Sustainable East Africa Research in Community Health (SEARCH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of California, San Francisco
Sponsor:
Collaborators:
Infectious Diseases Research Collaboration (IDRC)
Makerere University
Kenya Medical Research Institute
Gilead Sciences
World Bank
President's Emergency Plan for AIDS Relief (PEPFAR)
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01864603
First received: April 26, 2013
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

The SEARCH study will evaluate the health, economic and educational impact of early HIV diagnosis and immediate antiretroviral treatment using a streamlined care delivery system in rural communities in East Africa.


Condition Intervention
HIV
Tuberculosis
Hypertension
Diabetes
Maternal Child Health
Cost Effectiveness
Other: ART access with optimized linkage and retention and streamlined care delivery for all persons with HIV

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Sustainable East Africa Research in Community Health

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Cumulative HIV incidence [ Time Frame: 5 year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Time from diagnosis to AIDS [ Time Frame: After 1, 3 and 5 years follow up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    To compare mortality between the 2 study arms.

  • Maternal and child mortality [ Time Frame: After 1, 3 and 5 years follow up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To calculate the incremental cost-effectiveness of the intervention, as net cost per DALY averted.

  • Cumulative HIV incidence [ Time Frame: 3 year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 320000
Study Start Date: April 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ART (Efavirenz, Truvada) for all persons HIV+
Efavirenz and Truvada will be offered to all persons who otherwise do not meet country guidelines for ART treatment.
Other: ART access with optimized linkage and retention and streamlined care delivery for all persons with HIV
No Intervention: ART by country guidelines
ART by country policy

Detailed Description:

The SEARCH study is a cluster randomized community trial of 32 communities each with approximately 10,000 residents. Annual community health campaigns will be conducted in all study communities and will offer HIV testing and multi-disease prevention and treatment services. The intervention is antiretroviral therapy (ART), independent of CD4 cell count, delivered in a streamlined approach for all HIV infected adults and children. Components of streamlined care include ongoing HIV combination prevention strategies including male circumcision. Control communities will receive annual testing campaigns and ART will follow country guidelines for ART.

HIV incidence will be measured using an efficient community cohort design (ECCO) comprised of three key elements: A) baseline household community level census, B) annual community health campaigns (CHC) incorporating HIV testing that use unique identifiers to link individuals between successive waves of the intervention, and C) tracking and evaluation of individuals who do not participate in annual CHCs.

  Eligibility

Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01864603

Contacts
Contact: Tamara Clark, MHS tclark@medsfgh.ucsf.edu

Locations
Kenya
Nyanza Province Kenya Active, not recruiting
Nyanza Province, Kenya
Uganda
Eastern Uganda Recruiting
Mbale/Tororo region, Uganda
Principal Investigator: Moses Kamya, MBChB, PhD         
Southwestern Uganda Active, not recruiting
Mbarara region, Uganda
Sponsors and Collaborators
University of California, San Francisco
Infectious Diseases Research Collaboration (IDRC)
Makerere University
Kenya Medical Research Institute
Gilead Sciences
World Bank
President's Emergency Plan for AIDS Relief (PEPFAR)
Investigators
Study Chair: Diane Havlir, MD University of California, San Francisco
Study Chair: Moses Kamya, MBChB, PhD Makerere University
  More Information

Additional Information:
Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01864603     History of Changes
Other Study ID Numbers: SEARCH
Study First Received: April 26, 2013
Last Updated: June 25, 2014
Health Authority: United States: Institutional Review Board
Uganda: National Council for Science and Technology
Uganda: National Drug Authority
Uganda: Research Ethics Committee
Kenya: Institutional Review Board
Kenya: Pharmacy and Poisons Board

Keywords provided by University of California, San Francisco:
HIV treatment and prevention
Tuberculosis
Community health campaign

Additional relevant MeSH terms:
Hypertension
Tuberculosis
Vascular Diseases
Cardiovascular Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 26, 2014