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A randomized, controlled, pragmatic trial of an iPad-based, tailored messaging intervention to increase human papillomavirus vaccination among Latinos.

ABSTRACT: Human papillomavirus (HPV) causes a number of cancers that disproportionally affect Latinos yet there is a paucity of research on interventions to increase HPV vaccination among this population. We sought to evaluate the efficacy of a web-based, individually customizable intervention, called CHICOs (Combatting HPV Infection and Cancers, tailored intervention) for its impact on HPV vaccine utilization. We conducted a three-armed, randomized, controlled trial in the waiting rooms of five family medicine practices from June 2014-February 2016 where CHICOS was compared to an iPad-based version of the Vaccine Information Sheet from the Centers for Disease Control and Prevention (untailored intervention), and usual care. Pair-wise comparisons between study arms of 6 different measures of HPV vaccine uptake were assessed, with analyses stratified by adolescents versus young adults. Of the 1,294 participants enrolled in the study, 1,013 individuals could be assessed for vaccination. Across study arms, 265 adolescents, but only 18 young adults, received an HPV vaccine dose during the study period. In both intention-to-treat and per-protocol analyses there were essentially no differences between the CHICOS and untailored arms in any vaccination measure, or between the untailored or CHICOS arms and usual care. Our study suggests that a tailored educational intervention may not be effective for increasing HPV vaccine uptake among Latino adolescents or young adults. However, the higher than expected baseline levels of positive vaccination attitudes of study participants could have diminished the statistical power of the study. Trial Registration Number: ClinicalTrials.gov (NCT02145156).

SUBMITTER: Dempsey AF

PROVIDER: S-EPMC6746523 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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A randomized, controlled, pragmatic trial of an iPad-based, tailored messaging intervention to increase human papillomavirus vaccination among Latinos.

Dempsey Amanda F AF Maertens Julie J Sevick Carter C Jimenez-Zambrano Andrea A Juarez-Colunga Elizabeth E

Human vaccines & immunotherapeutics 20190220 7-8

Human papillomavirus (HPV) causes a number of cancers that disproportionally affect Latinos yet there is a paucity of research on interventions to increase HPV vaccination among this population. We sought to evaluate the efficacy of a web-based, individually customizable intervention, called CHICOs (Combatting HPV Infection and Cancers, tailored intervention) for its impact on HPV vaccine utilization. We conducted a three-armed, randomized, controlled trial in ...[more]

PMID: 30689494

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Project description:BACKGROUND:In the Netherlands, human papillomavirus (HPV) vaccination uptake remains low. To improve informed decision making (IDM) and HPV vaccination acceptability, we systematically developed an interactive, web-based tailored intervention to which mothers of Dutch girls were invited to participate. OBJECTIVE:The aim of this study was to provide insight into the intervention's working mechanisms by evaluating (1) program use, (2) program acceptability, and (3) the relationship of program use with program acceptability and intervention effects (ie, dose-response relationship). METHODS:Only mothers from the intervention arm of a randomized controlled trial that assessed the effectiveness of the web-based, tailored intervention were included in this study. They were invited to visit the website of the web-based intervention between baseline (January 2015, just before access to the intervention) and follow up (March 2015, prior to the first HPV vaccination). Indicators for program use were time of website use (ie, duration of intervention exposure) and completeness (ie, proportion of all available web pages visited). HPV vaccination uptake registered by Praeventis was used as the primary outcome. Secondary outcomes were IDM, decisional conflict, and social-psychological determinants of HPV vaccination uptake. RESULTS:Among the 3995 invited mothers, 2509 (62.80%) logged on to the website, 2239 of whom (89.24%) visited at least one page of the intervention components. On average, mothers spent 21.39 minutes (SD 12.41) on the website and completed 50.04% (SD 26.18%) of the website components. Participants rated the website 7.64 (SD 1.39) on a 10-point scale. Program acceptability was significantly associated with completeness (?=4.36, P<.001), but not with time of website use (?=-.07, P=.77). Intention-to-treat analysis (N=3995) showed a significant positive effect of completeness on all outcome measures (all P<.003; Bonferroni-corrected ?=.05/15 factors), including on HPV vaccination uptake. Time of website use had a significant positive effect on all outcomes (all P<.003), except for uptake (P=.20), risk perception when not vaccinated (P=.14), subjective norms (P=.03), and habit (P=.01). CONCLUSIONS:Program use and acceptability of the intervention were adequate. Completeness was positively associated with acceptability. Furthermore, positive effects (ie, dose-response effects) were found for completeness and time of website use on the mothers' IDM, decisional conflict, and almost all of the social-psychological determinants of HPV vaccination acceptability. In addition, the extent to which mothers completed the intervention had a positive impact on their daughters' vaccination uptake. This indicates that the web-based, tailored intervention fits well with the mothers' needs, and that completeness of use is essential for improving HPV vaccination uptake, acceptability, and IDM. Program use should therefore be promoted. TRIAL REGISTRATION:Netherlands Trial Register NTR4795; https://www.trialregister.nl/trial/4795.

Project description:BACKGROUND:There is a need to deliver smoking cessation support at a population level, both in developed and developing countries. Studies on internet-based and mobile phone-based smoking cessation interventions have shown that these methods can be as effective as other methods of support, and they can have a wider reach at a lower cost. OBJECTIVE:This randomized controlled trial (RCT) aimed to compare, on a population level, the efficacy of an identical, tailored smoking cessation intervention delivered by mobile text messaging versus email. METHODS:We conducted a nationwide 2-arm, double-blinded, fully automated RCT, close to a real-world setting, in Norway. We did not offer incentives to increase participation and adherence or to decrease loss to follow-up. We recruited users of the website, slutta.no, an open, free, multi-component Norwegian internet-based smoking cessation program, from May 2010 until October 2012. Enrolled smokers were considered as having completed a time point regardless of their response status if it was 1, 3, 6, or 12 months post cessation. We assessed 7315 participants using the following inclusion criteria: knowledge of the Norwegian language, age 16 years or older, ownership of a Norwegian cell phone, having an email account, current cigarette smoker, willingness to set a cessation date within 14 days (mandatory), and completion of a baseline questionnaire for tailoring algorithms. Altogether, 6137 participants were eligible for the study and 4378 participants (71.33%) provided informed consent to participate in the smoking cessation trial. We calculated the response rates for participants at the completed 1, 3, 6, and 12 months post cessation. For each arm, we conducted an intention-to-treat (ITT) analysis for each completed time point. The main outcome was 7-day self-reported point prevalence abstinence (PPA) at the completed 6 months post cessation. We calculated effect size of the 7-day self-reported PPA in the text message arm compared with the email arm as odds ratios (ORs) with 95% CIs for the 4 time points post cessation. RESULTS:At 6 months follow-up, 21.06% (384/1823) of participants in the text message arm and 18.62% (333/1788) in the email arm responded (P=.07) to the surveys. In the ITT analysis, 11.46% (209/1823) of participants in the text message arm compared with 10.96% (196/1788) in the email arm (OR 1.05, 95% CI 0.86-1.30) reported to have achieved 7 days PPA. CONCLUSIONS:This nationwide, double-blinded, large, fully automated RCT found that 1 in 9 enrolled smokers reported 7-day PPA in both arms, 6 months post cessation. Our study found that identical smoking cessation interventions delivered by mobile text messaging and email may be equally successful at a population level. TRIAL REGISTRATION:ClinicalTrials.gov NCT01103427; https://clinicaltrials.gov/ct2/show/NCT01103427.

Project description:Background and objectivesVaccination with Human Papillomavirus (HPV) vaccine is recommended for 11-12 years-old, but uptake is suboptimal. Current messaging focuses on HPV infection transmission and prevention. Parents and providers are often uncomfortable discussing sexual practices of adolescents, contributing to the delay/refusal of vaccine. We created a cervical cancer-salient message encouraging HPV vaccination, emphasizing disease salience and disease threat, while promoting self-efficacy. We hypothesized this message would have greater effects on vaccine confidence and intent to vaccinate compared to Centers for Disease Control and Prevention (CDC) and non-vaccine control messages.MethodsA 3-arm randomized trial was conducted. Parents of girls aged 9-17 were eligible for the study. We measured participants' vaccine confidence and intent to vaccinate at baseline and post intervention message. Recruitment and surveys were administered online through Amazon Mechanical Turk.Results762 participants completed both surveys. We saw modest increases in vaccine confidence when comparing cervical cancer arm and control arm, and CDC arm and control arm; estimates were not statistically significant. The odds of reporting intent to vaccinate among the cervical cancer message arm were 1.13 times the odds of reporting intent to vaccinate in the control arm (95% CI: 0.30. 4.29). Intent to vaccinate was also not statistically significantly different between CDC message arm and control arm (OR = 1.25, 95%CI: 0.66, 2.37).ConclusionNeither message had effect on intent to vaccinate, highlighting need for research to identify successful messaging strategies for HPV. Exploratory analyses suggest among parents with 'Low' vaccine confidence at baseline, the cervical cancer framed message may be more effective in changing intention than the CDC message or non-vaccine control. Future work should target groups with 'Low' or 'Medium' vaccine confidence at baseline - they may be more amenable to change, and more receptive to disease-salient messaging.Clinical trial registrationClinicaltrials.gov, Reference #: NCT03002324.

Project description:The effectiveness of mobile technology to improve medication adherence via customized Short Messaging Service (SMS) reminders for stroke has not been tested in resource poor areas. We designed a randomized controlled trial to test the effectiveness of SMS on improving medication adherence in stroke survivors in Pakistan.This was a parallel group, assessor-blinded, randomized, controlled, superiority trial. Participants were centrally randomized in fixed block sizes. Adult participants on multiple medications with access to a cell phone and stroke at least 4 weeks from onset (Onset as defined by last seen normal) were eligible. The intervention group, in addition to usual care, received reminder SMS for 2 months that contained a) Personalized, prescription tailored daily medication reminder(s) b) Twice weekly health information SMS. The Health Belief Model and Social Cognitive theory were used to design the language and content of messages. Frontline SMS software was used for SMS delivery. Medication adherence was self-reported and measured on the validated Urdu version of Morisky Medication Adherence Questionnaire. Multiple linear regression was used to model the outcome against intervention and other covariates. Analysis was conducted by intention-to-treat principle.Two hundred participants were enrolled. 38 participants were lost to follow-up. After 2 months, the mean medication score was 7.4 (95 % CI: 7.2-7.6) in the intervention group while 6.7 (95 % CI: 6.4-7.02) in the control group. The adjusted mean difference (?) was 0.54 (95 % CI: 0.22-0.85). The mean diastolic blood pressure in the intervention group was 2.6 mmHg (95 % CI; -5.5 to 0.15) lower compared to the usual care group.A short intervention of customized SMS can improve medication adherence and effect stroke risk factors like diastolic blood pressure in stroke survivors with complex medication regimens living in resource poor areas.Clinicaltrials.gov NCT01986023 last accessed at https://clinicaltrials.gov/ct2/show/NCT01986023.

Dataset Information

A randomized, controlled, pragmatic trial of an iPad-based, tailored messaging intervention to increase human papillomavirus vaccination among Latinos.

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A randomized, controlled, pragmatic trial of an iPad-based, tailored messaging intervention to increase human papillomavirus vaccination among Latinos.

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