Sustainable East Africa Research in Community Health

Study Overview
=================
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.

Official Title
-----------------
Sustainable East Africa Research in Community Health

Conditions
-----------------
HIV, Tuberculosis, Hypertension, Diabetes, Maternal Child Health, Cost Effectiveness

Intervention / Treatment
-----------------
* 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


Participation Criteria
=================
Eligibility Criteria
-----------------
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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1st: universal test and treat; 2nd: targeted PrEP and cascade<br>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<br>* immediate ART start for all HIV+ in community with streamlined care<br>Other: Annual Community Health Campaigns<br>* HIV and multi-disease testing for all community members<br>Other: Targeted PrEP and Targeted testing interventions<br> <br> |
| Active Comparator: 1st: baseline community testing; 2nd: None<br>Comparator arm first phase: baseline community-based HIV and multi-disease testing; ART by country standard of care | Other: Universal ART in a streamlined care model<br>* immediate ART start for all HIV+ in community with streamlined care<br>Other: Baseline community-based HIV and multi-disease testing<br>* HIV and multi-disease testing for all community members at baseline only<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative HIV Incidence | 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. | 3 years follow up | 
| HIV Incidence | HIV incidence rate in men and women ages ≥15 years after the start of Phase II intervention (started after 3 years of Phase I). | 3 years follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incident TB Associated With HIV | 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. | 3 years follow up | 
| Overall Mortality | Mortality risk among HIV+ population. Mean was calculated as the average across clusters of the cluster-level cumulative incidence. | 3 years follow up | 
| HIV-free Infant Survival | 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. | 3 years follow up | 
| Percent of HIV+ Adults With HIV RNA <=500 c/mL | Percent of HIV+ adults with HIV RNA <=500 c/mL. Mean was calculated as the average across clusters of the cluster-level cumulative incidence. | 3 years follow up | 
| Time in Care for HIV+ Adults With Baseline Viremia | Percent of time spent actively engaged in HIV care among HIV+ adults with baseline viremia | 3 years follow up | 
| Cumulative Incidence of ART-initiation | Proportion of baseline HIV+ ART-naive persons who initiate ART Mean was calculated as the average across clusters of the cluster-level cumulative incidence. | 3 years follow up | 
| Hypertension Control | 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. | 3 years follow up | 
| Adherence to PrEP Treatment | Number of patients with adherence to PrEP treatment (self reported adherence at >=1 visit) | 3 years follow up | 
| Average Adults' on- and Off-farm Employment | HIV+ adults with on- and off-farm employment | 3 years follow up | 
| Year 3 Viremia Among ART-experienced Persons With Baseline Viremia | Plasma HIV RNA <400 cps/ml Mean was calculated as the average across clusters of the cluster-level cumulative incidence. | 3 years follow up | 
| Linkage to Care | 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. | 30 days after HIV test | 
| HIV Incidence Rate | 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). | 3 years follow up | 
| Prevalence of Transmitted HIV Drug-resistance Mutations | HIV NNRTI drug-resistance mutations found at baseline | Baseline | 
| Prevalence of Chronic Kidney Disease (CKD) | Percentage of participants with chronic kidney disease (CKD) | 3 years follow up | 
| Total Costs of Programming (ART) | Cost of ART streamlined care delivery amount HIV+ persons | Follow up year 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV treatment and prevention, Tuberculosis, Community health campaign, PrEP