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

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Condition:	Hepatitis B Virus
Interventions:	Behavioral: Non-Framed-Offered; Behavioral: Non-Framed-Recommended; Behavioral: Gain-Framed-Offered; Behavioral: Gain-Framed-Recommended; Behavioral: Loss-Framed-Offered; Behavioral: Loss-Framed-Recommended

  Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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.

Participant Flow:   Overall Study

	Non-Framed-Offered	Non-Framed-Recommended	Gain-Framed-Offered	Gain-Framed-Recommended	Loss-Framed-Offered	Loss-Framed-Recommended
STARTED	299	284	292	288	291	293
COMPLETED	299	284	292	288	291	293
NOT COMPLETED	0	0	0	0	0	0

  Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
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.
Total	Total of all reporting groups

Baseline Measures

	Non-Framed-Offered	Non-Framed-Recommended	Gain-Framed-Offered	Gain-Framed-Recommended	Loss-Framed-Offered	Loss-Framed-Recommended	Total
Overall Participants Analyzed; [Units: Participants]	299	284	292	288	291	293	1747
Age; [Units: Years]; Mean (Standard Deviation)	31.2 (9.7)	31.8 (9.8)	31.2 (9.8)	31.7 (9.4)	32.1 (10.1)	32.3 (10.6)	31.7 (9.9)
Sex: Female, Male; [Units: Participants]; Count of Participants
Female	178 59.5%	179 63.0%	175 59.9%	166 57.6%	179 61.5%	177 60.4%	1054 60.3%
Male	121 40.5%	105 37.0%	117 40.1%	122 42.4%	112 38.5%	116 39.6%	693 39.7%
Ethnicity (NIH/OMB); [Units: Participants]; Count of Participants
Hispanic or Latino	7 2.3%	9 3.2%	9 3.1%	8 2.8%	6 2.1%	9 3.1%	48 2.7%
Not Hispanic or Latino	284 95.0%	272 95.8%	278 95.2%	275 95.5%	282 96.9%	278 94.9%	1669 95.5%
Unknown or Not Reported	8 2.7%	3 1.1%	5 1.7%	5 1.7%	3 1.0%	6 2.0%	30 1.7%
Race (NIH/OMB); [Units: Participants]; Count of Participants
American Indian or Alaska Native	1 0.3%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 0.1%
Asian	0 0.0%	1 0.4%	2 0.7%	0 0.0%	1 0.3%	2 0.7%	6 0.3%
Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	1 0.3%	0 0.0%	0 0.0%	1 0.1%
Black or African American	252 84.3%	233 82.0%	239 81.8%	233 80.9%	236 81.1%	233 79.5%	1426 81.6%
White	32 10.7%	37 13.0%	37 12.7%	38 13.2%	35 12.0%	45 15.4%	224 12.8%
More than one race	8 2.7%	8 2.8%	5 1.7%	6 2.1%	7 2.4%	9 3.1%	43 2.5%
Unknown or Not Reported	6 2.0%	5 1.8%	9 3.1%	10 3.5%	12 4.1%	4 1.4%	46 2.6%
Region of Enrollment; [Units: Participants]; Count of Participants
United States	299	284	292	288	291	293	1747

  Outcome Measures

1. Primary:

Number of Participants Administered Hepatitis B Vaccine [ Time Frame: Day of research visit ]

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  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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Certain Agreements:  

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  

Name/Title: Dr. Gregory Zimet
Organization: Indiana University
phone: 317-274-8812
e-mail: gzimet@iu.edu

Publications of Results:

Cox AD, Cox D, Zimet G. Promoting prevention and early detection: The impact of message framing, product function and perceived product risk. J Marketing 2006;70:79-91.

Responsible Party:	Gregory Zimet, Indiana University
ClinicalTrials.gov Identifier:	NCT00739752 History of Changes
Other Study ID Numbers:	0205-04; R01AI049644 ( U.S. NIH Grant/Contract )
First Submitted:	August 20, 2008
First Posted:	August 22, 2008
Results First Submitted:	April 6, 2017
Results First Posted:	October 16, 2017
Last Update Posted:	October 16, 2017