Sustainable East Africa Research in Community Health (SEARCH)

This study is currently recruiting participants.
Verified October 2013 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: October 22, 2013
Last verified: October 2013

April 26, 2013
October 22, 2013
April 2013
June 2018   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01864603 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Sustainable East Africa Research in Community Health
Sustainable East Africa Research in Community Health

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • 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
  • 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.
    Intervention: 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
320000
December 2018
June 2018   (final data collection date for primary outcome measure)

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.
Both
Not Provided
Yes
Contact: Tamara Clark, MHS tclark@medsfgh.ucsf.edu
Kenya,   Uganda
 
NCT01864603
SEARCH
Yes
University of California, San Francisco
University of California, San Francisco
  • Infectious Diseases Research Collaboration (IDRC)
  • Makerere University
  • Kenya Medical Research Institute
  • Gilead Sciences
  • World Bank
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • President's Emergency Plan for AIDS Relief (PEPFAR)
Study Chair: Diane Havlir, MD University of California, San Francisco
Study Chair: Moses Kamya, MBChB, PhD Makerere University
University of California, San Francisco
October 2013

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