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Clinical Science

A Multicenter Randomized Controlled Trial of Intensive Group Therapy for Tobacco Treatment in HIV-Infected Cigarette Smokers

Stanton, Cassandra A. PhDa,b; Kumar, Princy N. MDb,c; Moadel, Alyson B. PhDd; Cunningham, Chinazo O. MDe,f; Schechter, Clyde B. MDd,f; Kim, Ryung S. PhDd; Shuter, Jonathan MDd,e

Author Information
JAIDS Journal of Acquired Immune Deficiency Syndromes: April 1, 2020 - Volume 83 - Issue 4 - p 405-414
doi: 10.1097/QAI.0000000000002271

Abstract

INTRODUCTION

Persons living with HIV (PLWH) in the United States smoke cigarettes at 2–3 times the rate of the general population.1,2 Smoking rates have declined dramatically since the Surgeon General's landmark report in 1964 implicating tobacco use as a direct cause of lung cancer.3 At the time of that report, 42% of US adults smoked cigarettes compared with today's prevalence of 14%.4 The most comprehensive recent survey of tobacco use in PLWH found a smoking prevalence of 42%,1 identical to the 1964 rate in the US population before the Surgeon General's report. Clearly, not all segments of the US population have benefited equally from the public health successes in tobacco control of the past half-century.

The effectiveness of antiretroviral therapy at controlling the viral infection and its resultant immunosuppression has dramatically reduced the incidence of traditional HIV-associated morbidities and allowed tobacco use to emerge as the leading cause of death in PLWH.5,6 PLWH live much longer than they used to, but cigarette smoking is the most potent factor perpetuating the longevity gap between those living with and without HIV infection.7 Current estimates project that 9.3% of today's US PLWH will die of lung cancer if tobacco use behaviors do not change.8

A range of evidence-based tobacco treatment approaches have been adapted for PLWH smokers and tested in clinical trials. A meta-analysis of this research reached the disappointing conclusion that the tobacco treatment strategies tried to date may have yielded some short-term benefits in terms of quit rates (low-quality evidence), but there is no evidence of efficacy at 6 months or beyond.9

Group support and group therapy have been part of the culture of HIV management from the earliest days of the epidemic.10 Group treatment for tobacco use also has a long history, and meta-analytic data support its efficacy at promoting cessation.11,12 In a single-center pilot trial of Positively Smoke Free (PSF), a theory-driven, 6-week, 8-session intensive group intervention led by professional-peer pairs and designed specifically for PLWH smokers, the abstinence rate at 3 months was almost double in the group therapy condition compared with controls (19.2% vs. 9.7%), but the limited scope and duration of the trial precluded longer-term follow-up.13 In this report, we describe our experiences delivering the PSF group therapy intervention to a larger cohort of PLWH smokers in a multicenter study with 6-month follow-up.

METHODS

Between August 2014 and July 2017, we enrolled PLWH smokers into a prospective, randomized controlled trial of PSF group therapy vs. brief advice to quit at 3 different sites: Montefiore Medical Center's Center for Positively Living in the northwest Bronx, NY, Montefiore Medical Center's Comprehensive Health Care Center in the south Bronx, NY, and MedStar Georgetown University Hospital HIV Clinical Program in Washington, DC. Potential participants were recruited by referral from their primary care providers, direct invitation from the clinic waiting rooms, and self-referral in response to fliers. Interested individuals were screened for HIV infection status, current smoked tobacco use, motivation to quit, and contraindications to nicotine replacement therapy (NRT). Inclusion criteria were (1) laboratory-documented HIV infection, (2) age ≥18 years, (3) current tobacco smoking, defined as an affirmative response to “During the past 5 days, have you used any product containing nicotine including cigarettes, pipes or cigars?” 14 (4) motivation to quit, defined as a score in the 4–9 range on the Abrams-Biener Readiness to Quit Ladder,15 and (5) willingness to commit to eight 90-minute group therapy sessions if randomized to the PSF group therapy study condition. Exclusion criteria were (1) pregnancy, (2) previous participation in the trial, (3) contraindication to nicotine patch use, (4) and failure to meet any of the inclusion criteria. Candidates who met these criteria, remained interested in participating, and completed the written informed consent process with the research assistant, were randomized in a 1:1 schedule into the PSF group therapy condition (ie, the intervention) or the enhanced standard of care condition (ie, the control), using a computer-driven randomization algorithm that was concealed from the research assistant and the investigative team. The randomization was stratified by study site, and based on historical differences in response rates to tobacco treatment, it was stratified by motivation to quit [contemplation (scores 4–6) vs. preparation/action (scores 7–9)] and by race (black vs. non-black).

PSF group therapy is an 8-session, 42-day intensive behavioral tobacco treatment led by a professional-peer pair of group leaders, both of whom have completed tobacco treatment specialist training and certification. The professional leaders had either masters or doctoral level training in psychology or social work, and the peers were PLWH ex-smokers recruited from the clinic. The syllabus of the course was developed by members of the investigative team (J.S., A.B.M., and C.A.S.) according to the Social Cognitive Theory model16 with HIV-referent material thoroughly integrated into each session. A summary of the session content has been cataloged in a previous publication.13 PSF plans for quit day on session 5, 28 days after session 1, although participants may try to quit earlier if they are motivated to do so.

A new cycle of PSF group therapy was begun each time a group of 6–8 participants were randomized to the intervention. Participants who were randomized to the intervention condition were added to a list of individuals awaiting the next cycle of group therapy. Since this wait could last as long as several months, and there was concern that smoking behaviors could change in the interim, for these participants, the baseline interview was postponed until within 2 weeks before the scheduled start of the PSF group.

The PSF groups were conducted in a private conference room located at each clinical site. Lunch or dinner was served before each session, and transportation vouchers were provided to all attendees. Evening and weekend groups were offered to those individuals with scheduling conflicts during Monday through Friday daytime hours. All sessions were digitally recorded for the purpose of fidelity testing.

The control condition consisted of standardized brief (≤5 minutes) advice to quit cigarette smoking according the Tobacco Dependence Treatment Handbook17 and a PSF self-help brochure developed by the investigators (J.S. and A.B.M.) and targeting PLWH smokers.

All study participants, regardless of condition, were encouraged to use nicotine patches in their quit attempts. In the New York sites, where virtually all participants had full insurance coverage for nicotine patches without copay, they were given a prescription for a 12-week supply of patches dosed according to daily cigarette consumption as per manufacturer's guidelines. In the rare instances that insurance coverage was lacking, the study arranged for the free dispensation of the 12-week supply by the hospital pharmacy. At the Washington, DC site, where insurance coverage was less comprehensive, a supply of patches was purchased, stocked, and offered, free-of-charge, in 4-week increments (participants had to return twice to obtain the full 12-week supply), dosed identically to the New York sites.

All study participants were asked to complete 4 study interviews: baseline, day 28, day 120, and day 210. The latter 2 timepoints were selected to approximate 3 months and 6 months after quit date for those randomized to the group therapy intervention (quit day was scheduled for 28 days after the initial group session). Interviews were conducted through audio computer-assisted self-interview (QDS software) and queried participants about a range of sociodemographic, clinical, substance use, and behavioral parameters. The measures are summarized below. Certain questions, for example, about group cohesion or about study contamination, were restricted to intervention or control participants, respectively.

Measures

All participants were asked to complete an audio computer-assisted self-interview at the 4 study visits. The primary abstinence outcome was assessed with the question, “Have you smoked cigarettes (even a puff) in the last 7 days, including today?”14 A negative response to this question and exhaled carbon monoxide (ECO) level of <10 parts per million (ppm, Bedfont piCO+ Smokerlyzer; Bedfont Scientific Ltd., Kent, United Kingdom) constituted biochemically verified 7-day point-prevalence abstinence for the purpose of this study. Participants with discrepant results, that is, reporting no cigarette use but with ECO ≥10 ppm, were considered nonabstinent. Secondary outcomes included measures of smoking behaviors such as smoking intensity (ie, average number of cigarettes smoked per day), longest period of abstinence since the last study contact, nicotine dependence (Modified Fagerstrom Tolerance Questionnaire18), and behavioral domains that were specifically targeted by the intervention including motivation to quit (Abrams and Biener Readiness to Quit Ladder15), tobacco knowledge [questions derived from the Centers for Disease Control and Prevention Question Inventory on Tobacco (CDC QIT)14], self-efficacy (Self-efficacy/Temptations Scale19), and loneliness [modified-University of California, Los Angeles (UCLA) Loneliness Scale20]. Participants answered additional questions about lifetime and current (ie, within the past 30 days) use of a range of illicit substances and completed the Alcohol Use Disorders Identification Test (AUDIT) for alcohol use.21 Decisional balance was assessed with the Smoking Decisional Balance Short Form,22 which measures perceived pros and cons of smoking. Post-traumatic stress disorder (PTSD) was assessed with the Primary Care PTSD screen (PC-PTSD23). Depression and anxiety were assessed with the Center for Epidemiologic Studies Depression Scale24 and the General Anxiety Disorder 7-Item Scale.25 Perceived stress was assessed with the Perceived Stress Scale-4.26 Boredom was assessed with a modified Free-Time Boredom Scale.27 Perceived ethnic/racial discrimination was assessed with the Perceived Ethnic Discrimination Questionnaire.28 Distress tolerance was assessed with the Distress Tolerance Scale.29

Dose of Intervention

For PSF group therapy participants, attendance was taken at each group session, and dose of therapy was calculated as the total number of sessions attended by each participant. Nicotine patch use was assessed with questions about use vs. nonuse of the patch, duration of use, and reasons for nonuse.

Process Evaluation

All sessions were recorded. Twenty-five percent of the sessions, selected at random from the 3 sites and including all pairs of group leaders, were reviewed by a psychology graduate student who was otherwise uninvolved in the research. Topic coverage checklists were completed for each session. Checklists included a mean of 11 items/session, which could be scored as “Yes” or “No” for coverage during the session.

We used the Group Climate Questionnaire—Short Form 30 to assess the climate within the groups, and the Therapeutic Factors Inventory Cohesiveness Scale (Coh30) to assess participants' views of group cohesiveness.

Study Contamination Survey

Control subjects were asked a series of questions inquiring about discussion of program contents with intervention condition subjects and also inquiring about familiarity with specific cessation strategies (eg, deep-breathing techniques) taught in PSF.

Program Satisfaction Survey

PSF subjects rated the various components of the group therapy on a Likert scale ranging from “not helpful at all” to “extremely helpful.”

Sample Size Considerations

Based on our pilot trial of PSF group therapy, which measured the abstinence outcome at 3 months,13 and projecting for a 2%–3% smoking relapse rate between the 3-month and 6-month timepoint, we estimated that 16.2% of the PSF group participants and 6.7% of controls would achieve the primary study endpoint at 6 months. We planned to enroll 225 participants into each condition, generating a power of 89% to detect a difference between the conditions.

Statistical Analyses

Dichotomous variables were analyzed using the χ2 or Fisher exact test. Comparisons of mean values were accomplished using the Student t-test or the Mann–Whitney U test. Correlation of 2 continuous variables was performed using the Spearman rank correlation. In evaluating factors associated with the abstinence outcome, a backward, stepwise multivariate logistic regression analysis was performed incorporating those variables that were associated (P ≤ 0.10) with abstinence on preliminary analyses. The regression analysis used the Akaike information criterion strategy to arrive at the most parsimonious final model. Since this was a multicenter efficacy trial of PSF, study condition and study site were included in all multivariate models regardless of their level of association on preliminary analyses. Data analyses were performed using SPSS version 25.0 and R (R Core Team 2018).

Study Oversight

The study was reviewed and approved by the institutional review boards of all participating institutions.

RESULTS

During the 3-year recruitment phase of the trial, we enrolled 450 individuals (100% of the recruitment target). To reach this number, we screened 537 candidates. Reasons for screen failure are listed in the Figure 1 consort diagram. Because patients who screened out had not yet consented to participate in research, we did not systematically collect data from them. Of the 450 who passed screening, 8 were ultimately removed from the study cohort for reasons indicated in Figure 1. The final study cohort consisted of 442 participants or 98.2% of the original recruitment target. Of these, 226 were randomly allocated to the control condition and 216 to PSF group therapy.

FIGURE 1.
FIGURE 1.:
Flow of study participants.

Table 1 summarizes the baseline characteristics of the control and intervention groups, and the full list of variables may be found in Table 1, Supplemental Digital Content, http://links.lww.com/QAI/B416. The 2 groups were well-balanced on almost all baseline variables. Participants in the intervention group were more likely than those in the control group to have used e-cigarettes {24.1% vs. 15.5%, odds ratio (OR) = 1.73 [95% confidence interval (CI) = 1.06 to 2.84], P = 0.04}. There were no other significant differences in baseline characteristics between the 2 groups.

TABLE 1.
TABLE 1.:
Baseline Characteristics of the Intervention and Control Participants
TABLE 1-A.
TABLE 1-A.:
Baseline Characteristics of the Intervention and Control Participants

Abstinence Outcomes

Primary Study Outcome

The PSF group analytic sample included 176 participants (81.5%) evaluable for the primary study outcome of abstinence at the 6-month timepoint, and the control group sample was 196 (86.7%). The primary analyses used an intent-to-treat strategy, and participants who were not evaluable at the 6-month timepoint were treated as nonabstinent. Two participants, one in each study condition, died between the 3-month and 6-month follow-up visits. Since these 2 individuals could not be accurately characterized as either abstinent or nonabstinent at the 6-month timepoint, they were censored from the trial after the 3-month visit. At 3 months, 28 PSF participants (13.0%) and 15 control participants (6.6%) achieved biochemically confirmed, 7-day point-prevalence abstinence [OR = 2.10 (95% CI = 1.10 to 4.14), P = 0.04]. At 6 months, 28 PSF participants (13.0%) and 30 control participants (13.3%) achieved the primary study outcome of biochemically confirmed, 7-day point-prevalence abstinence [OR = 0.97 (95% CI = 0.56 to 1.69), P = 1.0]. Thus, PSF participants were almost twice as likely to achieve biochemically confirmed abstinence at 3 months compared with controls, but the abstinence advantage in the PSF group was no longer observed at the 6-month timepoint.

Secondary Abstinence, Smoking Behavior, and Intervention Target Outcomes

Table 2 summarizes 3-month and 6-month abstinence, other smoking endpoints, and psychobehavioral targets of the PSF intervention. Statistically significant differences in favor of the PSF intervention were observed in longer periods of abstinence since previous study contact, lower nicotine dependence, and higher self-efficacy to resist smoking temptation compared with control group participants. Assignment to PSF group therapy had no demonstrable effect on loneliness. The control group was not favored in any of the secondary outcome analyses.

TABLE 2.
TABLE 2.:
Seven-Day Point-Prevalence Abstinence Rates and Secondary Outcomes

Complete-Case, As-treated Analyses

For these analyses, we excluded participants who did not complete the 3- and/or 6-month assessments, and we also excluded PSF participants who never attended a single PSF group therapy session (N = 43). In the complete-case, as-treated analysis, 25/142 (17.6%) in the PSF group and 15/191 (7.9%) in the control group achieved biochemically confirmed, 7-day point-prevalence abstinence at 3 months [OR = 2.49 (95% CI = 1.27 to 5.03), P = 0.01], and 26/161 (16.1%) in the PSF group and 30/196 (15.3%) in the control group achieved biochemically confirmed, 7-day point-prevalence abstinence at 6 months [OR = 1.07 (95% CI = 0.60 to 1.89), P = 0.83].

Baseline Factors Associated With the Abstinence Endpoints in the Entire Study Cohort

We first performed analyses to assess the association of each baseline factor with 3-month and 6-month abstinence in the entire study cohort, using the ITT strategy, adjusting only by site and study condition. The results of these analyses are listed in Table 2, Supplemental Digital Content, http://links.lww.com/QAI/B416. Then, study condition, site, and all factors that were associated with the abstinence outcome at a significance level of <0.10 were entered into a multivariate logistic regression model that used a backward stepwise methodology. In the final model (Table 3), factors retained that were associated with 3-month abstinence were allocation to the PSF intervention condition adjusted OR (ORadj) = 2.20 (95% CI = 1.08 to 4.66, P = 0.03), living in transitional housing or being homeless ORadj = 0.10 (95% CI = 0.01 to 0.50, P = 0.03), quit attempt in the 12 months before enrollment ORadj = 2.44 (95% CI = 1.14 to 5.56, P = 0.03), motivation to quit ORadj = 1.43 (95% CI = 1.07 to 1.96, P = 0.02), nicotine dependence ORadj = 0.81 (95% CI = 0.69 to 0.95, P = 0.01), detectable HIV viral load ORadj = 0.37 (95% CI = 0.13 to 0.91, P = 0.04), and race reported as other than black or white ORadj = 0.32 (95% CI = 0.10 to 0.85, P = 0.03). In the final model (Table 3), factors retained that were associated with 6-month abstinence were current cocaine use ORadj = 0.15 (95% CI = 0.02 to 0.55, P = 0.01), distress tolerance score ORadj = 0.46 (95% CI = 0.27 to 0.73, P = 0.002), any use of NRT before study enrollment ORadj = 0.42 (95% CI = 0.20 to 0.86, P = 0.02), and educational attainment ≥high school graduation ORadj = 2.63 (95% CI = 1.15 to 6.59, P = 0.03).

TABLE 3.
TABLE 3.:
Multivariate Analysis of Baseline Factors Associated With Abstinence at 3 and 6 Months

Nicotine Patch Use and Other Pharmacotherapy

Use of any nicotine patches during the trial up until the 3-month timepoint was less common in the PSF group than the control group, whereas use of any bupropion, or varenicline during the trial up until the 3-month timepoint did not significantly differ between the PSF and control groups (54.2% vs. 64.9%, P = 0.04 for nicotine patches; 6.6% vs. 3.2%, P = 0.14 for bupropion; 6.0% vs. 5.3%, P = 0.79 for varenicline). There were no significant associations of any of these pharmacotherapy usages with 3-month abstinence. Use of any of the pharmacotherapies during the trial up until the 6-month timepoint did not significantly differ between the PSF and control groups (54.5% vs. 61.7%, P = 0.19 for nicotine patches; 8.0% vs. 4.1%, P = 0.17 for bupropion; 8.0% vs. 9.8%, P = 0.69 for varenicline), and there were no significant associations of any of these pharmacotherapy usages with 6-month abstinence.

Subgroup Analyses of Participants Randomized to the PSF Group Therapy Intervention

PSF Group Therapy Session Attendance, Group Climate, and Group Cohesiveness

The mean number of PSF group therapy sessions attended among those who were randomized to the PSF intervention was 3.78 ± 2.70, and the mean number of sessions attended among those who attended at least one session was 4.72 ± 2.16. Abstinence outcomes by session attendance are depicted in Figure 2. Participants who achieved 3-month abstinence compared with those who did not attended more sessions (4.79 ± 2.44 vs. 3.63 ± 2.71, P = 0.04). Dose of intervention was not significantly associated with 6-month abstinence. There was no significant association of group climate score or group cohesion score with 3- or 6-month abstinence.

FIGURE 2.
FIGURE 2.:
Abstinence outcomes according to session attendance among individuals randomized to Positively Smoke Free group therapy.

Program Satisfaction

Of the 156 respondents who completed the PSF group therapy satisfaction survey, 69.2% rated the sessions as either very or extremely helpful, 73.7% stated that the sessions met their expectations either very or extremely well, 78.8% stated that they were either very or extremely satisfied, 79.4% rated the sessions as either very or extremely relevant to themselves, 83.9% stated that the content that related specifically to living with HIV was either very or extremely helpful, and 98.7% stated that they would recommend the PSF group therapy program to HIV-infected family or friends who wanted to quit smoking.

Process Evaluations

Sensitivity Analyses

There were no significant differences in the primary or secondary outcomes by study site. Over the course of the study across the 3 sites, 3 professional group leaders and 4 peer group leaders delivered the PSF intervention, comprising 6 different combinations of professional-peer group leaders. There were no significant differences in the abstinence outcomes between any of the individual or pairs of group leaders.

Fidelity Rating

Overall fidelity to the PSF syllabus was excellent, with 90% of prescribed topics covered, and no difference between sites (90.0% at the 2 Bronx sites and 90.3% at the Washington D.C. site). There were minor differences in fidelity by group leader, with individual group leader fidelity scores ranging from 85.1% to 96.0%.

Study Condition Contamination

Of the 196 control participants who completed the study contamination questionnaire, 12.8% reported having discussed PSF group therapy session content with another person in the study who had been randomized to the PSF intervention and between 15.3% and 28.1% reported familiarity with the various techniques that PSF group sessions recommended to promote cessation.

DISCUSSION

We describe herein the results of a multicenter prospective randomized controlled trial of an intensive cognitive behavioral group cessation therapy and offer of free nicotine patches versus brief advice to quit and offer of free nicotine patches to an urban cohort of PLWH cigarette smokers from the Bronx, New York, and Washington, DC. A pilot study of this intervention showed significant increases in cessation rates at the 3-month timepoint for those randomized to receive group therapy.13 The current trial, similarly, showed a significant increase in biochemically verified abstinence at the 3-month timepoint but failed to show any cessation advantage at the 6-month timepoint. This finding is consistent with multiple previous trials of various behavioral interventions in failing to demonstrate long-term efficacy,31–34 notwithstanding the short-term efficacy observed in some studies.13,35,36 Different from other studies that showed a diminution in the abstinent proportion over time,31 our trial showed stability of the abstinence rate from 3 to 6 months in the group therapy condition, but a doubling in abstinence rates from third month to the sixth month in the control participants, who received no protocol-driven tobacco treatment during that time. We were not able to discern an explanation for the late rise in abstinence rates among control participants.

PSF participants demonstrated a significant increase in abstinence at the 3-month timepoint, and a dose–response relationship was observed, with abstinent subjects having attended more group therapy sessions. Moreover, a number of secondary tobacco behavior endpoints such as longest period of abstinence during the trial, nicotine dependence, and abstinence self-efficacy demonstrated significantly more favorable outcomes in PSF versus control participants, and these differences were sustained through the 6-month timepoint. Although the trial did not achieve its primary efficacy endpoint, the evidence suggests that the group therapy intervention generated more short-term quits and exerted salutary effects on other smoking beliefs and behaviors that were sustained.

Baseline predictors of successful cessation were, for the most part, unsurprising. Lower educational attainment and current cocaine use both predicted failure to quit. A history of NRT use was associated with lower quit rates, perhaps because past failure of this treatment lowered outcome expectation in the current trial. Finally, higher distress tolerance scores were associated with failure to quit. The significance of this unexpected finding is uncertain and should be explored in future studies.

We offered a 12-week supply of nicotine patches to all study participants. Pharmacotherapy is recommended as a component of almost all quit attempts, and nicotine patches are an evidence-based, logistically simple approach.11 Combination NRT, using both long- and short-acting agents, is now the standard of care,37 although it was not at the time that the trial was initiated. The experience with NRT in PLWH smokers is mixed, with some studies showing its efficacy as an adjunct to behavioral treatment34,38 and others, including the current trial, showing a lack of efficacy.13,39,40 Of note, 66% of intervention participants and 62% of controls (P = 0.41) had used nicotine patches before entry in the trial, and only slightly more than half of the participants used any of the patches that were offered to them in the trial, despite encouragement in both the intervention and control conditions. It is likely that past failure of nicotine patches and limited use during the trial explain the lack of efficacy that we observed.

Group therapy is an established and proven tobacco treatment strategy, and the 13% cessation rate in our group therapy cohort was comparable with the estimated 13.9% reported in a meta-analysis of group tobacco treatment in other populations.41 When considered in the context of a national annual quit rate of 4.5%–5.6% among US smokers,42 particularly in a population burdened with a range of psychosocial challenges, the quit rate that we report may be the source of some encouragement. Group therapy has not previously been studied in PLWH, notwithstanding certain benefits that it offered to this stigmatized and often lonely population, especially social support and inclusion of a peer as group leader. Participants on average attended about half of the scheduled sessions, despite transportation reimbursement and a free meal, suggesting that any future attempts at group therapy require aggressive efforts to maintain engagement. There were no demonstrable correlations between participant assessment of group dynamics with program efficacy. Fidelity to the counseling curriculum was high as were satisfaction survey scores.

Our trial had several limitations deserving mention. Participants were recruited from 2 urban centers in the Northeast and may not be representative of PLWH in other geographic regions. The PLWH clinic populations at our study sites have higher rates of heterosexual transmission and lower rates of same-sex transmission than the national average, so our findings may not be generalizable to PLWH populations with other risk profiles. Although the study completion rate was high (84.2%), 15.8% of the cohort was not available for the final study visit, and there is no assurance that the missing data were randomly distributed. Similar to most trials of intensive behavioral tobacco treatment, there was significant attrition from the group therapy intervention itself, and it is unknown whether more complete utilization of the intervention could have resulted in higher cessation rates. Finally, the study design did not allow for an assessment of the importance of the group environment over other counseling strategies (eg, individual counseling) and also did not permit us to evaluate the relative roles of counseling and pharmacotherapy in changing smoking behaviors. An ongoing study of PSF individual therapy (NCT02460900) will shed light on differences between group and individual tobacco treatments.

One HIV specialist clinician and noted author has aptly referred to HIV and tobacco use as “synergistic health catastrophes.”43 As the evidence accumulates on the key role that cigarette smoking plays in the public health of the PLWH community both in the United States and abroad, the need to develop more and better strategies for tobacco treatment in this population grows more urgent. The current study adds to the short list of adequately powered trials exploring behavioral tobacco treatment, generally paired with pharmacotherapy, to promote cessation in PLWH. Our results, considered against the background of modest quit rates reported in other trials of intensive behavioral tobacco treatments for PLWH,31–34 provide a sobering reminder of the need to improve our therapeutic approaches and to apply sensible harm reduction strategies, for example, cutting down, screening for lung cancer, and controlling other cardiovascular risk factors, to most PLWH smokers who are destined to continue smoking. Although our trial did not achieve its primary 6-month abstinence outcome, our overall findings show that group therapy holds promise as a tobacco treatment strategy for PLWH, and future studies should focus on ways to improve upon and sustain its effects with booster counseling sessions and/or longer courses of pharmacotherapy.

ACKNOWLEDGMENTS

The authors acknowledge with gratitude the efforts of Daniela Morales, Carol Rosario, Eileen Dolce, Doreen McGuire, Sean Durant, Giovanna Calderon-Di-Francesca, Kimberly Bennett, Noreen Cabellon, Sujana Lalagari, Veronika Sanderova, Terri Nochetto, Augusto Paredes, and all of the smoking cessation counselors who assisted in the completion of the study. The authors also gratefully acknowledge the patients and staff of the HIV care clinics at Montefiore Medical Center, the Comprehensive Health Care Center, and Medstar Georgetown University Hospital.

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Keywords:

HIV; tobacco use; cigarette; smoking; treatment; group therapy

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