Sustainable East Africa Research in Community Health

Not Applicable

Completed

• Conditions: Maternal Child Health; Cost Effectiveness; Hypertension; HIV; Diabetes; Tuberculosis
• Interventions: Other: Universal ART in a streamlined care model; Other: Annual Community Health Campaigns; Other: Baseline community-based HIV and multi-disease testing; Other: Targeted PrEP and Targeted testing interventions

• Registration Number: NCT01864603
• Lead Sponsor: University of California, San Francisco

Brief Summary

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".

Detailed Description

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".

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-26
• Study First Submitted QC: 2013-05-24
• Study First Posted: 2013-05-29
• Primary Completion: 2021-04
• Study Completion: 2021-04
• Results First Submitted: 2021-06-29
• Status Verified: 2022-02
• Results First Submitted QC: 2022-02-07
• Last Update Submitted: 2022-02-07
• Results First Posted: 2022-03-02
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150395

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1st: universal test and treat; 2nd: targeted PrEP and cascade	Annual Community Health Campaigns	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
1st: universal test and treat; 2nd: targeted PrEP and cascade	Targeted PrEP and Targeted testing interventions	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
1st: universal test and treat; 2nd: targeted PrEP and cascade	Universal ART in a streamlined care model	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
1st: baseline community testing; 2nd: None	Universal ART in a streamlined care model	Comparator arm first phase: baseline community-based HIV and multi-disease testing; ART by country standard of care
1st: baseline community testing; 2nd: None	Baseline community-based HIV and multi-disease testing	Comparator arm first phase: baseline community-based HIV and multi-disease testing; ART by country standard of care

Primary Outcome Measures

Name	Time	Method
HIV Incidence	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).
Cumulative HIV Incidence	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.

Secondary Outcome Measures

Name	Time	Method
Linkage to Care	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.
Incident TB Associated With HIV	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.
HIV-free Infant Survival	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.
Year 3 Viremia Among ART-experienced Persons With Baseline Viremia	3 years follow up	Plasma HIV RNA \<400 cps/ml Mean was calculated as the average across clusters of the cluster-level cumulative incidence.
Total Costs of Programming (ART)	Follow up year 3	Cost of ART streamlined care delivery amount HIV+ persons
Average Adults' on- and Off-farm Employment	3 years follow up	HIV+ adults with on- and off-farm employment
HIV Incidence Rate	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).
Hypertension Control	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.
Overall Mortality	3 years follow up	Mortality risk among HIV+ population. Mean was calculated as the average across clusters of the cluster-level cumulative incidence.
Percent of HIV+ Adults With HIV RNA <=500 c/mL	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	3 years follow up	Percent of time spent actively engaged in HIV care among HIV+ adults with baseline viremia
Cumulative Incidence of ART-initiation	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.
Adherence to PrEP Treatment	3 years follow up	Number of patients with adherence to PrEP treatment (self reported adherence at \>=1 visit)
Prevalence of Transmitted HIV Drug-resistance Mutations	Baseline	HIV NNRTI drug-resistance mutations found at baseline
Prevalence of Chronic Kidney Disease (CKD)	3 years follow up	Percentage of participants with chronic kidney disease (CKD)

Trial Locations

Locations (3)

Southwestern Uganda; 🇺🇬 Mbarara Region, Uganda

Nyanza Province Kenya; 🇰🇪 Nyanza Province, Kenya

Eastern Uganda; 🇺🇬 Mbale/Tororo Region, Uganda