ABSTRACT
BACKGROUND: Acellular pertussis (aP) vaccines replaced whole-cell pertussis (wP) vaccines for the US childhood primary series in 1997. As women primed with aP vaccines enter childbearing age, protection of infants through tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccination during pregnancy may be impacted. METHODS: Term infants born to women vaccinated with Tdap during pregnancy were included. Geometric mean concentrations (GMCs) of pertussis-specific immunoglobulin G antibodies (international units per milliliter) in cord blood of infants born to women born after 1997 (aP-primed) were compared with those born to women born before 1992 (wP-primed). RESULTS: 253 and 506 infants born to aP- and wP-primed women, respectively, were included. Compared with wP-primed women, aP-primed women were younger, more likely to be Hispanic or non-Hispanic Black, and had lower-birthweight infants (P < .01 for all). Antibodies against pertussis toxin (PT) and filamentous hemagglutinin (FHA) were lower among infants born to aP-primed vs wP-primed women (PT, 17.3 vs 36.4; GMC ratio, .475; 95% confidence interval [CI], .408-.552 and FHA, 104.6 vs 121.4; GMC ratio, 0.861; 95% CI, .776-.958). No differences were observed for anti-fimbriae or anti-pertactin antibodies. CONCLUSIONS: Transplacental anti-pertussis antibody concentrations in infants of women vaccinated with Tdap during pregnancy differed by type of childhood vaccine the women received. Notably, anti-PT antibody levels, considered most important in preventing severe infant disease, were lower in infants born to aP-primed vs wP-primed women. Maternal Tdap vaccination may confer less protection against pertussis in infants born to aP-primed vs those born to wP-primed women.
Subject(s)
Diphtheria-Tetanus-acellular Pertussis Vaccines , Diphtheria , Whooping Cough , Pregnancy , Infant , Female , Humans , Antibodies, Bacterial , Pertussis Vaccine , Whooping Cough/prevention & control , Pertussis Toxin , Vaccination , Diphtheria/prevention & controlABSTRACT
PURPOSE OF REVIEW: The successes of the coronavirus disease 2019 (COVID-19) mRNA vaccines have accelerated the development of mRNA vaccines against other respiratory pathogens. The aim of this review is to highlight COVID-19 mRNA vaccine advances and provide an update on the progress of mRNA vaccine development against other respiratory pathogens. RECENT FINDINGS: The COVID-19 mRNA vaccines demonstrated effectiveness in preventing severe COVID-19 and death. H7N9 and H10N8 avian influenza mRNA vaccines have demonstrated safety and immunogenicity in phase 1 clinical trials. Numerous seasonal influenza mRNA vaccines are in phase 1-3 clinical trials. Respiratory syncytial virus (RSV) mRNA vaccines have progressed to phase 2-3 clinical trials in adults and a phase 1 clinical trial in children. A combined human metapneumovirus and parainfluenza-3 mRNA vaccines was found to be well tolerated and immunogenic in a phase 1 trial among adults and trials are being conducted among children. Clinical trials of mRNA vaccines combining antigens from multiple respiratory viruses are underway. SUMMARY: The development of mRNA vaccines against respiratory viruses has progressed rapidly in recent years. Promising vaccine candidates are moving through the clinical development pathway to test their efficacy in preventing disease against respiratory viral pathogens.
Subject(s)
COVID-19 , Influenza A Virus, H7N9 Subtype , Influenza Vaccines , Influenza in Birds , Respiratory Syncytial Virus Infections , Respiratory Syncytial Virus Vaccines , Adult , Child , Animals , Humans , COVID-19 Vaccines , Antibodies, Viral , COVID-19/prevention & control , Respiratory Syncytial Virus Vaccines/genetics , Respiratory Syncytial Virus Infections/prevention & controlABSTRACT
Importance: Immunization with tetanus, diphtheria, and acellular pertussis (Tdap) vaccine is recommended in the United States during weeks 27 through 36 of pregnancy to prevent life-threatening infant pertussis. The optimal gestation for immunization to maximize concentrations of neonatal pertussis toxin antibodies is unknown. Objective: To determine pertussis toxin antibody concentrations in cord blood from neonates born to women immunized and unimmunized with Tdap vaccine in pregnancy and optimal gestational age for immunization to maximize concentrations of neonatal antibodies. Design, Setting, and Participants: Prospective, observational, cohort study of term neonates in Houston, Texas (December 2013-March 2014). Exposures: Tdap immunization during weeks 27 through 36 of pregnancy or no Tdap immunization. Main Outcomes and Measures: Primary outcome was geometric mean concentrations (GMCs) of pertussis toxin antibodies in cord blood of Tdap-exposed and Tdap-unexposed neonates and proportions of Tdap-exposed and Tdap-unexposed neonates with pertussis toxin antibody concentrations of 15 IU/mL or higher, 30 IU/mL or higher, and 40 IU/mL or higher, cutoffs representing quantifiable antibodies or levels that may be protective until the infant immunization series begins. Secondary outcome was the optimal gestation for immunization to achieve maximum pertussis toxin antibodies. Results: Six hundred twenty-six pregnancies (mean maternal age, 29.7 years; 41% white, 27% Hispanic, 26% black, 5% Asian, 1% other; mean gestation, 39.4 weeks) were included. Three hundred twelve women received Tdap vaccine at a mean gestation of 31.2 weeks (range, 27.3-36.4); 314 were unimmunized. GMC of neonatal cord pertussis toxin antibodies from the Tdap-exposed group was 47.3 IU/mL (95% CI, 42.1-53.2) compared with 12.9 IU/mL (95% CI, 11.7-14.3) in the Tdap-unexposed group, for a GMC ratio of 3.6 (95% CI, 3.1-4.2; P < .001). More Tdap-exposed than Tdap-unexposed neonates had pertussis toxin antibody concentrations of 15 IU/mL or higher (86% vs 37%; difference, 49% [95% CI, 42%-55%]), 30 IU/mL or higher (72% vs 17%; difference, 55% [95% CI, 49%-61%]), and 40 IU/mL or higher (59% vs 12%; difference, 47% [95% CI, 41%-54%]); P < .001 for each analysis. GMCs of pertussis toxin antibodies were highest when Tdap vaccine was administered during weeks 27 through 30 and declined thereafter, reaching a peak at week 30 (57.3 IU/mL [95% CI, 44.0-74.6]). Conclusions and Relevance: Immunization with Tdap vaccine during the third trimester of pregnancy, compared with no immunization, was associated with higher neonatal concentrations of pertussis toxin antibodies. Immunization early in the third trimester was associated with the highest concentrations.
Subject(s)
Antibodies, Bacterial/blood , Diphtheria-Tetanus-acellular Pertussis Vaccines/immunology , Infant, Newborn/immunology , Pertussis Toxin/immunology , Whooping Cough/immunology , Adolescent , Adult , Female , Gestational Age , Humans , Male , Pregnancy , Pregnancy Trimester, Third , Prospective Studies , Whooping Cough/prevention & control , Young AdultABSTRACT
Physician recommendation is a strong predictor of vaccine uptake, however their perceived barriers may prevent vaccination. Therefore, we determined the association between physicians' perceived barriers to HPV vaccination and vaccination initiation. We surveyed pediatricians in a large network of clinics in Houston, Texas to assess their perceived barriers to vaccinating adolescents. We combined survey data with electronic medical records to determine HPV vaccination initiation over a 12-month study period (July 2014-June 2015). Patients were 11-18year olds who had not begun the vaccination series, had a physician visit during the study period, and whose physician completed the survey. We conducted a multilevel model clustered by physician controlling for patient and physician demographics to calculate the association between physician-reported barriers and HPV vaccination initiation. Among 36,827 patients seen by 134 pediatricians, 18.6% initiated HPV vaccination. The relative risk of initiating HPV vaccination were lower for patients whose physician reported concerns about HPV vaccine safety (RR: 0.75, 95% CI: 0.58-0.97), efficacy (RR: 0.73, 95% CI: 0.54-0.99), and the financial burden of the vaccine on patients (RR: 0.72, 95% CI: 0.58-0.88). After controlling for patient and physician characteristics, physician concern about the financial burden on patients was significantly associated with lower relative risk of initiating HPV vaccination (RR: 0.76, 95% CI: 0.64-0.90). In this large study we observed that physician-reported barriers are associated with HPV vaccination initiation. Interventions should be implemented to educate physicians on vaccine safety, efficacy, and that there is no patient cost for CDC-recommended vaccines.
Subject(s)
Attitude of Health Personnel , Papillomavirus Vaccines/administration & dosage , Physicians, Primary Care/psychology , Practice Patterns, Physicians' , Adolescent , Adult , Child , Female , Humans , Male , Papillomavirus Infections/prevention & control , Surveys and Questionnaires , Texas , Uterine Cervical Neoplasms/prevention & control , Vaccination/methodsSubject(s)
Whooping Cough/epidemiology , Case-Control Studies , Disease Outbreaks , England , Humans , Pertussis Vaccine , Vaccines, AcellularABSTRACT
Hematopoietic stem cell transplantation (HSCT) outcomes in X-linked severe combined immune deficiency are most effective when performed with patients <3 months of age and without coexisting morbidity, and with donor cells from a matched sibling. Even under such favorable circumstances, outcomes can be suboptimal, and full cellular engraftment may not be complete, which results in poor B or natural killer cell function. Protein losing enteropathies can accompany persistent immune deficiency disorders with resultant low serum globulins (immunoglobulin A [IgA], IgG, IgM) and lymphopenia. Patients with immune disorders acquire infections that can be predicted by their immune dysfunction. Fungal infections are typically noted in neutropenic (congenital or acquired) and T-cell deficient individuals. Coexisting fungal infections are rare, even in hosts who are immunocompromised, and they require careful evaluation. Antifungal treatment may result in drug-drug interactions with significant complications.
Subject(s)
Bronchiectasis/diagnosis , Budesonide/therapeutic use , Cushing Syndrome/diagnosis , Fluticasone-Salmeterol Drug Combination/therapeutic use , Hematopoietic Stem Cell Transplantation , Histoplasma/immunology , Histoplasmosis/diagnosis , Itraconazole/therapeutic use , Protein-Losing Enteropathies/diagnosis , Severe Combined Immunodeficiency/diagnosis , Adolescent , Bronchiectasis/etiology , Bronchiectasis/therapy , Budesonide/adverse effects , Child , Chimerism/chemically induced , Cushing Syndrome/immunology , Drug Interactions , Fluticasone-Salmeterol Drug Combination/adverse effects , Hematopoietic Stem Cell Transplantation/adverse effects , Histoplasma/drug effects , Histoplasmosis/etiology , Histoplasmosis/therapy , Humans , Iatrogenic Disease , Immunosuppression Therapy , Infant, Newborn , Itraconazole/adverse effects , Male , Pedigree , Protein-Losing Enteropathies/etiology , Protein-Losing Enteropathies/therapy , Severe Combined Immunodeficiency/complications , Severe Combined Immunodeficiency/therapy , Weight Gain/immunologyABSTRACT
IMPORTANCE: Maternal immunization with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine could prevent infant pertussis. OBJECTIVE: To evaluate the safety and immunogenicity of Tdap immunization during pregnancy and its effect on infant responses to diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine. DESIGN, SETTING, AND PARTICIPANTS: Phase 1-2, randomized, double-blind, placebo-controlled, clinical trial conducted from 2008 to 2012. Forty-eight pregnant women aged 18 to 45 years received Tdap (n = 33) or placebo (n = 15) at 30 to 32 weeks' gestation, with crossover immunization postpartum. INTERVENTIONS: Tdap vaccination at 30 to 32 weeks' gestation or postpartum. MAIN OUTCOMES AND MEASURES: Primary outcomes were maternal and infant adverse events, pertussis illness, and infant growth and development until age 13 months. Secondary outcomes were antibody concentrations in pregnant women before and 4 weeks after Tdap immunization or placebo, at delivery and 2 months' postpartum, and in infants at birth, at 2 months, and after the third and fourth doses of DTaP. RESULTS: No Tdap-associated serious adverse events occurred in women or infants. Injection site reactions after Tdap immunization were reported in 26 (78.8% [95% CI, 61.1%-91.0%]) and 12 (80% [95% CI, 51.9%-95.7%]) pregnant and postpartum women, respectively (P > .99). Systemic symptoms were reported in 12 (36.4% [ 95% CI, 20.4%-54.9%]) and 11 (73.3% [95% CI, 44.9%-92.2%]) pregnant and postpartum women, respectively (P = .03). Growth and development were similar in both infant groups. No cases of pertussis occurred. Significantly higher concentrations of pertussis antibodies were measured at delivery in women who received Tdap during pregnancy vs postpartum (eg, pertussis toxin antibodies: 51.0 EU/mL [95% CI, 37.1-70.1] and 9.1 EU/mL [95% CI, 4.6-17.8], respectively; P < .001) and in their infants at birth (68.8 EU/mL [95% CI, 52.1-90.8] and 14.0 EU/mL [95% CI, 7.3-26.9], respectively; P < .001) and at age 2 months (20.6 EU/mL [95% CI, 14.4-29.6] and 5.3 EU/mL [95% CI, 3.0-9.4], respectively; P < .001). Antibody responses in infants born to women receiving Tdap during pregnancy were not different following the fourth dose of DTaP. CONCLUSIONS AND RELEVANCE: This preliminary assessment did not find an increased risk of adverse events among women who received Tdap vaccine during pregnancy or their infants. For secondary outcomes, maternal immunization with Tdap resulted in high concentrations of pertussis antibodies in infants during the first 2 months of life and did not substantially alter infant responses to DTaP. Further research is needed to provide definitive evidence of the safety and efficacy of Tdap immunization during pregnancy. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00707148.
Subject(s)
Diphtheria-Tetanus-Pertussis Vaccine/immunology , Diphtheria-Tetanus-acellular Pertussis Vaccines/immunology , Infant, Newborn/immunology , Whooping Cough/prevention & control , Adolescent , Adult , Antibody Formation , Child Development , Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Diphtheria-Tetanus-acellular Pertussis Vaccines/administration & dosage , Double-Blind Method , Female , Humans , Immunization , Infant , Postpartum Period , Pregnancy , Pregnancy Trimester, Third , Whooping Cough/immunology , Young AdultABSTRACT
OBJECTIVES: Data on US caregiver perceptions on coronavirus disease 2019 (COVID-19) and COVID-19 vaccination are limited. We identified trends in and associations with COVID-19 vaccine hesitancy in caregivers of hospitalized children. METHODS: Cross-sectional surveys on pediatric COVID-19 disease and vaccine attitudes, behaviors, and beliefs were administered across study years (December 8, 2020-April 5, 2021, November 30, 2021-March 15, 2022, and October 26, 2022-March 15, 2023). English and Spanish-speaking caregivers of hospitalized children ages 6 months to 11 years were included. General vaccine hesitancy was assessed using the Parent Attitudes about Childhood Vaccines survey. RESULTS: Of 1268 caregivers from diverse backgrounds, one-third vaccinated or intended to vaccinate their child. Half endorsed fear of their child receiving the COVID-19 vaccine and were concerned the vaccine was new. Over time, more believed "the COVID-19 vaccine does not work" and fewer agreed "children who are otherwise healthy can die from COVID-19." Study season (2022-2023), older child age, higher income, child receipt of influenza vaccine, caregiver receipt of COVID-19 vaccine, and not being worried about vaccine novelty were positively associated with child vaccination. Intent to vaccinate was negatively associated with study season (2022-2023), Parent Attitudes about Childhood Vaccines score ≥50, lack of child influenza and caregiver COVID-19 vaccination, lack of fear of their child "getting COVID-19" and being "worried that the COVID-19 vaccine is new." The majority who intended to vaccinate were willing to immunize before discharge. CONCLUSIONS: Vaccine novelty and perceived lack of need were associated with refusal. Caregiver COVID-19 and child influenza vaccine acceptance were positively associated with COVID-19 vaccine acceptance. The inpatient setting offers the opportunity to improve vaccine uptake.
ABSTRACT
Despite clear evidence of the public health benefits of the human papillomavirus (HPV) vaccine in preventing HPV-related cancers and genital warts, underutilization of HPV vaccination in the United States persists. Interventions targeting multi-level determinants of vaccination behavior are crucial for improving HPV vaccination rates. The study's purpose was to implement and evaluate the adapted Adolescent Vaccination Program (AVP), a clinic-based, multi-level, multi-component intervention aimed at increasing HPV vaccine initiation and completion rates in a five-clinic pediatric network in Bexar County, Texas. The adaptation process was guided by established frameworks and involved formative work with clinic stakeholders. The study utilized a quasi-experimental single group pre- and post- study design, with an external comparison data using the National Immunization Survey-Teen (NIS-Teen) datasets for the same time period to examine the AVP's effect on HPV vaccination initiation and completion. A series of interrupted time series analyses (ITSA) compared the clinic system patient outcomes (HPV vaccination initiation and completion rates) in the post-intervention to the general adolescent population (NIS-Teen). Of the 6438 patients (11-17 years) with clinic visits during the 3-year study period, HPV vaccination initiation rates increased from 64.7% to 80.2% (p < 0.05) and completion rates increased from 43.2% to 60.2% (p < 0.05). The AVP was effective across various demographic and economic subgroups, demonstrating its generalizability. ITSA findings indicated the AVP improved HPV vaccination initiation and completion rates in clinic settings and that AVP strategies facilitated resilience during the pandemic. The minimal adaptation required for implementation in a new clinic system underscores its feasibility and potential for widespread adoption.
ABSTRACT
BACKGROUND: Pertussis booster vaccine (Tdap) recommendations assume that pertussis-specific antibodies in women immunized preconception, during, or after previous pregnancies persist at sufficient levels to protect newborn infants. METHODS: Pertussis-specific immunoglobulin G (IgG) was measured by IgG-specific enzyme-linked immunosorbent assay (ELISA) in maternal-umbilical cord serum pairs where mothers received Tdap during the prior 2 years. Geometric mean concentrations (GMCs) of pertussis antibodies and cord-maternal GMC ratios were calculated. RESULTS: One hundred five mothers (mean age, 25.3 years [range, 15.3-38.4 years]; mean gestation, 39 weeks [range, 37-43 weeks]) immunized with Tdap vaccine a mean of 13.7 months (range, 2.3-23.9 months) previously were included; 72 (69%) had received Tdap postpartum, 31 at a routine healthcare visit and 2 as contacts of another newborn. There was no difference in GMCs for pertussis-specific IgG in maternal delivery or infant cord sera for women immunized before (n = 86) or during (n = 19) early pregnancy. Placental transport of antibodies was 121%-186% from mothers immunized before and during pregnancy, respectively. Estimated GMC of IgG to pertussis toxin was <5 ELISA units (EU)/mL at infant age 2 months (start of infant immunization series). More infants of mothers immunized during pregnancy had pertussis toxin levels estimated to be higher than the lower limit of quantitation of the assay (4 EU/mL) through age 2 months (52% vs 38%; P = .34). CONCLUSIONS: Infants of mothers immunized preconception or in early pregnancy have insufficient pertussis-specific antibodies to protect against infection. Maternal immunization during the third trimester, immunization of other infant contacts, and reimmunization during subsequent pregnancies may be necessary.
Subject(s)
Diphtheria-Tetanus-acellular Pertussis Vaccines/administration & dosage , Diphtheria/prevention & control , Immunity, Maternally-Acquired/immunology , Immunization/methods , Tetanus/prevention & control , Whooping Cough/prevention & control , Adolescent , Adult , Antibodies, Bacterial/blood , Diphtheria/immunology , Enzyme-Linked Immunosorbent Assay , Female , Humans , Immunoglobulin G/blood , Infant , Infant, Newborn , Pregnancy , Tetanus/immunology , Time Factors , Vaccination/methods , Whooping Cough/immunology , Young AdultABSTRACT
Parents' stigmatizing beliefs about the HPV vaccine, such as beliefs that it promotes adolescent sexual activity, constitute a notable barrier to vaccine uptake. The purpose of this study is to describe the associations between parents' stigmatizing beliefs about the HPV vaccine, psychosocial antecedents to vaccination, and parents' intentions to vaccinate their children. Parents of vaccine-eligible children (n = 512) were surveyed in a large urban clinical network. Results indicate that two stigmatizing beliefs were significantly associated with self-efficacy in talking with a doctor about the HPV vaccine. Believing that the vaccine would make a child more likely to have sex was associated with citing social media as a source of information about the vaccine. Other stigmatizing beliefs were either associated with citing healthcare professionals as sources of information about the vaccine, or they were not significantly associated with any information source. This finding suggests that stigmatizing beliefs might discourage parents from seeking out information about the vaccine. This study is significant because it further highlights the importance of doctor recommendations to all patients at recommended ages; doctor visits may represent one of the few opportunities to normalize HPV vaccination and address parents' stigmatizing beliefs about the HPV vaccine.
Subject(s)
Papillomavirus Infections , Papillomavirus Vaccines , Child , Adolescent , Humans , Information Seeking Behavior , Parents/psychology , Vaccination/psychology , Surveys and Questionnaires , Papillomavirus Infections/prevention & control , Health Knowledge, Attitudes, Practice , Patient Acceptance of Health Care/psychologyABSTRACT
BACKGROUND: Mothers often are the source of pertussis illness in young infants. The Centers for Disease Control and Prevention recommend tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine for postpartum women before hospital discharge. In January 2008, this recommendation was implemented in a predominantly Hispanic, medically underserved population at Ben Taub General Hospital (BTGH) in Houston (hereafter the intervention population). METHODS: A cross-sectional study compared preintervention (July 2000 through December 2007) and postintervention (January 2008 through May 2009) periods. Pertussis diagnosis was determined using International Classification of Diseases, Ninth Revision (ICD-9) codes and microbiology reports from 4 major children's hospitals in Houston. Only those infants ≤6 months of age with laboratory-confirmed pertussis illness were included. The proportions of pertussis-infected infants born at BTGH in the pre- and postintervention periods were compared. RESULTS: Of 514 infants with pertussis, 378 (73.5%) were identified during preintervention and 136 (26.5%) during postintervention years. These groups were similar in age (mean, 79.3 vs 72 days; P = .08), sex (males, 55% vs 52%; P = .48), length of hospitalization (mean, 9.7 vs 10.7 days; P = .62), mortality (2 deaths each; P = .29) and hospital of pertussis diagnosis. After adjustment for age, sex, and ethnicity, the proportions of pertussis-infected infants born at BTGH and potentially protected through maternal postpartum Tdap immunization were similar for the 2 periods (6.9% vs 8.8%; odds ratio, 1.06; 95% confidence interval, 0.5-2.2; P = .87). CONCLUSIONS: Immunizing only postpartum mothers with Tdap vaccine did not reduce pertussis illness in infants ≤6 months of age. Efforts should be directed at immunizing all household and key contacts of newborns with Tdap, not just mothers.
Subject(s)
Diphtheria-Tetanus-acellular Pertussis Vaccines/administration & dosage , Diphtheria-Tetanus-acellular Pertussis Vaccines/immunology , Immunization/methods , Whooping Cough/epidemiology , Whooping Cough/prevention & control , Cross-Sectional Studies , Female , Humans , Infant , Infant, Newborn , Male , Postpartum Period , TexasABSTRACT
Successful maternal immunization requires consideration of maternal and infant disease burden, biological factors affecting immune response and placental transport of antibodies, optimal timing of immunization, safety and acceptability. Tetanus, inactivated influenza and acellular pertussis vaccines are recommended during pregnancy; others are recommended when maternal risk of infection is high. The development of new conjugate vaccines for use in adults may reduce global maternal and infant disease burden. Maternal immunization against group B streptococcus is projected to be superior to current preventative strategies in decreasing disease. Further evaluation of maternal immunization strategies to prevent maternal and infant infections is needed.
Subject(s)
Immunity, Maternally-Acquired , Pregnancy Complications, Infectious/prevention & control , Developing Countries , Female , Haemophilus Vaccines , Humans , Influenza Vaccines , Meningococcal Vaccines , Pertussis Vaccine , Pneumococcal Vaccines , Pregnancy , Research , Respiratory Syncytial Virus Vaccines , Streptococcal Vaccines , Streptococcus agalactiae/immunology , Tetanus ToxoidABSTRACT
Studies have consistently shown that vaccination rates against human papillomavirus (HPV) lag far behind other adolescent vaccinations recommended at the same age, resulting in exposing adolescents to unnecessary future risk of infection, and genital and head and neck cancers. Studies also have demonstrated that a major barrier to vaccination is lack of a strong provider recommendation. Factors that providers offer for failing to give a strong recommendation range from perception that the child is not at risk or the need to explain that the vaccine is not mandated (lack of equity and justice) or respect for parental autonomy. We look at the issue through a different lens, and reframe the above viewpoint by describing how failing to make a strong recommendation means the provider is not meeting the four principles of medical ethics (justice, beneficence, non-maleficence and autonomy).
Subject(s)
Papillomavirus Infections , Papillomavirus Vaccines , Adolescent , Child , Ethics, Medical , Health Knowledge, Attitudes, Practice , Humans , Papillomaviridae , Papillomavirus Infections/prevention & control , VaccinationABSTRACT
BACKGROUND: Human papillomavirus (HPV)-attributed cancers are preventable, yet HPV vaccination rates severely lag behind other adolescent vaccinations. HPVcancerFree (HPVCF) is a mobile health (mHealth) intervention developed to influence parental HPV vaccination decision making by raising awareness of HPV, reducing HPV vaccination barriers, and enabling HPV vaccination scheduling and reminders through a smartphone app. Evaluating the user experience of mHealth interventions is a vital component in assessing their quality and success but tends to be underreported in mHealth intervention evaluation. OBJECTIVE: We aimed to evaluate the user experience of HPVCF, an HPV cancer prevention app designed for a pediatric clinic network, using mixed methods data collected from log files, survey measures, and qualitative feedback. METHODS: Study data were evaluated from parents in a large US pediatric clinic network using HPVCF in the treatment study condition of a group randomized controlled trial. Log data captured HPVCF retention and use. Postintervention rating scales and items assessed HPVCF utility, usefulness, understandability, appeal, credibility, and perceived impact. Overall quality was evaluated using the user version of the Mobile Application Rating Scale (uMars). Open-ended responses assessed parent recommendations for HPVCF enhancement. RESULTS: The 98 parents were mainly female (n=94, 96%), 41 (5.67) years of age, college educated (n=55, 56%), and White and non-Hispanic (n=55, 56%) and had private health insurance for their children (n=75, 77%). Parents used HPVCF 197 times, with the average visit duration approximating 3.5 minutes. The uMARS app quality score was positively skewed (4.2/5.0). Mean ratings were highest for information (4.46 [SD 0.53]) and lowest for engagement (3.74 [SD 0.69]). In addition, of 95 parents, 45 (47%) rated HPVCF as helpful in HPV vaccination decision making and 16 (17%) attributed HPV vaccine initiation to HPVCF. Parents reported that HPVCF increased their awareness (84/95, 88%), knowledge (84/95, 88%), and HPV vaccination intentions (64/95, 67%). Most of the 98 parents rated the 4 HPVCF components as useful (72-92 [73%-94%]). Parents also agreed that HPVCF is clear (86/95, 91%), accurate (86/95, 91%), and more helpful than other HPV vaccine information they had received (89/95, 94%) and that they would recommend it to others (81/95, 85%). In addition, parents suggested ways to increase awareness and engagement with the app, along with opportunities to enhance the content and functionality. CONCLUSIONS: HPVCF was well received by parents and performed well on indicators of quality, usefulness, utility, credibility, and perceived impact. This study contributes a multimethod and multimeasure evaluation to the growing body of literature focused on assessing the user experience of patient-focused technology-mediated applications for HPV education.
ABSTRACT
Parent hesitancy contributes to reduced HPV vaccination rates. The HPVcancerfree app (HPVCF) was designed to assist parents in making evidence-based decisions regarding HPV vaccination. This study examined if parents of vaccine-eligible youth (11-12 yrs.) who use HPVCF in addition to usual care demonstrate significantly more positive intentions and attitudes toward HPV vaccination and greater HPV vaccination rates compared to those not using HPVCF. Clinics (n = 51) within a large urban pediatric network were randomly assigned to treatment (HPVCF + usual care) or comparison (usual care only) conditions in a RCT conducted between September 2017 and February 2019. Parents completed baseline and 5-month follow-up surveys. Participant-level analysis determined 1) change in HPV vaccination initiation behavior and related psychosocial determinants and 2) predictors of HPV vaccine initiation. Parents (n = 375) who completed baseline and 5-month follow-up surveys were female (95.2%), 40.8 (±5.8) yrs. married (83.7%), employed (68.3%), college educated (61.9%), and privately insured (76.5%). Between-group analysis of HPVCF efficacy demonstrated that parents assigned to receive HPVCF significantly increased knowledge about HPV and HPV vaccination (p < .05). Parents who accessed content within HPVCF significantly increased knowledge about HPV & HPV vaccine (p < .01) and perceived effectiveness of HPV vaccine (p < .05). Change in HPV vaccine initiation was not significant. A multivariate model to describe predictors of HPV vaccine initiation demonstrated an association with Tdap and MCV vaccination adoption, positive change in perceived effectiveness of the HPV vaccine, and reduction in perceived barriers against HPV vaccination. HPVCF appears to be a feasible adjunct to the education received in usual care visits and reinforces the value of apps to support the important persuasive voice of the health-care provider in overcoming parent HPV vaccine hesitancy.
Subject(s)
Papillomavirus Infections , Papillomavirus Vaccines , Adolescent , Child , Female , Humans , Male , Health Knowledge, Attitudes, Practice , Papillomavirus Infections/prevention & control , Parents/psychology , Patient Acceptance of Health Care , VaccinationABSTRACT
Evaluating digital behavior change intervention engagement is complex and requires multidimensional and novel approaches that are emerging. The relationship and interdependence between engagement with the technology and engagement with the psychosocial or behavior change process often presents conceptual and evaluative challenges. Large objective data sets detailing technology use are plentiful but meaningful interpretation can be challenging at granular levels. Affiliation network analysis which describes two-mode network data may provide a novel approach to evaluate engagement of digital behavior change interventions. The purpose of this paper is to use affiliation network analysis as an exploratory method to describe, assess and visualize content-specific patterns underlying psychosocial characteristics related to HPV vaccine safety concerns of parents using the HPVcancerFree intervention. Results indicate that affiliation network analysis shows promise in supplementing existing methods to assess engagement of digital interventions.
Subject(s)
Neoplasms , Delivery of Health Care , Humans , Neoplasms/prevention & control , Parents , Research DesignABSTRACT
BACKGROUND: In 2006, the Advisory Committee on Immunization Practices recommended tetanus, diphtheria, acellular pertussis (Tdap) vaccination of all caregivers of infants aged <1 year ("cocooning") to prevent pertussis-related complications and deaths. We implemented cocooning in a predominantly Hispanic, medically underserved, uninsured population at a Houston hospital. Phase 1 (January 2008-January 2010) provided maternal postpartum Tdap vaccine; Phase 2 (June 2009-January 2010) also vaccinated infant contacts on-site. METHODS: Pertussis education was provided to health care personnel and mothers. Standing orders for maternal postpartum Tdap vaccination were initiated. Mothers were interviewed to ascertain the number of additional infant contacts eligible to receive Tdap vaccine. Consenting eligible contacts received Tdap vaccine as soon as possible after delivery. RESULTS: From 7 January 2008 through 31 January 2010, 8334 (75%) of 11,174 postpartum women received Tdap vaccine. During Phase 2, 2969 (86%) of 3455 postpartum women were vaccinated; another 197 (6%) had previously received Tdap vaccine. Mothers were Hispanic (91.4%), black (5.4%), white (0.8%), Asian (1.4%) and other (1.0%). A median of 3 (range, 1-11) other Tdap-eligible contacts per infant were identified, and a median of 2 (range, 0-10) contacts per infant received Tdap vaccine. Of 1860 contacts vaccinated, 1813 (98%) anticipated daily infant contact. A total of 1697 (91%) received Tdap vaccine before infant hospital discharge, and 144 (8%) received Tdap vaccine within 7 days after hospital discharge. Barriers to full cocooning included the need for extended vaccination hours, visiting restrictions because of pandemic H1N1 influenza, and inaccurate recall of vaccination history. CONCLUSION: Although practical and logistical barriers exist, Tdap cocooning was well accepted by and successfully implemented in a high-risk population by using standing orders and providing vaccinations on-site.