Utilization of HIV Clinical Services in Rural India | NCT00554567

Studies
Utilization of HIV Clinical Services in Rural India

NCT00554567

Sponsor

Institute of Health Management, Pachod, India

Status

Completed

Last Update Posted

Mar 8, 2016Estimated

Enrollment

1,300Actual

Phase

Phase 3

Conditions

HIV Infections
Sexually Transmitted Infections

Interventions

HIV Testing and Care Services

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Nov 2010Actual

Completion Date

Feb 2011Actual

First Submitted Date

Nov 5, 2007

First Submission Date that Met QC Criteria

Nov 5, 2007

First Posted Date

Nov 7, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2016

Last Update Posted Date

Mar 8, 2016Estimated

Name	Class
Johns Hopkins University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention Arm	Experimental	Fully Decentralized HIV Testing and Care Services	Behavioral: HIV Testing and Care Services

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HIV Testing and Care Services	Behavioral	Fully-decentralized HIV Voluntary Counseling and Testing and referral for care	Intervention Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Utilization of HIV Testing		Annual

Secondary Outcomes

Measure	Description	Time Frame
Proportion with Sexually Transmitted Infection History		Annual
Proportion with Behavioral HIV risk history		Annual
WHO Clinical Stage at time of HIV diagnosis

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Health Management, Pachod (IHMP)		Pachod, Aurangabad District	Maharashtra	431 121	India

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18340657	Result	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.
18462015	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.

ID	Term
D015658	HIV Infections
D012749	Sexually Transmitted Diseases
D000163	Acquired Immunodeficiency Syndrome

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

ID	Term
D008828	Microbiological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis