exclusion criteria

• Refusal, or Physical or Mental incapacity to give written informed consent

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,300 participants in 1 patient group

Intervention Arm

Experimental group

Description:

Fully Decentralized HIV Testing and Care Services

Treatment:

Behavioral: HIV Testing and Care Services