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Utilization of HIV Clinical Services in Rural India

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00554567
Enrollment
1300
Registered
2007-11-07
Start date
2007-01-31
Completion date
2011-02-28
Last updated
2016-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Sexually Transmitted Infections

Keywords

HIV/AIDS, Voluntary Counseling and Testing, Rural India, HIV Care, Health Services Research

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.

Interventions

BEHAVIORALHIV Testing and Care Services

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

Sponsors

Johns Hopkins University
CollaboratorOTHER
Institute of Health Management, Pachod, India
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Utilization of HIV TestingAnnual

Secondary

MeasureTime frame
Proportion with Behavioral HIV risk historyAnnual
WHO Clinical Stage at time of HIV diagnosisQuarterly
Proportion with Sexually Transmitted Infection HistoryAnnual
Birth outcomes for HIV-infected pregnant womenQuarterly
Awareness of HIV Testing ServicesAnnual
WHO Clinical Stage at first clinical care visitQuarterly

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026