Sustainable East Africa Research in Community Health (SEARCH)
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ClinicalTrials.gov Identifier: NCT01864603 |
Recruitment Status
:
Recruiting
First Posted
: May 29, 2013
Last Update Posted
: June 9, 2017
|
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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, Targeted testing, and Targeted care interventions Other: Baseline community-based HIV and multi-disease testing | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 340000 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 2020 |
Estimated Study Completion Date : | July 2020 |

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, targeted HIV testing, and targeted care 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, Targeted testing, and Targeted care 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
|
- Cumulative HIV incidence [ Time Frame: 3 years ]Cumulative 3 year HIV incidence in men and women ages ≥15 years after the start of Phase I intervention.
- Cumulative HIV incidence [ Time Frame: 3 years ]Cumulative 3 year HIV incidence in men and women ages ≥15 years after the start of Phase II intervention (started after 3 years of Phase I).
- Time from diagnosis to AIDS [ Time Frame: 3 and 6 years follow up ]To compare time from diagnosis to AIDS between the 2 study arms.
- Incidence of AIDS-defining events between the study arms [ Time Frame: 3 and 6 years follow up ]To compare incidence of AIDS-defining events between the study arms.
- Total TB and incident TB cases associated with HIV [ Time Frame: 3 and 6 years follow up ]TTo compare proportion of total TB and incident TB cases associated with HIV between the study arms.
- Overall mortality [ Time Frame: 3 and 6 years follow up ]To compare mortality between the 2 study arms.
- Maternal and child mortality [ Time Frame: 3 and 6 years follow up ]To compare number of maternal and child deaths between the 2 study arms.
- Mother to child HIV transmission [ Time Frame: 3 and 6 years follow up ]To compare mother to child HIV transmission between the 2 study arms.
- Population HIV RNA metrics [ Time Frame: 3 and 6 years follow up ]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: 3 and 6 years follow up ]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
- Prevalence of transmitted HIV drug-resistance mutations [ Time Frame: 3 and 6 years follow up ]To compare the prevalence (number of participants with) of transmitted HIV drug-resistance mutations and pharmacologic measures of ART between the study arms after 3 and 6 years of follow up.
- Rates of linkage to and retention in care for HIV [ Time Frame: 3 and 6 years follow up ]To compare rates of linkage to and retention in care for HIV between the study arms.
- Time to ART-initiation [ Time Frame: 3 and 6 years follow up ]To compare time to ART-initiation between the study arms.
- Time to CD4 cell count recovery in Phase I of high CD4 count individuals (CD4>350) [ Time Frame: 3 and 6 years follow up ]Time to CD4 cell count recovery above 350 after enrollment
- Rate of virologic suppression in Phase I of high CD4 count individuals (CD4>350) [ Time Frame: 3 and 6 years follow up ]Time to viral load measurements below detectable
- Treatment-associated toxicities and grade 3 and 4 adverse events in Phase I of high CD4 count individuals (CD4>350) [ Time Frame: 3 and 6 years follow up ]DAIDS toxicity table symptoms grade 3 or 4
- Prevalence of HIV drug resistant mutations after 1 and 2 years of treatment in Phase I of high CD4 count individuals (CD4>350) [ Time Frame: 3 years follow up ]Number of patients with HIV drug resistant mutations measured after 1 and 2 years of treatment
- Cumulative incidence of internally derived HIV infections [ Time Frame: 3 and 6 years follow up ]To compare the 3 and 6 year cumulative incidence of internally derived HIV infections (infections genetically linked to a prior infection among members of the same community) between the study arms.
- Evaluate attitudes of community, patients and providers on care delivery in control and intervention communities [ Time Frame: 3 and 6 years follow up ]To evaluate attitudes of community, patients and providers on care delivery in control and intervention communities using qualitative focus group interviews
- Evaluate implementation of other disease care cascades (hypertension, diabetes, women and children health services) [ Time Frame: 3 and 6 years follow up ]Uptake of testing, linkage to care and retention to care
- Prevalence of complications of diabetes, hypertension and chronic kidney disease (CKD) and to understand the genetic susceptibility of diseases in the study populations. [ Time Frame: 3 and 6 years follow up ]Number of patients with of complications of diabetes, hypertension and chronic kidney disease (CKD) and to understand the genetic susceptibility of diseases in the study populations in Phase II.
- Adherence to PrEP treatment [ Time Frame: 3 years follow up ]Number of patients who adherence to PrEP treatment
- Change in attitudes towards PrEP [ Time Frame: 3 years follow up ]Qualitative focus group discussions on attitudes toward PrEP
- Change in average levels of adults' on- and off-farm employment [ Time Frame: 3 and 6 years follow up ]To compare the trends in average levels of adults' on- and off-farm employment between the 2 study arms.
- Change in average levels of children's on- and off-farm employment [ Time Frame: 3 and 6 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.
- Change in average levels of children's time allocation to schooling and household activities [ Time Frame: 3 and 6 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.
- Change in average asset holdings [ Time Frame: 3 and 6 years follow up ]To compare the trends in average asset holdings (durable good and livestock) between the 2 study arms.
- Change in agricultural output and other economic production [ Time Frame: 3 and 6 years follow up ]To compare the trends in agricultural output and other economic production, such as fishing, between the 2 study arms.
- Change in average levels of cash and in-kind transfers [ Time Frame: 3 and 6 years follow up ]To compare the trends in average levels of cash and in-kind transfers between the 2 study arms.
- Total costs of programming [ Time Frame: 3 and 6 years follow up ]To compare costs of programming (campaigns, ART) and PrEP (Phase II only) between the study arms: overall; per person identified, linked to care, and started on ART; and per ART-month, CD4 level recovered, and viral load suppressed.
- Change in disease burden [ Time Frame: 3 and 6 years follow up ]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: 3 and 6 years follow up ]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: 3 and 6 years follow up ]To compare the occurrence and consequences of false positive (new) HIV diagnosis
- Cost-effectiveness of the intervention [ Time Frame: 3 and 6 years follow up ]To calculate the incremental cost-effectiveness of the intervention, as net cost per DALY averted.
- Evaluate streamlined care of HIV patients [ Time Frame: 3 and 6 years follow up ]To evaluate streamlined vs. non-streamlined care including time and motion studies for staff and clients (Phase I only).
- Number of participants in targeted PrEP vs. country standard PrEP [ Time Frame: 3 years follow up ]Numbers of participants who accept targeted linkage for PrEP, retention of PrEP treatment, and suppression interventions including time in motion studies for staff and clients (Phase II only).
- Adherence to PREP [ Time Frame: 6 months from start of PrEP ]To compare adherence (proportion of persons starting PrEP who follow-up at routine PrEP visits and proportion of persons with detectable tenofovir in plasma or hair samples) among persons receiving clinic vs community-based delivery
- 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
- Linkage to care defined as proportion of persons attending an HIV clinic visit by 30 days after HIV test among adolescents [ Time Frame: 30 days after HIV test ]To compare linkage to compare among adolescents with or without adolescent navigator
- HIV incidence rate [ Time Frame: 3 years follow up ]To compare HIV incidence rates between base-line and follow-up year 3

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Ages Eligible for Study: | Child, Adult, Senior |
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
Contact: Tamara Clark, MHS | tclark@medsfgh.ucsf.edu |
Kenya | |
Nyanza Province Kenya | Recruiting |
Nyanza Province, Kenya | |
Principal Investigator: Elizabeth Bukusi, MBChB, PhD | |
Uganda | |
Eastern Uganda | Recruiting |
Mbale/Tororo region, Uganda | |
Principal Investigator: Moses Kamya, MBChB, PhD | |
Southwestern Uganda | Recruiting |
Mbarara region, Uganda | |
Principal Investigator: Moses Kamya, MBChB, PhD |
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:
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT01864603 History of Changes |
Other Study ID Numbers: |
SEARCH |
First Posted: | May 29, 2013 Key Record Dates |
Last Update Posted: | June 9, 2017 |
Last Verified: | June 2017 |
Keywords provided by University of California, San Francisco:
HIV treatment and prevention Tuberculosis Community health campaign PrEP |
Additional relevant MeSH terms:
Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |