Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : 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

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".

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 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 355848 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
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

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: 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

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.

  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 cases associated with HIV [ Time Frame: 3 years follow up ]
    To compare incident TB among HIV+ and HIV- populations between the study arms.

  2. Overall mortality [ Time Frame: 3 years follow up ]
    To compare mortality between the 2 study arms.

  3. Child mortality [ Time Frame: 3 years follow up ]
    To compare number of child deaths between the 2 study arms.

  4. Mother to child HIV transmission [ Time Frame: 3 years follow up ]
    To compare mother to child HIV transmission between the 2 study arms.

  5. 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

  6. 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.

  7. Prevalence of transmitted HIV drug-resistance mutations [ Time Frame: Baseline ]
    To determine the prevalence of HIV drug-resistance mutations at baseline

  8. Rates of retention in care for HIV [ Time Frame: 3 years follow up ]
    To compare retention in care for HIV between the study arms.

  9. Time to ART-initiation [ Time Frame: 3 years follow up ]
    To compare time to ART-initiation between the study arms.

  10. 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

  11. Evaluate implementation of other disease care cascades (hypertension) [ Time Frame: 3 years follow up ]
    Uptake of testing, linkage to care and retention to care

  12. Prevalence of chronic kidney disease (CKD) [ Time Frame: 3 years follow up ]
    Number of patients with chronic kidney disease (CKD)

  13. Adherence to PrEP treatment [ Time Frame: 6 years follow up ]
    Number of patients who adherence to PrEP treatment

  14. Change in attitudes towards PrEP [ Time Frame: 3 years follow up ]
    Qualitative focus group discussions on attitudes toward PrEP

  15. 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.

  16. 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.

  17. 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.

  18. Total costs of programming [ Time Frame: 3 years follow up ]
    To describe costs of programming (campaigns, ART, HTN care)

  19. 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).

  20. 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

  21. HIV incidence rate [ Time Frame: 3 years follow up ]
    To compare HIV incidence rates between base-line and follow-up year 3



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Layout table for location information
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
Layout table for investigator information
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
Additional Information:
Publications of Results:

Other Publications:

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

Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01864603    
Other Study ID Numbers: SEARCH
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
Keywords provided by University of California, San Francisco:
HIV treatment and prevention
Tuberculosis
Community health campaign
PrEP
Additional relevant MeSH terms:
Layout table for MeSH terms
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections