Study Results
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Basic Information
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COMPLETED
PHASE3
1300 participants
INTERVENTIONAL
2007-01-31
2011-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Intervention Arm
Fully Decentralized HIV Testing and Care Services
HIV Testing and Care Services
Fully-decentralized HIV Voluntary Counseling and Testing and referral for care
Interventions
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HIV Testing and Care Services
Fully-decentralized HIV Voluntary Counseling and Testing and referral for care
Eligibility Criteria
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Inclusion Criteria
* Capacity to give written informed consent
Exclusion Criteria
18 Years
49 Years
ALL
Yes
Sponsors
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Johns Hopkins University
OTHER
Institute of Health Management, Pachod, India
OTHER
Responsible Party
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Johns Hopkins University School of Medicine
Principal Investigators
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Ashok Dyalchand, MD MPH
Role: PRINCIPAL_INVESTIGATOR
Institute for Health Management, Pachod (IHMP), Maharashtra, India
Gita Sinha, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University School of Medicine, Baltimore, USA
Locations
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Institute of Health Management, Pachod (IHMP)
Pachod, Aurangabad District, Maharashtra, India
Countries
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References
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Sinha G, Dyalchand A, Khale M, Kulkarni G, Vasudevan S, Bollinger RC. Low utilization of HIV testing during pregnancy: What are the barriers to HIV testing for women in rural India? J Acquir Immune Defic Syndr. 2008 Feb 1;47(2):248-52.
Celentano DD. Is HIV screening in the labor and delivery unit feasible and acceptable in low-income settings? PLoS Med. 2008 May 6;5(5):e107. doi: 10.1371/journal.pmed.0050107.
Other Identifiers
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VCTUtilizationStudy2007
Identifier Type: -
Identifier Source: org_study_id
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