Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Positively Smoke Free on the Web+
Subjects will be assigned to the PSFW+ website and social network. They will also be offered a three-month supply of nicotine patches.
  • Behavioral: PSFW+
    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.
    Other names:
    • AHA
  • Drug: Nicotine polacrilex
    All participants, in both study arms, will be offered a 3-month supply of nicotine patches
    Other names:
    • Nicotine patch
Placebo Comparator
American Heart Assoc Getting Healthy
Subjects will be assigned to the AHA Getting Healthy website. They will also be offered a three-month supply of nicotine patches.
  • Behavioral: AHA
    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
  • Drug: Nicotine polacrilex
    All participants, in both study arms, will be offered a 3-month supply of nicotine patches
    Other names:
    • Nicotine patch

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10804
Contact:
Jonathan Shuter, MD
718-920-7845
jshuter@montefiore.org

More Details

NCT ID
NCT02781090
Status
Recruiting
Sponsor
Montefiore Medical Center

Study Contact

Jonathan Shuter, MD
718-920-7845
jshuter@montefiore.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.