Trial Outcomes & Findings for Smoking Cessation Intervention in Public Housing (NCT NCT01035151)

NCT ID: NCT01035151

Last Updated: 2018-12-13

Results Overview

Reported abstinence validated by exhaled CO and saliva cotinine

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 420 participants
• Primary outcome timeframe: 12 month
• Results posted on: 2018-12-13

Participant Flow

Of the 34 subsidized housing neighborhoods in these two regions, the study was implemented in the 14 neighborhoods that met eligibility. Seven matched pairs were formed and randomly assigned one neighborhood in each pair to either the treatment condition or a delayed control condition. 27-32 participants enrolled in each neighborhood.

Common reasons for exclusions were not a resident of the neighborhood, not an active smokers.

Participant milestones

Measure	Delayed Control Women in the delayed control condition received culturally sensitive smoking cessation written materials at week 1, and mailed materials at week 6, 12, and 18. At the end of the study (i.e., after the 12 month data collection), participants were offered counseling, nicotine patches, and community health worker contacts. Control: Written Cessation Materials	Experimental Women in neighborhoods randomized to the S2S received 24-week bundled multi-level intervention. Individual-led strategies were led by paid community health workers (CHWs). The CHWs provided 1:1 contact to reinforce social support, and enhanced self-efficacy with cessation attempts. A certified smoking cessation counselor led behavioral group sessions using the S2S handbook based on the PHS Guidelines. The weekly group sessions were initiated during the 1st week of the intervention, with a total of 6 group sessions over a 6-week period. Transdermal nicotine patches were offered to participants who set a quit date. Within the 24-week study period, the neighborhood tenant association, in partnership with study staff, implemented at least two neighborhood level anti-smoking activities Experimental: Neighborhood level interventions, peer group (counseling, NRT), and individual level (Coach/CHW)
Overall Study STARTED	209	200
Overall Study COMPLETED	188	185
Overall Study NOT COMPLETED	21	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Smoking Cessation Intervention in Public Housing

Baseline characteristics by cohort

Measure	Delayed Control n=209 Participants Women in the delayed control condition received culturally sensitive smoking cessation written materials at week 1, and mailed materials at week 6, 12, and 18. At the end of the study (i.e., after the 12 month data collection), participants were offered counseling, nicotine patches, and community health worker contacts. Control: Written Cessation Materials	Experimental n=200 Participants Women in neighborhoods randomized to the S2S received 24-week bundled multi-level intervention. Individual-led strategies were led by paid community health workers (CHWs). The CHWs provided 1:1 contact to reinforce social support, and enhanced self-efficacy with cessation attempts. A certified smoking cessation counselor led behavioral group sessions using the S2S handbook based on the PHS Guidelines. The weekly group sessions were initiated during the 1st week of the intervention, with a total of 6 group sessions over a 6-week period. Transdermal nicotine patches were offered to participants who set a quit date. Within the 24-week study period, the neighborhood tenant association, in partnership with study staff, implemented at least two neighborhood level anti-smoking activities Experimental: Neighborhood level interventions, peer group (counseling, NRT), and individual level (Coach/CHW)	Total n=409 Participants Total of all reporting groups
Age, Continuous	43 years STANDARD_DEVIATION 15.6 • n=93 Participants	41 years STANDARD_DEVIATION 14.1 • n=4 Participants	42 years STANDARD_DEVIATION 14 • n=27 Participants
Sex: Female, Male Female	209 Participants n=93 Participants	200 Participants n=4 Participants	409 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	190 Participants n=93 Participants	180 Participants n=4 Participants	370 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	16 Participants n=93 Participants	16 Participants n=4 Participants	32 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Black or African American	192 Participants n=93 Participants	157 Participants n=4 Participants	349 Participants n=27 Participants
Race (NIH/OMB) White	11 Participants n=93 Participants	28 Participants n=4 Participants	39 Participants n=27 Participants
Race (NIH/OMB) More than one race	2 Participants n=93 Participants	13 Participants n=4 Participants	15 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Region of Enrollment United States	209 Participants n=93 Participants	200 Participants n=4 Participants	409 Participants n=27 Participants
Nicotine Dependence Score	4.8 units on a scale STANDARD_DEVIATION 2.2 • n=93 Participants	4.7 units on a scale STANDARD_DEVIATION 2.2 • n=4 Participants	4.7 units on a scale STANDARD_DEVIATION 2.2 • n=27 Participants

PRIMARY outcome

Timeframe: 12 month

Reported abstinence validated by exhaled CO and saliva cotinine

Outcome measures

Measure	Delayed Control n=188 Participants Women in the delayed control condition received culturally sensitive smoking cessation written materials at week 1, and mailed materials at week 6, 12, and 18. At the end of the study (i.e., after the 12 month data collection), participants were offered counseling, nicotine patches, and community health worker contacts. Control: Written Cessation Materials	Experimental n=185 Participants Women in neighborhoods randomized to the S2S received 24-week bundled multi-level intervention. Individual-led strategies were led by paid community health workers (CHWs). The CHWs provided 1:1 contact to reinforce social support, and enhanced self-efficacy with cessation attempts. A certified smoking cessation counselor led behavioral group sessions using the S2S handbook based on the PHS Guidelines. The weekly group sessions were initiated during the 1st week of the intervention, with a total of 6 group sessions over a 6-week period. Transdermal nicotine patches were offered to participants who set a quit date. Within the 24-week study period, the neighborhood tenant association, in partnership with study staff, implemented at least two neighborhood level anti-smoking activities Experimental: Neighborhood level interventions, peer group (counseling, NRT), and individual level (Coach/CHW)
Number of Participants Abstinent From Smoking	10 Participants	24 Participants

Adverse Events

Delayed Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Experimental

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeannette Andrews

University of South Caroina

Phone: 803 777 3862

Email: j.andrews@sc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place