Trial Outcomes & Findings for Interventions to Increase HBV Vaccinations in Sexually Transmitted Disease (STD) Clinics (NCT NCT00739752)

Last Updated: 2018-11-09

Results Overview

Mean Number of HBV vaccine doses received over an 8-month period, including the clinic visit. Count values ranged from 0 to 3 doses.

Recruitment status

COMPLETED

Study phase

Target enrollment

1747 participants

Primary outcome timeframe

Day of research visit with 8 month follow-up

Results posted on

2018-11-09

Participant Flow

Participant milestones

Participant milestones
Measure	Non-Framed-Offered Non-Framed, Information Only Condition. Vaccine Offered. Non-Framed-Offered: Subjects received information only and are offered the vaccine.	Non-Framed-Recommended Non-Framed, Information Only Condition. Vaccine Recommended. Non-Framed-Recommended: Subjects receive information only and are recommended the vaccine.	Gain-Framed-Offered Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Offered. Gain-Framed-Offered: Subjects receive gain-framed messages and are offered the vaccine.	Gain-Framed-Recommended Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Recommended. Gain-Framed-Recommended: Subjects receive gain-framed messages and are recommended the vaccine.	Loss-Framed-Offered Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Offered. Loss-Framed-Offered: Subjects receive loss-framed messages and are offered the vaccine.	Loss-Framed-Recommended Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Recommended. Loss-Framed-Recommended: Subjects receive loss-framed messages and are recommended the vaccine.
Overall Study STARTED	299	284	292	288	291	293
Overall Study COMPLETED	299	284	292	288	291	293
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Interventions to Increase HBV Vaccinations in Sexually Transmitted Disease (STD) Clinics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non-Framed-Offered n=299 Participants Non-Framed, Information Only Condition. Vaccine Offered. Non-Framed-Offered: Subjects received information only and are offered the vaccine.	Non-Framed-Recommended n=284 Participants Non-Framed, Information Only Condition. Vaccine Recommended. Non-Framed-Recommended: Subjects receive information only and are recommended the vaccine.	Gain-Framed-Offered n=292 Participants Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Offered. Gain-Framed-Offered: Subjects receive gain-framed messages and are offered the vaccine.	Gain-Framed-Recommended n=288 Participants Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Recommended. Gain-Framed-Recommended: Subjects receive gain-framed messages and are recommended the vaccine.	Loss-Framed-Offered n=291 Participants Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Offered. Loss-Framed-Offered: Subjects receive loss-framed messages and are offered the vaccine.	Loss-Framed-Recommended n=293 Participants Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Recommended. Loss-Framed-Recommended: Subjects receive loss-framed messages and are recommended the vaccine.	Total n=1747 Participants Total of all reporting groups
Age, Continuous	31.2 Years STANDARD_DEVIATION 9.7 • n=5 Participants	31.8 Years STANDARD_DEVIATION 9.8 • n=7 Participants	31.2 Years STANDARD_DEVIATION 9.8 • n=5 Participants	31.7 Years STANDARD_DEVIATION 9.4 • n=4 Participants	32.1 Years STANDARD_DEVIATION 10.1 • n=21 Participants	32.3 Years STANDARD_DEVIATION 10.6 • n=8 Participants	31.7 Years STANDARD_DEVIATION 9.9 • n=8 Participants
Sex: Female, Male Female	178 Participants n=5 Participants	179 Participants n=7 Participants	175 Participants n=5 Participants	166 Participants n=4 Participants	179 Participants n=21 Participants	177 Participants n=8 Participants	1054 Participants n=8 Participants
Sex: Female, Male Male	121 Participants n=5 Participants	105 Participants n=7 Participants	117 Participants n=5 Participants	122 Participants n=4 Participants	112 Participants n=21 Participants	116 Participants n=8 Participants	693 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	8 Participants n=4 Participants	6 Participants n=21 Participants	9 Participants n=8 Participants	48 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	284 Participants n=5 Participants	272 Participants n=7 Participants	278 Participants n=5 Participants	275 Participants n=4 Participants	282 Participants n=21 Participants	278 Participants n=8 Participants	1669 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	3 Participants n=21 Participants	6 Participants n=8 Participants	30 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	6 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Black or African American	252 Participants n=5 Participants	233 Participants n=7 Participants	239 Participants n=5 Participants	233 Participants n=4 Participants	236 Participants n=21 Participants	233 Participants n=8 Participants	1426 Participants n=8 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	37 Participants n=7 Participants	37 Participants n=5 Participants	38 Participants n=4 Participants	35 Participants n=21 Participants	45 Participants n=8 Participants	224 Participants n=8 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	7 Participants n=21 Participants	9 Participants n=8 Participants	43 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants	10 Participants n=4 Participants	12 Participants n=21 Participants	4 Participants n=8 Participants	46 Participants n=8 Participants
Region of Enrollment United States	299 Participants n=5 Participants	284 Participants n=7 Participants	292 Participants n=5 Participants	288 Participants n=4 Participants	291 Participants n=21 Participants	293 Participants n=8 Participants	1747 Participants n=8 Participants

PRIMARY outcome

Timeframe: Day of research visit with 8 month follow-up

Mean Number of HBV vaccine doses received over an 8-month period, including the clinic visit. Count values ranged from 0 to 3 doses.