Clinical Trial Summary
This pilot, three-arm, randomized trial study involves 200 18-24-year-old young adult
men-who-have-sex-with-men (YMSM) recruited through the internet. YMSM are eligible if they
are 18-24 years-old, live in the United States, are not known to be HIV infected
(self-report), have ever had condomless anal sex with another man, and have never taken HIV
pre-exposure prophylaxis (PrEP). The aim of this pilot project is to compare the effect of
financial incentives on encouraging YMSM to get tested for HIV and start PrEP for HIV.
Potential study participants will be recruited online through advertising on the internet and
complete the study eligibility and consent procedures. Following provision of consent online,
participants will be contacted via the email they provided and asked to confirm their
willingness to participate. Email addresses are being collected as part of this study to help
ensure that individuals do not attempt to participate more than once in this study. Study
staff will review the email addresses for duplications. Anyone who attempts to enroll more
than once will be disqualified from the study. Participants will not ask for their name as
part of the study. Once study interest is confirmed, participants will be provided a study
identification number and study arm assignment. They also will be provided with instructions
specific to their study arm assignment for the study as well as online resources about HIV
testing and PrEP, including options for paying for PrEP.
Participants will be randomly assigned to one of three study arms (no financial incentive, a
fixed incentive ($25 Amazon.com gift card) or a lottery (20% for a $100 Amazon.com gift
card). Participants in each study arm will be asked to contact the telehealth company
PlushCare and make an appointment within two weeks. For this appointment, participants will
speak with a PlushCare doctor about being tested for HIV and starting PrEP. They will provide
PlushCare with their study identification number. As part of their services, PlushCare will
obtain personal identifiers from participants but will not share this information with the
study staff.
For this study, participants are asked to undergo an evaluation for PrEP through the
PlushCare doctor, but will NOT be required to be tested for HIV nor start PrEP. It will be
the participants choice whether or not to be tested for HIV and start or continue PrEP after
consultation with the PlushCare doctor. For some participants, the PlushCare doctor might
recommend against starting PrEP. PlushCare will follow usual standard-of-care practices for
their evaluation, counseling and consideration of PrEP as well as provision and maintenance
of services for PrEP. Using only the study identification numbers and not the participant's
personal identifiers, PlushCare will provide the study staff with data on completion of the
primary and secondary study outcomes.
Participants will be informed that they or their healthcare insurance will bear the costs of
HIV testing and PrEP, but not the consultation with PlushCare. They will be provided with
resources about how to pay for PrEP from the study as well as PlushCare.
Completion of the primary study outcome (completing an appointment with the telehealth
provider PlushCare for a PrEP evaluation) and secondary outcomes (undergoing HIV testing,
starting PrEP, time elapsed from study enrollment to PlushCare evaluation, time elapsed to
HIV testing and PrEP initiation) will be compared by study arms.
