The Positively Quit Trial for Smoking Cessation

Description

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, we 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", we have a robust plan for maintaining engagement/preventing attrition. 1) We will have a study website that serves as a portal for participants to track their 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) We will maintain a social media presence and encourage participants who are comfortable doing so to "friend" us. 5) We 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, we 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).

Details