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HIV/AIDS SerodiagnosisNCT03224741

Behavioral Economics Field Experiment in HIV Testing

A study testing Monetary Incentive, Information and Active Choice in people with HIV/AIDS Serodiagnosis, run by Johns Hopkins University at 1 site in Ecuador.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
HIV/AIDS Serodiagnosis
What is being tested?
Monetary Incentive, Information and Active Choice
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
7,720 participants
Where
1 siteEcuador
Study dates
12 Jun 2017to 1 Jan 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • All participants able to understand the instructions and provide consent

Who cannot join

  • Under 18 years of age (age of consent)

Trial locations and contacts

1 site in 1 country.

Ecuador1 site
  • Universidad San Francisco de Quito

    Quito

Other trials in Ecuador

About this study

Official title: Behavioral Nudges, Information and Incentives for HIV Testing: A Field Experiment in Ecuador

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. 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. 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".
  3. Whether participants subsequently showed up at a medical facility to get tested for HIV/AIDS is noted in the record.
Read the 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.

Being tested
Monetary Incentive, Information, Active Choice
Keywords
Behavioral Economics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Monetary IncentiveBehavioural

    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).

  • InformationBehavioural

    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.

  • Active ChoiceBehavioural

    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).

Study groups in NCT03224741
Study groupRoleWhat they receive
InformationPlacebo comparatorNot described
Receives: Behavioral: Information
Active ChoiceActive comparatorNot described
Receives: Behavioral: Active Choice
Monetary incentiveExperimentalNot described
Receives: Behavioral: Monetary Incentive

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2017
  2. Study start12 Jun 2017
  3. Primary completion1 Jan 2019
  4. Study completion1 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Factorial
Model description
Randomized Control Trial
Masking
Single blind
Who is masked
Participant
Enrolment
7,720 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03224741
Sponsor's protocol ID
HIRB00004772
Status last verified
Feb 2019
First submitted
18 Jul 2017
Last updated
4 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Monetary Incentive, Information and Active Choice in people with HIV/AIDS Serodiagnosis, run by Johns Hopkins University at 1 site in Ecuador.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ecuador. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants in each experimental condition that showed up for the HIV sero test. (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.

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