Experimental Design Details
We propose to conduct a randomized controlled trial in collaboration with the Fundacion Raices, an 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 people 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 the person is interested, the monitor will begin the three steps of the experiment:
(1) The subject fills out a brief, anonymous survey with demographics, socio- economic characteristics, and whether they have been tested for HIV/AIDS in the past.
(2) The subject receives the script and actions associated with the experimental condition she/he is assigned to according to the randomization.
There are three experimental conditions:
- T1 = “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.
- T2 = “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).
- T3 = “Monetary incentive”. Subjects in this condition will receive the same information and flyer as in T1; in 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).
(3) 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 participants will be told to give the second part of their card to the medical personnel at the health facility if and when they go there to get tested. The personnel at the lab will retain that portion of the card and note the subject's study ID in the test tube. 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 they were assigned to, the location where they were recruited, the staff member who recruited them; and (b) determine the outcomes (whether they got tested or not, and what the results were), while preserving the anonymity of the participants.
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 staff. The implementation schedule will be designed to guarantee balance of treatment conditions across locations and days of the week.
To provide the subjects with privacy when filling the questionnaire, after the initial approach the interaction between the subjects and the research personnel 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 informing them that they are being invited to participate in a study; to protect their privacy, verbal consent will be obtained.
Above, we described our main intervention where participants are drawn from the general population. In addition, we also plan to test our experimental conditions with subjects from high-risk population groups. For high-risk population groups, we will rely on previous experience form the research team members. Specifically, Drs. Teran, Izurieta and Reina-Ortiz have collaborated in a research project where 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 our monitors, after having been randomly assigned (previously through a computer randomization algorithm) to one of our three experimental conditions described above. Participants will be read a statement informing them that they are being invited to participate in a study; to protect their privacy, verbal consent will be obtained. We expect to include about 1,000 subjects from these high-risk populations.
The testing facility where the participants will be invited to go is “Microlab – Laboratiorio Clinico Bacteriologico”, centrally located in Esmeraldas (across the street from the Delfina Torres Public Hospital) and is a private facility staffed by healthcare professionals connected to the testing lab at the Medical School and Hospital of the Universidad de San Francisco de Quito in Quito, Ecuador’s capital, where the actual testing will be performed.
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 study participants will not give their names to the lab personnel. They will simply give them the second portion of their card, which indicates their study ID. The lab staff will write the study ID in the test tube’s label. The blood samples will be sent to the testing facility at the Universidad San Francisco de Quito for testing. Trained laboratory personnel at USFQ will be in charge to 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 individual’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 in a pre-designed “HIV screening Test Results” Form. Individual results will be put in an envelope. Envelopes will be sealed and mailed back to the testing facility in Esmeraldas through a private carrier. After arrival, results will be archived in a locked unit and delivered to participants as they come to claim their results. Participants will receive their results in a timely manner, according to the local health policies. HIV positive individuals will be encouraged to visit the local health district for their enrollment into the national HIV/AIDS program for treatment.