Sustainable East Africa Research in Community Health (SEARCH)

February 7, 2022 updated by: University of California, San Francisco
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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".

Study Type

Interventional

Enrollment (Actual)

150395

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Nyanza Province, Kenya
        • Nyanza Province Kenya
  • Uganda
      • Mbale/Tororo Region, Uganda
        • Eastern Uganda
      • Mbarara Region, Uganda
        • Southwestern Uganda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1st: universal test and treat; 2nd: targeted PrEP and cascade

Intervention arm first phase: annual universal community-based HIV and multi-disease testing; ART for all HIV+ using streamlined care delivery

Intervention arm second phase: baseline universal community-based HIV and multi-disease testing; ART for all HIV+ using streamlined care delivery + targeted PrEP, and targeted HIV testing interventions
Other: Universal ART in a streamlined care model
immediate ART start for all HIV+ in community with streamlined care
Other: Annual Community Health Campaigns
HIV and multi-disease testing for all community members
Other: Targeted PrEP and Targeted testing interventions
Active Comparator: 1st: baseline community testing; 2nd: None
Comparator arm first phase: baseline community-based HIV and multi-disease testing; ART by country standard of care
Other: Universal ART in a streamlined care model
immediate ART start for all HIV+ in community with streamlined care
Other: Baseline community-based HIV and multi-disease testing
HIV and multi-disease testing for all community members at baseline only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative HIV Incidence
Time Frame: 3 years follow up

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incident TB Associated With HIV
Time Frame: 3 years follow up
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.
3 years follow up
Overall Mortality
Time Frame: 3 years follow up
Mortality risk among HIV+ population. Mean was calculated as the average across clusters of the cluster-level cumulative incidence.
3 years follow up
HIV-free Infant Survival
Time Frame: 3 years follow up

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.
3 years follow up
Percent of HIV+ Adults With HIV RNA <=500 c/mL
Time Frame: 3 years follow up
Percent of HIV+ adults with HIV RNA <=500 c/mL. Mean was calculated as the average across clusters of the cluster-level cumulative incidence.
3 years follow up
Time in Care for HIV+ Adults With Baseline Viremia
Time Frame: 3 years follow up
Percent of time spent actively engaged in HIV care among HIV+ adults with baseline viremia
3 years follow up
Cumulative Incidence of ART-initiation
Time Frame: 3 years follow up
Proportion of baseline HIV+ ART-naive persons who initiate ART Mean was calculated as the average across clusters of the cluster-level cumulative incidence.
3 years follow up
Hypertension Control
Time Frame: 3 years follow up

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.
3 years follow up
Adherence to PrEP Treatment
Time Frame: 3 years follow up
Number of patients with adherence to PrEP treatment (self reported adherence at >=1 visit)
3 years follow up
Average Adults' on- and Off-farm Employment
Time Frame: 3 years follow up
HIV+ adults with on- and off-farm employment
3 years follow up
Year 3 Viremia Among ART-experienced Persons With Baseline Viremia
Time Frame: 3 years follow up
Plasma HIV RNA <400 cps/ml Mean was calculated as the average across clusters of the cluster-level cumulative incidence.
3 years follow up
Linkage to Care
Time Frame: 30 days after HIV test
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.
30 days after HIV test
HIV Incidence Rate
Time Frame: 3 years follow up
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).
3 years follow up
Prevalence of Transmitted HIV Drug-resistance Mutations
Time Frame: Baseline
HIV NNRTI drug-resistance mutations found at baseline
Baseline
Prevalence of Chronic Kidney Disease (CKD)
Time Frame: 3 years follow up
Percentage of participants with chronic kidney disease (CKD)
3 years follow up
Total Costs of Programming (ART)
Time Frame: Follow up year 3
Cost of ART streamlined care delivery amount HIV+ persons
Follow up year 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
Gilead Sciences
Bill and Melinda Gates Foundation
Makerere University
Kenya Medical Research Institute
World Bank
Infectious Diseases Research Collaboration, Uganda
United States President's Emergency Plan for AIDS Relief

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

April 1, 2021

Study Completion (Actual)

April 1, 2021

Study Registration Dates

First Submitted

April 26, 2013

First Submitted That Met QC Criteria

May 24, 2013

First Posted (Estimate)

May 29, 2013

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEARCH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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