Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05072093 |
| Other study ID # |
STUDY00000608 |
| Secondary ID |
5R01MH123724-02 |
| Status |
Active, not recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
November 20, 2021 |
| Est. completion date |
February 2025 |
Study information
| Verified date |
June 2024 |
| Source |
Emory University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The study is a prospective cohort of young MSM who are followed for 2 years either in-person
at the PRISM Health Research Clinic and/or virtually with telehealth study visits. Follow-up
visits occur as frequently as every 3 months, or as appropriate to clinical needs of HIV PrEP
or STI PEP. The investigators will enroll men who may decide to start or stop PrEP, change
from daily oral PrEP to on-demand oral PrEP or from on-demand oral PrEP to daily PrEP, to
start or stop STI PEP at any point in the study period, or injectable PrEP as an alternative
to daily oral PrEP or on-demand oral PrEP. All men will be provided with the study's mobile
smart phone app to support early identification of risks for PrEP discontinuation, to provide
information about STI PEP and document usage patterns of on-demand oral PrEP and STI PEP, and
to support easy linkage to support services for PrEP counseling and addressing concerns or
questions about STI PEP and injectable PrEP.
Description:
Men who have sex with men (MSM) are disproportionately impacted by the U.S. HIV epidemic.
Pre-exposure prophylaxis, or PrEP, is a relatively newer HIV prevention strategy that
involves taking HIV antiviral medications either daily or on-demand to prevent HIV infection
following high risk sexual activity. Both daily and on-demand PrEP have been shown to prevent
infection if taken consistently and correctly. A prior research with this high-risk
population in Atlanta, where it was offered daily PrEP to study participants, resulted in
significant PrEP interest and initiation however high rates of PrEP discontinuation
throughout the study were of great concern and, in some cases, led to HIV infection.
Additionally, the study found high rates of bacterial sexually transmitted infection (STI)
diagnoses both independent of, and concurrent with, higher PrEP use leading to concerns that
condoms are not being used among MSM on PrEP.
The proposed work will expand upon the previous study with an intervention focus for MSM in
Atlanta with aims of (1) preventing daily oral PrEP discontinuation; (2) offering on-demand
oral PrEP as an alternative for MSM not interested in daily oral PrEP, (3) decreasing the
incidence of bacterial STIs by offering STI post-exposure prophylaxis (PEP) which involves
taking doxycycline immediately following high risk sexual behavior, 4) to start injectable
PrEP as an alternative to daily oral PrEP or on-demand PrEP.
The study will involve a cohort of 200 MSM aged 18-45 in Atlanta who will be followed for two
years. Participants will be recruited online from social media and dating websites, and
in-person from different venues and events where MSM are known to attend. Men will take a
short online eligibility screener either on a tablet, if recruited in-person, or on their own
device if recruited online. Participants will be compensated for the various study activities
(e.g., study visits, online behavioral surveys, weekly/monthly surveys).
If men screen eligible, they will be invited to a baseline study visit that will occur either
in-person at the research clinic or virtually. Because of the ongoing COVID-19 pandemic, the
plan is to offer participants the option of conducting study activities virtually or
in-person. Consent will occur at the beginning of the baseline visit. Following the baseline
visit, all participants will have two more study visits at months 12 and 24. At the three
study visits, participants will be tested for HIV, STIs and drugs of abuse and take an online
behavioral survey. Participants will also take an online behavioral survey at months 4, 7 and
19.
At all study visits, participants will discuss with the study counselor the various
prevention options the study is offering-daily PrEP, on-demand PrEP, STI PEP or injectable
PrEP as an alternative to daily oral PrEP or on-demand oral PrEP. If a participant elects to
begin any of these, study staff will assist them in accessing oral PrEP from a community
pharmacy and STI PEP (doxycycline) from the Emory Investigational Drug Service. Participants
who start oral PrEP and/or STI PEP will take short weekly surveys for the first 2 weeks to
monitor use and side effects. Following that 2-week period, daily oral PrEP users will get a
monthly survey to try and detect warning signs of discontinuation so that the study can
intervene to prevent that from happening. On-demand oral PrEP and STI PEP users will continue
to get weekly surveys to monitor use and side effects. Oral PrEP and STI PEP users will have
a 3-monthly visit-either in-person or virtually-to monitor their use and to test for HIV and
STIs. Oral PrEP users will also have their kidney function monitored by creatinine testing.
Participants electing to do their study activities virtually will be sent specimen collection
kits so that they can self-collect specimens for all the required labs. They will mail back
the specimens to the lab in a pre-paid postage mailer. Participants who elect injectable PrEP
will be referred to local providers to access the medication; as part of our study, we will
monitor their use through monthly surveys. Injectable PrEP Participants will have the option
to switch prevention options at any point during the study by indicating their interest
during monthly surveys or contacting study staff directly. Study clinicians will develop
transition plan based on clinical indications.
All participants will be required to download the study app at the baseline visit and will be
oriented to using it to retrieve study communication, surveys, lab results, etc.
Additionally, the app will be used to schedule and conduct video conferencing sessions
between participants and study clinicians/staff. If a participant reports warning signs of
daily PrEP discontinuation, a peer navigator on staff will reach out through the app to try
and schedule a counseling session that will use a motivational interviewing approach to
support PrEP persistence.
The proposed work is of great significance for the field as novel approaches to preventing
early discontinuation of PrEP are of utmost importance for preventing HIV transmission among
MSM. If engaging with them frequently and assessing for warning signs of discontinuation is
shown to be an effective strategy for intervening and preventing stoppage, then the
implications for future interventions by community PrEP providers and clinicians is
significant.
