Evaluation of an integrated treatment to address smoking cessation and anxiety/depressive symptoms among people living with HIV: Study protocol for a randomized controlled trial

May combine two claims.

People living with HIV who smoke lose more life-years than people living with HIV who do not smoke and than people who smoke without HIV.

“PLWH who smoke (SLWH) lose more life-years than PLWH who do not smoke and people who smoke who do not have HIV.3–5”

• cites [3] sourceNot checked — no full text of the source
• cites [4] sourcePartly supported

  The Results (Life expectancies and life years lost; page not provided) report that 35-year-old men with HIV who smoked lost 7.9 potential life-years compared with nonsmokers with HIV. The paper does not establish that they lost more life-years than smokers without HIV; the Discussion says it lacked an HIV-negative control group with smoking-status data. (LLM, conf=0.88)

  Experimental — accuracy not yet measured
• cites [5] sourcePartly supported

  The Results passage reports that HIV-infected smokers entering care at age 40 lost 6.7 years (men) and 6.3 years (women) compared with HIV-infected never smokers. But “Life Expectancy Losses From Smoking and From HIV Infection” reports larger smoking-associated losses for HIV-uninfected people—10.7 and 10.6 years, respectively—so it does not support the claim that smokers with HIV lose more life-years from smoking than smokers without HIV. Page numbers are unavailable in our copy. (LLM, conf=0.89)

  Experimental — accuracy not yet measured

Probably not a substantial claim: may not pass S3 (load-bearing).

People living with HIV smoke at rates two to three times higher than people without HIV, with estimates of 33.6% to 74% among people living with HIV versus 16.8% to 18% in the general population.

“People living with HIV (PLWH) smoke at rates 2–3 times higher than people without HIV, with smoking estimates of 33.6%−74% among PLWH compared to 16.8–18% among the general population.1,2”

• cites [1] sourcePartly supported

  The Introduction (page unavailable) says smoking prevalence among people living with HIV is approximately two to three times that of the general population. It gives estimates of 40.5–74% for people living with HIV and 18% for the general population, but does not support the claimed lower bounds of 33.6% and 16.8%. (LLM, conf=0.89)

  Experimental — accuracy not yet measured
• cites [2]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Classified as probably not a substantial claim.

If cotinine, anabasine, or other verification data are missing at an assessment, abstinence will be treated as missing data.

“If cotinine, anabasine, or ‘other verified’ data are not available to verify abstinence at an assessment, abstinence will be considered missing data.46”

• cites [46] sourceCould not verify

  The cited paper discusses cost-effectiveness analysis and reporting of intermediate outcomes (Reporting of Intermediate End Points and Disaggregated Results, p. 7). Searches for cotinine, anabasine, biochemical verification, and missing abstinence data found no passage addressing how unverified abstinence should be classified. (LLM, conf=0.77)

  Experimental — accuracy not yet measured

May combine two claims.

The EQ-5D is a five-item scale that has been shown to be sensitive to health-state variations related to HIV, mental health, and tobacco use.

“a 5-item scale that has been shown sensitive to variations in health states related to HIV, mental health,53,54 and tobacco use.55,56”

• cites [52] sourceNot checked — no full text of the source
• cites [53] sourceNot checked — no full text of the source
• cites [54] sourcePartly supported

  The Methods (Measurements; page not available) describe the EQ-5D’s five health-state dimensions and its use in this smoking-cessation study. The paper does not show that the scale is sensitive to tobacco-related health-state variations; the Discussion (Main Findings; page not available) says the 12-month follow-up may have been too short for benefits to become detectable as quality-of-life changes. The HIV and mental-health portions are attached to other citations and are not assessed here. (LLM, conf=0.86)

  Experimental — accuracy not yet measured
• cites [55] sourceSupported
• cites [56] sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing).

Previous research indicates that people living with HIV who smoke may have difficulty with ART uptake.

“previous research has shown that SLWH may have difficulties with ART uptake.65–67”

• cites [65] sourceCould not verify

  The Methods (page unavailable) say participants were already receiving antiretroviral treatment, and the Results (page unavailable) describe medication monitoring. Searches for smoking, tobacco, and ART uptake found no passage addressing whether people living with HIV who smoke have difficulty starting ART. (LLM, conf=0.76)

  Experimental — accuracy not yet measured
• cites [66] sourceNot checked — no full text of the source
• cites [67] sourceCould not verify

  The participant eligibility and smoking-outcome passages (indexed as Abstract; page unavailable) describe a trial of smokers with panic symptoms, not ART uptake among people living with HIV. A References passage names a smoking-cessation trial in people living with HIV but says nothing about ART uptake. Searches for HIV, ART, antiretroviral therapy, and treatment uptake found no passage addressing the claim. (LLM, conf=0.76)

  Experimental — accuracy not yet measured

Classified as probably not a substantial claim.

The study will calculate incremental cost per quit for QUIT and for TMC relative to SOC using standard methods, as done in prior studies.

“We will calculate the incremental cost per quit of the QUIT intervention, as well as the TMC relative to SOC using standard methods77 as we have done in our prior studies,78–80”

• cites [77] sourceSupported
• cites [78]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites [79] sourceNot checked — no full text of the source
• cites [80] sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

Following standard economic evaluation methods, the study will perform parameter-specific sensitivity analyses varying individual parameters singly and in combination across plausible ranges.

“Following standard methods of economic evaluation, we will also perform parameter-specific sensitivity analyses in which individual parameters are varied singly and in combination, through plausible ranges to assess the relative impact different elements of the program have on overall cost-effectiveness.80–83”

• cites [80] sourceNot checked — no full text of the source
• cites [81] sourceCould not verify

  The Cost-Effectiveness section (page unavailable) calculates incremental cost per quit for smoking-cessation therapies, but does not describe parameter-specific sensitivity analyses or varying parameters singly and in combination. Searches for sensitivity analyses, parameter ranges, and variation of assumptions found no supporting passage in our copy. (LLM, conf=0.76)

  Experimental — accuracy not yet measured
• cites [82]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites [83]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

For longitudinal smoking cessation trials, the recommended intent-to-treat method is GLMM.

“GLMM is the recommended intent-to-treat approach for longitudinal smoking cessation trials.69”

• cites [69] sourceCould not verify

  The “Discrete Distributions of the TVC” section says the authors’ methods extend to generalized multilevel models for discrete outcomes, including binary drug use. Our copy does not address intent-to-treat analysis or recommend GLMM for longitudinal smoking cessation trials (searched: smoking cessation, intent-to-treat, and generalized linear mixed models). (LLM, conf=0.76)

  Experimental — accuracy not yet measured

Probably not a substantial claim: may not pass S3 (load-bearing).

Sensitivity analyses will compare findings when missing abstinence data are coded using last observation carried forward and when all missing data are coded as smoking.

“We also will conduct sensitivity analyses to compare findings when missing abstinence data are coded in two additional ways: (1) using last observation carried forward (LOCF) and (2) coding all missing data as “smoking”.46”

• cites [46] sourceCould not verify

  The Worked Examples section (p. 9) mentions sensitivity and uncertainty analyses generally, but does not address missing abstinence data or either proposed coding method. Searches for last observation carried forward, smoking, and missing-data imputation found no passage supporting those details. (LLM, conf=0.76)

  Experimental — accuracy not yet measured

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

A recent cohort study found that life-years lost among people living with HIV who smoke was 12.3, nearly four times that of HIV-negative smokers and more than twice that of people living with HIV who did not smoke.

“Indeed, a recent cohort study found that life-years lost among SLWH (12.3) was nearly quadruple that of HIV-negative individuals who smoked (3.6) and more than double PLWH who did not smoke (5.1).3”

• cites [3] sourceNot checked — no full text of the source

May combine two claims.

QUIT can successfully increase smoking abstinence and decrease anxiety/depression symptomology from end-of-treatment through 6-month follow-up among people living with HIV who smoke.

“providing evidence that QUIT can successfully increase smoking abstinence and decrease anxiety/depression symptomology at EOT through a 6MFU among SLWH.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Depression and anxiety are common psychiatric disorders.

“are common psychiatric disorders,23”

• cites [23] sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

The Fagerstrom Test for Nicotine Dependence is a 6-item scale designed to assess gradations in tobacco dependence.

“The FTND is a 6-item scale designed to assess gradations in tobacco dependence.37”

• cites [37] sourceNot checked — no full text of the source

Classified as probably not a substantial claim.

Following current methodological recommendations, the study will assess cost-effectiveness from both a societal perspective and a health system perspective.

“Following current methodological recommendations, we will assess these measures of cost-effectiveness from both a societal perspective and from a health system perspective.47”

• cites [47]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

The REDCap randomization module was tested thoroughly before the trial began to ensure that outputs mirrored the allocations in the original tables.

“The REDCap randomization module was tested thoroughly before the trial began, to ensure that outputs mirrored the allocations in the original tables.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The study will examine correlations among putative mediators to check for multicollinearity, and if any mediators correlate at r≥.75 they will be averaged together for mediation analyses.

“We also will examine the correlation between putative mediators to evaluate potential multicollinearity that may dampen effects; if any of the mediators (depression, anxiety, anxiety sensitivity, distress tolerance, and/or anhedonia) are highly correlated (r≥.75), they will be combined (averaged together) for the mediation analyses.”

Probably not a substantial claim: may not pass S3 (load-bearing).

After each randomization, the Project Manager compares the REDCap allocation to the statistician's tables as a secondary check.

“Additionally, after each randomization, the Project Manager compares the randomization allocation in REDCap to the tables provided by the study statistician as a secondary check.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Only the study Project Manager can see and access the randomization tables; other team members use the REDCap randomization module, which hides allocation until randomization is prompted.

“Only the study Project Manager can see and access the tables once uploaded to REDCap – all other study team members will utilize the REDCap randomization module, which hides the allocation until randomization is prompted.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Because of resource constraints, the study will not estimate cost per QALY over participants' complete lifespans, as that would require substantial mathematical modeling.

“Given resource constraints, we will not estimate cost per QALY over participants’ complete lifespans as that would require a significant mathematical modeling effort.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Participants who cannot or will not provide a urine sample for anabasine testing will need a significant other to confirm their abstinence status.

“Participants who are unable or unwilling to provide urine assessment to test for anabasine will be required to have a significant other confirm the participant’s abstinence status (other verified);”

Classified as probably not a substantial claim.

To better estimate the causal relation between mediators and abstinence, the study will use cross-lag mediation analysis where mediators at time t predict the outcome at t+1 while controlling for the outcome at time t.

“In order for the “b” path to more closely estimate the causal relation between putative mediators and abstinence, we will use a cross lag mediation analysis, in which the mediators at time “t” predict the outcome at the next assessment (“t+1”), controlling for the outcome at time “t” (as we have done in previous multimediator longitudinal models).71”

Probably not a substantial claim: may not pass S3 (load-bearing).

A Data Safety and Monitoring Board provides ongoing oversight.

“and a Data Safety and Monitoring Board provides ongoing oversight.”

Classified as probably not a substantial claim.

The standard-of-care control condition was selected as the most appropriate comparison because time-matched control is not a strategy that would be used outside the research setting.

“The SOC control condition was selected as the most appropriate comparison condition because TMC is not a strategy that would be used outside the research setting.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Randomization schema tables are stratified by sex assigned at birth and implementation site.

“Prior to study implementation, randomization schema tables (stratified by sex assigned at birth and implementation site) will be created by the study statistician.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The trial is registered on clinicaltrials.gov with identifier NCT03904186.

“is registered on clinicaltrials.gov (ID: NCT03904186).”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The Smoking History Questionnaire is a 30-item measure that includes items on smoking rate, age of initiation, and years of smoking habitually.

“Smoking history and pattern will be assessed with the SHQ, a 30-item measure that includes items pertaining to smoking rate, age of initiation, years of smoking habitually.38”

• cites [38]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

All treatment sessions are audio-recorded to assist with supervision and treatment fidelity assessment.

“To assist with supervision and treatment fidelity assessment, all treatment sessions will be audio-recorded.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Therapists consistently not meeting acceptable treatment adherence, therapist competency, or contamination ratings receive remedial training.

“Therapists consistently not meeting acceptable treatment adherence, therapist competency, or contamination ratings will receive remedial training.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The study statistician, who has no contact with participants, oversees the randomization process, preventing experimenter bias.

“The study statistician, who will have no contact with participants thereby preventing experimenter bias in randomization, will oversee the randomization process.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The SHAPS is a 14-item self-report measure of current anhedonia.

“The SHAPS is a 14-item self-report measure that assesses participants’ current levels of anhedonia.51”

• cites [51]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

Participants are randomized using variable-sized permuted block randomization to allocate them to treatment condition at each site.

“Participants will be randomized using variable-sized permuted block-randomization to allocate participants to treatment condition at each site”

Classified as probably not a substantial claim. May combine two claims.

The study will first test baseline equivalence between treatment groups on key demographic and psychological variables, and any variables showing group differences will be used as covariates in final analyses.

“We will first assess the equivalence of the treatment groups on key baseline variables (demographics and psychological variables); variables on which the groups differ will be used as covariates in the final analyses.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Fenway Health will provide a greater subset of participants with diverse sexual orientations, with the majority of patients being gay or bisexual.

“Fenway Health will provide a greater subset of participants with diverse sexual orientations: the majority of patients at Fenway Health are gay or bisexual.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The PHQ-8 is an eight-item measure of current depression severity or absence.

“The PHQ-8 is an 8-item measure of current severity of depression (or lack of depression).47”

• cites [47]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

The EQ-5D has been validated in HIV-positive samples in North America.

“Recently, this instrument has also been validated in HIV positive samples in North America.57”

• cites [57]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

After training, treatment fidelity is continually monitored and assessed during ongoing weekly supervision meetings.

“After successfully completing the training, treatment fidelity will be continually monitored and assessed during on-going weekly supervision meetings.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The MINI will be given at baseline by trained research staff holding a master's degree in psychology or a related mental-health field.

“The MINI will be administered by trained research personnel with a master’s degree in psychology or another mental-health related field at baseline.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The MINI is a brief structured clinical interview used to diagnose psychiatric disorders according to DSM-5.

“The MINI is a short structured clinical interview for diagnosis of psychiatric disorders according to DSM-5.39”

• cites [39]Not checked — no full text of the source

Classified as probably not a substantial claim. May combine two claims.

Self-reported smoking abstinence will be checked with expired carbon monoxide at every timepoint and biochemically confirmed at all follow-up assessments using saliva cotinine for those not reporting NRT use and urine anabasine for those reporting NRT use.

“Self-reported abstinence will be verified via an expired carbon monoxide (CO) breath analysis at all timepoints, as well as biochemically confirmed at all follow up assessments by saliva cotinine for participants who do not report NRT use and a urine assessment of anabasine for participants who report using NRT.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The Institutional Review Board at Mass General Brigham approved the study and serves as the Single IRB for all sites under the National Institutes of Health Single IRB policy.

“The Institutional Review Board at Mass General Brigham approved the study and serves as the Single IRB for all sites under the National Institutes of Health Single IRB policy29”

• cites [29]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

Twenty percent of all audio recordings will be rated for therapist competency, fidelity, and contamination by other study clinicians and principal investigators.

“20% of all audio recordings will be rated for therapist competency, fidelity (if session 1 or QUIT), and contamination (if TMC) by other study clinicians and PIs.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The SSASI is a five-item measure of sensitivity to and discomfort with physical sensations.

“The SSASI is a 5-item measure that assesses sensitivity to, and discomfort with, physical sensations.49”

• cites [49] sourceNot checked — no full text of the source

Classified as probably not a substantial claim. May combine two claims.

A positive saliva cotinine result above 30 ng/mL, a positive anabasine result above 3 ng/mL, or positive smoking status from other verification will override self-reported abstinence.

“Self-reported abstinence will be overridden by a positive saliva cotinine (>30 ng/mL) or anabasine (>3 ng/mL) assessment or positive smoking status according to ‘other verified’ data.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The SSASI was derived from the original 18-item Anxiety Sensitivity Index-3.

“This measure was derived from the original 18-item Anxiety Sensitivity Index-3.22”

• cites [22] sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

Therapists complete a multi-day training on QUIT and time-matched control with a PhD-level clinician with expertise in delivering QUIT and smoking cessation treatment.

“Therapists will complete a multi-day training on QUIT and TMC with a PhD-level clinician with expertise delivering QUIT and smoking cessation treatment.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The study will examine missing data patterns, dropout rates, and distributional properties of measures, and will use transformations to improve distributions if needed.

“We will then examine missing data patterns, dropout rates (see below), and distributional properties of measures, and use transformations to improve distributions if necessary.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The DTS is a 15-item self-report measure of perceived ability to tolerate emotional distress.

“The DTS is a 15-item self-report measure that assesses participants’ perceived ability to tolerate emotional distress.50”

• cites [50] sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Participants in each condition receive the same set of questionnaires at every visit, standardized across all visits and conditions.

“Participants in each condition will receive the same set of questionnaires at every visit. These questionnaires are standardized across all visits and conditions”

Probably not a substantial claim: may not pass S3 (load-bearing).

The three implementation sites provide depth and breadth across multiple spectra of diversity.

“The three implementation sites will provide great depth and breadth across multiple spectra of diversity.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The study's short-term cost and QALY data will be readily usable to assess lifetime cost per QALY using advanced modeling techniques developed by Reddy and others.

“However, our data on short-term costs and QALY improvements will be readily usable to assess lifetime cost per QALY using advanced modeling techniques developed by Reddy and others.76”

• cites [76] sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

Monte Carlo simulation methods incorporating parameter uncertainty will be used to develop confidence bounds on cost-per-quit and cost-per-QALY estimates.

“We will use Monte Carlo simulation methods incorporating uncertainty in the calculation parameters to develop confidence bounds on our cost per quit and cost per QALY estimates.”

Probably not a substantial claim: may not pass S3 (load-bearing).

OASIS is a five-item scale assessing the severity and impairment of anxiety-related symptoms.

“OASIS is a 5-item scale that assesses the severity and impairment related to anxiety-related symptoms.48”

• cites [48] sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

The study follows Food and Drug Administration guidelines for nicotine replacement therapy dose and time administration.

“We will follow the Food and Drug Administration guidelines for dose and time administration.31”

• cites [31]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

Thomas Street Health Center will provide greater gender diversity, with more than 25% of patients identifying as cis-gender female.

“Additionally, Thomas Street Health Center will provide greater gender diversity as more than 25% of the patients identify as cis-gender female.”

Probably not a substantial claim: may not pass S2 (checkable).

Treatment delivered through adaptable platforms might reach and affect more people living with HIV who smoke, a group that is underserved and difficult to reach.

“Such flexible platforms for treatment delivery may have greater potential to reach and impact SLWH, which constitutes an underserved, harder-to-reach population.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Initial analyses will test whether remote status from COVID-19 affects outcomes at each assessment.

“Preliminary data analyses will determine whether outcomes at each assessment are impacted by remote status due to COVID-19.”

Probably not a substantial claim: may not pass S2 (checkable).

The study could provide a valuable model for conducting remote or virtual smoking cessation research with people living with HIV who smoke.

“As such, this study may serve as a clinically important example for how to implement remote/virtual smoking cessation research among SLWH.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The current attrition rate was approximately 9.8%, which was much better than anticipated.

“Our current attrition rate is much better than anticipated, standing at approximately 9.8%.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The study will rerun analyses coding for various missing data patterns to determine whether missingness affects findings and how treatment differences depend on the missing data pattern.

“We will rerun our analyses coding for various missing data patterns (no missing data, sporadic missing, dropouts, etc.) to determine (1) if missingness impacts our findings and (2) how the differences between treatment conditions depends on the missing data pattern.”

Probably not a substantial claim: may not pass S3 (load-bearing).

For sex moderating the effect of condition on PPA, the study would have .80 power to detect an approximately 16% difference between males and females in the treatment effect on abstinence.

“For the aim of sex moderating the effects of condition on PPA, again we would have .80 power to detect a difference of approximately 16% between males and females in the effect of treatment condition on abstinence.”

May combine two claims.

They chose the patch alone because short-term NRT could interfere with QUIT's behavioral exercises, potentially leading participants to use NRT during cravings rather than riding them out.

“This decision was made as inclusion of a short-term NRT may undermine the function of the behavioral experiments (i.e., to move through the craving/urge without smoking) taught in the QUIT condition as participants may be included to use a short-term NRT when experiencing withdrawal instead of ‘surfing the urge.’”

Probably not a substantial claim: may not pass S3 (load-bearing).

All but one enrolled participant were willing and able to switch to remote visits.

“However, all but one of our enrolled participants were willing and able to shift to remote visits.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

New participants were enrolled through a fully remote process at the two Boston sites, and recruitment continued without interruption under these new processes.

“New participants were enrolled under a fully remote process at our two Boston sites, and recruitment was able to continue uninterrupted under these new processes.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

By April 13, 2021, screening had reached 90 individuals; 51 had consented and finished baseline; 46 were enrolled after baseline; 41 had been randomized; and 12 had completed all follow-ups.

“As of April 13, 2021, 90 participants have been screened for the study; 51 have given verbal and/or written consent to participate in the study and have completed a baseline assessment; 46 have been enrolled post-baseline; 41 have been randomized; and 12 have completed the study (including all follow-ups).”

Probably not a substantial claim: may not pass S4 (based). May combine two claims.

This study aims to help people living with HIV who smoke to quit, which ought to lower smoking-related illness and death in this group.

“Ultimately, the goal of the present study is to help SLWH stop smoking, which should decrease smoking-related morbidity and mortality in SWLH.”

Classified as probably not a substantial claim. May combine two claims.

The study was powered for QUIT compared to TMC, with the understanding that the cessation rate for SOC would be lower than for TMC.

“The study was powered for QUIT compared to TMC with the understanding that the cessation rate for SOC would be lower than TMC.”

Classified as probably not a substantial claim.

Such materials should make it easier to adopt QUIT in point-of-care settings.

“These resources will support the easy adoption of QUIT into point of care settings.”

Classified as probably not a substantial claim.

A Monte Carlo study was performed to calculate the minimum between-group differences in abstinence rates detectable by the planned analysis.

“We performed a Monte Carlo study to calculate the minimum between-group differences in abstinence rates detectable by our analysis.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Pattern mixture modeling will be used to assess the effect of missing data.

“We will use pattern mixture modeling to assess the effect of missing data.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The study has produced training materials, including agendas and slide decks, for its clinicians; these can be readily modified for community clinicians with less CBT expertise.

“Training tools (e.g., agendas and PowerPoints) have been created as part of the study to train our clinicians and can be easily adapted to community-based clinicians who may have less knowledge of CBT techniques.”

May combine two claims.

This three-arm hybrid efficacy/effectiveness design, though complex, lets the research move forward rapidly, using a time-matched control for efficacy and a standard-of-care arm for cost-effectiveness.

“The complexity of the 3-arm hybrid efficacy/effectiveness design allows us to advance the science expeditiously, with a time-matched control to answer the efficacy questions and a standard of care condition to address cost effectiveness.”

Classified as probably not a substantial claim. May combine two claims.

Certain studies indicate that dual or combination NRT may improve quitting more than single NRT, but behavioral support levels differed across those studies.

“Yet, some research would suggest that use of combination/dual NRT (e.g., long-acting nicotine patches along with short-term gum or lozenges) is more efficacious in cessation success than single NRT; however, the level of behavioral support in these studies was variable.30”

• cites [30]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

An initial analysis will examine if remote status from COVID-19 restrictions, treated as a time-varying predictor, predicts or moderates each outcome.

“Preliminary analysis will investigate whether remote status due to COVID-19 restrictions (as a time-varying predictor) predicts or moderates each outcome.”