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

Conditions:Smoking Cessation, HIV / AIDS, Tobacco Consumers
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Age Range:18 - Any
Start Date:July 2016
End Date:March 2020
Contact:Jonathan Shuter, MD

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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.

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

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

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.
We found this trial at
Baltimore, Maryland 21218
(410) 516-8000
Phone: 410-955-1725
Johns Hopkins The Johns Hopkins University opened in 1876, with the inauguration of its first...
Baltimore, MD
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Phone: 718-920-7845
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
Bronx, NY
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