Tobacco Use Disorder, HIV
Conditions
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
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.
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving 7-day Point Prevalence Abstinence From Tobacco Use | 6 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Website Satisfaction | Up to 6 months | 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 506 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 3-Month Follow-Up | Death | 1 | 0 |
| 3-Month Follow-Up | Lost to Follow-up | 40 | 34 |
| 3-Month Follow-Up | Missed Visit | 20 | 20 |
| 3-Month Follow-Up | Withdrawal by Subject | 4 | 3 |
| 6-Month Follow-Up | Death | 0 | 1 |
| 6-Month Follow-Up | Lost to Follow-up | 20 | 22 |
| 6-Month Follow-Up | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Positively Smoke Free on the Web (PSFW+) | Total | American Heart Association Getting Healthy (AHA) |
|---|---|---|---|
| Age, Continuous | 50.47 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 Participants | 97 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 204 Participants | 409 Participants | 205 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 10 Participants | 8 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 213 Participants | 418 Participants | 205 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 12 Participants | 9 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 36 Participants | 65 Participants | 29 Participants |
| Region of Enrollment United States | 255 participants | 506 participants | 251 participants |
| Sex: Female, Male Female | 106 Participants | 216 Participants | 110 Participants |
| Sex: Female, Male Male | 149 Participants | 290 Participants | 141 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 255 | 1 / 251 |
| other Total, other adverse events | 0 / 255 | 0 / 251 |
| serious Total, serious adverse events | 0 / 255 | 0 / 251 |
Outcome results
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Positively Smoke Free on the Web (PSFW+) | Number of Participants Achieving 7-day Point Prevalence Abstinence From Tobacco Use | Abstinent | 38 Participants |
| Positively Smoke Free on the Web (PSFW+) | Number of Participants Achieving 7-day Point Prevalence Abstinence From Tobacco Use | Non-Abstinent | 217 Participants |
| American Heart Association Getting Healthy (AHA) | Number of Participants Achieving 7-day Point Prevalence Abstinence From Tobacco Use | Abstinent | 22 Participants |
| American Heart Association Getting Healthy (AHA) | Number of Participants Achieving 7-day Point Prevalence Abstinence From Tobacco Use | Non-Abstinent | 229 Participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Positively Smoke Free on the Web (PSFW+) | Website Satisfaction | Moderately satisfied | 62 participants |
| Positively Smoke Free on the Web (PSFW+) | Website Satisfaction | A little satisfied | 34 participants |
| Positively Smoke Free on the Web (PSFW+) | Website Satisfaction | Extremely satisfied | 25 participants |
| Positively Smoke Free on the Web (PSFW+) | Website Satisfaction | Very satisfied | 68 participants |
| Positively Smoke Free on the Web (PSFW+) | Website Satisfaction | Refused or missing | 1 participants |
| Positively Smoke Free on the Web (PSFW+) | Website Satisfaction | Not at all satisfied | 16 participants |
| American Heart Association Getting Healthy (AHA) | Website Satisfaction | Refused or missing | 6 participants |
| American Heart Association Getting Healthy (AHA) | Website Satisfaction | Not at all satisfied | 16 participants |
| American Heart Association Getting Healthy (AHA) | Website Satisfaction | A little satisfied | 45 participants |
| American Heart Association Getting Healthy (AHA) | Website Satisfaction | Moderately satisfied | 50 participants |
| American Heart Association Getting Healthy (AHA) | Website Satisfaction | Extremely satisfied | 24 participants |
| American Heart Association Getting Healthy (AHA) | Website Satisfaction | Very satisfied | 63 participants |