Note: Public-facing information will not reveal that the study is specifically for people
living with HIV; instead these documents refer to "people living with certain health
conditions. This trial involves a highly stigmatized, vulnerable, and private group:
people living with HIV. The team does not wish to make it known publicly that this trial
is for people living with HIV, as that could lead to other people inadvertently learning
someone's HIV-positive status, which would be a major privacy violation. For example, if
a participant receives email or text from the Positively Quit Study, there is no easy way
for another person to know the study is only for those living with HIV. However, if the
website notes the inclusion requirement of living with HIV on clinicaltrials.gov, a
boyfriend, roommate, family member, etc., could look up the Positively Quit Trial on
clinicaltrials.gov and then determine that their boyfriend, roommate, family member, etc.
is HIV-positive. Eligibility criteria are deliberately incomplete to protect the privacy
of people living with HIV. Moreover, some details are left out of the eligibility
criteria to prevent participants from qualifying for the study because they knew the
"correct" answers to the eligibility screens--not because they actually met criteria.
After completing eligibility screening, including a video-conferencing observed swab test
to measure levels of cotinine (a marker of cigarette smoking chemicals), those eligible
will be invited to complete the baseline assessment and enroll in the trial.
Enrolled participants will then complete a baseline assessment (the first assessment for
the trial, consisting of a secure online survey). Then they will be randomized to either
the treatment condition or the AMC. Randomization is a fair way of selecting who will be
in each condition. It is like flipping a coin. In this study, instead of actually
flipping a coin, the team will use a web-based randomization software that basically does
the same thing. Once a participant learns their randomized condition, they will receive
brief cessation counseling and an offer of nicotine replacement therapy (NRT) patches.
For participants who would like NRT, study staff will help determine if the participant
can get NRT through their insurance or related assistance program (e.g., ADAP); if it is
possible, the study staff will facilitate that process. If getting NRT through insurance,
etc. is not possible, NRT will be provided by the study.
Participants will begin their group sessions within approximately 2 weeks of
randomization. For both conditions, the group sessions will all be conducted using
group-based video-conferencing via Zoom, a HIPAA compliant video-conferencing system that
is easy to use, works well even at lower internet speeds, and is free to trial
participants; this will be the same system participants used during eligibility
screening. Participants will be required to join the group from a private space, with no
others present, to ensure confidentiality for all participants. Those who violate this
requirement will be asked to resolve the situation immediately or log out of the session.
A second violation will lead to permanent removal from the group sessions, because
confidentiality is critical. Groups for both conditions will consist of 8 sessions over 6
weeks, with subsequent booster sessions 2,4,8, and 12 weeks after the end of the main
interventions.
For each condition, one facilitator will be a master's level counselor and one will be a
peer (person living with certain health condition). Facilitators will be trained for only
one group type (there will be 1-2 sets of facilitators for treatment and a separate 1-2
sets of facilitators for AMC). All facilitators will undergo supervision with the PI and
Co-I.
Participants will complete assessments at days 0 (baseline), 42, 90, 180, and 360, to
include questions about smoking, health, utilized cessation treatments, and potential
mediators (variables that changed as a result of the program and subsequently led to
smoking cessations). These assessments will involve a secure online survey. Smoking
abstinence will be confirmed with a video-conferencing observed oral swab test for
cotinine, a biological marker of cigarette smoking. Note that the initial swab test will
be done at the end of eligibility screening instead of at baseline, as this is part of
eligibility determination. Participants will be remunerated for their time via gift
cards.
In addition to the 5 major assessments, participants will receive "brief check-ins" to
confirm/validate contact information approximately every 45 days, and again remunerated.
This is important because the success of the trial is dependent upon keeping participants
involved and reminding them about study activities to ensure retention and reduce
attrition/missing data.
In addition to the "brief check-ins", there is a robust plan for maintaining
engagement/preventing attrition. 1) The team will closely monitor participant
involvement, update contact information, and communicate with the study staff. The
website will also serve as a portal for study staff to track participant involvement. 2)
Participants will receive physical reminders of the study (e.g., pens, magnets, etc.)
bearing the study name and contact information, so they will retain our contact
information and remember they are involved in the study. 3) assessments are incentivized
and the compensation escalates over time to keep participants engaged. 4) The team will
maintain a social media presence and encourage participants who are comfortable doing so
to "friend" us. 5) The team will send birthday cards. 6) Participants will be reminded of
scheduled assessments and sessions via text and/or email (user preference). 7)
Additionally, because study staff will interact over video-conferencing during cotinine
assessments, the team will develop relationships with participants that may help to
foster retention (e.g., they may look forward to talking with us or updating us about
their lives).
