Sustainable East Africa Research in Community Health

University of California, San Francisco150,395 enrolled

Overview

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".

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

150,395

Conditions

HIV Tuberculosis

Interventions

Universal ART in a streamlined care modelOTHER

immediate ART start for all HIV+ in community with streamlined care

Annual Community Health CampaignsOTHER

HIV and multi-disease testing for all community members

Targeted PrEP and Targeted testing interventionsOTHER

Baseline community-based HIV and multi-disease testingOTHER

HIV and multi-disease testing for all community members at baseline only

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

Nyanza Province Kenya

Nyanza Province, Kenya

Eastern Uganda

Mbale/Tororo Region, Uganda

Southwestern Uganda

Mbarara Region, Uganda

Outcomes

Primary Outcomes

Cumulative HIV Incidence

Cumulative 3 year HIV incidence in men and women ages ≥15 years after the start of Phase I intervention. Mean was calculated as the average across clusters of the cluster-level cumulative incidence.

Time frame: 3 years follow up

HIV Incidence

HIV incidence rate in men and women ages ≥15 years after the start of Phase II intervention (started after 3 years of Phase I).

Time frame: 3 years follow up

Secondary Outcomes

Incident TB Associated With HIV

Cumulative incidence of TB or death due to illness among HIV+ population. Mean was calculated as the average across clusters of the cluster-level cumulative incidence.

Time frame: 3 years follow up

Overall Mortality

Mortality risk among HIV+ population. Mean was calculated as the average across clusters of the cluster-level cumulative incidence.

Time frame: 3 years follow up

HIV-free Infant Survival

Probability of an infant born to an HIV+ mother remaining alive and HIV uninfected. Mean was calculated as the average across clusters of the cluster-level cumulative incidence.

Time frame: 3 years follow up

Percent of HIV+ Adults With HIV RNA <=500 c/mL

Percent of HIV+ adults with HIV RNA \<=500 c/mL. Mean was calculated as the average across clusters of the cluster-level cumulative incidence.

Time frame: 3 years follow up

Time in Care for HIV+ Adults With Baseline Viremia

Percent of time spent actively engaged in HIV care among HIV+ adults with baseline viremia

Time frame: 3 years follow up

Cumulative Incidence of ART-initiation

Proportion of baseline HIV+ ART-naive persons who initiate ART Mean was calculated as the average across clusters of the cluster-level cumulative incidence.

Time frame: 3 years follow up

Hypertension Control

hypertension control (greater than or equal to 140 mg Hg systolic or 90 mg Hg diastolic after 3 repeated readings) at year 3 among adults aged \>= 30 years with hypertension. Mean was calculated as the average across clusters of the cluster-level cumulative incidence.

Time frame: 3 years follow up

Adherence to PrEP Treatment

Number of patients with adherence to PrEP treatment (self reported adherence at \>=1 visit)

Time frame: 3 years follow up

Average Adults' on- and Off-farm Employment

HIV+ adults with on- and off-farm employment

Time frame: 3 years follow up

Year 3 Viremia Among ART-experienced Persons With Baseline Viremia

Plasma HIV RNA \<400 cps/ml Mean was calculated as the average across clusters of the cluster-level cumulative incidence.

Time frame: 3 years follow up

Linkage to Care

Proportion of Persons Attending an HIV Clinic Visit by 30 Days After HIV Test Mean was calculated as the average across clusters of the cluster-level cumulative incidence.

Time frame: 30 days after HIV test

HIV Incidence Rate

HIV incidence rates during the first and third year of follow up; Results from the Control arm are not provided because annual HIV incidence was not measured in the control arm (annual HIV testing was only conducted in the intervention arm).

Time frame: 3 years follow up

Prevalence of Transmitted HIV Drug-resistance Mutations

HIV NNRTI drug-resistance mutations found at baseline

Time frame: Baseline

Prevalence of Chronic Kidney Disease (CKD)

Percentage of participants with chronic kidney disease (CKD)

Time frame: 3 years follow up

Total Costs of Programming (ART)

Cost of ART streamlined care delivery amount HIV+ persons

Time frame: Follow up year 3