Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07518914
Acronym
PROTECT-L
Enrollment
1500
Registered
2026-04-09
Start date
2026-05-19
Completion date
2029-04-01
Last updated
2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lenacapavir, Misinformation

Keywords

South Africa, Lenacapavir, Adolescent Girls and Young WOmen, PrEP

Brief 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.

Interventions

BEHAVIORALDiabetes 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

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.

Sponsors

University of Pennsylvania
Lead SponsorOTHER
Health Economics and Epidemiology Research Office, University of the Witwatersrand
CollaboratorUNKNOWN
University of Cape Town
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 29 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Lenacapavir intention, at the end of the baseline assessmentAt the end of the baseline assessmentIntention 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.

Secondary

MeasureTime frameDescription
Credibility of inoculated exposure #7,follow-up2-4 weeksExtent 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.
Credibility of inoculated exposure #8,follow-up2-4 weeksExtent 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.
Credibility of inoculated exposure #9,follow-up2-4 weeksExtent 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.
Credibility of inoculated exposure #10,follow-up2-4 weeksExtent 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.
Anxiousness of inoculated exposure #1At the end of the baseline assessmentExtent 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.
Anxiousness of inoculated exposure #2At the end of the baseline assessmentExtent 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.
Anxiousness of inoculated exposure #3At the end of the baseline assessmentExtent 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.
Anxiousness of inoculated exposure #4At the end of the baseline assessmentExtent 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.
Anxiousness of inoculated exposure #5At the end of the baseline assessmentExtent 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.
Anxiousness of inoculated exposure #6At the end of the baseline assessmentExtent 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.
Anxiousness of inoculated exposure #7,follow-up2-4 weeksExtent 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.
Anxiousness of inoculated exposure #8,follow-up2-4 weeksExtent 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.
Anxiousness of inoculated exposure #9,follow-up2-4 weeksExtent 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.
Anxiousness of inoculated exposure #10,follow-up2-4 weeksExtent 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.
Shareability of inoculated exposure #1At the end of the baseline assessmentLikelihood 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.
Shareability of inoculated exposure #2At the end of the baseline assessmentLikelihood 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.
Shareability of inoculated exposure #3At the end of the baseline assessmentLikelihood 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.
Shareability of inoculated exposure #4At the end of the baseline assessmentLikelihood 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.
Shareability of inoculated exposure #5At the end of the baseline assessmentLikelihood 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.
Shareability of inoculated exposure #6At the end of the baseline assessmentLikelihood 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.
Shareability of inoculated exposure #7,follow-up2-4 weeksLikelihood 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.
Shareability of inoculated exposure #8,follow-up2-4 weeksLikelihood 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.
Shareability of inoculated exposure #9,follow-up2-4 weeksLikelihood 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.
Lenacapavir intention, follow-up2-4 weeksIntention to get Lenacapavir, measured at follow-up survey following misinformation exposure and intervention. Measured on a 1-10 scale. Higher score meaning you are extremely likely to do the action.
Recommend to friends, at the end of the baseline assessmentAt the end of the baseline assessmentIntention to recommend Lenacapavir to friends, measured at survey baseline following misinformation exposure and intervention. Measured on a 1-10 scale. Higher score meaning you are extremely likely to do the action.
Recommend to friends, follow-up2-4 weeksIntention 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 1-10 scale. Higher score meaning you are extremely likely to do the action.
Credibility of inoculated exposure #1At the end of the baseline assessmentExtent 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.
Credibility of inoculated exposure #2At the end of the baseline assessmentExtent 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.
Shareability of inoculated exposure #10,follow-up2-4 weeksLikelihood 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.
Credibility of inoculated exposure #3At the end of the baseline assessmentExtent 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.
Credibility of inoculated exposure #4At the end of the baseline assessmentExtent 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.
Credibility of inoculated exposure #6At the end of the baseline assessmentExtent 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.
Credibility of inoculated exposure #5At the end of the baseline assessmentExtent 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.

Countries

South Africa

Contacts

CONTACTTeniola Egbe, MPH, MBE
tegbe@pennmedicine.upenn.edu215-898-2939
CONTACTAlison Buttenheim, PhD
butt@nursing.upenn.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 25, 2026