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Sustainable East Africa Research in Community Health (SEARCH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01864603
Recruitment Status : Completed
First Posted : May 29, 2013
Results First Posted : March 2, 2022
Last Update Posted : March 2, 2022
Sponsor:
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
Information provided by (Responsible Party):
University of California, San Francisco

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".

Condition or disease Intervention/treatment Phase
HIV Tuberculosis Hypertension Diabetes Maternal Child Health Cost Effectiveness Other: Universal ART in a streamlined care model Other: Annual Community Health Campaigns Other: Targeted PrEP and Targeted testing interventions Other: Baseline community-based HIV and multi-disease testing Not Applicable

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".

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150395 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Sustainable East Africa Research in Community Health
Study Start Date : April 2013
Actual Primary Completion Date : April 2021
Actual Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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




Primary Outcome Measures :
  1. 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.


  2. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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. 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.


  4. 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.

  5. 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

  6. 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.

  7. 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.


  8. Adherence to PrEP Treatment [ Time Frame: 3 years follow up ]
    Number of patients with adherence to PrEP treatment (self reported adherence at >=1 visit)

  9. Average Adults' on- and Off-farm Employment [ Time Frame: 3 years follow up ]
    HIV+ adults with on- and off-farm employment

  10. 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.

  11. 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.

  12. 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).

  13. Prevalence of Transmitted HIV Drug-resistance Mutations [ Time Frame: Baseline ]
    HIV NNRTI drug-resistance mutations found at baseline

  14. Prevalence of Chronic Kidney Disease (CKD) [ Time Frame: 3 years follow up ]
    Percentage of participants with chronic kidney disease (CKD)

  15. Total Costs of Programming (ART) [ Time Frame: Follow up year 3 ]
    Cost of ART streamlined care delivery amount HIV+ persons



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864603


Locations
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Kenya
Nyanza Province Kenya
Nyanza Province, Kenya
Uganda
Eastern Uganda
Mbale/Tororo Region, Uganda
Southwestern Uganda
Mbarara Region, Uganda
Sponsors and Collaborators
University of California, San Francisco
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
Investigators
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Study Chair: Diane Havlir, MD University of California, San Francisco
Principal Investigator: Moses Kamya, MBChB, PhD Makerere University
Principal Investigator: Maya Petersen, PhD University of California, Berkeley
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Study Protocol  [PDF] July 20, 2018
Statistical Analysis Plan  [PDF] November 27, 2017

Additional Information:
Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01864603    
Other Study ID Numbers: SEARCH
First Posted: May 29, 2013    Key Record Dates
Results First Posted: March 2, 2022
Last Update Posted: March 2, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of California, San Francisco:
HIV treatment and prevention
Tuberculosis
Community health campaign
PrEP
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections