Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
7720 participants
INTERVENTIONAL
2017-06-12
2019-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Innovative Behavioral Economics Incentives Strategies for Health
NCT02890459
Self-Test Strategies and Linkage Incentives to Improve ART and PrEP Uptake in Men
NCT04772469
Behavioral Economics Incentives to Support HIV Treatment Adherence in Sub-Saharan Africa
NCT03494777
A Savings Intervention to Reduce Men's Engagement in HIV Risk Behaviors
NCT05385484
Steering Together in a New Direction: Reducing the Risk of HIV/STD Among African American Men
NCT02572401
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
SCREENING
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Information
Information
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 Choice
Active Choice
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).
Monetary incentive
Monetary Incentive
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Monetary Incentive
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).
Information
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 Choice
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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universidad San Francisco de Quito
OTHER
University of South Florida
OTHER
Johns Hopkins University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universidad San Francisco de Quito
Quito, , Ecuador
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HIRB00004772
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.