Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03224741 |
| Other study ID # |
HIRB00004772 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 12, 2017 |
| Est. completion date |
January 1, 2019 |
Study information
| Verified date |
February 2019 |
| Source |
Johns Hopkins University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
