Protecting Against Lenacapavir Misinformation With Young Women in Gauteng, South Africa ( PROTECT-L)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diabetes information, Enhanced inoculation message.
- Who it may be relevant to
- Registry conditions: Misinformation, Lenacapavir. Basic parameters: 18 years — 29 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Africa
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Protecting Against Lenacapavir Misinformation With Young Women in Gauteng, South Africa
Overview
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.
Interventions
- Behavioral 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 - Behavioral 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
Primary outcome measures
- Lenacapavir intention, at the end of the baseline assessment [Time frame: At the end of the baseline assessment]
Secondary outcome measures (12)
- Lenacapavir intention, follow-up [Time frame: 2-4 weeks]
- Recommend to friends, at the end of the baseline assessment [Time frame: At the end of the baseline assessment]
- Recommend to friends, follow-up [Time frame: 2-4 weeks]
- Credibility of inoculated exposure #1 [Time frame: At the end of the baseline assessment]
- Credibility of inoculated exposure #2 [Time frame: At the end of the baseline assessment]
- Credibility of inoculated exposure #3 [Time frame: At the end of the baseline assessment]
- Credibility of inoculated exposure #4 [Time frame: At the end of the baseline assessment]
- Credibility of inoculated exposure #5 [Time frame: At the end of the baseline assessment]
- Credibility of inoculated exposure #6 [Time frame: At the end of the baseline assessment]
- Credibility of inoculated exposure #7,follow-up [Time frame: 2-4 weeks]
- Credibility of inoculated exposure #8,follow-up [Time frame: 2-4 weeks]
- Credibility of inoculated exposure #9,follow-up [Time frame: 2-4 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
Unwilling or unable to provide consent for study participation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
South Africa · 1 center
- Health Economics and Epidemiology Research Office, University of the Witwatersrand — Johannesburg
Identifiers
NCT: NCT07518914 · 859478