Skip to main content
OpenTrials
Completed

NCT Number: NCT01864603

Sustainable East Africa Research in Community Health

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".

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Cardiovascular Diseases Cost Effectiveness Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Gram-Positive Bacterial Infections Hypertension Infections Maternal Child Health Metabolic Diseases Mycobacterium Infections Nutritional and Metabolic Diseases Tuberculosis Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nyanza Province Kenya, Nyanza Province, Kenya

Loading trial locations.

About this study

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".

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Universal ART in a streamlined care model

Other

immediate ART start for all HIV+ in community with streamlined care

Annual Community Health Campaigns

Other

HIV and multi-disease testing for all community members

Targeted PrEP and Targeted testing interventions

Other

Baseline community-based HIV and multi-disease testing

Other

HIV and multi-disease testing for all community members at baseline only

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • Gilead Sciences
  • Infectious Diseases Research Collaboration, Uganda
  • Kenya Medical Research Institute
  • Makerere University
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • United States President's Emergency Plan for AIDS Relief
  • World Bank

Registry information

Acronym: SEARCH

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
May 29, 2013
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.