Dataset Information

Pilot Randomized Controlled Trial of a Digital Storytelling Intervention for Smoking Cessation in Women Living With HIV.

ABSTRACT:

Background

People living with HIV in the USA smoke at a rate nearly three times that of the general population, and Black women are disproportionately affected by HIV infection.

Purpose

This study was conducted to test the preliminary efficacy of a digital storytelling intervention for smoking cessation in U.S. women living with HIV.

Methods

Participants in the treatment arm viewed a film in which women living with HIV talk about quitting smoking, and those in the control arm viewed an attention-control film in which women talk about living with HIV infection. Participants in both arms received eight weekly video-call counseling sessions focused on smoking cessation and nicotine patches or gum during the same period. Participants were followed on a monthly basis from quit day for 3 months.

Results

Of the 53 participants randomized, four withdrew before receiving any intervention, one dropped out during the intervention, and 48 (90.6%) completed the study. No difference was found in the baseline characteristics between the two arms with the exception that the treatment arm had higher nicotine dependence scores [t(1.51) = 2.30, p = .03] than the control arm. Seven day point-prevalence abstinence rates at 3 month follow-up were not found to differ between the two arms. However, the odds of achieving 3 month prolonged abstinence were four times greater (odds ratio = 4.23, 95% confidence interval = 1.10, 16.23) in the treatment arm than the control arm when the analysis was performed with those (n = 49, 92.5%) who received any part of the allotted intervention.

Conclusions

A digital storytelling intervention seems to be a valuable strategy to enhance the effect of conventional tobacco dependence treatment for women living with HIV. However, the underlying mechanism of the effect of digital storytelling necessitates further investigations in a large RCT.Clinical Trials Registration No. NCT03289676.

SUBMITTER: Kim SS

PROVIDER: S-EPMC7391216 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Publications

Pilot Randomized Controlled Trial of a Digital Storytelling Intervention for Smoking Cessation in Women Living With HIV.

Kim Sun S SS Lee Sang A SA Mejia Jeannette J Cooley Mary E ME Demarco Rosanna F RF

Annals of behavioral medicine : a publication of the Society of Behavioral Medicine 20200501 6

<h4>Background</h4>People living with HIV in the USA smoke at a rate nearly three times that of the general population, and Black women are disproportionately affected by HIV infection.<h4>Purpose</h4>This study was conducted to test the preliminary efficacy of a digital storytelling intervention for smoking cessation in U.S. women living with HIV.<h4>Methods</h4>Participants in the treatment arm viewed a film in which women living with HIV talk about quitting smoking, and those in the control a ...[more]

PMID: 31863582

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Project description:Background:People living with HIV smoke at a rate three times that of the general population. This randomized controlled pilot trial tested the feasibility and acceptability of a video-call smoking cessation intervention in women living with HIV and its preliminary efficacy compared with a voice-call smoking cessation intervention. The study focused on women due to a paucity of studies among this population, and women are less likely than men to quit smoking when provided with conventional treatment. Methods:Participants in both arms received an HIV-tailored smoking cessation intervention comprising eight 30-minute weekly counseling sessions in conjunction with active nicotine patches for 8 weeks. The only difference between the two arms was the delivery mode of the intervention: via either telephone-based video or voice call. Survival analysis and a Cox proportional hazard regression model were performed to identify factors predicting 6-month prolonged abstinence from smoking. Results:A video-call intervention was almost 30% less feasible than a voice-call intervention because women in their 50s and 60s or poorer women living in some southern states did not have access to video-call equipment. However, those who received the video-call intervention were more likely to complete the study than those who had the voice-call intervention. There was no difference in the acceptability of the two interventions. A survival analysis revealed that those in the video arm were significantly more likely to maintain smoking abstinence over the 6-month follow-up period than those in the voice arm (log rank ? 2=4.02, P<0.05). Conclusion:Although a video-call intervention is less feasible than a voice-call intervention, the former seems to outperform the latter in achieving long-term smoking abstinence for women living with HIV, which may offer an advantage over establishing therapeutic alliance and visually monitoring their adherence to nicotine patches. Clinical trial registration:ClinicalTrials.gov NCT02898597.

Project description:BackgroundHeavy drinking (HD) is far more common among smokers compared with nonsmokers and interferes with successful smoking cessation. Alcohol-focused smoking cessation interventions delivered by counselors have shown promise, but digital versions of these interventions-which could have far greater population reach-have not yet been tested.ObjectiveThis pilot randomized controlled trial aimed to examine the feasibility, acceptability, and effect sizes of an automated digital smoking cessation program that specifically addresses HD using an interactive web-based intervention with an optional text messaging component.MethodsParticipants (83/119, 69.7% female; 98/119, 82.4% white; mean age 38.0 years) were daily smokers recruited on the web from a free automated digital smoking cessation program (BecomeAnEX.org, EX) who met the criteria for HD: women drinking 8+ drinks/week or 4+ drinks on any day and men drinking 15+ drinks/week or 5+ drinks on any day. Participants were randomized to receive EX with standard content (EX-S) or an EX with additional content specific to HD (EX-HD). Outcomes were assessed by web-based surveys at 1 and 6 months.ResultsParticipants reported high satisfaction with the website and the optional text messaging component. Total engagement with both EX-S and EX-HD was modest, with participants visiting the website a median of 2 times, and 52.9% of the participants enrolled to receive text messages. Participants in both the conditions showed substantial, significant reductions in drinking across 6 months of follow-up, with no condition effects observed. Although smoking outcomes tended to favor EX-HD, the condition effects were small and nonsignificant. A significantly smaller proportion of participants in EX-HD reported having a lapse back to smoking when drinking alcohol (7/58, 16%) compared with those in EX-S (18/61, 41%; χ21=6.2; P=.01).ConclusionsThis is the first trial to examine a digital smoking cessation program tailored to HD smokers. The results provide some initial evidence that delivering such a program is feasible and may reduce the risk of alcohol-involved smoking lapses. However, increasing engagement in this and other web-based interventions is a crucial challenge to address in future work.Trial registrationClinicalTrials.gov NCT03068611; https://clinicaltrials.gov/ct2/show/NCT03068611.

Project description:IntroductionWe Can Quit" (WCQ) is community-based stop-smoking program delivered by trained community facilitators, based on the socio-ecological framework and developed using a Community-based Participatory Research approach, targeting women living in socioeconomically disadvantaged (SED) areas of Ireland.Aims and methodsThe We Can Quit2 (WCQ2) pilot trial assessed the feasibility of WCQ. A pragmatic cluster randomized controlled trial with a process evaluation WCQ2, was conducted in four matched pairs of SED districts (8-10 000 women per district). Districts were independently randomized to WCQ (group support + nicotine replacement therapy), or to individual support delivered by health professionals. Participants were adult women smokers interested in quitting, who were living or working in trial districts. Recruitment of districts and 194 women in four waves (49 women per wave); retention at 12 weeks and 6 months; fidelity to intervention delivery and acceptability of trial-related processes were assessed. Validated smoking abstinence at 12-week and 6-month post-intervention was recorded, missing data assumed as continued smoking.ResultsEight districts were recruited. 125/188 (66.5%) eligible women consented. The 49 women target was reached in wave4. Retention at 12 weeks was (Intervention [I]: 55.4%; Control [C]: 51.7%), at 6 months (I: 47.7%; C: 46.7%). Smoking abstinence at 12 weeks was (I: 23.1%, [95% CI: 14.5 to 34.7]; C: 13%, [95% CI: 6.9 to 24.1]). 83.8% of session activities were delivered. Trial-related processes were acceptable to facilitators. Low literacy was highlighted as a barrier for participants' acceptability.ConclusionsWCQ was feasible to deliver by trained facilitators and indicated a positive direction in abstinence rates. Low literacy will need to be addressed in a future trial design.ImplicationsThis pilot trial showed that a stop-smoking intervention tailored to a group of women smokers living in SED areas which was delivered by trained local women within their local communities was feasible. Furthermore, although not formally compared, more WCQ women were abstinent from smoking at the end of treatment. The results are relevant to enhance the design of a fully powered effectiveness trial, and provide important evidence on the barriers to deliver a tailored smoking cessation service to SED women smokers in Ireland.

Project description:BACKGROUND:Smartphone apps for smoking cessation could offer easily accessible, highly tailored, intensive interventions at a fraction of the cost of traditional counseling. Although there are hundreds of publicly available smoking cessation apps, few have been empirically evaluated using a randomized controlled trial (RCT) design. The Smart-Treatment (Smart-T2) app is a just-in-time adaptive intervention that uses ecological momentary assessments (EMAs) to assess the risk for imminent smoking lapse and tailors treatment messages based on the risk of lapse and reported symptoms. OBJECTIVE:This 3-armed pilot RCT aimed to determine the feasibility and preliminary efficacy of an automated smartphone-based smoking cessation intervention (Smart-T2) relative to standard in-person smoking cessation clinic care and the National Cancer Institute's free smoking cessation app, QuitGuide. METHODS:Adult smokers who attended a clinic-based tobacco cessation program were randomized into groups and followed for 13 weeks (1 week prequitting through 12 weeks postquitting). All study participants received nicotine patches and gum and were asked to complete EMAs five times a day on study-provided smartphones for 5 weeks. Participants in the Smart-T2 group received tailored treatment messages after the completion of each EMA. Both Smart-T2 and QuitGuide apps offer on-demand smoking cessation treatment. RESULTS:Of 81 participants, 41 (50%) were women and 55 (68%) were white. On average, participants were aged 49.6 years and smoked 22.4 cigarettes per day at baseline. A total of 17% (14/81) of participants were biochemically confirmed 7-day point prevalence abstinent at 12 weeks postquitting (Smart-T2: 6/27, 22%, QuitGuide: 4/27, 15%, and usual care: 4/27, 15%), with no significant differences across groups (P>.05). Participants in the Smart-T2 group rated the app positively, with most participants agreeing that they can rely on the app to help them quit smoking, and endorsed the belief that the app would help them stay quit, and these responses were not significantly different from the ratings given by participants in the usual care group. CONCLUSIONS:Dynamic smartphone apps that tailor intervention content in real time may increase user engagement and exposure to treatment-related materials. The results of this pilot RCT suggest that smartphone-based smoking cessation treatments may be capable of providing similar outcomes to traditional, in-person counseling. TRIAL REGISTRATION:ClinicalTrials.gov NCT02930200; https://clinicaltrials.gov/show/NCT02930200.

Project description:BackgroundTobacco use is the leading cause of preventable death in Ireland with almost 6000 smokers dying each year from smoking-related diseases. The 'We Can Quit2' (WCQ2) study is a pilot pragmatic two-arm, parallel-group, cluster randomised trial that aims to explore the feasibility and acceptability of trial processes including recruitment and to estimate parameters to inform sample size estimates needed for an effectiveness trial. This future trial will assess the effectiveness of a community-based smoking cessation intervention for women living in disadvantaged areas on short- and medium-term cessation rates.Methods/designFour matched pairs of districts (eight clusters) selected by area level of deprivation, geographical proximity, and eligibility for free medical services will be randomised to receive either WCQ (behavioural support + access to Nicotine Replacement Therapy (NRT)) delivered over 12 weeks by trained Community Facilitators (CFs) or to a form of usual care, a one-to-one smoking cessation service delivered by Smoking Cessation Officers from Ireland's national health service, the Health Service Executive (HSE). Within each cluster, 24-25 women will be recruited (97 per arm; 194 in total) in 4 phases with consent obtained prior to cluster randomisation. The outcome measures will assess feasibility and acceptability of trial processes, including randomisation. Outcome data for a future definitive intervention (biochemically validated smoking abstinence) will be collected at end of programme (12 weeks) and at 6 months. WCQ2 has an embedded process evaluation using both qualitative and quantitative methods. This will be conducted (semi-structured client and CF interviews, intervention delivery checklist, and diary) to explore acceptability of trial processes, intervention fidelity, trial context, and implementation. Trial processes will be assessed against domains of the PRECIS-2 wheel to inform a future definitive trial design.DiscussionData from this pilot trial will inform the design and sample size for a full cluster randomised trial to determine the effectiveness of an intervention tailored to disadvantaged women in improving smoking cessation rates. It will provide transferable learning on the systems and implementation strategies needed to support effective design of future pragmatic community-based trials which address health promotion interventions for women in disadvantaged communities.Trial registrationConcurrent to publication. Controlled trials ISRCTN74721694.

Project description:BackgroundTobacco smoking remains the leading cause of preventable death and disease worldwide. Digital interventions delivered through smartphones offer a promising alternative to traditional methods, but little is known about their effectiveness.ObjectiveOur objective was to test the preliminary effectiveness of Quit Genius, a novel digital therapeutic intervention for smoking cessation.MethodsA 2-arm, single-blinded, parallel-group randomized controlled trial design was used. Participants were recruited via referrals from primary care practices and social media advertisements in the United Kingdom. A total of 556 adult smokers (aged 18 years or older) smoking at least 5 cigarettes a day for the past year were recruited. Of these, 530 were included for the final analysis. Participants were randomized to one of 2 interventions. Treatment consisted of a digital therapeutic intervention for smoking cessation consisting of a smartphone app delivering cognitive behavioral therapy content, one-to-one coaching, craving tools, and tracking capabilities. The control intervention was very brief advice along the Ask, Advise, Act model. All participants were offered nicotine replacement therapy for 3 months. Participants in a random half of each arm were pseudorandomly assigned a carbon monoxide device for biochemical verification. Outcomes were self-reported via phone or online. The primary outcome was self-reported 7-day point prevalence abstinence at 4 weeks post quit date.ResultsA total of 556 participants were randomized (treatment: n=277; control: n=279). The intention-to-treat analysis included 530 participants (n=265 in each arm; 11 excluded for randomization before trial registration and 15 for protocol violations at baseline visit). By the quit date (an average of 16 days after randomization), 89.1% (236/265) of those in the treatment arm were still actively engaged. At the time of the primary outcome, 74.0% (196/265) of participants were still engaging with the app. At 4 weeks post quit date, 44.5% (118/265) of participants in the treatment arm had not smoked in the preceding 7 days compared with 28.7% (76/265) in the control group (risk ratio 1.55, 95% CI 1.23-1.96; P<.001; intention-to-treat, n=530). Self-reported 7-day abstinence agreed with carbon monoxide measurement (carbon monoxide <10 ppm) in 96% of cases (80/83) where carbon monoxide readings were available. No harmful effects of the intervention were observed.ConclusionsThe Quit Genius digital therapeutic intervention is a superior treatment in achieving smoking cessation 4 weeks post quit date compared with very brief advice.Trial registrationInternational Standard Randomized Controlled Trial Number (ISRCTN) 65853476; https://www.isrctn.com/ISRCTN65853476.

Dataset Information

Pilot Randomized Controlled Trial of a Digital Storytelling Intervention for Smoking Cessation in Women Living With HIV.

Background

Purpose

Methods

Results

Conclusions

Publications

Pilot Randomized Controlled Trial of a Digital Storytelling Intervention for Smoking Cessation in Women Living With HIV.

Similar Datasets

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