Clinical trial NCT00554567: Utilization of HIV Clinical Services in Rural India
Official title: Utilization of Decentralized HIV Testing and Care Services in Rural Maharashtra, India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Sexually Transmitted Infections
Keywords: HIV/AIDS
Voluntary Counseling and Testing
Rural India
HIV Care
Health Services Research
Lead sponsor: Institute of Health Management, Pachod, India
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
First posted: 2007-11-07
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

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

Primary outcomes:
measure: Utilization of HIV Testing
timeFrame: Annual
Secondary outcomes:
measure: Proportion with Sexually Transmitted Infection History
timeFrame: Annual
measure: Proportion with Behavioral HIV risk history
timeFrame: Annual
measure: WHO Clinical Stage at time of HIV diagnosis
timeFrame: Quarterly
measure: WHO Clinical Stage at first clinical care visit
timeFrame: Quarterly
measure: Birth outcomes for HIV-infected pregnant women
timeFrame: Quarterly
measure: Awareness of HIV Testing Services
timeFrame: Annual
Other outcomes:
Locations:
city: Pachod, Aurangabad District
country: India
facility: Institute of Health Management, Pachod (IHMP)
state: Maharashtra
Study officials:
affiliation: Institute for Health Management, Pachod (IHMP), Maharashtra, India
name: Ashok Dyalchand, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University School of Medicine, Baltimore, USA
name: Gita Sinha, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.