N/A
N=506
RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers
Tobacco Use Disorder · HIV
Bottom Line
View on ClinicalTrials.gov: NCT02781090 ↗Enrolled (actual)
506
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Number of Participants Achieving 7-day Point Prevalence Abstinence From Tobacco Use — 38; 22; 217; 229 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PSFW+ (Behavioral); AHA (Behavioral); Nicotine polacrilex (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Achieving 7-day Point Prevalence Abstinence From Tobacco Use |
38; 22; 217; 229 | — |
| SECONDARY Website Satisfaction |
16; 16; 34; 45; 62; 50 | — |
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.
Eligibility Criteria
Inclusion Criteria
- age 18 or older
- current smoking as defined by a validated tobacco use measure
- laboratory confirmed HIV-infection; 3) residence in commuting distance to the Bronx, NY or Baltimore, MD
- English language fluency
- motivation to quit within the next 30 days
- at least weekly Internet and email access
- 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)
- willingness to provide informed consent and undergo randomization.
Exclusion Criteria
- previous participation in any trial of Positively Smoke Free interventions or use of PSFW+
- pregnancy
- contraindication to nicotine replacement therapy
- current participation in an active smoking cessation treatment (e.g., group therapy, use of pharmacotherapy)
- PSFW+ seed users will be excluded
- 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.
Data sourced from ClinicalTrials.gov (NCT02781090). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.