Trial record 10 of 21 for:    " October 17, 2007":" November 16, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Utilization of HIV Clinical Services in Rural India

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by:
Institute of Health Management, Pachod, India
ClinicalTrials.gov Identifier:
NCT00554567
First received: November 5, 2007
Last updated: December 18, 2008
Last verified: December 2008
  Purpose

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 Intervention Phase
HIV Infections
Sexually Transmitted Infections
Behavioral: HIV Testing and Care Services
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Utilization of Decentralized HIV Testing and Care Services in Rural Maharashtra, India

Resource links provided by NLM:


Further study details as provided by Institute of Health Management, Pachod, India:

Primary Outcome Measures:
  • Utilization of HIV Testing [ Time Frame: Annual ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion with Sexually Transmitted Infection History [ Time Frame: Annual ] [ Designated as safety issue: No ]
  • Proportion with Behavioral HIV risk history [ Time Frame: Annual ] [ Designated as safety issue: No ]
  • WHO Clinical Stage at time of HIV diagnosis [ Time Frame: Quarterly ] [ Designated as safety issue: No ]
  • WHO Clinical Stage at first clinical care visit [ Time Frame: Quarterly ] [ Designated as safety issue: No ]
  • Birth outcomes for HIV-infected pregnant women [ Time Frame: Quarterly ] [ Designated as safety issue: No ]
  • Awareness of HIV Testing Services [ Time Frame: Annual ] [ Designated as safety issue: No ]

Estimated Enrollment: 1300
Study Start Date: January 2007
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional 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
Study First Received: November 5, 2007
Last Updated: December 18, 2008
Health Authority: India: Institutional Review Board
India: Central Drugs Standard Control Organization

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:
HIV Infections
Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
HIV Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014