Protecting Against Lenacapavir Misinformation With Young Women in Gauteng, South Africa ( PROTECT-L)

Официальное название

Protecting Against Lenacapavir Misinformation With Young Women in Gauteng, South Africa

Обзор

Adolescent girls and young women (AGYW) in South Africa remain disproportionately affected by HIV, with prevalence among 15-24-year-olds at 9.4% in 2024 despite expanded access to condoms, HIV testing, and oral PrEP. While oral PrEP is effective, its reliance on daily adherence and regular follow-up has limited impact for many young women. Lenacapavir (LEN), the first long-acting injectable PrEP administered twice yearly, offers a promising alternative that could improve persistence and protection. However, LEN's potential may be undermined by misinformation, particularly around safety and trust, which has been shown in other HIV prevention contexts to reduce uptake and demand. Proactive strategies, such as psychological inoculation, are therefore needed to prebunk misinformation and support future LEN implementation among AGYW. Primary objective: To compare changes in intentions to receive Lenacapavir 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 Lenacapavir in South Africa. Participants will be randomly assigned to a control group or an intervention arm: enhanced inoculation message with insights from behavioural economics.

Вмешательства

• Поведенческое Diabetes information
  Participants enrolled in the control group will receive unrelated information on diabetes 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
• Поведенческое Enhanced inoculation message
  Participants enrolled in the enhanced inoculation message arm will receive messages that warn them about impending Lenacapavir 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 me

Первичные конечные точки

• Lenacapavir intention, at the end of the baseline assessment [Срок оценки: At the end of the baseline assessment]

Вторичные конечные точки (12)

• Lenacapavir intention, follow-up [Срок оценки: 2-4 weeks]
• Recommend to friends, at the end of the baseline assessment [Срок оценки: At the end of the baseline assessment]
• Recommend to friends, follow-up [Срок оценки: 2-4 weeks]
• Credibility of inoculated exposure #1 [Срок оценки: At the end of the baseline assessment]
• Credibility of inoculated exposure #2 [Срок оценки: At the end of the baseline assessment]
• Credibility of inoculated exposure #3 [Срок оценки: At the end of the baseline assessment]
• Credibility of inoculated exposure #4 [Срок оценки: At the end of the baseline assessment]
• Credibility of inoculated exposure #5 [Срок оценки: At the end of the baseline assessment]
• Credibility of inoculated exposure #6 [Срок оценки: At the end of the baseline assessment]
• Credibility of inoculated exposure #7,follow-up [Срок оценки: 2-4 weeks]
• Credibility of inoculated exposure #8,follow-up [Срок оценки: 2-4 weeks]
• Credibility of inoculated exposure #9,follow-up [Срок оценки: 2-4 weeks]

Критерии участия

Критерии включения

• Female (cisgender or transgender)
• 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 consent
• Able to read and understand English

Критерии исключения

Unwilling or unable to provide consent for study participation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

ЮАР · 1 центр

• Health Economics and Epidemiology Research Office, University of the Witwatersrand — Johannesburg

Идентификаторы

NCT: NCT07518914 · 859478

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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