Adolescent Participation in HPV Vaccine Clinical Trials: Are Parents Willing?

Abstract

Approximately one-quarter of human papillomavirus (HPV) infections are acquired by adolescents, with a higher burden among racial/ethnic minorities. However, racial/ethnic minorities have been underrepresented in previous HPV vaccine trials. Ongoing and future HPV vaccine optimization trials would benefit from racially- and ethnically-diverse sample of adolescent trial participants. This study examined factors influencing parental willingness to consent to their adolescents’ participation in HPV vaccine clinical trials and tested for possible racial differences. A convenience sample of parents of adolescents (N = 256) completed a cross-sectional survey. Chi square analyses were used to assess racial differences in parental HPV vaccine awareness and intentions and willingness to consent to their child participating in an HPV vaccine clinical trial. Ordinal logistic regression was used to identify factors associated with willingness. Approximately 47% of parents were willing to allow their adolescent to participate in HPV vaccine clinical trials (30.7% African American and 48.3% Caucasian, p = .081). African Americans had lower HPV vaccine awareness (p = .006) but not lower intentions to vaccinate (p = .086). Parental willingness was positively associated with the following variables: Child’s age (p < .039), Perceived Advantages of HPV Vaccination for Adolescents (p = .002), Parental Trust in Medical Researchers (p < .001), and Level of Ease in Understanding Clinical Trial Information (p = .010). Educating parents about the advantages of HPV vaccines for younger adolescents using low-literacy educational materials and building trust between parents and researchers may increase parental willingness to consent to adolescent participation in HPV vaccine clinical trials.

Factors that Predict Parental Willingness to Have Their Children Vaccinated against HPV in a Country with Low HPV Vaccination Coverage

“…Parents should be informed that it is a cancer-prevention vaccine, which can offer substantial benefits and might reduce the likelihood of serious outcomes [ 36 ]. The wider adoption of the Gardasil 9 vaccine (which prevents both low-risk HPV subtypes 6 and 11, which can cause genital warts, and high-risk HPV subtypes 16, 18, 31, 33, 45, 52, and 58, causing cervical dysplasia and cancer) in immunization programs, promises to increase vaccine effectiveness, which may in turn restore confidence [ 3 , 9 , 33 ]. Advances in vaccine technology which could possibly reduce the number of required doses to just one may additionally increase its use.…”

“…Worldwide, an estimated 630 million persons are infected with human papillomavirus (HPV) [ 1 ]. The prevalence of HPV infections peaks in adolescence in both genders and increases every year from 14 to 24 years of age [ 2 ]; it is estimated that approximately one-quarter of HPV infections are acquired by adolescents [ 3 ]. Most of these infections are transient and asymptomatic.…”

Adolescent and Parent Perceptions about Participation in Biomedical Sexual Health Trials

“…When presented with hypothetical biomedical sexual health trials, parents have also expressed willingness to enroll their adolescent in studies. With regard to hypothetical HPV vaccine trials, parents' expressed willingness to have their adolescents participate ranged from 36% to 84%, 16 and for a hypothetical microbicide trial, expressed willingness to have their adolescents participate was over 50% 17 . The range of adolescent and parent willingness across hypothetical trials likely reflects differences in the target condition, the type of prevention trial, the demographics of each study sample, and the method of measuring willingness to participate.…”

“…Many of the factors that affect adolescents' willingness to participate and parents' willingness to let them participate in biomedical sexual health trials are similar to those cited by adult participants in sexual health and other types of trials. These factors include altruism, 21 trust in researchers, 22 subjective norms, 23 and perceived benefits of the research, which in the case of adolescent sexual health trials have been described as sexual health education, STI testing and counseling, health benefits, and compensation for participating 24 . Barriers to participation include concerns about trial safety and product side effects, 25 stigma and discrimination, 26 and distrust of research personnel and fear of scientific exploitation 27 .…”

Altruism, Scepticism, and collective decision-making in foreign-born U.S. residents in a tuberculosis vaccine trial

“…Vere ([ 36 ]: p. 142) argues that risk acceptance among young subjects (i.e. college students) is high, and they can ‘deny that payment is for risk [and] assert that it is for inconvenience’ to justify participating [ 37 , 38 ]. This was relevant to our study in that it was being conducted in a college town, where many potentially eligible foreign-born, BCG-vaccinated individuals would be undergraduate or graduate students.…”