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

What Was Tested

The trial (not phased) is built around Therapeutic nicotine (patch, non-peptide).

All participants will be offered a three-month supply of nicotine patches.

It had two arms (groups): Positively Smoke Free on the Web (PSFW+) (experimental) and American Heart Association Getting Healthy (AHA) (placebo comparator).

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.

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.

The registry classes the interventions as behavioral and drug.

More on the Plan

Almost none are currently accessing smoking cessation interventions designed to meet their specific needs and concerns.

It is driving the alarming rise in lung cancers in this highly vulnerable population.

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.

Who Took Part

512 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 8 inclusion and 6 exclusion criteria; among the exclusions: previous participation in any trial of positively smoke free interventions or use of psfw+; contraindication to nicotine replacement therapy; PSFW+ seed users will be excluded.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Therapeutic nicotine (patch, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Therapeutic nicotine (patch, non-peptide) study did not mask who received what.

It started in 2016-07-06 with completion listed for 2020-09-14.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Participants Achieving 7-day Point Prevalence Abstinence From Tobacco Use (time frame: 6 months).

It also tracked 1 secondary outcome, for example Website Satisfaction.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 512 people.

With 512 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.