Utilization of HIV Clinical Services in Rural India

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Utilization of Decentralized HIV Testing and Care Services in Rural Maharashtra, India

Conditions
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HIV Infections, Sexually Transmitted Infections

Intervention / Treatment
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* Behavioral: HIV Testing and Care Services


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>Fully Decentralized HIV Testing and Care Services | Behavioral: HIV Testing and Care Services<br>* Fully-decentralized HIV Voluntary Counseling and Testing and referral for care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Utilization of HIV Testing |  | Annual | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion with Sexually Transmitted Infection History |  | Annual | 
| Proportion with Behavioral HIV risk history |  | Annual | 
| WHO Clinical Stage at time of HIV diagnosis |  | Quarterly | 
| WHO Clinical Stage at first clinical care visit |  | Quarterly | 
| Birth outcomes for HIV-infected pregnant women |  | Quarterly | 
| Awareness of HIV Testing Services |  | Annual | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV Care, HIV/AIDS, Voluntary Counseling and Testing, Rural India, Health Services Research