Protecting Against Lenacapavir Misinformation With Young Women in Gauteng, South Africa
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Lenacapavir intention, at the end of the baseline assessment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Unwilling or unable to provide consent for study participation.
研究组 & 干预措施
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
干预措施: Diabetes information (Behavioral)
Enhanced inoculation message
Participants enrolled in the enhanced inoculation message arm will receive messages that warn them about impendingLlenacapavir 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
干预措施: Enhanced inoculation message (Behavioral)
结局指标
主要结局
Lenacapavir intention, at the end of the baseline assessment
时间窗: At the end of the baseline assessment
Intention to get the Lenacapavir, measured after inoculation intervention and misinformation exposure The intention to get Lenacapavir will be measured on a 1-10 scale. Higher score meaning you are extremely likely to do the action.
次要结局
- Credibility of inoculated exposure #1(At the end of the baseline assessment)
- Credibility of inoculated exposure #2(At the end of the baseline assessment)
- Credibility of inoculated exposure #3(At the end of the baseline assessment)
- Credibility of inoculated exposure #4(At the end of the baseline assessment)
- Credibility of inoculated exposure #5(At the end of the baseline assessment)
- Credibility of inoculated exposure #6(At the end of the baseline assessment)
- Credibility of inoculated exposure #7,follow-up(2-4 weeks)
- Credibility of inoculated exposure #8,follow-up(2-4 weeks)
- Credibility of inoculated exposure #9,follow-up(2-4 weeks)
- Credibility of inoculated exposure #10,follow-up(2-4 weeks)
- Anxiousness of inoculated exposure #1(At the end of the baseline assessment)
- Anxiousness of inoculated exposure #2(At the end of the baseline assessment)
- Anxiousness of inoculated exposure #3(At the end of the baseline assessment)
- Anxiousness of inoculated exposure #4(At the end of the baseline assessment)
- Anxiousness of inoculated exposure #5(At the end of the baseline assessment)
- Anxiousness of inoculated exposure #6(At the end of the baseline assessment)
- Anxiousness of inoculated exposure #7,follow-up(2-4 weeks)
- Anxiousness of inoculated exposure #8,follow-up(2-4 weeks)
- Anxiousness of inoculated exposure #9,follow-up(2-4 weeks)
- Anxiousness of inoculated exposure #10,follow-up(2-4 weeks)
- Shareability of inoculated exposure #1(At the end of the baseline assessment)
- Shareability of inoculated exposure #2(At the end of the baseline assessment)
- Shareability of inoculated exposure #3(At the end of the baseline assessment)
- Shareability of inoculated exposure #4(At the end of the baseline assessment)
- Shareability of inoculated exposure #5(At the end of the baseline assessment)
- Shareability of inoculated exposure #6(At the end of the baseline assessment)
- Shareability of inoculated exposure #7,follow-up(2-4 weeks)
- Shareability of inoculated exposure #8,follow-up(2-4 weeks)
- Shareability of inoculated exposure #9,follow-up(2-4 weeks)
- Shareability of inoculated exposure #10,follow-up(2-4 weeks)
- Lenacapavir intention, follow-up(2-4 weeks)
- Recommend to friends, at the end of the baseline assessment(At the end of the baseline assessment)
- Recommend to friends, follow-up(2-4 weeks)