NCT03224741

Brief Summary

The investigators propose to conduct a randomized controlled trial in collaboration with the Fundacion Raices, a non-governmental organization (NGO) with strong ties to the local community of Esmeraldas, Ecuador. A total of about 3,000 subjects will be involved in the full-scale study over the course of 2 years. In partnership with the Fundacion Raices, the research team will set up stands at four public places in the city of Esmeraldas: the "malecon" (esplanade on the town's waterfront), the "Centro Comercial Multiplaza" (Esmeraldas' large shopping mall), the municipal market (a popular destination for groceries, etc.), and a public park located in the city center. Each stand will feature a sign inviting individuals to stop and "get their health checked", and will provide free refreshments (juice boxes and water). A monitor will approach individuals at the malecon/shopping center/municipal market/public park and ask whether they are interested to learn about a health initiative by the Fundacion Raices and a group of public health researchers. If an individual is interested, the monitor will begin the three steps of the experiment:

  1. 1.Participants fill out a brief, anonymous survey with demographics, socio- economic characteristics, and whether they have been tested for HIV/AIDS in the past.
  2. 2.Participants receive the script and actions associated with the experimental condition into which they are assigned to according to the randomization table.
  3. 3.Whether participants subsequently showed up at a medical facility to get tested for HIV/AIDS is noted in the record.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,720

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 18, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

1.6 years

First QC Date

July 18, 2017

Last Update Submit

February 1, 2019

Conditions

Keywords

Behavioral Economics

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants in each experimental condition that showed up for the HIV sero test.

    The outcome measure is a relative proportion of participants in each experimental condition that showed up at the 'Microlab - Laboratiorio Clinico Bacteriologico' to provide a blood sample for the HIV sero test. It is calculated as the number of tested participants divided by the total number of participants enrolled into each experimental condition. An enrolled participant is defined as an individual that received the information and instructions in T1, T2 and T3.

    2 weeks

Study Arms (3)

Information

PLACEBO COMPARATOR
Behavioral: Information

Active Choice

ACTIVE COMPARATOR
Behavioral: Active Choice

Monetary incentive

EXPERIMENTAL
Behavioral: Monetary Incentive

Interventions

Subjects in this condition will be read a script informing them of the benefits and importance of routine HIV/AIDS testing for themselves, the benefits for one's partner and loved ones, and for the broader community; they are also given a flyer including the same information.Iin addition, they will be told that if they will get tested for HIV/AIDS within the next two weeks, they will receive $10 (the US dollar became Ecuador's official currency in 2001).

Monetary incentive
InformationBEHAVIORAL

Subjects assigned to this condition are read a script informing them of the benefits and importance of routine HIV/AIDS testing for themselves, the benefits for one's partner and loved ones, and for the broader community; they are also given a flyer including the same information. Then, they are invited to get tested in the next two weeks.

Information
Active ChoiceBEHAVIORAL

Subjects in this condition will receive the same information and flyer as in T1; in addition, they are told that they have the opportunity to express their intention to get tested for HIV/AIDS. To this aim, they will be given a sheet of paper and asked to tick one of two boxes. The first box will say "I intend to get tested within the next two weeks", and the second will say "I will consider getting tested within the next two weeks but I am not ready to commit at this time". They will also be asked to write their initials at the bottom of the sheet, and will be told to keep it. This is a form of "soft commitment" which has proven effective in other contexts (Bryan et al. 2010).

Active Choice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All participants able to understand the instructions and provide consent

You may not qualify if:

  • Under 18 years of age (age of consent)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad San Francisco de Quito

Quito, Ecuador

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The subject receives the script and actions associated with the experimental condition she/he is assigned to according to the randomization. The subject receives a card consisting of three detachable parts. Each part includes a numerical ID that uniquely identifies each participant. The first part of the card will remain with the researchers. The second part of the card does to the medical personnel at the health facility if and when they go there to get tested. The third part of the card will remain with the participant. This procedure and the study ID will enable the research team to (a) associate participants to the treatment conditions and (b) determine the outcomes (whether they got tested or not, and what the results were), while preserving the anonymity of the participants.
Purpose
SCREENING
Intervention Model
FACTORIAL
Model Details: Randomized Control Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2017

First Posted

July 21, 2017

Study Start

June 12, 2017

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

February 4, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations