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Behavioral Economics Field Experiment in HIV Testing

Primary Purpose

HIV/AIDS Serodiagnosis

Status
Completed
Phase
Not Applicable
Locations
Ecuador
Study Type
Interventional
Intervention
Monetary Incentive
Information
Active Choice
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for HIV/AIDS Serodiagnosis focused on measuring Behavioral Economics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All participants able to understand the instructions and provide consent

Exclusion Criteria:

  • Under 18 years of age (age of consent)

Sites / Locations

  • Universidad San Francisco de Quito

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

Information

Active Choice

Monetary incentive

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 18, 2017
Last Updated
February 1, 2019
Sponsor
Johns Hopkins University
Collaborators
Universidad San Francisco de Quito, University of South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT03224741
Brief Title
Behavioral Economics Field Experiment in HIV Testing
Official Title
Behavioral Nudges, Information and Incentives for HIV Testing: A Field Experiment in Ecuador
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 12, 2017 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
January 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Universidad San Francisco de Quito, University of South Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: Participants fill out a brief, anonymous survey with demographics, socio- economic characteristics, and whether they have been tested for HIV/AIDS in the past. Participants receive the script and actions associated with the experimental condition into which they are assigned to according to the randomization table. There are three experimental conditions: T1 = "Information". T2 = "Active Choice". T3 = "Monetary incentive". Whether participants subsequently showed up at a medical facility to get tested for HIV/AIDS is noted in the record.
Detailed Description
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 expresses interest, a field worker will begin the three steps of the experiment: (1) The participant completes a brief, anonymous survey with demographics, socio- economic, and past HIV/AIDS testing information. (2) The participant receives the script and actions associated with the assigned randomized experimental condition. There are three experimental conditions: - T1 = "Information". T2 = "Active Choice". T3 = "Monetary incentive". (3) Whether the participant shows up at the medical facility to get tested is entered in the record. Randomization: The randomization will vary by week (i.e., all participants who present on the same week will be assigned to the same experimental condition) to minimize spillover effects due to communication between participants assigned to different groups, and to avoid confusion among the field staff. The implementation schedule will be designed to guarantee balance of treatment conditions across locations and days of the week. To provide the participants with privacy when filling the questionnaire, after the initial approach, the interaction between the participants and field staff will occur in a booth next to the desk which will obscure the participant from the view of others. Participants will be read a statement inviting participation; description of privacy protection measures; and solicitation of verbal consent. The investigators also plan to test our experimental conditions with subjects from high-risk population groups. For high-risk population groups, the investigators will rely on the previous experience of research team members in which Female Sex Workers (FSWs) and Men who have Sex with Men (MSM) were contacted through the official registry and local MSM association, respectively. A similar approach will be used in this project. Participants in these high-risk groups will be approached individually by field staff, after having been randomly assigned to one of three experimental conditions. Participants will be read a statement inviting participation; description of privacy protection measures; and solicitation of verbal consent. The investigators expect to include about 1,000 subjects from the high-risk populations. The medical testing facility where participants will go is "Microlab - Laboratiorio Clinico Bacteriologico", centrally located in Esmeraldas (across the street from the Delfina Torres Public Hospital). It is a private facility staffed by healthcare professionals connected to the testing lab at the Medical School and Hospital of the Universidad San Francisco de Quito (USFQ) in Quito, Ecuador. Blood samples will be tested using standardized commercially available HIV testing kits. Participants in the financial incentive condition will receive their reward from the staff at the Microlab in Esmeraldas. The participants will not provide names to the lab personnel. Instead, they will give them the second portion of the registration card, which indicates their study identification number (ID). The lab staff will write the study ID onto the sample collection label. Blood samples will be sent to the testing facility at the USFQ. There, trained laboratory personnel will conduct the HIV screening test following Standard Operating Procedures. After conducting the test, laboratory personnel will record the results in an excel spreadsheet using the participant's ID number as identifier (i.e., there will be no record of name or other personal identifiable information). Afterwards, the results will be individually printed on a pre-designed "HIV screening Test Results" Form. Individual results will be put in an envelope. Envelopes will be sealed and sent back to the testing facility in Esmeraldas via a private carrier. After arrival, results will be archived in a locked unit and delivered to participants as they arrive to claim their results. Participants will receive their results in a timely manner, according to local health policies. HIV positive individuals will be encouraged to visit the local health district to enroll into the national HIV/AIDS program for treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS Serodiagnosis
Keywords
Behavioral Economics

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Randomized Control Trial
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
7720 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Information
Arm Type
Placebo Comparator
Arm Title
Active Choice
Arm Type
Active Comparator
Arm Title
Monetary incentive
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Monetary Incentive
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Information
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Active Choice
Intervention Description
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).
Primary Outcome Measure Information:
Title
Proportion of participants in each experimental condition that showed up for the HIV sero test.
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All participants able to understand the instructions and provide consent Exclusion Criteria: Under 18 years of age (age of consent)
Facility Information:
Facility Name
Universidad San Francisco de Quito
City
Quito
Country
Ecuador

12. IPD Sharing Statement

Plan to Share IPD
No

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Behavioral Economics Field Experiment in HIV Testing

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