Utilization of HIV Clinical Services in Rural India

Phase 3

Completed

• Conditions: Sexually Transmitted Infections; HIV Infections
• Interventions: Behavioral: HIV Testing and Care Services

• Registration Number: NCT00554567
• Lead Sponsor: Institute of Health Management, Pachod, India

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.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-11-05
• Study First Submitted QC: 2007-11-05
• Study First Posted: 2007-11-07
• Status Verified: 2008-12
• Primary Completion: 2010-11
• Study Completion: 2011-02
• Last Update Submitted: 2016-03-07
• Last Update Posted: 2016-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	HIV Testing and Care Services	Fully Decentralized HIV Testing and Care Services

Primary Outcome Measures

Name	Time	Method
Utilization of HIV Testing	Annual

Secondary Outcome Measures

Name	Time	Method
Awareness of HIV Testing Services	Annual
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

Trial Locations

Locations (1)

Institute of Health Management, Pachod (IHMP); 🇮🇳 Pachod, Aurangabad District, Maharashtra, India