Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04155502 |
| Other study ID # |
CTN-0083, STUDY00031899 |
| Secondary ID |
UG1DA040309 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 6, 2020 |
| Est. completion date |
September 25, 2020 |
Study information
| Verified date |
December 2020 |
| Source |
Dartmouth-Hitchcock Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The primary objective of this study is to compare the relative effectiveness of three
web-based platforms: social media sites (e.g., Facebook), dating applications [apps] (e.g.,
Grindr), and informational sites (e.g., Google) to promote self-testing of Human
Immunodeficiency Virus (HIV) infection among men who have sex with men (MSM) who are at
increased risk of HIV exposure and/or infection. In addition, we will measure Pre-Exposure
Prophylaxis (PrEP) uptake and evaluate the degree to which substance use and, separately, the
participant's intention to test affect HIV self-testing and PrEP uptake. Through this
research, we will also examine how participants' social media use, attitudes on HIV testing,
perceptions of sexual risk behavior, medical mistrust, and stigma impact HIV testing and PrEP
uptake.
Description:
Culturally appropriate advertisements (designed specifically for the study population and
advertisement method) for promoting HIV testing and PrEP uptake will be created by the study
team. These advertisements will be placed on social media sites (Facebook, Instagram,
Twitter), informational sites (Google, Bing, Yahoo) and dating apps (Grindr, Hornet, Jack'd)
in the form of blast advertisements ("ads"). The advertisements will display on specific days
and times (e.g., high traffic utilization) in the geographical locations selected for
participation in the study.
Upon clicking the ad, users will land on the study informational page on Qualtrics, where
they will receive information about the study, undergo eligibility screening and, if
eligible, electronically sign the informed consent. Participants will receive information
about HIV testing and PrEP and will be asked to complete the baseline assessment and order
their HIV home self-test kit.
Participants will be followed up at two intervals after the baseline assessment. The first
will occur 14 days post-baseline, where participants will be asked about their test use and
may be asked if they visited a PrEP provider and/or if they started PrEP and about PrEP
opinions and facilitators and barriers. If they tested positive for HIV on the home self-test
kit, they will be asked whether they have visited an HIV treatment provider. Participants
will be asked to upload a picture of their test result for validation on the secure Qualtrics
server during the 14-day follow-up assessment. Photographs will be interpreted by the study
team and the result will be entered into the study database; photographs will then be
deleted.
At the 60-day follow-up, all participants will be asked to respond to study evaluation
questions. Additionally, participants may respond to a subset of the questions that is the
same as the 14-day follow-up, based on their responses on the first follow-up survey. Those
who reported that they received a negative HIV self-test result and started PrEP at the
14-day follow-up will not be asked to answer these questions at the 60-day follow-up.
Participants who either did not take the HIV test or did not start PrEP by the 14-day
follow-up may be asked about PrEP facilitators and barriers, their self-test use, if they
visited a PrEP provider, whether they started PrEP, and if applicable, whether they have
visited an HIV treatment provider, depending on their responses during the 14-day follow-up.
Participants will be asked to upload a picture of their test result (unless provided at the
14-day follow-up) for validation on the secure Qualtrics server during the 60-day follow-up
assessment. Photographs will be interpreted by the study team and the result will be entered
into the study database; photographs will then be deleted.
Participants who report a preliminary positive, invalid, or indeterminate result on the HIV
home self-test kit will be referred to local brick-and-mortar clinics for additional services
and asked to continue participating in follow-up assessments. Regardless of their result, all
participants will be offered information on HIV and STD prevention, and locations of clinics
and PrEP providers near them.
Data will be collected both indirectly from each website's metrics and directly from the
online questionnaires that the participants will complete.