Utilization of HIV Clinical Services in Rural India

NCT ID: NCT00554567

Last Updated: 2016-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2011-02-28

Brief Summary

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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

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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.

Conditions

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HIV Infections Sexually Transmitted Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention Arm

Fully Decentralized HIV Testing and Care Services

Group Type EXPERIMENTAL

HIV Testing and Care Services

Intervention Type BEHAVIORAL

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

Interventions

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HIV Testing and Care Services

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role collaborator

Institute of Health Management, Pachod, India

OTHER

Sponsor Role lead

Responsible Party

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Johns Hopkins University School of Medicine

Principal Investigators

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Ashok Dyalchand, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Institute for Health Management, Pachod (IHMP), Maharashtra, India

Gita Sinha, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University School of Medicine, Baltimore, USA

Locations

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Institute of Health Management, Pachod (IHMP)

Pachod, Aurangabad District, Maharashtra, India

Site Status

Countries

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India

References

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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.

Reference Type RESULT
PMID: 18340657 (View on PubMed)

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.

Reference Type RESULT
PMID: 18462015 (View on PubMed)

Other Identifiers

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VCTUtilizationStudy2007

Identifier Type: -

Identifier Source: org_study_id

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