Utilization of HIV Clinical Services in Rural India

NCT00554567 | Completed Phase 3 DMC

• 1 other identifier: VCTUtilizationStudy2007
• Study Type: interventional
• Target: 1,300
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Sexually Transmitted Infections

Keywords

HIV/AIDS; Voluntary Counseling and Testing; Rural India; HIV Care; Health Services Research

Outcome Measures

Primary Outcomes (1)

• Utilization of HIV Testing

  Annual

Secondary Outcomes (6)

• 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

Study Arms (1)

Intervention Arm

EXPERIMENTAL

Fully Decentralized HIV Testing and Care Services

Behavioral: HIV Testing and Care Services

Interventions

HIV Testing and Care Services BEHAVIORAL

Fully-decentralized HIV Voluntary Counseling and Testing and referral for care

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult Male Age 18 - 49 or Pregnant Female age 18 and older
• Capacity to give written informed consent

You may not qualify if:

• Refusal, or Physical or Mental incapacity to give written informed consent

Sponsors & Collaborators

• Institute of Health Management, Pachod, India: lead
• Johns Hopkins University: collaborator

Study Sites (1)

Institute of Health Management, Pachod (IHMP)

Pachod, Aurangabad District, Maharashtra, 431 121, India

Location

Related Publications (2)

• 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.

  PMID: 18340657 RESULT

• 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.

  PMID: 18462015 RESULT

MeSH Terms

Conditions

HIV Infections; Sexually Transmitted Diseases; Acquired Immunodeficiency Syndrome

Interventions

HIV Testing

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 5, 2007
• First Posted: November 7, 2007
• Study Start: January 1, 2007
• Primary Completion: November 1, 2010
• Study Completion: February 1, 2011
• Last Updated: March 8, 2016

Record last verified: 2008-12

Locations

IN (1)