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Sustainable East Africa Research in Community Health (SEARCH)

Primary Purpose

HIV, Tuberculosis, Hypertension

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Universal ART in a streamlined care model
Annual Community Health Campaigns
Targeted PrEP and Targeted testing interventions
Baseline community-based HIV and multi-disease testing
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for HIV focused on measuring HIV treatment and prevention, Tuberculosis, Community health campaign, PrEP

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Nyanza Province Kenya
  • Eastern Uganda
  • Southwestern Uganda

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1st: universal test and treat; 2nd: targeted PrEP and cascade

1st: baseline community testing; 2nd: None

Arm Description

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

Comparator arm first phase: baseline community-based HIV and multi-disease testing; ART by country standard of care

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

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.
Overall Mortality
Mortality risk among HIV+ population. Mean was calculated as the average across clusters of the cluster-level cumulative incidence.
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.
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 in Care for HIV+ Adults With Baseline Viremia
Percent of time spent actively engaged in HIV care among HIV+ adults with baseline viremia
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.
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.
Adherence to PrEP Treatment
Number of patients with adherence to PrEP treatment (self reported adherence at >=1 visit)
Average Adults' on- and Off-farm Employment
HIV+ adults with on- and off-farm employment
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.
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.
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).
Prevalence of Transmitted HIV Drug-resistance Mutations
HIV NNRTI drug-resistance mutations found at baseline
Prevalence of Chronic Kidney Disease (CKD)
Percentage of participants with chronic kidney disease (CKD)
Total Costs of Programming (ART)
Cost of ART streamlined care delivery amount HIV+ persons

Full Information

First Posted
April 26, 2013
Last Updated
February 7, 2022
Sponsor
University of California, San Francisco
Collaborators
Infectious Diseases Research Collaboration, Uganda, Makerere University, Kenya Medical Research Institute, Gilead Sciences, World Bank, National Institute of Allergy and Infectious Diseases (NIAID), United States President's Emergency Plan for AIDS Relief, Bill and Melinda Gates Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01864603
Brief Title
Sustainable East Africa Research in Community Health
Acronym
SEARCH
Official Title
Sustainable East Africa Research in Community Health
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2021 (Actual)
Study Completion Date
April 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Infectious Diseases Research Collaboration, Uganda, Makerere University, Kenya Medical Research Institute, Gilead Sciences, World Bank, National Institute of Allergy and Infectious Diseases (NIAID), United States President's Emergency Plan for AIDS Relief, Bill and Melinda Gates Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Tuberculosis, Hypertension, Diabetes, Maternal Child Health, Cost Effectiveness
Keywords
HIV treatment and prevention, Tuberculosis, Community health campaign, PrEP

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150395 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1st: universal test and treat; 2nd: targeted PrEP and cascade
Arm Type
Experimental
Arm Description
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
Arm Title
1st: baseline community testing; 2nd: None
Arm Type
Active Comparator
Arm Description
Comparator arm first phase: baseline community-based HIV and multi-disease testing; ART by country standard of care
Intervention Type
Other
Intervention Name(s)
Universal ART in a streamlined care model
Intervention Description
immediate ART start for all HIV+ in community with streamlined care
Intervention Type
Other
Intervention Name(s)
Annual Community Health Campaigns
Intervention Description
HIV and multi-disease testing for all community members
Intervention Type
Other
Intervention Name(s)
Targeted PrEP and Targeted testing interventions
Intervention Type
Other
Intervention Name(s)
Baseline community-based HIV and multi-disease testing
Intervention Description
HIV and multi-disease testing for all community members at baseline only
Primary Outcome Measure Information:
Title
Cumulative HIV Incidence
Description
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
Title
HIV Incidence
Description
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 Outcome Measure Information:
Title
Incident TB Associated With HIV
Description
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
Title
Overall Mortality
Description
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
Title
HIV-free Infant Survival
Description
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
Title
Percent of HIV+ Adults With HIV RNA <=500 c/mL
Description
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
Title
Time in Care for HIV+ Adults With Baseline Viremia
Description
Percent of time spent actively engaged in HIV care among HIV+ adults with baseline viremia
Time Frame
3 years follow up
Title
Cumulative Incidence of ART-initiation
Description
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
Title
Hypertension Control
Description
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
Title
Adherence to PrEP Treatment
Description
Number of patients with adherence to PrEP treatment (self reported adherence at >=1 visit)
Time Frame
3 years follow up
Title
Average Adults' on- and Off-farm Employment
Description
HIV+ adults with on- and off-farm employment
Time Frame
3 years follow up
Title
Year 3 Viremia Among ART-experienced Persons With Baseline Viremia
Description
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
Title
Linkage to Care
Description
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
Title
HIV Incidence Rate
Description
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
Title
Prevalence of Transmitted HIV Drug-resistance Mutations
Description
HIV NNRTI drug-resistance mutations found at baseline
Time Frame
Baseline
Title
Prevalence of Chronic Kidney Disease (CKD)
Description
Percentage of participants with chronic kidney disease (CKD)
Time Frame
3 years follow up
Title
Total Costs of Programming (ART)
Description
Cost of ART streamlined care delivery amount HIV+ persons
Time Frame
Follow up year 3

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diane Havlir, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Moses Kamya, MBChB, PhD
Organizational Affiliation
Makerere University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maya Petersen, PhD
Organizational Affiliation
University of California, Berkeley
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nyanza Province Kenya
City
Nyanza Province
Country
Kenya
Facility Name
Eastern Uganda
City
Mbale/Tororo Region
Country
Uganda
Facility Name
Southwestern Uganda
City
Mbarara Region
Country
Uganda

12. IPD Sharing Statement

Plan to Share IPD
No
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Links:
URL
http://www.searchendaids.com
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SEARCH Collaboration website

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