A Phase 3 interventional study of HIV Testing and Care Services in HIV Infections and Sexually Transmitted Infections, sponsored by Institute of Health Management, Pachod, India. Completed at 1 site in India. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-08.
Sponsored by Institute of Health Management, Pachod, India · Phase 3, Interventional, and Health services research
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 1,300 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →This is the only study on the registry with Institute of Health Management, Pachod, India as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Fully Decentralized HIV Testing and Care Services
Behavioral: HIV Testing and Care Services
Fully-decentralized HIV Voluntary Counseling and Testing and referral for care
Utilization of HIV Testing
Time frame: Annual
Proportion with Sexually Transmitted Infection History
Time frame: Annual
Proportion with Behavioral HIV risk history
Time frame: Annual
WHO Clinical Stage at time of HIV diagnosis
Time frame: Quarterly
WHO Clinical Stage at first clinical care visit
Time frame: Quarterly
Birth outcomes for HIV-infected pregnant women
Time frame: Quarterly
Awareness of HIV Testing Services
Time frame: Annual
This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.