A brief intervention to promote HPV vaccine initiation among young women attending federally supported clinics: a randomized controlled pilot study

doi:10.21203/rs.3.rs-3098204/v1

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Research Article

A brief intervention to promote HPV vaccine initiation among young women attending federally supported clinics: a randomized controlled pilot study

https://doi.org/10.21203/rs.3.rs-3098204/v1

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Approximately 90% of HPV-associated cancers are preventable with HPV vaccination, yet uptake is suboptimal, particularly among minority and low-income young women. A theory-based intervention (Step Up to Prevention) was developed to enhance knowledge and promote favorable attitudes about HPV vaccination among young women aged 18-26 attending federally supported clinics. This mixed-method study evaluated the acceptability, feasibility, and preliminary efficacy of the intervention. We presented the brief intervention to participants before their scheduled clinic visit and measured the impact on HPV vaccine uptake. We offered the information and tailored components of the intervention together and separately and compared them to usual care. Women (n=60) were randomized into four groups (computerized information, 1-to-1 tailored, combined, and usual care). They responded to pre/post-surveys before and immediately after the intervention and after their clinic visit. Significant differences in initial HPV vaccine uptake were observed among all intervention groups as compared to usual care (computerized information (p=0.006), 1-to-1 tailored (p=0.007), combined (p=0.043)). The qualitative findings suggest the various components of the intervention were all acceptable highlighting aspects that were empowering and informative. Results suggest this intervention has potential efficacy to provide additional support to providers and patients by promoting favorable views and improving health literacy among young women about HPV vaccination.

Clinical Trial Registration: NCT02046265

primary prevention

cancer

young women

randomized controlled trial HPV vaccine

intervention

Human papillomavirus (HPV) infection causes most cases of cervical cancer and contributes to the growing incidence of vulvar, vaginal, anal, or oropharyngeal cancers (Lu et al., 2015). Globally, of the more than 630,000 HPV-attributable cancer cases per year, the most common are cervical cancers, which lead to approximately 341,831 deaths per year (de Martel et al., 2017; Globocan, 2021). In the US, an estimated 47,199 new HPV-associated cancers occur yearly, and about 4,000 women die of this cancer (CDC, 2022). HPV vaccines are highly effective in preventing cervical cancers and have also been found to reduce the risk of HPV-associated vulvar, vaginal, oropharyngeal, and anal cancers (CDC, 2022). The 3-dose HPV vaccine series has been approved in the US for adolescent and young women ages 11–26 since 2006; however, adoption of this vaccine has been remarkably slow compared to other vaccines for this age group. Over the years, the guidance has expanded to include males ages 11–26 and updated to recommend a 2-dose schedule for both males and females who received their first dose prior to age 15 (Meites et al., 2016)

Strategies to increase the uptake of this life-saving therapeutic among unvaccinated young women could hasten reductions in population-wide cancer burden (Lu et al., 2021). Recent statistics indicate that only 47% of 18–26 years old women ever received the HPV vaccine, well under the Healthy People: 2030 goal of achieving 80% vaccine completion (Black, 2021; CDC, 2021; US Department of Health Human Services et al., 2018). Only 53% have started the three-dose vaccine series, with uptake lower among Black women (45%) and Hispanic women (50%) compared to White women (57%)(Williams et al., 2017). In addition, women aged 18– 26 years without health insurance were less likely to receive the first dose compared to same-age peers with health insurance (Lu et al., 2021; Williams et al., 2017). Such differential uptake could worsen disparities in cervical cancer outcomes (Burger et al., 2016).

According to recent reviews, few studies have evaluated HPV vaccination initiation interventions for young women aged 18–26, and among those, almost all involved college women (Lott et al., 2020; Mavundza et al., 2021). In one study, vaccine decision narratives delivered by video demonstrated significant improvement in uptake of the 1st dose of the HPV vaccine (22%) compared to non-narrative video information or no information (12%) with an overall uptake of 15% (Hopfer, 2012). In another study, comparing college women provided with an HPV and vaccination fact sheet and peers who had not received that information demonstrated overall low uptake (5.5%) and no difference between groups (Patel et al., 2012). A third study provided college women with HPV and vaccine content from either a tailored website or a standardized factsheet website, resulting in 8% uptake overall and no difference between groups (Bennett et al., 2015). In the U.S., minority and low-income women experience greater morbidity and mortality from cervical cancer compared to other groups (Buskwofie et al., 2020). Effective interventions to improve uptake of the HPV vaccine, especially among lower-income and minority young women are urgently needed.

Several prominent theories posit the importance of psychological factors, such as beliefs and attitudes, for influencing health behaviors (Glanz, 2008). Identifying such modifiable perceptions in a target population provides specific guidance for intervention development and evaluation. Using the Integrative Model of Behavioral (IBM) Prediction (Fishbein & Ajzen, 2010) in our prior research, we identified salient beliefs and knowledge deficits about HPV vaccination among young urban women (Teitelman et al., 2011). Our findings were consistent with other extensive national studies that revealed common reasons why young women are not getting the HPV vaccine, including perceived lack of need, knowledge, and safety concerns (Schmidt & Parsons, 2014). We subsequently utilized those findings to create the current study’s-clinic-based educational intervention to enhance knowledge and favorable HPV vaccine views (attitudes, norms and control/self-efficacy) as a theory-guided strategy to promote the uptake of the HPV vaccine among young women aged 18–26 attending federally supported health clinics.

This intervention was designed to enhance knowledgeand promote favorable views about the HPV vaccine using a theory-based approach to enhance uptake. The objective of the present study was to evaluate that intervention, called “Step Up to Prevention,” for acceptability, feasibility, and preliminary efficacy. Many health behavior change theories consider knowledge as an essential prerequisite for effective behavior change but insufficient alone to address other factors (e.g., cognitive and environmental barriers) that influence behavioral outcomes (Glanz, 2008). We designed this randomized controlled pilot study to assess the knowledge and belief components separately and together, compared to a usual care group. The primary outcome was receiving the first dose of the HPV vaccine. We hypothesized that: 1) all three active HPV vaccine promotion arms would be more efficacious than the usual care group and that; 2) the combined computerized information and 1-to1 tailored group would be most efficacious. The secondary outcome was the intention to receive the first dose of the HPV vaccine.

Recruitment and Study Procedures

We recruited female participants (n = 60) ages 18–26 to “Step Up to Prevention,” an HPV-associated cancer risk reduction project to understand HPV associated cancer risk behaviors and identify optimal strategies to provide health information on this topic. The source population was women aged 18–26 who attended two outpatient clinics in a large diverse metropolitan area in the northeastern U.S between July 2014 and March 2016. One clinic was a federally supported family planning program within an OB/GYN practice, and the other an adolescent clinic that was part of a federally qualified health center (FQHC) seeing patients up to age 24. Both clinics provided subsidized care for low-income patients. For the OB/GYN clinic, recruiters had access to clinic schedules and phoned women who were scheduled for an upcoming clinic visit within the next couple of weeks. For the adolescent clinic, recruiters posted flyers in the clinic and gave flyers to patients in the waiting room. Flyers in this clinic were also distributed from the waiting room into the surrounding community. The recruiters provided a brief explanation of the study to potential participants and if interested and they provided verbal consent for screening, they were assessed for eligibility over the phone or in a private area. Participants were initially eligible if they were women between 18–26 years of age; self-identified as not yet having received the HPV vaccine; ever had vaginal sex; and were able to: 1) schedule a sufficient time to complete the intervention and pre/post evaluations; 2) receive reminder texts or emails; 3) speak, read, and understand English at a 5th-grade level or above. Basic English proficiency was intitailly assessed during eligibility screening and re-assessed when reviewing the written informed consent form. Initial exclusion criteria were being pregnant and/or planning to be pregnant in the next six months. Research team members also searched clinic medical records and the statewide vaccine database for prior HPV vaccination among potential participants and deemed ineligible if records indicated they had received at least one dose of the HPV vaccine. Additional exclusion criteria, assessed by providers during the clinic visit included any prior HPV vaccination and any medical contraindications to the HPV vaccine, such as being immunocompromised or pregnant. Institutional Review Board approval was obtained from the appropriate university and clinic organizations. This study followed the CONSORT guidelines for randomized pilot trial (Eldridge et al., 2016)

If the participant was initially eligible, the recruiter invited them to participate in the “Step Up to Prevention” Research Study. Recruiters scheduled those interested in participating in the intervention study for a pre-clinic appointment. The pre-clinic study visit took place in a private office in the clinic or a nearby university building based on their preference. For those recruited by phone, this visit was scheduled within a few days or just prior to their clinic visit. For those recruited in the waiting room, this visit occurred that same day prior to their clinic visit or prior to their next scheduled appointment.

At the pre-clinic visit, a research assistant first met with the participant to conduct informed consent. The participant was then randomized to one of four intervention conditions (described below). All participants then completed a baseline computer-assisted self-interview (CASI) survey. An intervention facilitator proceeded according to the appropriate intervention protocol (described below). After the intervention, the participant completed a brief post-intervention CASI survey. Subsequently, the participant attended their clinic visit on the same day or within the next few days. A research assistant was available in a clinic research office during this visit.

During their clinic visit, participants were offered an HPV vaccine by a nurse practitioner if medically appropriate. Nurse practitioners and other clinic staff were informed about the study in general but were blinded to the intervention condition of the participants. If the participant decided to receive the HPV vaccine, a research assistant would administer a second study consent form, and clinic staff or a research nurse would administer the 4 valent HPV vaccine (available at the time of the study). The cost of the HPV vaccine was provided as part of the study so that participants did not have to pay for the vaccine. The participant then completed a brief post-clinic CASI survey.

Randomization to Interventions

The study utilized a randomized controlled trial design with a block randomization technique. A computer-generated random number sequence with a block size of four was performed by our study statistician, who had no contact with participants and placed them in plain white envelopes, which were numbered sequentially. During the pre-clinic visit, a research assistant randomly assigned participants to one of four intervention conditions using the pre-numbered envelopes to one of four intervention groups: 1) Combined computer information & tailored 1-to-1 session; 2) Tailored 1-to-1 session; 3) Computer information session; 4) Usual care. We divided the envelopes between the two sites, resulting in slightly uneven enrollment among the groups.

Intervention Sessions

The Step Up to Prevention intervention was comprised of two components, The information component was delivered through an interactive computer session and was designed to enhance knowledge. The individually tailored 1-to-1 session was delivered face-to-face with a trained facilitator (see below) and was designed to address underlying beliefs as a way to foster more favorable attitudes, norms and control/self efficacy. We offered the information and tailored components of the intervention together and separately and compared them to usual care. Each participant met with a facilitator and received the intervention content for their intervention arm (see Fig. 1 for a description of each component). All intervention arms (including usual care) received a brief introduction to an information packet, which lasted 3–4 minutes. Those randomized to the the usual group received only this brief session and packet. The computer information session and the tailored 1-to-1 session each took approximately 10 minutes to complete. For those in the combined session, the computer information session took place first.

We drew upon the Integrated Theory of Behavior (Fishbein & Ajzen, 2010) in our formative research, which included focus groups and a survey with young economically disadvantaged women up to 26 years of age (Teitelman et al., 2011), as well as input from a Community Advisory Board and Clinic Staff Advisory Board (providers and other staff). We used this information to develop Step Up to Prevention, a cervical cancer risk reduction intervention that was both grounded in theory and appropriate for young urban women seeking health care in federally-funded health clinics. The 1–1 and combined intervention sessions targeted underlying HPV vaccine beliefs related to attitudes, norms and control., The salient outcome expectancies (behavioral beliefs) underlying attitude included that getting the HPV vaccine would reduce their chances of getting an HPV infection or cervical cancer.Tthe normative beliefs underlying norms included approval from mother/mother figure, partner, or friends of their getting the HPV vaccine. Perceived behavioral control beliefs underlying control/self efficay related to the challenges of finding a provider who would offer the vaccine at their clinic visit and paying for the HPV vaccine. In the computer information and combined sessions relevant informational topics were targeted regarding the HPV virus, the HPV vaccine, and the link between HPV and cervical cancer.

The intervention facilitators were all female students at the affiliated university ages 23–28 studying in health professions and represented a diversity of backgrounds. Individual training sessions were conducted by the Principal Investigator or the Project Director using a standardized training manual. Following the training sessions, the facilitator-in-training would observe the four types of intervention sessions, then be observed by a more senior team member while conducting all the various sessions until competency was achieved.

Data Collection and Measures

The participants completed confidential surveys before the intervention (baseline), immediately after the intervention (post-intervetnion), and after their clinic visit (post-clinic) using a computer-assisted self-interview (CASI). As compensation for participating in the study, each participant was given $35.

Baseline data consisted of demographic and health variables as well as social-cognitive mediators (e.g. knowledge, attitudes, norms, control/self-efficacy regarding HPV vaccination). Demographic and health variables included age, race/ethnicity, mothers’ education, having a well-woman exam in the past year, a history of a sexually transmitted infection (STI), condom use at last sex, and cigarette smoking in the past two months. We assessed cigaretted smoking since it is a risk factor for cervical cancer. We assessed HPV and cervical cancer knowledge with 9 statements eliciting true/false/don’t know responses, such as: “Women who get the HPV vaccine can reduce the risk of getting cervical cancer” and “Having HPV is associated with getting cervical cancer.” We assessed the theoretical mediators of HPV vaccine initiation using 5-point Likert scale response sets for attitudes (2 questions: alpha = .941), norms (1 question), and control/self-efficacy (4 questions; alpha = .874)) see Fig. 3 for a list of specific questions). The secondary outcome measure was the intention to receive the HPV vaccine assessed with one question: “How likely is it that you will get the HPV vaccine during today’s/your next clinic visit?” (5-point Likert response set ranging from 1 = very unlikely to 5 = very likely).

The post-intervention data focused on social-cognitive mediators (described above) including intention which were targeted in the active arms of the intervention and acceptability feedback about the intervention. To assess acceptability participants evaluated their intervention condition with several open-ended questions, and one question assessing how helpful it was with a Likert scale response ranging from 1 = very unhelpful to 5 = very helpful.

The post-clinic data assessed uptake of the first dose of the HPV vaccine, which was the primary outcome measure. This was assessed with one question: “I received the first dose of the HPV vaccine (yes/no). If they did not receive a vaccine, we also elicited the reason why in an open-ended format and categorized responses as follows: not interested right now or provider indicated not eligible. We verfired this with medical records. Reasons for not being eligible included pregnancy or possible pregnancy, being immunocompromised, or having already received at least one dose of the HPV vaccine that was not previously eliciticed from participants or records.

Data Analysis

Descriptive statistics were used to summarize demographic, prior health behavior, and outcome variables, and Fisher’s exact test was used to compare participant characteristics by intervention group at baseline. The efficacy of each active intervention group as compared with the usual care group over the baseline and post-intervention time points using pairwise comparison with an unstructured covariance matrix in SPSS version 29(IBM Corporation, 2022; SAS Institute Inc., 2011). For binary measures, the binominal distribution was specified with the logic link function, and for continuous measures, the normal distribution was specified with the identity link function. The estimate statements obtained odds ratios (OR) for binary measures, model-based mean differences for continuous measures, and corresponding 95% confidence intervals. The model included the baseline measure of the criterion, intervention condition, and time point (baseline and post-intervention)

Qualitative analysis

We used content analysis to code the data, examine patterns, and identify common themes in the open-ended responses provided at the end of the intervention session. Two members of the research team coded the data using an Excel spreadhseet. Patterns were identified through a process of comparing and contrasting data within and across intervention groups. Major themes were identified from these patterns (Glaser, 2004; Strauss & Corbin, 1998).

Sample Characteristics

A total of 60 participants were enrolled and completed a baseline survey during their pre-clinic visits (see Fig. 2: Consort Diagram),and 59 completed the post-intervention survey due to being lost to follow-up (LTF). Six participants were identified as not eligible to receive the HPV vaccine during their clinic visit with the nurse practitioner because they either had a prior HPV vaccination or had another contraindication to the HPV vaccine which was not identified during initial enrollment screening, and one participant did not complete a post-clinic survey (LTF), resulting in a valid analytic data set of n = 53 for initial vaccine uptake. These seven participants did not significantly differ from those who remained eligible with regard to baseline characteristics. All participants were ages between 18 and 26, and the mean age was 21 years old. Most participants were African American (61.7%), and non-Hispanic (91.7%). There were no significant age and race/ethnicity differences between groups.

The baseline survey (n = 60), showed almost two-thirds (n = 36, 60%) had a well-woman visit within the past year, and less than half (n = 26, 44%) responded that they intended to get the HPV vaccine (likely/very likely). Approximately one-third of the participants (32%; n = 19) reported a history of sexually transmitted infection (STI), and less than half(n = 25, 42%) reported using a condom during their last vaginal sexual encounter. Approximately one-third (n = 21, 35%) of the participants smoked cigarettes in the past two months. Baseline characteristics were similar between the groups (Table 1). There were no significant baseline group differences in their intention to get the HPV vaccine (p = 0.86).

Table 1

**Participant characteristics at baseline by intervention condition** (Number/%)
Variables	Combined N = 12	1-to-1 tailored N = 17	Computer Information N = 17	Usual Care N = 14
Mother finished high school	8(66.67%)	16 (94.12%)	14 (82.35%)	12 (85.71%)
History of sexually transmitted infection ever	4(33.33%)	8 (47.06%)	4 (23.53%)	3 (21.43%)
Condom use during last vaginal sex	5(41.67%)	6(35.29%)	8(50.00%)	6(42.86%)
Had well-woman (OBGYN) visit in past one year	4(33.3%)	11(64.71%)	12(70.59%)	9 (64.29%)
Any cigarette smoking past 2 months	3(25.00%)	8(47.06%)	5(29.41%)	5(35.71%)
Intention to get HPV vaccine (during today’s/your next clinic visit	4(33.33%)	8(50%)	8 (47.06)	6 (42.86)

Social Cognitive Factors

Participants had relatively low levels of cervical cancer and HPV vaccine knowledge prior to the intervention. For example, 66% of participants at baseline believed getting the HPV vaccine would reduce their chances of getting cervical cancer, which increased to 90% following the intervention. At baseline, 67% of participants indicated it was true that having HPV was associated with cervical cancer, and this increased to 95% after the intervention.

Table 2 presents baseline to post-intervention changes in theoretical mediators of attitude, control (self-efficacy), norm, and knowledge about HPV and HPV vaccination. All intervention arms positively impacted participants’ attitudes, control, norms, and knowledge about HPV and the HPV vaccine as compared to the usual care arm. Although all groups showed improvement in normative beliefs, the usual care group showed the most improvement compared to all intervention groups. Comparing across groups, the combined intervention group showed the most improvement of knowledge (9 questions : pre: 32% and post: 88%), followed by those in the computerized Information session (pre: 44% and post: 88%), (Table 2). A significant improvement (p-value: 0.034, 95% confidence interval 1.6–53.9 effect size 27.8) was observed in knowledge among the combined group (55.6%) compared to the usual care group (27.8%).

Table 2

HPV vaccine Theoretical mediators/knowledge mean percent increase (percent mean baseline/post-intervention)
Variables	Combined (n = 12)	1-to-1 tailored (n = 17)	Computer information (n = 16)	Usual Care (n = 14)
Attitude- Mean pre/post^ percent baseline/post-intervention percent increase	3.70/4.35 74.0/87.0 13.0	4.11/4.60 82.1/92.0 9.3	3.75/4.27 75.0/85.3 8.7	3.46/3.79 69.2/75.8 6.7
Control Mean pre/post^ percent baseline/post-intervention percent increase	4.30/4.43 86.0/88.5 2.5	4.32/4.52 86.5/90.3 2.3	4.11/4.53 82.2/90.7 7.3	4.27/4.42 85.4/88.3 2.9
Norm Mean pre/post^ percent baseline/post-intervention percent increase	3.60/4.00 72.0/80.0 8.0	3.86/4.20 77.1/84.0 5.7	3.50/4.00 70.0/80.0 6.7	3.58/4.17 71.7/83.3 11.7
Knowledge Mean pre/post^^ percent baseline/post-intervention percent increase	2.90/7.90 32.2/87.8 55.6 p = 0.034	4.15/7.14 46.2/79.4 28.7	4.00/7.93 44.4/88.1 41.3	3.83/6.33 42.6/70.4 27.8
^ Mean 1–5 Likert scale response
^^ Mean of 9 Knowledge questions correct responses

Table 3 summarizes the results of the baseline to post-intervention changes in HPV vaccine intention. There was a significant improvement in intention for HPV vaccine uptake among the 1-to-1 tailored group (p = 0.020). The computerized information session group and combined intervention did not show a significant difference in HPV vaccination intention compared to the usual care group.

Table 3

**Linear Pairwise Comparison of intervention groups to usual care group in HPV vaccine initiation intention** [Mean difference (S.E.), Confidence interval, P value]
Criteria	Combined Intervention (n = 10)	1-to1 tailored (n = 15)	Computerized Information (n = 15)
HPV vaccine initiation intention	-0.25(0.44) -1.11-0.61, 0.57	-0.95(0.40) -1.73- -017, 0.02*	-0.62(0.40), -1.40-0.16, 0.12
*significant at p ≤ 0.05

Outcome: HPV Vaccine initiation.

The HPV vaccine initiation rate of the sample was 66.04% (n = 35/53). Only 25% (n = 3/12) in the usual care group initiated the HPV vaccine, while those in the three intervention groups were more likely to initiate the first dose of the HPV vaccine (computerized information, 81.25% (n = 13/16), 1-to-1 tailored, 80% (n = 12/15), combined intervention, 70% (n = 7/10)). All active intervention groups (computerized information,1-to-1 tailored, combined) showed a significant improvement in HPV vaccine initiation compared to the usual care-only group (p = 0.006, p = 0.007, p = 0.043). Table 4 summarizes the results. Outcomes by the group did not differ between the two clinical sites. There were no differences in group outcomes between those who completed their pre-clinic study visit and clinic appointment on the same day and those who did so on separate days.

Table 4

**Binary Pairwise Comparison of intervention groups to usual care group in HPV vaccine initiation** [Odd Ratio (S.E), Confidence interval, P value]
Criteria	Combined Intervention (n = 10)	1-to1 tailored (n = 15)	Computerized Information (n = 16)
HPV vaccine initiation	7.0 (2.6) 1.07-46.0, 0.043*	12.0 (2.5) 1.95-74.0, 0.007**	13.0 (2.5) 2.12–79.6, 0.006**
*significant at p ≤ 0.05
**significant at p ≤ 0.01

Qualitative findings

On the intervention feedback survey collected at the post-intervention time point (completed by n = 48), in response to the question: “How helpful was your intervention?” (1 = very unhelpful) to (5 = very helpful), the mean rating for each of the four intervention groups ranged from 4.2 to 4.8 (between helpful and very helpful). The remaining questions were all open-ended. Across all four intervention groups, participants’ comments were generally favorable, and when asked if they would recommend the intervention to a friend, all (N = 48) indicated “yes.” Many participants mentioned that they knew nothing about HPV prior to receiving their intervention.

In addition, participants were asked to provide details about what they liked and did not like about their intervention. A majority of participants (n = 36/48) indicated “nothing” about what they did not like or what could make it better. Several strong themes emerged that distinguished the intervention groups. Among those in the usual care group (n = 11), the most frequent comments indicated they liked that it was “clear,” “quick,” “concise,” and “full of information.” Participants in the computerized information group (n = 15) enjoyed the educational aspect of the intervention and noted that the voice-supported PowerPoint presentation made it “easy to understand” and “more interesting than reading” (in contrast to the handouts provided to all participants). Those in the 1-to-1 tailored group (n = 13) described their intervention as personally and emotionally engaging during the conversations with the facilitator. Most participants in this group mentioned that they enjoyed talking about their beliefs and noted that the intervention was “very empowering” and “makes you think.” The combined intervention group participants (n = 9) pointed out both educational and engaging aspects of the interventions, describing the content as both “informative” and “interactive.”

All three active arms of the Step Up to Prevention intervention showed improved uptake of the HPV vaccine compared to the usual care group. Our overall HPV vaccine uptake was 66% for the entire sample which is a marked improvement over prior studies of the same age group of young women with uptake rates ranging from 5.5%-15% (Bennett et al., 2015; Hopfer, 2012; Patel et al., 2012). In comparison to our usual care group (25% uptake), all three active intervention groups performed better, ranging from 70–81.25%. These promising findings suggest a way to reach the Healthy People: 2020 goal of achieving an 80% vaccine completion rate among this demographic (U. S. Department of Health Human). Given that our sample was comprised of low-income, predominantly minority, young adult participants seeking services at federally supported clinics, a group less likely to receive the first dose of the HPV vaccine, these findings are especially notable. Increasing HPV vaccine uptake among this population could help reduce HPV associated cancer morbidity and mortality disparities long-term (Lu et al., 2021).

Consistent with our hypothesis, those exposed to the combined intervention, computerized information intervention session and 1-to-1 tailored intervention arms showed a statistically significant improvement in uptake of the first HPV vaccination compared to the usual care group. However, contrary to our hypothesis, the combined intervention was not the most efficacious among the intervention arms, with an odds ratio of 7.0 (95% CI), compared to the other two active intervention arms: computerized info session (OR = 13, 95% CI) and 1–1 tailored session (OR = 12, 95% CI). The combined intervention session was the longest in duration, lasting approximately 20 + minutes, which may have led to participants to lose focus or attention and not fully engage with the content.

Regarding the secondary outcome of HPV vaccine intention, those in the 1-to-1 tailored session showed a significant improvement (pre/post intervention) in comparison to usual care group. This is not surprising since these sessions were designed to address social cognitive factors such as a beliefs and intention. This finding are consistent with the outcome behavior described above and support the theoretical link that highlights intention as the proximal predictor of behavior (Fishbein and Ajzen, 2010).

The level of HPV and cervical cancer knowledge increased for all active arms, with the greatest improvement in the 1–1 tailored and computerized Information sessions. Both groups received the interactive PowerPoint focused on conveying information. Our qualitative findings indicate that those who received this content stated that information was presented in a clear,easy to understand way. In addition, this content was presented using colorful visual material, included an audio option, and was self-paced, all features consistent with best practices in health communication messaging (Houts et al., 2006). Improvements in both the attitude and control measures (pre/post intervention) were seen for all active arms compared to usual care, a finding consistent with the expectations of our IBM theoretical approach Unexpectedly, for norms there was a greater endorsement among usual care participants compared to the other three intervention groups, regarding the item “ Most people who are important to me would approve of my getting the HPV vaccine during today’sclinic visit”. It is possible that the active arms encouraged more reflection, including the possibility of disapproval from others, leading participants to doubt the support of others. Once doubts are embraced they may be difficult to overcome.

Given the small sample size, our study findings suggest substantive improvement in HPV vaccine initiation for those who received both or a single component of the StepUp to Prevention intervention. Although information alone is often not sufficient to change behavior, for a one-time and immediate behavior such as getting a vaccine (without added expense), information may boost acceptance if presented in a clear, simple, and engaging format. In addition, the intervention was provided in the clinic just prior to seeing a clinician who offered eligible women the vaccine. As such, the active intervention content was immediately actionable, which may have contributed to the high level of vaccination across multiple intervention groups in our study. Finally, addressing modifiable beliefs may result in longer lasting behavior change needed for longer term adherence, such as completing the HPV vaccine series.

The interventions were designed for young women aged 18–26 years to provide information about HPV and the vaccine, address modifiable beliefs, assist with HPV vaccine initiation access, and enhance HPV-associated cancer prevention behaviors. The long-term goal of this intervention is to increase knowledge and promote favorable views of HPV vaccine and support self-efficacy of HPV-associated cancer prevention behaviors (such as cancer screening, condom use, and smoking cessation). The interventions specifically targeted the catch-up vaccine population who missed their initial HPV vaccination opportunity in early adolescence (ages 11–14 years), possibly due to their parents’ decisions and/or access to the vaccines. Since young women aged 18 and older have more agency related to their own health decision-making, the intervention directly engages this group to provide an opportunity to make an informed decision about their cancer prevention choices. Another goal of this intervention was to provide additional support to providers before and after the women’s health visit by priming their patients with knowledge. Undoubtedly, a strong provider recommendation is one of the most influencial factors on vaccine uptake (Walker et al., 2019). If this intervention were provided to potential patients in the waiting area prior to the visit in conjunction with the providers’ strong recommendation, the efficacy of this type of intervention could be maximized.

We also demonstrated that the components of the Step Up to Prevention intervention, combined and separately, were acceptable to the target population, based on the very positive qualitative feedback and ratings. Furthernore, this study also demonstrated this intervention is feasible to administer within busy clinic settings servicing a lower income urban population of young adult women and that it is possible to recruit our pilot sample size of n = 60, randomize and provide 4 different intervention strategies, and collect the necessary evaluation data.

Limitations

This study has a few limitations. This was a pilot study and therefore has a small sample size which may limit generalizability. Much of the data collected was measured with self-report, which can be affected by a social desirability bias. However, using CASI would likely reduce such potential problems (Metzger et al., 2000). The study also has some important strengths. It employed a randomized controlled design. In addition, the lengths of the interventions were relatively short, ranging between 4–20 + minutes, and thus could be feasibly integrated as a waiting room activity (the computerized information session) or conducted by a medical assistant after a short period of training (1-to-1 tailored session).

In addition, the content targeted young adult urban women. Because we recruited in an OB/GYN care facility, this study did not include young men or others who could have benefited from HPV-associated cancer prevention intervention. Future intervention and evaluation research could include other populations but may need different content given the different contexts and risks. While our current findings are promising, future research is needed to assess these interventions more fully in a larger and more diverse sample over time.

This randomized controlled pilot study of Step Up to Prevention, a technology-enhanced brief intervention to promote HPV vaccine initiation, has demonstrated feasibility and high level of acceptability among young women attending federally supported clinics. These data show that while all active intervention groups improved HPV vaccine initiation relative to the usual care group, the computerized Information session (provided with information from the usual care group) was the most effective format for promoting HPV vaccination in this target population. This suggests that using waiting room time to provide engaging technology-enhanced health promotion information is a feasible way to ease the burden of busy providers. We have demonstrated the preliminary efficacy of both components of the Step Up to Prevention intervention for HPV vaccine initiation, and shown it is feasible and acceptable to patients most vulnerable to HPV-related cancer morbidity and mortality. Further research is needed to extend these findings in a larger study.

Acknowledgments:

Supported in part by a research grant from Investigator Initiated Studies Program of Merck Sharp & Dohme Corp./MSD K.K. The opinions expressed in this paper are those of the authors and do not necessarily represent those of Merck Sharp & Dohme Corp./MSD K.K.

In addition, this research was supported by a grant from The American Academy of Nurse Practitioners Foundation.This project was aided by guidance from members of our Community Advisory Board and Provider Advisory Board.

Conflict of Interest Statement:

The authors have no conflicts of interest

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A brief intervention to promote HPV vaccine initiation among young women attending federally supported clinics: a randomized controlled pilot study

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