Sustainable East Africa Research in Community Health (SEARCH)
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ClinicalTrials.gov Identifier: NCT01864603 |
Recruitment Status :
Completed
First Posted : May 29, 2013
Results First Posted : March 2, 2022
Last Update Posted : March 2, 2022
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Condition or disease | Intervention/treatment | Phase |
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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 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 150395 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 |
Actual Primary Completion Date : | April 2021 |
Actual Study Completion Date : | April 2021 |
Arm | Intervention/treatment |
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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: None
Comparator arm first phase: baseline community-based HIV and multi-disease testing; ART by country standard of care
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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 |
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- Adherence to PrEP Treatment [ Time Frame: 3 years follow up ]Number of patients with adherence to PrEP treatment (self reported adherence at >=1 visit)
- Average Adults' on- and Off-farm Employment [ Time Frame: 3 years follow up ]HIV+ adults with on- and off-farm employment
- 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.
- 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.
- 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).
- Prevalence of Transmitted HIV Drug-resistance Mutations [ Time Frame: Baseline ]HIV NNRTI drug-resistance mutations found at baseline
- Prevalence of Chronic Kidney Disease (CKD) [ Time Frame: 3 years follow up ]Percentage of participants with chronic kidney disease (CKD)
- Total Costs of Programming (ART) [ Time Frame: Follow up year 3 ]Cost of ART streamlined care delivery amount HIV+ persons

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.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

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
Kenya | |
Nyanza Province Kenya | |
Nyanza Province, Kenya | |
Uganda | |
Eastern Uganda | |
Mbale/Tororo Region, Uganda | |
Southwestern Uganda | |
Mbarara Region, Uganda |
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 |
Documents provided by University of California, San Francisco:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT01864603 |
Other Study ID Numbers: |
SEARCH |
First Posted: | May 29, 2013 Key Record Dates |
Results First Posted: | March 2, 2022 |
Last Update Posted: | March 2, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
HIV treatment and prevention Tuberculosis Community health campaign PrEP |
Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections |
Bacterial Infections Bacterial Infections and Mycoses Infections |