Защита девочек-подростков и молодых женщин от дезинформации о вакцине против ВИЧ в Южной Африке (PROTECT)
Adolescent girls and young women (AGYW) between the ages of 15-29 years continue to bear the brunt of Human Immunodeficiency Virus (HIV) infections in South Africa despite progress recorded in prevention and treatment programmes. The ongoing susceptibility of young women to HIV infection and the sub-optimal uptake of prevention options such as Pre-Exposure Prophylaxis (PrEP) that are highly effective creates a need for an HIV vaccine to benefit populations at substantial risk of HIV infection. However, lessons from previous vaccine studies and the recent COVID-19 vaccine have highlighted significant barriers to vaccine uptake, such as widespread misinformation and vaccine hesitancy. These challenges threaten the successful implementation of a future HIV vaccine. Building on these insights, this study will utilise psychological inoculation theory to develop and evaluate HIV vaccine messages among adolescent girls and young women. Primary objective: To compare changes in intentions to receive HIV vaccine following misinformation exposure in groups with and without psychological inoculation and behavioural economics boost.
Secondary objectives: (1) To compare believability and persuasiveness of misinformation claims and motivational threat associated with misinformation in groups with and without psychological inoculation and behavioural economics boost. (2) To explore subgroup effects by relevant sociodemographic and behavioural factors including HIV risk, PrEP history, COVID-19 vaccine history, general vaccine hesitancy, and information avoidance. The investigators will conduct a two-arm randomized controlled trial of 2-3 inoculation messages that address emerging myths and misinformation about the HIV vaccine in South Africa. Participants will be randomly assigned to a control group or an intervention arm: enhanced inoculation message with insights from behavioural economics.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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-
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Johannesburg, Южная Африка
- Health Economics and Epidemiology Research Office, University of the Witwatersrand
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Female
- Age 18-29 years
- Self-reported history of sexual activity in the past 12 months
- Self-reported HIV-negative status or unknown HIV status at enrolment
- Willing and able to provide written informed consent
- Able to read and understand English
Exclusion Criteria:
- Unwilling or unable to provide consent for study participation.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: Control
Participants enrolled in the control group will receive unrelated information on diabetes and nutrition topics of the same length as the inoculation messages. Please see Appendix 6 for an example of how this message will be structured. This will make the control group an attention control group and ensure that findings are not confounded by the intervention group spending more time and attentional resources on participation in the study. |
Participants enrolled in the control group will receive unrelated information on diabetes and nutrition topics of the same length as the inoculation messages. Please see Appendix 6 for an example of how this message will be structured. This will make the control group an attention control group and ensure that findings are not confounded by the intervention group spending more time and attentional resources on participation in the study. |
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Другой: Enhanced inoculation message
Participants enrolled in the enhanced inoculation message arm will receive messages that warn them about impending HIV vaccine misinformation and explains why those claims are false or misleading, the messages will be enhanced with insights from behavioural economics see Appendix 5: "Inoculation message with a BE boost" for an example of the inoculation message. As part of the behavioural economics boost, participants may choose to receive a small token (e.g., sticker, badge, bracelet) with a message promoting vaccination as a consistency and commitment prime. |
Participants enrolled in the enhanced inoculation message arm will receive messages that warn them about impending HIV vaccine misinformation and explains why those claims are false or misleading, the messages will be enhanced with insights from behavioural economics see Appendix 5: "Inoculation message with a BE boost" for an example of the inoculation message. As part of the behavioural economics boost, participants may choose to receive a small token (e.g., sticker, badge, bracelet) with a message promoting vaccination as a consistency and commitment prime. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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HIV Vaccine Intention, at the End of the Baseline Assessment
Временное ограничение: At the end of the baseline assessment
|
Intention to get the HIV vaccine, measured after inoculation intervention and misinformation exposure The intention to get the vaccine will be measured on a 1-10 scale. Higher score means they are more likely to get the HIV vaccine. |
At the end of the baseline assessment
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
HIV Vaccine Intention, Follow-up
Временное ограничение: 2-4 weeks
|
Intention to get the HIV vaccine, measured at follow-up survey following misinformation exposure and intervention. Measured on a 1-10 scale. Higher score means they are more likely to get the HIV vaccine. |
2-4 weeks
|
|
Recommend to Friends, at the End of the Baseline Assessment
Временное ограничение: At the end of the baseline assessment
|
Intention to recommend the HIV vaccine to friends, measured at survey baseline following misinformation exposure and intervention. Measured on a 1-10 scale. Higher score means they are more likely to recommend the HIV vaccine to a friend. |
At the end of the baseline assessment
|
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Recommend to Friends, Follow-up
Временное ограничение: 2-4 weeks
|
Intention to recommend the HIV vaccine to friends, measured at follow-up survey following misinformation exposure and intervention, controlling for baseline pre-intervention/exposure intention. Measured on a 1-10 scale. Higher score means they are more likely to recommend the HIV vaccine to a friend. |
2-4 weeks
|
|
Credibility of Inoculated Exposure #1
Временное ограничение: At the end of the baseline assessment
|
Extent to which claim #1 made the participants believe the credibility of the information about the HIV vaccine. They were provided information on this claim and how to recognize it as misinformation. The scale is measured on 1-7. Higher number means they are more likely to believe the claim. |
At the end of the baseline assessment
|
|
Credibility of Inoculated Exposure #2
Временное ограничение: At the end of the baseline assessment
|
Extent to which claim #2 made the participants believe the credibility of the information about the HIV vaccine. They were provided information on this claim and how to recognize it as misinformation. The scale is measured on 1-7. Higher number means they are more likely to believe the claim. |
At the end of the baseline assessment
|
|
Credibility of Inoculated Exposure #3
Временное ограничение: At the end of the baseline assessment
|
Extent to which claim #3 made the participants believe the credibility of the information about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number means they are more likely to believe the claim. |
At the end of the baseline assessment
|
|
Credibility of Inoculated Exposure #4
Временное ограничение: At the end of the baseline assessment
|
Extent to which claim #4 made the participants believe the credibility of the information about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number means they are more likely to believe the claim. |
At the end of the baseline assessment
|
|
Credibility of Inoculated Exposure #5
Временное ограничение: At the end of the baseline assessment
|
Extent to which claim #5 made the participants believe the credibility of the information about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number means they are more likely to believe the claim. |
At the end of the baseline assessment
|
|
Credibility of Inoculated Exposure #6
Временное ограничение: At the end of the baseline assessment
|
Extent to which claim #6 made the participants believe the credibility of the information about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number means they are more likely to believe the claim. |
At the end of the baseline assessment
|
|
Anxiousness of Inoculated Exposure #1
Временное ограничение: At the end of the baseline assessment
|
Extent to which claim #1 made the participants anxious or nervous about the HIV vaccine. They were provided information on this claim and how to recognize it as misinformation. The scale is measured on 1-7. Higher number indicates more self-reported anxiousness. |
At the end of the baseline assessment
|
|
Anxiousness of Inoculated Exposure #2
Временное ограничение: At the end of the baseline assessment
|
Extent to which claim #2 made the participants anxious or nervous about the HIV vaccine. They were provided information on this claim and how to recognize it as misinformation. The scale is measured on 1-7. Higher number indicates more self-reported anxiousness. |
At the end of the baseline assessment
|
|
Anxiousness of Inoculated Exposure #3
Временное ограничение: At the end of the baseline assessment
|
Extent to which claim #3 made the participants anxious or nervous about the HIV vaccine. TThey were not provided prior information on this claim. The scale is measured on 1-7. Higher number indicates more self-reported anxiousness. |
At the end of the baseline assessment
|
|
Anxiousness of Inoculated Exposure #4
Временное ограничение: At the end of the baseline assessment
|
Extent to which claim #4 made the participants anxious or nervous about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number indicates more self-reported anxiousness. |
At the end of the baseline assessment
|
|
Anxiousness of Inoculated Exposure #5
Временное ограничение: At the end of the baseline assessment
|
Extent to which claim #5 made the participants anxious or nervous about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number indicates more self-reported anxiousness. |
At the end of the baseline assessment
|
|
Anxiousness of Inoculated Exposure #6
Временное ограничение: At the end of the baseline assessment
|
Extent to which claim #6 made the participants anxious or nervous about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number indicates more self-reported anxiousness. |
At the end of the baseline assessment
|
|
Shareability of Inoculated Exposure #1
Временное ограничение: At the end of the baseline assessment
|
Extent to which claim #1 made the participants more likely to share information about the HIV vaccine. They were provided information on this claim and how to recognize it as misinformation. The scale is measured on 1-7. Higher number means they are more likely to share the claim. |
At the end of the baseline assessment
|
|
Shareability of Inoculated Exposure #7
Временное ограничение: At the end of the baseline assessment
|
Extent to which claim #7 made the participants more likely to share information about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number means they are more likely to share the claim. |
At the end of the baseline assessment
|
|
Shareability of Inoculated Exposure #3
Временное ограничение: At the end of the baseline assessment
|
Extent to which claim #3 made the participants more likely to share information about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number means they are more likely to share the claim. |
At the end of the baseline assessment
|
|
Shareability of Inoculated Exposure #4
Временное ограничение: At the end of the baseline assessment
|
Extent to which claim #4 made the participants more likely to share information about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number means they are more likely to share the claim. |
At the end of the baseline assessment
|
|
Shareability of Inoculated Exposure #5
Временное ограничение: At the end of the baseline assessment
|
Extent to which claim #5 made the participants more likely to share information about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number means they are more likely to share the claim. |
At the end of the baseline assessment
|
|
Shareability of Inoculated Exposure #6
Временное ограничение: At the end of the baseline assessment
|
Extent to which claim #6 made the participants more likely to share information about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number means they are more likely to share the claim. |
At the end of the baseline assessment
|
|
Credibility of Inoculated Exposure #1, Follow-up
Временное ограничение: 2-4 weeks
|
Extent to which claim #1 made the participants believe the credibility of the information about the HIV vaccine. They were provided information on this claim and how to recognize it as misinformation. The scale is measured on 1-7. Higher number means they are more likely to believe the claim. |
2-4 weeks
|
|
Credibility of Inoculated Exposure #2, Follow-up
Временное ограничение: 2-4 weeks
|
Extent to which claim #2 made the participants believe the credibility of the information about the HIV vaccine. They were provided information on this claim and how to recognize it as misinformation. The scale is measured on 1-7. Higher number means they are more likely to believe the claim. |
2-4 weeks
|
|
Shareability of Inoculated Exposure #1, Follow-up
Временное ограничение: 2-4 weeks
|
Extent to which claim #1 made the participants more likely to share information about the HIV vaccine. They were provided information on this claim and how to recognize it as misinformation. The scale is measured on 1-7. Higher number means they are more likely to share the claim. |
2-4 weeks
|
|
Shareability of Inoculated Exposure #2, Follow-up
Временное ограничение: 2-4 weeks
|
Extent to which claim #2 made the participants more likely to share information about the HIV vaccine. They were provided information on this claim and how to recognize it as misinformation. The scale is measured on 1-7. Higher number means they are more likely to share the claim. |
2-4 weeks
|
|
Anxiousness of Inoculated Exposure #1, Follow-up
Временное ограничение: 2-4 weeks
|
Extent to which claim #1 made the participants anxious or nervous about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number indicates more self-reported anxiousness. |
2-4 weeks
|
|
Anxiousness of Inoculated Exposure #2, Follow-up
Временное ограничение: 2-4 weeks
|
Extent to which claim #2 made the participants anxious or nervous about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number indicates more self-reported anxiousness. |
2-4 weeks
|
|
Credibility of New Claims, Exposure #12, Follow-up
Временное ограничение: 2-4 weeks
|
Extent to which claim #12 made the participants believe the credibility of the information about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number means they are more likely to believe the claim. |
2-4 weeks
|
|
Credibility of New Claims, Exposure #8, Follow-up
Временное ограничение: 2-4 weeks
|
Extent to which claim #8 made the participants believe the credibility of the information about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number means they are more likely to believe the claim. |
2-4 weeks
|
|
Credibility of New Claims, Exposure #9, Follow-up
Временное ограничение: 2-4 weeks
|
Extent to which claim #9 made the participants believe the credibility of the information about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number means they are more likely to believe the claim. |
2-4 weeks
|
|
Credibility of New Claims, Exposure #10, Follow-up
Временное ограничение: 2-4 weeks
|
Extent to which claim #10 made the participants believe the credibility of the information about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number means they are more likely to believe the claim. |
2-4 weeks
|
|
Credibility of New Claims, Exposure #11, Follow-up
Временное ограничение: 2-4 weeks
|
Extent to which claim #11 made the participants believe the credibility of the information about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number means they are more likely to believe the claim. |
2-4 weeks
|
|
Anxiousness o of New Claims, Exposure #12, Follow-up
Временное ограничение: 2-4 weeks
|
Extent to which claim #12 made the participants anxious or nervous about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number indicates more self-reported anxiousness. |
2-4 weeks
|
|
Anxiousness of New Claims, Claim #8, Follow-up
Временное ограничение: 2-4 weeks
|
Extent to which claim #8 made the participants anxious or nervous about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number indicates more self-reported anxiousness. |
2-4 weeks
|
|
Anxiousness of New Claims, Exposure #9, Follow-up
Временное ограничение: 2-4 weeks
|
Extent to which claim #9 made the participants anxious or nervous about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number indicates more self-reported anxiousness. |
2-4 weeks
|
|
Anxiousness of New Claims, Exposure #10, Follow-up
Временное ограничение: 2-4 weeks
|
Extent to which claim #10 made the participants anxious or nervous about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number indicates more self-reported anxiousness. |
2-4 weeks
|
|
Anxiousness of New Claims, Exposure #11, Follow-up
Временное ограничение: 2-4 weeks
|
Extent to which claim #11 made the participants anxious or nervous about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number indicates more self-reported anxiousness. |
2-4 weeks
|
|
Shareability of New Claims, Exposure #12, Follow-up
Временное ограничение: 2-4 weeks
|
Extent to which claim #12 made the participants more likely to share information about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number means they are more likely to share the claim. |
2-4 weeks
|
|
Shareability of New Claims, Exposure #8, Follow-up
Временное ограничение: 2-4 weeks
|
Extent to which claim #8 made the participants more likely to share information about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number means they are more likely to share the claim. |
2-4 weeks
|
|
Shareability of New Claims, Exposure #9, Follow-up
Временное ограничение: 2-4 weeks
|
Extent to which claim #9 made the participants more likely to share information about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number means they are more likely to share the claim. |
2-4 weeks
|
|
Shareability of New Claims, Exposure #10, Follow-up
Временное ограничение: 2-4 weeks
|
Extent to which claim #10 made the participants more likely to share information about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number means they are more likely to share the claim. |
2-4 weeks
|
|
Shareability of New Claims, Exposure #11, Follow-up
Временное ограничение: 2-4 weeks
|
Extent to which claim #11 made the participants more likely to share information about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number means they are more likely to share the claim. |
2-4 weeks
|
|
Credibility of Inoculated Exposure #7
Временное ограничение: At the end of the baseline assessment
|
Extent to which claim #7 made the participants believe the credibility of the information about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number means they are more likely to believe the claim. |
At the end of the baseline assessment
|
|
Anxiousness of Inoculated Exposure #7
Временное ограничение: At the end of the baseline assessment
|
Extent to which claim #7 made the participants anxious or nervous about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number indicates more self-reported anxiousness. |
At the end of the baseline assessment
|
|
Shareability of Inoculated Exposure #2
Временное ограничение: At the end of the baseline assessment
|
Extent to which claim #2 made the participants more likely to share information about the HIV vaccine. They were provided information on this claim and how to recognize it as misinformation. The scale is measured on 1-7. Higher number means they are more likely to share the claim. |
At the end of the baseline assessment
|
|
Credibility of New Claims, Exposure #13, Follow-up
Временное ограничение: 2-4 weeks
|
Extent to which claim #13 made the participants believe the credibility of the information about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number means they are more likely to believe the claim. |
2-4 weeks
|
|
Anxiousness of New Claims, Exposure #13, Follow-up
Временное ограничение: 2-4 weeks
|
Extent to which claim #13 made the participants anxious or nervous about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number indicates more self-reported anxiousness. |
2-4 weeks
|
|
Shareability of New Claims, Exposure #13, Follow-up
Временное ограничение: 2-4 weeks
|
Extent to which claim #13 made the participants more likely to share information about the HIV vaccine. They were not provided prior information on this claim. The scale is measured on 1-7. Higher number means they are more likely to share the claim. |
2-4 weeks
|
Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 1R01MH132401 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
The investigators are still determining the data sharing plan and if we will be sharing IPD yet
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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. .