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Utilization of HIV Clinical Services in Rural India

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00554567
Recruitment Status : Completed
First Posted : November 7, 2007
Last Update Posted : March 8, 2016
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Infections Sexually Transmitted Infections Behavioral: HIV Testing and Care Services Phase 3

Detailed 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Utilization of Decentralized HIV Testing and Care Services in Rural Maharashtra, India
Study Start Date : January 2007
Primary Completion Date : November 2010
Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Intervention Arm
Fully Decentralized HIV Testing and Care Services
Behavioral: HIV Testing and Care Services
Fully-decentralized HIV Voluntary Counseling and Testing and referral for care


Outcome Measures

Primary Outcome Measures :
  1. Utilization of HIV Testing [ Time Frame: Annual ]

Secondary Outcome Measures :
  1. Proportion with Sexually Transmitted Infection History [ Time Frame: Annual ]
  2. Proportion with Behavioral HIV risk history [ Time Frame: Annual ]
  3. WHO Clinical Stage at time of HIV diagnosis [ Time Frame: Quarterly ]
  4. WHO Clinical Stage at first clinical care visit [ Time Frame: Quarterly ]
  5. Birth outcomes for HIV-infected pregnant women [ Time Frame: Quarterly ]
  6. Awareness of HIV Testing Services [ Time Frame: Annual ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00554567


Locations
India
Institute of Health Management, Pachod (IHMP)
Pachod, Aurangabad District, Maharashtra, India, 431 121
Sponsors and Collaborators
Institute of Health Management, Pachod, India
Johns Hopkins University
Investigators
Principal Investigator: Ashok Dyalchand, MD MPH Institute for Health Management, Pachod (IHMP), Maharashtra, India
Principal Investigator: Gita Sinha, MD Johns Hopkins University School of Medicine, Baltimore, USA
More Information

Publications:
Responsible Party: Gita Sinha, MD MPH, Johns Hopkins University School of Medicine
ClinicalTrials.gov Identifier: NCT00554567     History of Changes
Other Study ID Numbers: VCTUtilizationStudy2007
First Posted: November 7, 2007    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: December 2008

Keywords provided by Institute of Health Management, Pachod, India:
HIV/AIDS
Voluntary Counseling and Testing
Rural India
HIV Care
Health Services Research

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Immune System Diseases
Genital Diseases, Male
Genital Diseases, Female