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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Misinformation; Lenacapavir
• Intervention / Treatment: Behavioral: Diabetes information; Behavioral: Enhanced inoculation message

• Study Type: Interventional
• Enrollment (Estimated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Teniola Egbe, MPH, MBE; Phone Number: 215-898-2939; Email: tegbe@pennmedicine.upenn.edu
• Study Contact Backup: Name: Alison Buttenheim, PhD; Email: butt@nursing.upenn.edu

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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
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	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 message promoting vaccination as a consistency and commitment prime.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lenacapavir intention, 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 0-10 scale. Higher score meaning you are extremely likely to do the action.	At the end of the baseline assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lenacapavir intention, follow-up	Intention to get Lenacapavir, measured at follow-up survey following misinformation exposure and intervention. Measured on a 0-10 scale. Higher score meaning you are extremely likely to do the action.	2-4 weeks
Recommend to friends, at the end of the baseline assessment	Intention to recommend Lenacapavir to friends, measured at survey baseline following misinformation exposure and intervention. Measured on a 0-10 scale. Higher score meaning you are extremely likely to do the action.	At the end of the baseline assessment
Recommend to friends, follow-up	Intention to recommend Lenacapavir to friends, measured at follow-up survey following misinformation exposure and intervention, controlling for baseline pre-intervention/exposure intention. Measured on a 0-10 scale. Higher score meaning you are extremely likely to do the action.	2-4 weeks
Credibility of inoculated exposure #1	Extent to which the claim is credible, extent to which the claim makes you anxious or nervous about Lenacapavir, likelihood of your sharing the claim, for the main lenacapavir claims specifically inoculated against and five new claims. All measured on a 1-7 scale. Higher score means you believe the claim is real.	At the end of the baseline assessment
Credibility of inoculated exposure #2	Extent to which the claim is credible, extent to which the claim makes you anxious or nervous about Lenacapavir, likelihood of your sharing the claim, for the main lenacapavir claims specifically inoculated against and five new claims. All measured on a 1-7 scale. Higher score means you believe the claim is real.	At the end of the baseline assessment
Credibility of inoculated exposure #3	Extent to which the claim is credible, extent to which the claim makes you anxious or nervous about Lenacapavir, likelihood of your sharing the claim, for the main lenacapavir claims specifically inoculated against and five new claims. All measured on a 1-7 scale. Higher score means you believe the claim is real.	At the end of the baseline assessment
Credibility of inoculated exposure #4	Extent to which the claim is credible, extent to which the claim makes you anxious or nervous about Lenacapavir, likelihood of your sharing the claim, for the main lenacapavir claims specifically inoculated against and five new claims. All measured on a 1-7 scale. Higher score means you believe the claim is real.	At the end of the baseline assessment
Credibility of inoculated exposure #5	Extent to which the claim is credible, extent to which the claim makes you anxious or nervous about Lenacapavir, likelihood of your sharing the claim, for the main lenacapavir claims specifically inoculated against and five new claims. All measured on a 1-7 scale. Higher score means you believe the claim is real.	At the end of the baseline assessment
Credibility of inoculated exposure #6	Extent to which the claim is credible, extent to which the claim makes you anxious or nervous about Lenacapavir, likelihood of your sharing the claim, for the main lenacapavir claims specifically inoculated against and five new claims. All measured on a 1-7 scale. Higher score means you believe the claim is real.	At the end of the baseline assessment
Credibility of inoculated exposure #7,follow-up	Extent to which the claim is credible, extent to which the claim makes you anxious or nervous about Lenacapavir, likelihood of your sharing the claim, for the main lenacapavir claims specifically inoculated against and five new claims. All measured on a 1-7 scale. Higher score means you believe the claim is real.	2-4 weeks
Credibility of inoculated exposure #8,follow-up	Extent to which the claim is credible, extent to which the claim makes you anxious or nervous about Lenacapavir, likelihood of your sharing the claim ,for the main lenacapavir claims specifically inoculated against and five new claims. All measured on a 1-7 scale. Higher score means you believe the claim is real.	2-4 weeks
Credibility of inoculated exposure #9,follow-up	Extent to which the claim is credible, extent to which the claim makes you anxious or nervous about Lenacapavir, likelihood of your sharing the claim, for the main lenacapavir claims specifically inoculated against and five new claims. All measured on a 1-7 scale. Higher score means you believe the claim is real.	2-4 weeks
Credibility of inoculated exposure #10,follow-up	Extent to which the claim is credible, extent to which the claim makes you anxious or nervous about Lenacapavir, likelihood of your sharing the claim, for the main lenacapavir claims specifically inoculated against and five new claims. All measured on a 1-7 scale. Higher score means you believe the claim is real.	2-4 weeks
Anxiousness of inoculated exposure #1	Extent to which the claim makes you anxious or nervous about lenacapavir for the main lenacapavir claims specifically inoculated against and five new claims. All measured on a 1-7 scale. Higher score means the claim makes you anxious or worried.	At the end of the baseline assessment
Anxiousness of inoculated exposure #2	Extent to which the claim makes you anxious or nervous about lenacapavir for the main lenacapavir claims specifically inoculated against and five new claims. All measured on a 1-7 scale. Higher score means the claim makes you anxious or worried.	At the end of the baseline assessment
Anxiousness of inoculated exposure #3	Extent to which the claim makes you anxious or nervous about lenacapavir for the main lenacapavir claims specifically inoculated against and five new claims. All measured on a 1-7 scale. Higher score means the claim makes you anxious or worried.	At the end of the baseline assessment
Anxiousness of inoculated exposure #4	Extent to which the claim makes you anxious or nervous about lenacapavir for the main lenacapavir claims specifically inoculated against and five new claims. All measured on a 1-7 scale. Higher score means the claim makes you anxious or worried.	At the end of the baseline assessment
Anxiousness of inoculated exposure #5	Extent to which the claim makes you anxious or nervous about lenacapavir for the main lenacapavir claims specifically inoculated against and five new claims. All measured on a 1-7 scale. Higher score means the claim makes you anxious or worried.	At the end of the baseline assessment
Anxiousness of inoculated exposure #6	Extent to which the claim makes you anxious or nervous about lenacapavir for the main lenacapavir claims specifically inoculated against and five new claims. All measured on a 1-7 scale. Higher score means the claim makes you anxious or worried.	At the end of the baseline assessment
Anxiousness of inoculated exposure #7,follow-up	Extent to which the claim makes you anxious or nervous about lenacapavir for the main lenacapavir claims specifically inoculated against and five new claims. All measured on a 1-7 scale. Higher score means the claim makes you anxious or worried.	2-4 weeks
Anxiousness of inoculated exposure #8,follow-up	Extent to which the claim makes you anxious or nervous about lenacapavir for the main lenacapavir claims specifically inoculated against and five new claims. All measured on a 1-7 scale. Higher score means the claim makes you anxious or worried.	2-4 weeks
Anxiousness of inoculated exposure #9,follow-up	Extent to which the claim makes you anxious or nervous about lenacapavir for the main lenacapavir claims specifically inoculated against and five new claims. All measured on a 1-7 scale. Higher score means the claim makes you anxious or worried.	2-4 weeks
Anxiousness of inoculated exposure #10,follow-up	Extent to which the claim makes you anxious or nervous about lenacapavir for the main lenacapavir claims specifically inoculated against and five new claims. All measured on a 1-7 scale. Higher score means the claim makes you anxious or worried.	2-4 weeks
Shareability of inoculated exposure #1	Likelihood of your sharing the claim for for the main lenacapavir claims specifically inoculated against and five new claims. All measured on a 1-7 scale. Higher score means you are more likely to share the claim.	At the end of the baseline assessment
Shareability of inoculated exposure #2	Likelihood of your sharing the claim for for the main lenacapavir claims specifically inoculated against and five new claims. All measured on a 1-7 scale. Higher score means you are more likely to share the claim.	At the end of the baseline assessment
Shareability of inoculated exposure #3	Likelihood of your sharing the claim for for the main lenacapavir claims specifically inoculated against and five new claims. All measured on a 1-7 scale. Higher score means you are more likely to share the claim.	At the end of the baseline assessment
Shareability of inoculated exposure #4	Likelihood of your sharing the claim for for the main lenacapavir claims specifically inoculated against and five new claims. All measured on a 1-7 scale. Higher score means you are more likely to share the claim.	At the end of the baseline assessment
Shareability of inoculated exposure #5	Likelihood of your sharing the claim for for the main lenacapavir claims specifically inoculated against and five new claims. All measured on a 1-7 scale. Higher score means you are more likely to share the claim.	At the end of the baseline assessment
Shareability of inoculated exposure #6	Likelihood of your sharing the claim for for the main lenacapavir claims specifically inoculated against and five new claims. All measured on a 1-7 scale. Higher score means you are more likely to share the claim.	At the end of the baseline assessment
Shareability of inoculated exposure #7,follow-up	Likelihood of your sharing the claim for for the main lenacapavir claims specifically inoculated against and five new claims. All measured on a 1-7 scale. Higher score means you are more likely to share the claim.	2-4 weeks
Shareability of inoculated exposure #8,follow-up	Likelihood of your sharing the claim for for the main lenacapavir claims specifically inoculated against and five new claims. All measured on a 1-7 scale. Higher score means you are more likely to share the claim.	2-4 weeks
Shareability of inoculated exposure #9,follow-up	Likelihood of your sharing the claim for for the main lenacapavir claims specifically inoculated against and five new claims. All measured on a 1-7 scale. Higher score means you are more likely to share the claim.	2-4 weeks
Shareability of inoculated exposure #10,follow-up	Likelihood of your sharing the claim for for the main lenacapavir claims specifically inoculated against and five new claims. All measured on a 1-7 scale. Higher score means you are more likely to share the claim.	2-4 weeks

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: University of Cape Town; Health Economics and Epidemiology Research Office, University of the Witwatersrand

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: PrEP; South Africa; Lenacapavir; Adolescent Girls and Young WOmen
• Additional Relevant MeSH Terms: Behavior; Communication
• Other Study ID Numbers: 859478

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The investigators are still determining the data sharing plan and if we will be sharing IPD yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No