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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 29
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
South Africa
Health Economics and Epidemiology Research Office, University of the Witwatersrand
RECRUITING
Johannesburg
Contact Information
Primary
Teniola Egbe, MPH, MBE
tegbe@pennmedicine.upenn.edu
215-898-2939
Backup
Alison Buttenheim, PhD
butt@nursing.upenn.edu
Time Frame
Start Date: 2026-05-19
Estimated Completion Date: 2029-04
Participants
Target number of participants: 1500
Treatments
Active_comparator: 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
Other: 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
Related Therapeutic Areas
Sponsors
Leads: University of Pennsylvania
Collaborators: Health Economics and Epidemiology Research Office, University of the Witwatersrand, University of Cape Town

This content was sourced from clinicaltrials.gov