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Utilization of HIV Clinical Services in Rural India

Primary Purpose

HIV Infections, Sexually Transmitted Infections

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
HIV Testing and Care Services
Sponsored by
Institute of Health Management, Pachod, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV Infections focused on measuring HIV/AIDS, Voluntary Counseling and Testing, Rural India, HIV Care, Health Services Research

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Institute of Health Management, Pachod (IHMP)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Arm

Arm Description

Fully Decentralized HIV Testing and Care Services

Outcomes

Primary Outcome Measures

Utilization of HIV Testing

Secondary Outcome Measures

Proportion with Sexually Transmitted Infection History
Proportion with Behavioral HIV risk history
WHO Clinical Stage at time of HIV diagnosis
WHO Clinical Stage at first clinical care visit
Birth outcomes for HIV-infected pregnant women
Awareness of HIV Testing Services

Full Information

First Posted
November 5, 2007
Last Updated
March 7, 2016
Sponsor
Institute of Health Management, Pachod, India
Collaborators
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT00554567
Brief Title
Utilization of HIV Clinical Services in Rural India
Official Title
Utilization of Decentralized HIV Testing and Care Services in Rural Maharashtra, India
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Institute of Health Management, Pachod, India
Collaborators
Johns Hopkins University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Sexually Transmitted Infections
Keywords
HIV/AIDS, Voluntary Counseling and Testing, Rural India, HIV Care, Health Services Research

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Fully Decentralized HIV Testing and Care Services
Intervention Type
Behavioral
Intervention Name(s)
HIV Testing and Care Services
Intervention Description
Fully-decentralized HIV Voluntary Counseling and Testing and referral for care
Primary Outcome Measure Information:
Title
Utilization of HIV Testing
Time Frame
Annual
Secondary Outcome Measure Information:
Title
Proportion with Sexually Transmitted Infection History
Time Frame
Annual
Title
Proportion with Behavioral HIV risk history
Time Frame
Annual
Title
WHO Clinical Stage at time of HIV diagnosis
Time Frame
Quarterly
Title
WHO Clinical Stage at first clinical care visit
Time Frame
Quarterly
Title
Birth outcomes for HIV-infected pregnant women
Time Frame
Quarterly
Title
Awareness of HIV Testing Services
Time Frame
Annual

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashok Dyalchand, MD MPH
Organizational Affiliation
Institute for Health Management, Pachod (IHMP), Maharashtra, India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gita Sinha, MD
Organizational Affiliation
Johns Hopkins University School of Medicine, Baltimore, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Health Management, Pachod (IHMP)
City
Pachod, Aurangabad District
State/Province
Maharashtra
ZIP/Postal Code
431 121
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
18340657
Citation
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.
Results Reference
result
PubMed Identifier
18462015
Citation
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.
Results Reference
result

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Utilization of HIV Clinical Services in Rural India

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