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RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers

RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02781090
Acronym
PSFW+
Enrollment
512
Registered
2016-05-24
Start date
2016-07-06
Completion date
2020-09-14
Last updated
2023-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use Disorder, HIV

Keywords

HIV, Tobacco, Cigarette, Smoking, Social Network, Internet, Cessation

Brief summary

This trial will compare the efficacy of Positively Smoke Free on the Web+ (a smoking cessation program + social network for HIV-infected smokers) to the American Heart Association Getting Healthy website in promoting abstinence in a group of HIV-infected smokers. All participants will be offered a three-month supply of nicotine patches.

Detailed description

There are 1.1 million persons living with HIV (PLWH) in the US: 60% smoke cigarettes and 75% are interested in quitting. Two-thirds of PLWH use the Internet, making this a promising avenue to deliver smoking cessation treatment. Almost none are currently accessing smoking cessation interventions designed to meet their specific needs and concerns. Cigarette smoking is responsible for 24%--61% of deaths among PLWH, and 30% of non-AIDS defining malignancies. It is driving the alarming rise in lung cancers in this highly vulnerable population. The lack of access to proven, effective, culturally appropriate tobacco cessation services represents a health disparity of the first order. Cessation websites offer smokers convenience, low (or no) cost, and anonymity; however, there are no publicly available web-based cessation programs specifically designed for PLWH smokers. Smokers living with HIV have high rates of nicotine dependence, anxiety, depression, loneliness, and substance use. The investigators developed Positively Smoke Free on the Web (PSFW), a theory-driven, culturally tailored web-based program designed to address the specific needs of PLWH smokers. The investigators' NCI-funded R21 pilot of PSFW demonstrated moderate-high levels of adherence and yielded higher 3-month abstinence rates compared to standard care (10% vs. 4%). The investigators' prior research on web-based cessation interventions has shown that smokers who participate in an online community - whether passively reading posts by others or actively engaging in online discussions - are more than twice as likely to achieve abstinence even after controlling for a broad range of covariates. In preparation for the proposed study, the investigators' partners at Truth Initiative (formerly known as the American Legacy Foundation) have enhanced and modernized PSFW by integrating an online community platform (now PSFW+), developing a training protocol for PLWH smoker seed users (to provide a critical mass of social network participants), and recruiting and training 11 PLWH smokers for this role. The prototype PSFW+ application has been successfully alpha- and beta-tested in anticipation of the randomized controlled trial. The investigators propose a study that will compare the efficacy of the PSFW+ smoking cessation website to an attention-matched website promoting cardiovascular health in a randomized controlled trial with repeated measures at baseline, 1, 3, and 6 months. Participants will be N=550 PLWH smokers interested in quitting in the next 30 days. All participants will be offered nicotine replacement therapy. It is hypothesized that PSFW+ will outperform the control condition on the primary outcome of 7-day point prevalence abstinence at 6 months post-randomization. Secondary aims and exploratory analyses will examine theory-driven hypotheses about the mediators and moderators of treatment outcome (e.g., depression, anxiety, social support, loneliness, self-efficacy). Establishing the effectiveness of a web-based smoking cessation program for PLWH that has broad reach and could be scaled to reach PLWH smokers throughout the US would not only represent an enormous advance in the fight against tobacco use in PLWH, but would also provide a clearer understanding of the role of targeted, web-based health interventions in comprehensive HIV care.

Interventions

BEHAVIORALPSFW+

PSFW+ is an eight session motivational/educational web-program promoting cessation for HIV-infected smokers. It includes a professionally administered social network/online support community.

BEHAVIORALAHA

The AHA Getting Healthy website is a health-promoting, seven-module website developed by the American Heart Association to encourage healthy behaviors in the general population

All participants, in both study arms, will be offered a 3-month supply of nicotine patches

Sponsors

Westat
CollaboratorOTHER
Johns Hopkins University
CollaboratorOTHER
Montefiore Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. age 18 or older 2. current smoking as defined by a validated tobacco use measure 3. laboratory confirmed HIV-infection; 3) residence in commuting distance to the Bronx, NY or Baltimore, MD 4. English language fluency 5. motivation to quit within the next 30 days 6. at least weekly Internet and email access 7. REALM literacy score of 19/66 or above, indicating reading level of at least 4-6 grade (PSFW content was written for this literacy level) 8. willingness to provide informed consent and undergo randomization.

Exclusion criteria

1. previous participation in any trial of Positively Smoke Free interventions or use of PSFW+ 2. pregnancy 3. contraindication to nicotine replacement therapy 4. current participation in an active smoking cessation treatment (e.g., group therapy, use of pharmacotherapy) 5. PSFW+ seed users will be excluded 6. To avoid study condition contamination and to maintain the statistical independence of subject outcomes, otherwise eligible individuals who are spouses, partners, and/or roommates of study participants will be excluded. All ineligible patients will receive a Positively Smoke Free smoking cessation brochure and will be encouraged to access nationally-available (free) quitline counseling.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Achieving 7-day Point Prevalence Abstinence From Tobacco Use6 monthsThe number of participants achieving 7-day Point Prevalence Abstinence (PPA) from tobacco use at 6 months was determined for each study arm. 7-day PPA parameters for this study were based on the number of participants demonstrating biochemically confirmed exhaled carbon monoxide (\< 10ppm).

Secondary

MeasureTime frameDescription
Website SatisfactionUp to 6 monthsQuestionnaires were administered to all study participants at 6 months to assess participant satisfaction with the PSFW+ and AHA 'Getting Healthy' website and online tools. Participants were asked to provide feedback regarding their level of satisfaction with the online platform using the following response options: Not at all Satisfied, A little Satisfied, Moderately Satisfied, Very Satisfied, or Extremely Satisfied. Participants responses were aggregated and tabulated.

Countries

United States

Participant flow

Recruitment details

Participants were recruited through provider referrals from the two clinical trial sites, Montefiore Medical Center's Center for Positive Living in the Bronx, NY and Johns Hopkins Bartlett Clinic for Infectious Diseases in Baltimore, MD, between July 2016 and March 2020. Participants were also recruited by direct contact in the clinical waiting areas, and by self-referral in response to study advertisements.

Pre-assignment details

Of 512 enrolled participants, 506 met inclusion criteria and were randomized into one of the two study arms/groups. Six of the 512 trial enrollees were excluded from the final trial data set for the following reasons: two participants disenrolled immediately following randomization, two participants were ineligible due to seed user status, and two participants were excluded for enrolling in the trial a second time.

Participants by arm

ArmCount
Positively Smoke Free on the Web (PSFW+)
Participants were assigned to the multimodal PSFW+ interactive web-based behavioral intervention hosted within an online social network. PSFW+: PSFW+ is an intensive eight session motivational/educational web-program, based on social cognitive theory, designed to promote cessation among HIV-infected smokers. It included a professionally administered social network/online support community. Nicotine polacrilex: All participants were offered a 3-month supply of nicotine patches
255
American Heart Association Getting Healthy (AHA)
Participants were assigned to the AHA Getting Healthy web-based control intervention program (the AHA later changed in name from Getting Healthy to My Life's Check, Life's Simple 7 AHA: The AHA Getting Healthy website is an attention-matched, health-promoting, seven-module website developed by the American Heart Association to encourage healthy behaviors in the general population Nicotine polacrilex: All participants were offered a 3-month supply of nicotine patches
251
Total506

Withdrawals & dropouts

PeriodReasonFG000FG001
3-Month Follow-UpDeath10
3-Month Follow-UpLost to Follow-up4034
3-Month Follow-UpMissed Visit2020
3-Month Follow-UpWithdrawal by Subject43
6-Month Follow-UpDeath01
6-Month Follow-UpLost to Follow-up2022
6-Month Follow-UpWithdrawal by Subject12

Baseline characteristics

CharacteristicPositively Smoke Free on the Web (PSFW+)TotalAmerican Heart Association Getting Healthy (AHA)
Age, Continuous50.47 years
STANDARD_DEVIATION 10.2
50.21 years
STANDARD_DEVIATION 10.41
49.95 years
STANDARD_DEVIATION 10.63
Ethnicity (NIH/OMB)
Hispanic or Latino
51 Participants97 Participants46 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
204 Participants409 Participants205 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants10 Participants8 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
213 Participants418 Participants205 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
3 Participants12 Participants9 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants0 Participants
Race (NIH/OMB)
White
36 Participants65 Participants29 Participants
Region of Enrollment
United States
255 participants506 participants251 participants
Sex: Female, Male
Female
106 Participants216 Participants110 Participants
Sex: Female, Male
Male
149 Participants290 Participants141 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 2551 / 251
other
Total, other adverse events
0 / 2550 / 251
serious
Total, serious adverse events
0 / 2550 / 251

Outcome results

Primary

Number of Participants Achieving 7-day Point Prevalence Abstinence From Tobacco Use

The number of participants achieving 7-day Point Prevalence Abstinence (PPA) from tobacco use at 6 months was determined for each study arm. 7-day PPA parameters for this study were based on the number of participants demonstrating biochemically confirmed exhaled carbon monoxide (\< 10ppm).

Time frame: 6 months

Population: Intention to treat (ITT) analysis. Lost to follow-up participants were assumed to be non-abstinent

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Positively Smoke Free on the Web (PSFW+)Number of Participants Achieving 7-day Point Prevalence Abstinence From Tobacco UseAbstinent38 Participants
Positively Smoke Free on the Web (PSFW+)Number of Participants Achieving 7-day Point Prevalence Abstinence From Tobacco UseNon-Abstinent217 Participants
American Heart Association Getting Healthy (AHA)Number of Participants Achieving 7-day Point Prevalence Abstinence From Tobacco UseAbstinent22 Participants
American Heart Association Getting Healthy (AHA)Number of Participants Achieving 7-day Point Prevalence Abstinence From Tobacco UseNon-Abstinent229 Participants
Secondary

Website Satisfaction

Questionnaires were administered to all study participants at 6 months to assess participant satisfaction with the PSFW+ and AHA 'Getting Healthy' website and online tools. Participants were asked to provide feedback regarding their level of satisfaction with the online platform using the following response options: Not at all Satisfied, A little Satisfied, Moderately Satisfied, Very Satisfied, or Extremely Satisfied. Participants responses were aggregated and tabulated.

Time frame: Up to 6 months

Population: The Overall Number of Participants analyzed for this outcome measure is indicative of satisfaction survey questionnaires completed and received at both the 3 month and the 6 month follow-up visits. Some participants who did not show up for the 3-month visit were successfully recalled for the 6-month visit.

ArmMeasureGroupValue (NUMBER)
Positively Smoke Free on the Web (PSFW+)Website SatisfactionModerately satisfied62 participants
Positively Smoke Free on the Web (PSFW+)Website SatisfactionA little satisfied34 participants
Positively Smoke Free on the Web (PSFW+)Website SatisfactionExtremely satisfied25 participants
Positively Smoke Free on the Web (PSFW+)Website SatisfactionVery satisfied68 participants
Positively Smoke Free on the Web (PSFW+)Website SatisfactionRefused or missing1 participants
Positively Smoke Free on the Web (PSFW+)Website SatisfactionNot at all satisfied16 participants
American Heart Association Getting Healthy (AHA)Website SatisfactionRefused or missing6 participants
American Heart Association Getting Healthy (AHA)Website SatisfactionNot at all satisfied16 participants
American Heart Association Getting Healthy (AHA)Website SatisfactionA little satisfied45 participants
American Heart Association Getting Healthy (AHA)Website SatisfactionModerately satisfied50 participants
American Heart Association Getting Healthy (AHA)Website SatisfactionExtremely satisfied24 participants
American Heart Association Getting Healthy (AHA)Website SatisfactionVery satisfied63 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026