Trial Outcomes & Findings for RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers (NCT NCT02781090)

Last Updated: 2023-08-04

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

512 participants

Primary outcome timeframe

6 months

Results posted on

2023-08-04

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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	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
3-Month Follow-Up STARTED	251	255
3-Month Follow-Up COMPLETED	194	190
3-Month Follow-Up NOT COMPLETED	57	65
6-Month Follow-Up STARTED	194	190
6-Month Follow-Up COMPLETED	169	169
6-Month Follow-Up NOT COMPLETED	25	21

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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
3-Month Follow-Up Missed Visit	20	20
3-Month Follow-Up Lost to Follow-up	34	40
3-Month Follow-Up Withdrawal by Subject	3	4
3-Month Follow-Up Death	0	1
6-Month Follow-Up Withdrawal by Subject	2	1
6-Month Follow-Up Lost to Follow-up	22	20
6-Month Follow-Up Death	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Positively Smoke Free on the Web (PSFW+) n=255 Participants 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	American Heart Association Getting Healthy (AHA) n=251 Participants 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	Total n=506 Participants Total of all reporting groups
Age, Continuous	50.47 years STANDARD_DEVIATION 10.20 • n=5 Participants	49.95 years STANDARD_DEVIATION 10.63 • n=7 Participants	50.21 years STANDARD_DEVIATION 10.41 • n=5 Participants
Sex: Female, Male Female	106 Participants n=5 Participants	110 Participants n=7 Participants	216 Participants n=5 Participants
Sex: Female, Male Male	149 Participants n=5 Participants	141 Participants n=7 Participants	290 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	51 Participants n=5 Participants	46 Participants n=7 Participants	97 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	204 Participants n=5 Participants	205 Participants n=7 Participants	409 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) Black or African American	213 Participants n=5 Participants	205 Participants n=7 Participants	418 Participants n=5 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants	29 Participants n=7 Participants	65 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	255 participants n=5 Participants	251 participants n=7 Participants	506 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Intention to treat (ITT) analysis. Lost to follow-up participants were assumed to be non-abstinent

Outcome measures

Outcome measures
Measure	Positively Smoke Free on the Web (PSFW+) n=255 Participants 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	American Heart Association Getting Healthy (AHA) n=251 Participants 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
Number of Participants Achieving 7-day Point Prevalence Abstinence From Tobacco Use Abstinent	38 Participants	22 Participants
Number of Participants Achieving 7-day Point Prevalence Abstinence From Tobacco Use Non-Abstinent	217 Participants	229 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Positively Smoke Free on the Web (PSFW+) n=206 Participants 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	American Heart Association Getting Healthy (AHA) n=204 Participants 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
Website Satisfaction Refused or missing	1 participants	6 participants
Website Satisfaction Not at all satisfied	16 participants	16 participants
Website Satisfaction A little satisfied	34 participants	45 participants
Website Satisfaction Moderately satisfied	62 participants	50 participants
Website Satisfaction Very satisfied	68 participants	63 participants
Website Satisfaction Extremely satisfied	25 participants	24 participants

Adverse Events

Positively Smoke Free on the Web (PSFW+)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

American Heart Association Getting Healthy (AHA)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jonathan Shuter

Montefiore Medical Center

Phone: 718-920-7845

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place