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Sustainable East Africa Research in Community Health (SEARCH)

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ClinicalTrials.gov Identifier: NCT01864603
Recruitment Status : Active, not recruiting
First Posted : May 29, 2013
Last Update Posted : July 27, 2020
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

Tracking Information
First Submitted Date  ICMJE April 26, 2013
First Posted Date  ICMJE May 29, 2013
Last Update Posted Date July 27, 2020
Study Start Date  ICMJE April 2013
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2020)
  • 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.
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: May 24, 2013)
Cumulative HIV incidence [ Time Frame: 5 year ]
To determine the effect of a strategy to start ART in HIV diagnosed persons at any CD4 count with streamlined delivery of HIV care compared to a country based ART guidelines on 5-year cumulative HIV incidence in rural communities with annual HIV testing.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2020)
  • Incident TB cases associated with HIV [ Time Frame: 3 years follow up ]
    To compare incident TB among HIV+ and HIV- populations between the study arms.
  • Overall mortality [ Time Frame: 3 years follow up ]
    To compare mortality between the 2 study arms.
  • Child mortality [ Time Frame: 3 years follow up ]
    To compare number of child deaths between the 2 study arms.
  • Mother to child HIV transmission [ Time Frame: 3 years follow up ]
    To compare mother to child HIV transmission between the 2 study arms.
  • Population HIV RNA metrics [ Time Frame: 3 years follow up ]
    To compare population HIV RNA metrics between the 2 study arms.HIV metrics include: % with HIV viral suppression
  • Association between population HIV RNA metrics and HIV incidence [ Time Frame: 3 years follow up ]
    To determine the association between population HIV RNA metrics and HIV incidence.
  • Prevalence of transmitted HIV drug-resistance mutations [ Time Frame: Baseline ]
    To determine the prevalence of HIV drug-resistance mutations at baseline
  • Rates of retention in care for HIV [ Time Frame: 3 years follow up ]
    To compare retention in care for HIV between the study arms.
  • Time to ART-initiation [ Time Frame: 3 years follow up ]
    To compare time to ART-initiation between the study arms.
  • Evaluate attitudes of community, patients and providers on care delivery in control and intervention communities [ Time Frame: 3 years follow up ]
    To evaluate attitudes of community, patients and providers on care delivery in control and intervention communities using qualitative focus group interviews
  • Evaluate implementation of other disease care cascades (hypertension) [ Time Frame: 3 years follow up ]
    Uptake of testing, linkage to care and retention to care
  • Prevalence of chronic kidney disease (CKD) [ Time Frame: 3 years follow up ]
    Number of patients with chronic kidney disease (CKD)
  • Adherence to PrEP treatment [ Time Frame: 6 years follow up ]
    Number of patients who adherence to PrEP treatment
  • Change in attitudes towards PrEP [ Time Frame: 3 years follow up ]
    Qualitative focus group discussions on attitudes toward PrEP
  • Change in average levels of adults' on- and off-farm employment [ Time Frame: 3 years follow up ]
    To compare the trends in average levels of adults' on- and off-farm employment between the 2 study arms.
  • Change in average levels of children's on- and off-farm employment [ Time Frame: 3 years follow up ]
    To compare the trends in average levels of children's on- and off-farm employment (child labor) between the 2 study arms.
  • Change in average levels of children's time allocation to schooling and household activities [ Time Frame: 3 years follow up ]
    To compare the trends in average levels of children's time allocation to schooling and household activities between the 2 study arms.
  • Total costs of programming [ Time Frame: 3 years follow up ]
    To describe costs of programming (campaigns, ART, HTN care)
  • Evaluate streamlined care of HIV patients [ Time Frame: 3 years follow up ]
    To evaluate streamlined vs. non-streamlined care including time and motion studies for staff and clients (Phase I only).
  • Linkage to care defined as proportion of persons attending an HIV clinic visit by 30 days after HIV test [ Time Frame: 30 days after HIV test ]
    To compare linkage to care with or without a phone call from clinic
  • HIV incidence rate [ Time Frame: 3 years follow up ]
    To compare HIV incidence rates between base-line and follow-up year 3
Original Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2013)
  • Time from diagnosis to AIDS [ Time Frame: After 1, 3 and 5 years follow up ]
    To compare time from diagnosis to AIDS between the 2 study arms.
  • HIV care implementation [ Time Frame: After 1, 3 and 5 years follow up ]
    Analysis of HIV care cascade:
    1. HIV testing, linkage, retention, re-engagement
    2. Clinic efficiencies
    3. Provider attitude and behavior
    4. Patient social networks
    5. Patient satisfaction
  • Total TB and incident TB cases [ Time Frame: After 1, 3 and 5 years follow up ]
    To compare proportion of total TB and incident TB cases associated with HIV between the 2 study arms.
  • Overall mortality [ Time Frame: After 1, 3 and 5 years follow up ]
    To compare mortality between the 2 study arms.
  • Maternal and child mortality [ Time Frame: After 1, 3 and 5 years follow up ]
    To compare number of maternal and child deaths between the 2 study arms.
  • Mother to child transmission [ Time Frame: After 1, 3 and 5 years follow up ]
    To compare mother to child HIV transmission between the 2 study arms.
  • Population HIV RNA metrics [ Time Frame: After 1, 3 and 5 years follow up ]
    To compare population HIV RNA metrics between the 2 study arms. HIV metrics include: % with HIV viral suppression; median population HIV RNA level; % HIV RNA by strata i.e. greater than 100,000 vs. <100,000 copies/ml
  • Association between population HIV RNA metrics and HIV incidence [ Time Frame: After 1, 3 and 5 years follow up ]
    To determine the association between population HIV RNA metrics and HIV incidence. HIV metrics include: % with HIV viral suppression; median population HIV RNA level; % HIV RNA by strata i.e. greater than 100,000 vs. <100,000 copies/ml
  • Transmitted HIV drug-resistance mutations [ Time Frame: After 1, 3 and 5 years follow up ]
    To compare the prevalence of transmitted HIV drug-resistance mutations between the 2 study arms.
  • Rates of linkage and retention for hypertension and diabetes [ Time Frame: After 1, 3 and 5 years follow up ]
    To evaluate predictors of linkage and retention for hypertension and diabetes care
  • Virologic suppression in high CD4 count individuals [ Time Frame: After 1, 3 and 5 years follow up ]
    rate of virologic suppression in high CD4 count individuals (CD4>350)
  • Five year cumulative incidence of internally derived HIV infections [ Time Frame: After 1, 3 and 5 years follow up ]
    To compare the five year cumulative incidence of internally derived HIV infections (infections genetically linked to a prior infection among members of the same community) between the 2 study arms.
  • Average levels of adults' on- and off-farm employment [ Time Frame: After 1, 3 and 5 years follow up ]
    To compare the trends in average levels of adults' on- and off-farm employment between the 2 study arms.
  • Average levels of children's on- and off-farm employment [ Time Frame: After 1, 3 and 5 years follow up ]
    To compare the trends in average levels of children's on- and off-farm employment (child labor) between the 2 study arms.
  • Average levels of children's time allocation to schooling and household activities [ Time Frame: After 1, 3 and 5 years follow up ]
    To compare the trends in average levels of children's time allocation to schooling and household activities between the 2 study arms.
  • Average asset holdings [ Time Frame: After 1, 3 and 5 years follow up ]
    To compare the trends in average asset holdings (durable good and livestock) between the 2 study arms.
  • Agricultural output and other economic production [ Time Frame: After 1, 3 and 5 years follow up ]
    To compare the trends in agricultural output and other economic production, such as fishing, between the 2 study arms.
  • Average levels of cash and in-kind transfers [ Time Frame: After 1, 3 and 5 years follow up ]
    To compare the trends in average levels of cash and in-kind transfers between the 2 study arms.
  • Costs of programming [ Time Frame: After 1, 3 and 5 years follow up ]
    To compare costs of programming (campaigns, ART) between the 2 study arms: overall; per person identified, linked to care, and started on ART; and per ART-month, CD4 level recovered, and viral load suppressed.
  • Disease burden [ Time Frame: After 1, 3 and 5 years follow up ]
    To compare disease burden (expressed in disability adjusted life years, DALYs) between the 2 study arms, during and modelled beyond the study period.
  • Savings from averted disease associated treatment costs [ Time Frame: After 1, 3 and 5 years follow up ]
    To compare the savings from averted disease associated treatment costs between the 2 study arms.
  • Occurrence and consequences of false positive HIV diagnosis [ Time Frame: After 1, 3 and 5 years follow up ]
    To compare the occurrence and consequences of false positive HIV diagnosis (new).
  • Cost-effectiveness of the intervention [ Time Frame: After 1, 3 and 5 years follow up ]
    To calculate the incremental cost-effectiveness of the intervention, as net cost per DALY averted.
  • Cumulative HIV incidence [ Time Frame: 3 year ]
    To determine the effect of a strategy to start ART in HIV diagnosed persons at any CD4 count with streamlined delivery of HIV care compared to a country based ART guidelines on 3-year cumulative HIV incidence in rural communities with annual HIV testing.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sustainable East Africa Research in Community Health
Official Title  ICMJE Sustainable East Africa Research in Community Health
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). This first phase will be completed in July 2017. The second phase of the study, will quantify the health, economic and educational impact of targeted Pre-Exposure Prophylaxis (PrEP), and targeted HIV testing in the context of universal treatment and streamlined care. This second phase will be completed in July 2020. 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 health, economic and educational impact of early HIV diagnosis using a streamlined and immediate ART (antiretroviral therapy). This first phase will be completed in July 2017. The second phase of the study, will quantify the impact of targeted Pre-Exposure Prophylaxis (PrEP), and targeted HIV testing in the context of universal treatment and streamlined care. This second phase will be completed in July 2020. The study intervention is designed to improve the entire continuum of care, to reduce structural barriers for all populations including those most "at risk". Primary endpoint for the first phase is HIV incidence measured at 3 years follow up.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • HIV
  • Tuberculosis
  • Hypertension
  • Diabetes
  • Maternal Child Health
  • Cost Effectiveness
Intervention  ICMJE
  • 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
  • Other: Baseline community-based HIV and multi-disease testing
    HIV and multi-disease testing for all community members at baseline only
Study Arms  ICMJE
  • 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

    Interventions:
    • Other: Universal ART in a streamlined care model
    • Other: Annual Community Health Campaigns
    • Other: Targeted PrEP and Targeted testing interventions
  • Active Comparator: 1st: baseline community testing; 2nd: universal test & treat

    Intervention arm first phase: baseline community-based HIV and multi-disease testing

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

    Interventions:
    • Other: Universal ART in a streamlined care model
    • Other: Baseline community-based HIV and multi-disease testing
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 18, 2020)
355848
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2013)
320000
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kenya,   Uganda
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01864603
Other Study ID Numbers  ICMJE SEARCH
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE
  • 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  ICMJE
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
PRS Account University of California, San Francisco
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP