Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01AI049644 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
Not provided
Not provided
Not provided
Not provided
The goal of this study is to evaluate two sets of interventions to increase acceptance of hepatitis B virus (HBV) vaccination in patients attending sexually transmitted disease (STD) clinics. The 1st set of interventions, with 3 levels, is based on message framing. The 3 levels are: 1. information only; 2. gain-framed message; and 3. loss-framed message. The 2nd set of interventions, with 2 levels, involves how the vaccine is recommended by the health care provider. The 2 levels are: 1. HBV vaccine offered; and 2. HBV vaccine recommended. The outcome of interest is1st dose acceptance.
The goal of this study is to evaluate two sets of interventions to increase acceptance of hepatitis B virus (HBV) vaccination in patients attending sexually transmitted disease (STD) clinics. The 1st specific aim is to assess the effect of message-framing on vaccine acceptance. Framing theory suggests that positively framed messages (i.e., benefits of getting vaccine) are more effective than negatively framed messages (i.e., dangers of not getting vaccine) in stimulating preventive health behaviors. Research on Framing Theory and engagement in health behaviors suggests also that the effects may be moderated by other attitudinal factors, including perceived risk of the behavior and degree of involvement in the message. The 2nd aim is to evaluate the effect of provider-based interventions. Prior research suggests that recommendations by health providers are very important in patients' decisions regarding acceptance of health care procedures. Patients (18 years and older) will be recruited and followed from Chicago and Indianapolis STD clinics during routine medical visits. An audio computer-assisted self-interview (A-CASI) will cover demographics, risk behaviors, and perceived risk associated with vaccination. Subjects then will be randomized to receive a gain-framed, loss-framed, or information only message regarding HBV immunization (also delivered by A-CASI). Upon completion of the message-framing intervention, subjects will complete additional attitude questions via A-CASI. Upon completion of the A-CASI subjects will be randomly assigned to one of two provider intervention conditions: 1. vaccine offered or 2. vaccine recommended. For both conditions free HBV immunization will be provided by a nurse practitioner. Subsequently, postcard reminders will be sent and phone call reminders made for follow-up appointments for those receiving the first and second doses of vaccine. The primary outcome measure is HBV vaccination.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Framed-Offered | Experimental | Non-Framed, Information Only Condition. Vaccine Offered. |
|
| Non-Framed-Recommended | Experimental | Non-Framed, Information Only Condition. Vaccine Recommended. |
|
| Gain-Framed-Offered | Experimental | Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Offered. |
|
| Gain-Framed-Recommended | Experimental | Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Recommended. |
|
| Loss-Framed-Offered | Experimental | Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Offered. |
|
| Loss-Framed-Recommended |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Framed-Offered | Behavioral | Subjects received information only and are offered the vaccine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Doses of HBV Vaccine Received | Mean Number of HBV vaccine doses received over an 8-month period, including the clinic visit. Count values ranged from 0 to 3 doses. | Day of research visit with 8 month follow-up |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gregory D Zimet, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chicago Department of Public Health | Chicago | Illinois | 60604 | United States | ||
| Bell Flower Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. | ||
| 31404569 | Derived | Kasting ML, Head KJ, Cox D, Cox AD, Zimet GD. The effects of message framing and healthcare provider recommendation on adult hepatitis B vaccination: A randomized controlled trial. Prev Med. 2019 Oct;127:105798. doi: 10.1016/j.ypmed.2019.105798. Epub 2019 Aug 9. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Non-Framed-Offered | Non-Framed, Information Only Condition. Vaccine Offered. Non-Framed-Offered: Subjects received information only and are offered the vaccine. |
| FG001 | Non-Framed-Recommended |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
2 X 3 Factorial Design
Not provided
Not provided
Not provided
Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Recommended. |
|
| Non-Framed-Recommended | Behavioral | Subjects receive information only and are recommended the vaccine. |
|
| Gain-Framed-Offered | Behavioral | Subjects receive gain-framed messages and are offered the vaccine. |
|
| Gain-Framed-Recommended | Behavioral | Subjects receive gain-framed messages and are recommended the vaccine. |
|
| Loss-Framed-Offered | Behavioral | Subjects receive loss-framed messages and are offered the vaccine. |
|
| Loss-Framed-Recommended | Behavioral | Subjects receive loss-framed messages and are recommended the vaccine. |
|
| Indianapolis |
| Indiana |
| 46202 |
| United States |
Non-Framed, Information Only Condition. Vaccine Recommended.
Non-Framed-Recommended: Subjects receive information only and are recommended the vaccine.
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Non-Framed-Offered | Non-Framed, Information Only Condition. Vaccine Offered. Non-Framed-Offered: Subjects received information only and are offered the vaccine. |
| BG001 | Non-Framed-Recommended | Non-Framed, Information Only Condition. Vaccine Recommended. Non-Framed-Recommended: Subjects receive information only and are recommended the vaccine. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Number of Doses of HBV Vaccine Received | Mean Number of HBV vaccine doses received over an 8-month period, including the clinic visit. Count values ranged from 0 to 3 doses. | Posted | Mean | Standard Deviation | Doses of HBV Vaccine | Day of research visit with 8 month follow-up |
|
|
|
|
8 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non-Framed-Offered | Non-Framed, Information Only Condition. Vaccine Offered. Non-Framed-Offered: Subjects received information only and are offered the vaccine. | 0 | 299 | 0 | 299 | 0 | 299 |
| EG001 | Non-Framed-Recommended | Non-Framed, Information Only Condition. Vaccine Recommended. Non-Framed-Recommended: Subjects receive information only and are recommended the vaccine. | 0 | 284 | 0 | 284 | 0 | 284 |
| EG002 | 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. | 0 | 292 | 0 | 292 | 0 | 292 |
| EG003 | 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. | 0 | 288 | 0 | 288 | 0 | 288 |
| EG004 | 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. | 0 | 291 | 0 | 291 | 0 | 291 |
| EG005 | 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. | 0 | 293 | 0 | 293 | 0 | 293 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gregory Zimet | Indiana University | 317-274-8812 | gzimet@iu.edu |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D003142 | Communication |
| D012725 | Sexual Behavior |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001519 | Behavior |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Groups receiving any framed interventions (gain-framed or loss-framed) were compared to those in the two non-framed control groups.
| Regression, Poisson |
| <.01 |
| Risk Ratio (RR) |
| 1.17 |
| 2-Sided |
| 95 |
| 1.06 |
| 1.31 |
| Superiority |
| The 3 vaccine-recommended groups were compared with the 3 vaccine-offered groups using poisson regression. | Regression, Poisson | <.01 | Risk Ratio (RR) | 1.16 | 2-Sided | 95 | 1.05 | 1.28 | Superiority |