Vouchers to Promote Tdap Vaccination

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Robert Wood Johnson Foundation
University of Pennsylvania
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01860378
First received: May 20, 2013
Last updated: March 18, 2014
Last verified: February 2014
  Purpose

This study is a small-scale randomized, placebo-controlled factorial trial of two interventions to increase Tetanus, diphtheria and acellular pertussis (Tdap) immunization rates among infant caregivers. Specifically, the trial will compare a full cost vs. $5 Tdap voucher with or without an educational video.


Condition Intervention Phase
Whooping Cough
Other: Full price
Other: $5 off
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Retail Pharmacy Vouchers to Promote Tdap Vaccination for Adults Living With Infants

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Rate of Tdap Vaccination [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    The primary outcome of interest is the difference in vaccination rates between those who received the vouchers vs. those who did not and between those who received the educational video vs. those who did not. We are also interested in measuring whether the educational video acts as an effect modifier in the association between receipt of the voucher and vaccination rates.


Secondary Outcome Measures:
  • Proportion of all vouchers that are redeemed [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    We will measure the redemption rate of the Tdap voucher by treatment arm ($5 voucher vs. full-cost voucher, and video vs. no video), adjusting for sociodemographic characteristics. We will also determine the proportion of baby care product vouchers redeemed by treatment arm.


Other Outcome Measures:
  • Feasibility of voucher distribution [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    We will assess the feasibility and acceptability of voucher distribution by measuring the proportion of potential subjects who consent to join the study and are eligible for participation, time required for enrollment, proportion of participants who withdraw from the study, the completeness of redemption data recorded at the pharmacy, and the ability to assess caregiver vaccination status using self-report.


Estimated Enrollment: 240
Study Start Date: July 2013
Estimated Study Completion Date: June 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: No Video: Full price & $5 off
Participants will not view the pertussis video
Other: Full price
Participants will receive a voucher for the full price of a Tdap vaccine ($63.99) + a baby care product voucher or gift card
Other: $5 off
Participants will receive a voucher for $5 off a Tdap vaccine + a baby care product voucher or gift card.
Experimental: Video: Full price & $5 off
Participants will watch a brief (~ 1 minute) video about Tdap vaccination
Other: Full price
Participants will receive a voucher for the full price of a Tdap vaccine ($63.99) + a baby care product voucher or gift card
Other: $5 off
Participants will receive a voucher for $5 off a Tdap vaccine + a baby care product voucher or gift card.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. All caregivers who report that they have never received Tdap
  2. Mothers who did not receive Tdap during their most recent pregnancy or since the birth of the child, even if she received Tdap during a previous pregnancy, as Tdap is now recommended for all pregnant women during each pregnancy.
  3. Previous receipt of a tetanus containing vaccine (i.e. Td or TT), regardless of the time interval since receipt of the tetanus-containing vaccine will be also eligible for the study.
  4. If a participant is certain they have not received Tdap within the past year but uncertain whether he/she has ever received Tdap, we will offer enrollment and encourage participants to obtain immunization records to confirm their status before voucher redemption. Rite Aid will follow their screening procedures which also includes assessing immunization status. Participants who do not know their Tdap vaccination status will receive the voucher intervention.

Exclusion Criteria:

  1. Any adult caregiver who has previously received Tdap
  2. For recently-pregnant women: If a mother who received Tdap during her most recent pregnancy (2nd trimester or 3rd trimester) or since the birth of the child. Also, if the mother is unsure of her vaccination status and possibly received the vaccine during this pregnancy or in the last year
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01860378

Locations
United States, Pennsylvania
Karabots Primary Care Center - The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19139
Sponsors and Collaborators
Children's Hospital of Philadelphia
Robert Wood Johnson Foundation
University of Pennsylvania
Investigators
Principal Investigator: Kristen A Feemster, M.D. Children's Hospital of Philadelphia
  More Information

Publications:

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01860378     History of Changes
Other Study ID Numbers: 13-010045
Study First Received: May 20, 2013
Last Updated: March 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
Whooping Cough
Pertussis
Tdap vaccination
Randomized placebo controlled factorial trial

Additional relevant MeSH terms:
Cough
Whooping Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection

ClinicalTrials.gov processed this record on July 22, 2014