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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Sexually Transmitted Infections
• Intervention / Treatment: Behavioral: HIV Testing and Care Services

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 Type: Interventional
• Enrollment (Actual): 1300
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Pachod, Aurangabad District, Maharashtra, India, 431 121
      • Institute of Health Management, Pachod (IHMP)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Utilization of HIV Testing	Annual

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Awareness of HIV Testing Services	Annual

Collaborators and Investigators

• Sponsor: Institute of Health Management, Pachod, India
• Collaborators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: November 5, 2007
• First Submitted That Met QC Criteria: November 5, 2007
• First Posted (Estimate): November 7, 2007

Study Record Updates

• Last Update Posted (Estimate): March 8, 2016
• Last Update Submitted That Met QC Criteria: March 7, 2016
• Last Verified: December 1, 2008

More Information

Terms related to this study

• Keywords: Health Services Research; HIV/AIDS; Voluntary Counseling and Testing; Rural India; HIV Care
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Sexually Transmitted Diseases
• Other Study ID Numbers: VCTUtilizationStudy2007