Clinical trial NCT01864603: Sustainable East Africa Research in Community Health
Official title: Sustainable East Africa Research in Community Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Tuberculosis
Hypertension
Diabetes
Maternal Child Health
Cost Effectiveness
Keywords: HIV treatment and prevention
Tuberculosis
Community health campaign
PrEP
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Infectious Diseases Research Collaboration, Uganda
name: Makerere University
name: Kenya Medical Research Institute
name: Gilead Sciences
name: World Bank
name: National Institute of Allergy and Infectious Diseases (NIAID)
name: United States President's Emergency Plan for AIDS Relief
name: Bill and Melinda Gates Foundation
First posted: 2013-05-29
Enrollment: 150395
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The SEARCH study aims to test evidenced-based innovative community based interventions that lead to the elimination of HIV in rural communities in East Africa using a multi-disease approach. The first phase of the study will quantify the impact of early HIV diagnosis using a streamlined and immediate ART (antiretroviral therapy). The second phase of the study, will quantify the impact of targeted Pre-Exposure Prophylaxis (PrEP) in the context of universal treatment and streamlined care. The study intervention is designed to improve the entire continuum of care, to reduce structural barriers for all populations including those most "at risk".

Detailed description: The SEARCH study aims to test evidenced-based innovative community based interventions that lead to the elimination of HIV in rural communities in East Africa using a multi-disease approach. The first phase of the study will quantify the impact of early HIV diagnosis using a streamlined and immediate ART (antiretroviral therapy). The second phase of the study, will quantify the impact of targeted Pre-Exposure Prophylaxis (PrEP) in the context of universal treatment and streamlined care. The study intervention is designed to improve the entire continuum of care, to reduce structural barriers for all populations including those most "at risk".

Eligibility criteria: Community Level Inclusion Criteria:

* Non-adjacent geopolitical units in south-western and eastern Uganda and western Kenya.
* Most recent census population between 9,000 and 11,000 individuals.
* Served by an ART providing health center.
* Community leader commitment for study participation and implementation.
* Accessibility to health center via a maintained transportation route.
* Community location with sufficient distance from other potential study communities to limit contamination of intervention or control conditions (buffer zone)

Individual Level Inclusion Criteria:

* Residency of individual in community, defined as present in household for at least 6 months of the calendar year.

Community Level Exclusion Criteria:

* Presence of ongoing community-based ART intervention strategies that provide treatment outside of the current in-country treatment guidelines.
* An urban setting defined as a city with a population of 100,000 or more inhabitants.
* Absence of a health center able to provide ART.

Primary outcomes:
measure: Cumulative HIV Incidence
timeFrame: 3 years follow up
measure: HIV Incidence
timeFrame: 3 years follow up
Secondary outcomes:
measure: Incident TB Associated With HIV
timeFrame: 3 years follow up
measure: Overall Mortality
timeFrame: 3 years follow up
measure: HIV-free Infant Survival
timeFrame: 3 years follow up
measure: Percent of HIV+ Adults With HIV RNA <=500 c/mL
timeFrame: 3 years follow up
measure: Time in Care for HIV+ Adults With Baseline Viremia
timeFrame: 3 years follow up
measure: Cumulative Incidence of ART-initiation
timeFrame: 3 years follow up
measure: Hypertension Control
timeFrame: 3 years follow up
measure: Adherence to PrEP Treatment
timeFrame: 3 years follow up
measure: Average Adults' on- and Off-farm Employment
timeFrame: 3 years follow up
measure: Year 3 Viremia Among ART-experienced Persons With Baseline Viremia
timeFrame: 3 years follow up
measure: Linkage to Care
timeFrame: 30 days after HIV test
measure: HIV Incidence Rate
timeFrame: 3 years follow up
measure: Prevalence of Transmitted HIV Drug-resistance Mutations
timeFrame: Baseline
measure: Prevalence of Chronic Kidney Disease (CKD)
timeFrame: 3 years follow up
measure: Total Costs of Programming (ART)
timeFrame: Follow up year 3
Other outcomes:
Locations:
city: Nyanza Province
country: Kenya
facility: Nyanza Province Kenya
city: Mbale/Tororo Region
country: Uganda
facility: Eastern Uganda
city: Mbarara Region
country: Uganda
facility: Southwestern Uganda
Study officials:
affiliation: University of California, San Francisco
name: Diane Havlir, MD
role: STUDY_CHAIR
affiliation: Makerere University
name: Moses Kamya, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Berkeley
name: Maya Petersen, PhD
role: PRINCIPAL_INVESTIGATOR
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