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Trial in HPV Prevention for the U.S. Vietnamese Community (HERO)

5 ноября 2026 г. обновлено: Milkie Vu, Northwestern University

Applying the Multiphase Optimization Strategy to Develop and Test a Culturally-Relevant Digital Health Intervention Targeting HPV Vaccination Among U.S. Vietnamese

The purpose of the HERO study is to leverage the Multiphase Optimization Strategy (MOST) framework to conduct a pilot trial testing four different intervention components (expert video, self-persuasion, narrative storytelling, and motivational interviewing) targeting HPV vaccination among U.S. Vietnamese.

PRIMARY AIM To assess the feasibility and acceptability of each of the four digital HERO intervention components in a pilot optimization trial using the MOST framework. Using a highly efficient design, the study team will randomize 96 Vietnamese parents of unvaccinated adolescents to receive 0 to 4 HERO components. The study team will establish the feasibility (reach, retention, adherence) and acceptability (usability, satisfaction, usefulness, cultural relevance) of each component (expert video, self-persuasion, narrative storytelling, and motivational interviewing).

SECONDARY AIM To investigate effects of each component on HPV vaccination outcomes and psychosocial mediators. The study team will examine the effects on HPV vaccination (initiation and intention) and psychosocial mediators.

Обзор исследования

Подробное описание

The purpose of the HERO study is to leverage the Multiphase Optimization Strategy (MOST) framework to conduct a pilot trial testing four different intervention components (expert video, self-persuasion, narrative storytelling, and motivational interviewing) targeting HPV vaccination among U.S. Vietnamese.

PRIMARY AIM To assess the feasibility and acceptability of each of the four digital HERO intervention components in a pilot optimization trial using the MOST framework. Using a highly efficient design, the study team will randomize 96 Vietnamese parents of unvaccinated adolescents to receive 0 to 4 HERO components. The study team will establish the feasibility (reach, retention, adherence) and acceptability (usability, satisfaction, usefulness, cultural relevance) of each component (expert video, self-persuasion, narrative storytelling, and motivational interviewing).

SECONDARY AIM To investigate effects of each component on HPV vaccination outcomes and psychosocial mediators. The study team will examine the effects on HPV vaccination (initiation and intention) and psychosocial mediators.

Research participants will be identified and recruited through online recruitment, community organizations, social media, research team social networks and personal contacts, and in-person events targeting U.S. Vietnamese parents of adolescents. Interested potential participants will answer an online screener for eligibility. When appropriate, potential participants can also be screened via a brief Zoom, telephone, or in-person interview. Once a participant is determined to be eligible for study participation, the study team will communicate via telephone or send a follow up email to them to invite them to participate in the research. Participants will provide eConsent via a form hosted on REDCap, including accepting that the interviews will be audio and/or video recorded. After consent is received, all additional study procedures will be handled by the study team.

Assessments. Participants will also fill out a short survey that captures sociodemographic information and vaccine beliefs and attitudes. This short survey cannot be completed until after participants have consented to participate. Participants will complete follow-up assessments at 1, 3, and 6 months post-baseline, including a survey and interview at Month 1 and surveys at Months 3 and 6.

Randomization and Study Orientation. Following the completion of the baseline assessment, participants will be randomized using computer-generated randomly permuted blocks, stratified by the sex of the adolescent (to acknowledge historical differences in HPV uptake among male and female adolescents). All participants will receive the constant component through the study website. Depending on the intervention condition, participants will receive 0 to 4 intervention components and complete them within 4 weeks from the baseline assessment.

Intervention Components

Constant component: Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).

Expert video: Participants will watch a video featuring Vietnamese healthcare providers. In the video, the providers will endorse vaccine safety and efficacy, dispel common misconceptions or concerns, and use verbal persuasion techniques to recommend HPV vaccination.

Self-persuasion: Participants will complete an interactive web-based task where they audio record reasons, summarized in their own words, for getting their adolescent the HPV vaccine.

Narrative storytelling: Participants will watch a video featuring U.S. Vietnamese parents. In the video, featured parents will describe stories of their experiences learning about the HPV vaccine as well as motivations to initiate and complete the vaccine series on-time for their adolescents.

Motivational interviewing: Participants will receive 2 calls (phone or Zoom) from a trained U.S. Vietnamese health educator. The health educator will use motivation interviewing (e.g., open-ended questions, acknowledging feelings, affirmations, reflective listening) to increase opportunities for and commitment to HPV vaccination while decreasing barriers (e.g., safety or access concerns).

Participants will be followed for a maximum of 6 months from the baseline assessment and will complete up to 3 additional assessments (1-month, 3-month, and 4-month post-randomization).

Тип исследования

Интервенционный

Регистрация (Оцененный)

96

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Учебное резервное копирование контактов

Места учебы

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

  • Self-identify as U.S. Vietnamese.
  • Are the parent of a youth ages 9-18 who have not initiated the HPV vaccine series. Only one parent per household will be able to participate.
  • Have lived in the U.S. for 12 months or more.

Exclusion Criteria:

  • Planning to move out of the U.S. within the next 6 months.
  • Not fluent in either spoken and written Vietnamese or spoken and written English.
  • Inability to provide informed consent.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Experimental: Exp Condition 1

Research participant receives the Constant component + Expert video + Self-persuasion + Narrative storytelling + Motivational interviewing

Participants will watch a video featuring Vietnamese healthcare providers. In the video, the providers will endorse vaccine safety and efficacy, dispel common misconceptions or concerns, and use verbal persuasion techniques to recommend HPV vaccination.

Participants will complete an interactive web-based task where they audio record reasons, summarized in their own words, for getting their adolescent the HPV vaccine.

Participants will watch a video featuring U.S. Vietnamese parents. In the video, featured parents will describe stories of their experiences learning about the HPV vaccine as well as motivations to initiate and complete the vaccine series on-time for their adolescents.

Participants will receive 2 calls (phone or Zoom) from a trained U.S. Vietnamese health educator. The health educator will use motivation interviewing (e.g., open-ended questions, acknowledging feelings, affirmations, reflective listening) to increase opportunities for and commitment to HPV vaccination while decreasing barriers (e.g., safety or access concerns).

Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).

Экспериментальный: Experimental: Exp Condition 2

Research participant receives Constant + Expert video + Self-persuasion + Narrative storytelling.

Participants will watch a video featuring Vietnamese healthcare providers. In the video, the providers will endorse vaccine safety and efficacy, dispel common misconceptions or concerns, and use verbal persuasion techniques to recommend HPV vaccination.

Participants will complete an interactive web-based task where they audio record reasons, summarized in their own words, for getting their adolescent the HPV vaccine.

Participants will watch a video featuring U.S. Vietnamese parents. In the video, featured parents will describe stories of their experiences learning about the HPV vaccine as well as motivations to initiate and complete the vaccine series on-time for their adolescents.

Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).

Экспериментальный: Experimental: Exp Condition 3

Research participant receives Constant + Expert video + Self-persuasion + Motivational interviewing

Participants will watch a video featuring Vietnamese healthcare providers. In the video, the providers will endorse vaccine safety and efficacy, dispel common misconceptions or concerns, and use verbal persuasion techniques to recommend HPV vaccination.

Participants will complete an interactive web-based task where they audio record reasons, summarized in their own words, for getting their adolescent the HPV vaccine.

Participants will receive 2 calls (phone or Zoom) from a trained U.S. Vietnamese health educator. The health educator will use motivation interviewing (e.g., open-ended questions, acknowledging feelings, affirmations, reflective listening) to increase opportunities for and commitment to HPV vaccination while decreasing barriers (e.g., safety or access concerns).

Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).

Экспериментальный: Experimental: Exp Condition 4

Research participant receives Constant + Expert video + Self-persuasion

Participants will watch a video featuring Vietnamese healthcare providers. In the video, the providers will endorse vaccine safety and efficacy, dispel common misconceptions or concerns, and use verbal persuasion techniques to recommend HPV vaccination.

Participants will complete an interactive web-based task where they audio record reasons, summarized in their own words, for getting their adolescent the HPV vaccine.

Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).

Экспериментальный: Experimental: Exp Condition 5

Research participant receives Constant + Expert video + Narrative storytelling + Motivational interviewing

Participants will watch a video featuring Vietnamese healthcare providers. In the video, the providers will endorse vaccine safety and efficacy, dispel common misconceptions or concerns, and use verbal persuasion techniques to recommend HPV vaccination.

Participants will watch a video featuring U.S. Vietnamese parents. In the video, featured parents will describe stories of their experiences learning about the HPV vaccine as well as motivations to initiate and complete the vaccine series on-time for their adolescents.

Participants will receive 2 calls (phone or Zoom) from a trained U.S. Vietnamese health educator. The health educator will use motivation interviewing (e.g., open-ended questions, acknowledging feelings, affirmations, reflective listening) to increase opportunities for and commitment to HPV vaccination while decreasing barriers (e.g., safety or access concerns).

Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).

Экспериментальный: Experimental: Exp Condition 6

Research participant receives Constant + Expert video + Narrative storytelling

Participants will watch a video featuring Vietnamese healthcare providers. In the video, the providers will endorse vaccine safety and efficacy, dispel common misconceptions or concerns, and use verbal persuasion techniques to recommend HPV vaccination.

Participants will watch a video featuring U.S. Vietnamese parents. In the video, featured parents will describe stories of their experiences learning about the HPV vaccine as well as motivations to initiate and complete the vaccine series on-time for their adolescents.

Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).

Экспериментальный: Experimental: Exp Condition 7

Research participant receives Constant + Expert video + Motivational interviewing

Participants will watch a video featuring Vietnamese healthcare providers. In the video, the providers will endorse vaccine safety and efficacy, dispel common misconceptions or concerns, and use verbal persuasion techniques to recommend HPV vaccination.

Participants will receive 2 calls (phone or Zoom) from a trained U.S. Vietnamese health educator. The health educator will use motivation interviewing (e.g., open-ended questions, acknowledging feelings, affirmations, reflective listening) to increase opportunities for and commitment to HPV vaccination while decreasing barriers (e.g., safety or access concerns).

Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).

Экспериментальный: Experimental: Exp Condition 8

Research participant receives Constant + Expert video

Participants will watch a video featuring Vietnamese healthcare providers. In the video, the providers will endorse vaccine safety and efficacy, dispel common misconceptions or concerns, and use verbal persuasion techniques to recommend HPV vaccination.

Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).

Экспериментальный: Experimental: Exp Condition 9

Research participant receives Constant + Self-persuasion + Narrative storytelling + Motivational interviewing

Participants will complete an interactive web-based task where they audio record reasons, summarized in their own words, for getting their adolescent the HPV vaccine.

Participants will watch a video featuring U.S. Vietnamese parents. In the video, featured parents will describe stories of their experiences learning about the HPV vaccine as well as motivations to initiate and complete the vaccine series on-time for their adolescents.

Participants will receive 2 calls (phone or Zoom) from a trained U.S. Vietnamese health educator. The health educator will use motivation interviewing (e.g., open-ended questions, acknowledging feelings, affirmations, reflective listening) to increase opportunities for and commitment to HPV vaccination while decreasing barriers (e.g., safety or access concerns).

Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).

Экспериментальный: Experimental: Exp Condition 10

Research participant receives Constant + Self-persuasion + Narrative storytelling

Participants will complete an interactive web-based task where they audio record reasons, summarized in their own words, for getting their adolescent the HPV vaccine.

Participants will watch a video featuring U.S. Vietnamese parents. In the video, featured parents will describe stories of their experiences learning about the HPV vaccine as well as motivations to initiate and complete the vaccine series on-time for their adolescents.

Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).

Экспериментальный: Experimental: Exp Condition 11

Research participant receives Constant + Self-persuasion + Motivational interviewing

Participants will complete an interactive web-based task where they audio record reasons, summarized in their own words, for getting their adolescent the HPV vaccine.

Participants will receive 2 calls (phone or Zoom) from a trained U.S. Vietnamese health educator. The health educator will use motivation interviewing (e.g., open-ended questions, acknowledging feelings, affirmations, reflective listening) to increase opportunities for and commitment to HPV vaccination while decreasing barriers (e.g., safety or access concerns).

Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).

Экспериментальный: Experimental: Exp Condition 12

Research participant receives Constant + Self-persuasion

Participants will complete an interactive web-based task where they audio record reasons, summarized in their own words, for getting their adolescent the HPV vaccine.

Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).

Экспериментальный: Experimental: Exp Condition 13

Research participant receives Constant + Narrative storytelling + Motivational interviewing

Participants will watch a video featuring U.S. Vietnamese parents. In the video, featured parents will describe stories of their experiences learning about the HPV vaccine as well as motivations to initiate and complete the vaccine series on-time for their adolescents.

Participants will receive 2 calls (phone or Zoom) from a trained U.S. Vietnamese health educator. The health educator will use motivation interviewing (e.g., open-ended questions, acknowledging feelings, affirmations, reflective listening) to increase opportunities for and commitment to HPV vaccination while decreasing barriers (e.g., safety or access concerns).

Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).

Экспериментальный: Experimental: Exp Condition 14

Research participant receives Constant + Narrative storytelling

Participants will watch a video featuring U.S. Vietnamese parents. In the video, featured parents will describe stories of their experiences learning about the HPV vaccine as well as motivations to initiate and complete the vaccine series on-time for their adolescents.

Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).

Экспериментальный: Experimental: Exp Condition 15

Research participant receives Constant + Motivational interviewing

Participants will receive 2 calls (phone or Zoom) from a trained U.S. Vietnamese health educator. The health educator will use motivation interviewing (e.g., open-ended questions, acknowledging feelings, affirmations, reflective listening) to increase opportunities for and commitment to HPV vaccination while decreasing barriers (e.g., safety or access concerns).

Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).

Экспериментальный: Experimental: Exp Condition 16

Research participant receives the Constant component only

Each participant will receive the constant component through the study website, which includes a vaccine information statement from the CDC with details on HPV vaccine benefits, potential side effects, and recommended vaccination schedule, as well as online information on access and locations for HPV vaccine (e.g., list of Vaccines for Children providers where Medicaid, uninsured, or underinsured adolescents can be vaccinated for free).

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Feasibility: Reach
Временное ограничение: Baseline

Number of enrolled participants divided by number of eligible individuals

Baseline
Feasibility: Retention
Временное ограничение: 1, 3, and 6 months post-randomization

Number of of participants who drop out divided by number of randomized participants

1, 3, and 6 months post-randomization
Feasibility: Adherence
Временное ограничение: 1-month post randomization

Self-persuasion task: number of web launches and length of time spent completing task;

Expert video and narrative storytelling: number of views and length of engagement time;

Motivational interviewing: number of completed motivational interviewing calls and length of each call

1-month post randomization
Acceptability
Временное ограничение: 1-month post randomization

Survey questions and semi-structured interviews exploring cultural relevance; reason for use/lack of use; aspects participants liked the most/least; ideas for improvement

1-month post randomization

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
HPV vaccine initiation (adolescents)
Временное ограничение: 1, 3 and 6 months post-randomization

Adolescent's receipt (yes or no) of ≥1 vaccine doses; uploads of adolescent vaccination cards (preferred) or self-reported if vaccination card is unavailable.

Questions used:

1. You previously indicated in the baseline survey that you have a <sex - link from baseline> child aged <age - link from baseline>. Since our last survey, please indicate whether your child has gotten any HPV vaccine shot.

  1. No
  2. Yes

2. (if Yes to 1) If your child has received an HPV vaccine shot, you may upload a photo of your child's vaccination card or record here. This will help us confirm the information you shared. Your information will be kept confidential.

1, 3 and 6 months post-randomization
HPV vaccine intention
Временное ограничение: Baseline, 1-month, 3-month, and 6-month post-randomization

"How likely is it that [your adolescent] will receive HPV shots in the next 12 months?"

Baseline, 1-month, 3-month, and 6-month post-randomization
Beliefs, attitudes, and trust in HPV vaccine
Временное ограничение: Baseline, 1-month, 3-month, and 6-month post randomization

Measuring beliefs, attitudes, and trust in HPV vaccine

Questions are adapted from the Carolina HPV Immunization Attitudes and Beliefs Scale (McRee et al., 2010). There are 16 questions, each scored on a 4-point Likert scale with 1=Strongly disagree and 4=Strongly agree. Higher scores indicate more favorable or positive beliefs, attitudes, and trust in HPV vaccine.

Baseline, 1-month, 3-month, and 6-month post randomization
Beliefs, attitudes, and trust in other childhood/adolescent vaccines
Временное ограничение: Baseline, 1-month, 3-month, and 6-month post randomization

Measuring beliefs, attitudes, and trust in other childhood and adolescent vaccines

Questions are adapted from the World Health Organization (Strategic Advisory Group of Experts on Immunization) Vaccine Hesitancy Scale. There are 10 questions, each scored on a 4-point Likert scale with 1=Strongly disagree and 4=Strongly agree. Higher scores indicated more favorable or positive beliefs, attitudes, and trusts in other childhood and adolescent vaccines.

Baseline, 1-month, 3-month, and 6-month post randomization

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Следователи

  • Главный следователь: Milkie Vu, PhD, Northwestern University
  • Директор по исследованиям: Namratha Kandula, Northwestern University
  • Директор по исследованиям: Siobhan Phillips, Northwestern University
  • Директор по исследованиям: Juned Siddique, Northwestern University

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

5 июня 2026 г.

Первичное завершение (Оцененный)

30 июня 2029 г.

Завершение исследования (Оцененный)

30 июня 2029 г.

Даты регистрации исследования

Первый отправленный

26 мая 2026 г.

Впервые представлено, что соответствует критериям контроля качества

5 июня 2026 г.

Первый опубликованный (Действительный)

10 июня 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

9 ноября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

5 ноября 2026 г.

Последняя проверка

1 июня 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Описание плана IPD

Individual participant data will not be shared due to the risk of re-identification. We want to protect participant confidentiality.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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