We evaluated a newly developed tailored smoking cessation program for PLWH in D.C. via a pilot randomized controlled trial. This study was approved and overseen by the Chesapeake Institutional Review Board (IRB), now Advarra. All participants provided written informed consent prior to study enrollment.
A convenience sample of smokers was recruited via flyers in clinics and community centers serving PLWH, and word of mouth. Participants were recruited from September to December of 2017. Follow-up continued through February of 2018. Given the nature of the pilot study, sample size was determined based off of feasibility and cost considerations. Participants were eligible if they were 1) 18 years or older, 2) living in the D.C. metro area, 3) self-reported PLWH, 4) currently smoking cigarettes daily, 5) willing to set a quit date within seven days of the first meeting, 6) engaged in primary care, and 7) equipped with a mobile phone that could receive SMS text messages. At baseline, smoking status was confirmed by a carbon monoxide (CO) breath test where smoking was defined as a reading of greater than or equal to seven parts per million (ppm) using the coVita Smokerlyzer (21). Participants were excluded if they were 1) using smokeless tobacco or electronic cigarettes at least once per day, 2) currently enrolled in a quit smoking program, 3) using nicotine replacement therapy (NRT), 4) currently in an alcohol treatment program, 5) pregnant, breastfeeding or planning to become pregnant, or 6) diagnosed with heart disease or high blood pressure that was not controlled by medication. They were also excluded if they had a heart attack in the last two weeks, serious underlying irregular heartbeat, serious or worsening chest pain, or active TMJ syndrome.
Once determined eligible and consented, participants were randomly assigned 1:1 to either the intervention or control arm. A computer-generated randomization sequence was used for individual randomization. Neither the participant nor study staff were blinded. Outcomes were determined at a follow-up visit one month later. The trial was completed at the conclusion of the funding period.
Control Condition. Participants were provided a one-time standard of care (SOC) in-person cessation counseling session lasting approximately one hour and received a 30-day supply of nicotine replacement therapy (NRT) consisting of nicotine gum and patches. The SOC cessation counseling was adapted from the current clinical practice guidelines. (22).
Experimental Condition. Participants in the intervention arm were provided a one-time tailored cognitive-behavioral therapy (CBT) in-person cessation counseling intervention (TI) lasting approximately one hour, a 30-day supply of NRT, and a tailored bi-directional text messaging program delivering two messages per day for four weeks. Participants were asked to bring their mobile phones and were instructed by study staff how to opt into the text message program during their baseline visit. Two participants in the TI group were not enrolled due to mobile-phone difficulties at baseline. The TI session was adapted from the clinical practice guidelines to include the elements of our conceptual framework rooted in the minority stress model (18, 22). The intervention used a CBT approach to address issues of stress related to HIV stigma, minority status and socioeconomic condition. The conceptual framework supporting the TI theorizes that resilience-based coping has the potential to attenuate the negative effect of stigma on the relationship between stress and smoking. Positive coping strategies delivered to participants through the intervention are theorized to improve self-efficacy to cease smoking in the face of stress, adapting Teti et al.’s work on resilience (23–26).
At the baseline session, information was collected on sociodemographic characteristics, smoking patterns, past cessation attempts, and perceived access to quitting resources.
Our primary outcome of interest was self-reported smoking cessation at 30-days after baseline, verified by a CO reading of less than seven ppm. Secondary outcomes included changes in cigarettes per day (CPD), CO levels, and self-efficacy for cigarette abstinence (27).
Self-efficacy for cigarette abstinence was evaluated using a validated tool from Spek et al. wherein participants were asked to rate their confidence in not smoking given certain situations (27). Response options included a five-point scale ranging from, “certainly not” to “certainly,” and the tool contained 6 items. Values 0–4 were assigned to the response options for each item and values were averaged to create a summary score.
Participant characteristics and demographic variables obtained at baseline were compared across treatment groups using Pearson’s Chi-Squared or Fisher’s Exact tests, as appropriate, for categorical variables. Wilcoxon Mann-Whitney tests were used to evaluate differences between the study arms for continuous variables. Frequencies and percentages were reported for categorical variables while medians and inter-quartile ranges (IQRs) were reported for continuous variables. To assess the primary outcome of smoking cessation, cessation status at follow up was compared across treatment groups and Fisher’s exact test was performed to assess differences between treatment arms.
An intent-to-treat analysis was used wherein participants lost to follow up (n = 2) were left in the dataset and were treated as if they did not quit and as if their continuous outcomes had not changed from baseline to follow-up. Scales for secondary outcomes were summarized by median value and change from baseline to follow-up. Change in scale from baseline to follow-up was evaluated across treatment groups using Wilcoxon Signed Rank Sum tests. All analyses were conducted using SAS 9.4 (28).