Effectiveness of a multicomponent focalized hotspot targeted strategy to reduce dengue transmission

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

EFFECTIV-HOTSPOT/DENGUE

Scientific title:

Effectiveness of a multicomponent focalized hotspot targeted strategy to reduce dengue transmission

Acronym of Scientific Title:

EFFECTIVENESS-HOTSPOT/DENGUE

Secondary indentifying numbers:

EFECTIV-HOTSPOT-dengue-STG

Issuing authority of the secondary identifying numbers:

Pedro Kouri Institute of Tropical Medicine (IPK)

Source(s) of monetary or material support:

Cuban Ministry of Public Health (MINSAP) // FA 4 Belgica

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Maria

Midle name:

Eugenia

Last name:

Toledo Romani

Medical Specialty :

Specialist of first degree in General Comprehensive Medicine

Affiliation:

Pedro Kouri Institute of Tropical Medicine (IPK)

Postal address:

Novia del Mediodia avenue, KM 6 1/2, La Lisa

City:

Havana

Country:

Cuba

Zip Code:

11400

Telephone:

+53-72020372

+53-72553146

Email address:

mariaeugenia@ipk.sld.cu [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Santiago de Cuba, Popular Councils of Santiago de Cuba Municipalities, PhD. Luis Eugenio Valdes Garcia, Specialist of second degree in Epidemiology

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

01/05/2017

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Dengue

Intervention(s):

Group 1 Strategy (Experimental): The targeted strategy comprised three components: I) Increased surveillance activities within the intervention areas to identify place and time for targeted control actions; II) Identification of hotspot houseblocks within the intervention area to target control actions; and III) Implementation of control and treatment activities in the hotspots. Component III included: a) Intensification of vector control activities (Use of indoor residual insecticidal spraying within hotspot houseblocks, on a regular basis (each six months) and use of residual spraying within sites with high population densities in case of increased entomological infestation); and b) Community-based actions within sites with high population densities (School-based health promotion activities to engage children as health promoters (Within hotspot houseblocks: Environmental risk identification and control with community participation; and Multisectoral coordination for risk detection and management)) Group 2 No intervention (Control): Only the routine vector control activities mandated by MINSAP were carried out throughout the entire study period

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

1. House index (percentage of houses positive for Aedes larvae or pupae). Measuring time: Monthly, from January,2015 to March,2020 2. Dengue incidence (number of subjects positive to IgM dengue test divided by the estimated population). Measuring time: Monthly, from January,2015 to March,2020

Key secondary outcomes:

Not applicable

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

None

Maximum age:

None

Inclusion criteria:

Not applicable

Exclusion criteria:

Not applicable

Type of population:

Children and Adults

Type of participant:

Healthy volunteers

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Prevention

Allocation:

Non-randomized controlled trial

Masking:

Open

Control group:

No intervention

Study design:

Parallel

Phase:

N/A

Target sample size:

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Waldemar

Last Name:

Baldoquin Rodriguez

Specialty:

Specialist of first degree in Biostatistics

Affiliation:

Pedro Kouri Institute of Tropical Medicine (IPK)

Postal Address:

Novia del Mediodia avenue, KM 6 1/2, La Lisa

City:

Havana

Country:

Cuba

Zip Code:

11400

Telephone:

+53-72553208, +53-72553199

Email :

wbaldoquin@ipk.sld.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Maria

Middle Name:

Eugenia

Last Name:

Toledo Romani

Specialty:

Specialist of second degree in Epidemiology

Affiliation:

Pedro Kouri Institute of Tropical Medicine (IPK)

Postal Address:

Novia del Mediodia avenue, KM 6 1/2, La Lisa

City:

Havana

Country:

Cuba

Zip Code:

11400

Telephone:

+53-72553204, +53-72553199

Email :

mariaeugenia@ipk.sld.cu [1]

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Pedro Kouri Institute of Tropical Medicine (IPK)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

03/11/2016

Postal address of Ethic Committee :

Novia del Mediodia avenue, KM 6 1/2, La Lisa, ZC:11400. Havana, Cuba

Telephone:

+53-2553160

Email:

daniel@ipk.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

91434

Study completion date:

30/03/2020

Results Study

Section to complete the data related to the summarized results.

Summary study:

In the urban area of Santiago de Cuba, a total of 19,031 dengue cases were diagnosed between January 2015 and March 2020. Two epidemic periods (one during the PI and one during the PR period) were identified within the endemic channel at the municipal level. The DI reached a peak of approximately 700 cases per 100,000 inhabitants in November 2015. The analysis based on routine data showed that during PR, the house index was lower in the intervention area compared to the control (2018 relative risk, RR=0.50, 95% confidence interval (CI) [0.42,0.59]), as was the case for dengue incidence (in 2018, RR=0.41, 95% CI [0.30,0.54], and in 2019, RR=0.76, 95% CI [0.65,0.88]). The controlled interrupted time series revealed an immediate decrease in the house index (72.8%, 95% CI: [51.1, 84.9]) and dengue incidence (76.9%, 95% CI: [20.7, 93.3]) at the start of the intervention. Difference-in-differences analysis revealed a significant effect during nonepidemic periods (incidence rate ratio, IRR = 0.40, 95% CI: [0.17, 0.92]) but not during epidemics (IRR = 0.68, 95% CI: [0.26, 1.81]). The intervention also reduced the contribution of the area to the dengue caseload incidence at the municipal level, decreasing from 67.1% at the start of the intervention to 51.3% in 2019. Given the growing focus on reconsidering dengue control measures with an emphasis on spatial transmission variability, the positive impact on vector density and dengue incidence of a multicomponent vector control strategy targeting transmission hotspots is encouraging but needs to be further confirmed by larger trials.

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000472

Date of Registration in Primary Registry:

02/03/2026

Record Verification Date:

2026/03/02

Next update date:

2027/03/02

Link to the spanish version:

Click here [3]