Utilization of HIV Clinical Services in Rural India
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Sexually Transmitted Infections |
Behavioral: HIV Testing and Care Services |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Utilization of Decentralized HIV Testing and Care Services in Rural Maharashtra, India |
- Utilization of HIV Testing [ Time Frame: Annual ] [ Designated as safety issue: No ]
- Proportion with Sexually Transmitted Infection History [ Time Frame: Annual ] [ Designated as safety issue: No ]
- Proportion with Behavioral HIV risk history [ Time Frame: Annual ] [ Designated as safety issue: No ]
- WHO Clinical Stage at time of HIV diagnosis [ Time Frame: Quarterly ] [ Designated as safety issue: No ]
- WHO Clinical Stage at first clinical care visit [ Time Frame: Quarterly ] [ Designated as safety issue: No ]
- Birth outcomes for HIV-infected pregnant women [ Time Frame: Quarterly ] [ Designated as safety issue: No ]
- Awareness of HIV Testing Services [ Time Frame: Annual ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1300 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | February 2011 |
| Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intervention Arm
Fully Decentralized HIV Testing and Care Services
|
Behavioral: HIV Testing and Care Services
Fully-decentralized HIV Voluntary Counseling and Testing and referral for 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.
Eligibility| Ages Eligible for Study: | 18 Years to 49 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| India | |
| Institute of Health Management, Pachod (IHMP) | |
| Pachod, Aurangabad District, Maharashtra, India, 431 121 | |
| Principal Investigator: | 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 |
More Information
Additional Information:
Publications:
| Responsible Party: | Gita Sinha, MD MPH, Johns Hopkins University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00554567 History of Changes |
| Other Study ID Numbers: | VCTUtilizationStudy2007 |
| Study First Received: | November 5, 2007 |
| Last Updated: | December 18, 2008 |
| Health Authority: | India: Institutional Review Board India: Central Drugs Standard Control Organization |
Keywords provided by Institute of Health Management, Pachod, India:
|
HIV/AIDS Voluntary Counseling and Testing Rural India HIV Care Health Services Research |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Immunologic Deficiency Syndromes |
Immune System Diseases Slow Virus Diseases Infection Genital Diseases, Male Genital Diseases, Female HIV Antibodies Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013