Utilization of HIV Clinical Services in Rural India

HIV Infections Clinical Trial

Official title:

Utilization of Decentralized HIV Testing and Care Services in Rural Maharashtra, India

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00554567
• Other study ID #: VCTUtilizationStudy2007
• Status: Completed
• Phase: Phase 3
• First received: November 5, 2007
• Last updated: March 7, 2016
• Start date: January 2007
• Est. completion date: February 2011

Study information

• Verified date: December 2008
• Source: Institute of Health Management, Pachod, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review BoardIndia: Central Drugs Standard Control Organization
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1300
• Est. completion date: February 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• HIV Infections
• Infection
• Sexually Transmitted Diseases
• Sexually Transmitted Infections

Intervention

Behavioral:
• HIV Testing and Care Services
Fully-decentralized HIV Voluntary Counseling and Testing and referral for care

Locations

Country	Name	City	State
India	Institute of Health Management, Pachod (IHMP)	Pachod, Aurangabad District	Maharashtra

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Health Management, Pachod, India	Johns Hopkins University

Country where clinical trial is conducted

India, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Utilization of HIV Testing		Annual	No
Secondary	Proportion with Sexually Transmitted Infection History		Annual	No
Secondary	Proportion with Behavioral HIV risk history		Annual	No
Secondary	WHO Clinical Stage at time of HIV diagnosis		Quarterly	No
Secondary	WHO Clinical Stage at first clinical care visit		Quarterly	No
Secondary	Birth outcomes for HIV-infected pregnant women		Quarterly	No
Secondary	Awareness of HIV Testing Services		Annual	No

External Links

•   Description of IHMP organization and activities