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

November 5, 2007
December 18, 2008
January 2007
November 2010   (final data collection date for primary outcome measure)
Utilization of HIV Testing [ Time Frame: Annual ] [ Designated as safety issue: No ]
Utilization of HIV Testing [ Time Frame: Annual ]
Complete list of historical versions of study NCT00554567 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Proportion with Sexually Transmitted Infection History [ Time Frame: Annual ]
  • Proportion with Behavioral HIV risk history [ Time Frame: Annual ]
  • WHO Clinical Stage at time of HIV diagnosis [ Time Frame: Quarterly ]
  • WHO Clinical Stage at first clinical care visit [ Time Frame: Quarterly ]
  • Birth outcomes for HIV-infected pregnant women [ Time Frame: Quarterly ]
Not Provided
Not Provided
 
Utilization of HIV Clinical Services in Rural India
Utilization of Decentralized HIV Testing and Care Services in Rural Maharashtra, India

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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • HIV Infections
  • Sexually Transmitted Infections
Behavioral: HIV Testing and Care Services
Fully-decentralized HIV Voluntary Counseling and Testing and referral for care
Experimental: Intervention Arm
Fully Decentralized HIV Testing and Care Services
Intervention: Behavioral: HIV Testing and Care Services

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
1300
February 2011
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 49 Years
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00554567
VCTUtilizationStudy2007
Yes
Gita Sinha, MD MPH, Johns Hopkins University School of Medicine
Institute of Health Management, Pachod, India
Johns Hopkins University
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
Institute of Health Management, Pachod, India
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP