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NCT Number: NCT07518914

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

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.

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Key information

Conditions

Misinformation Behavior Communication Lenacapavir

Age range

18 year–29 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Health Economics and Epidemiology Research Office, University of the Witwatersrand

Johannesburg, South Africa

Location status: Recruiting

Location contact

Candice Chetty-Makkan, PhD

CONTACT

[email protected]

+27 (0) 10 001 7941

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diabetes information

Behavioral

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

Enhanced inoculation message

Behavioral

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.

Primary outcomes

  1. Lenacapavir intention, at the end of the baseline assessment

    Time frame: 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.

Secondary outcomes

  1. Lenacapavir intention, follow-up

    Time frame: 2-4 weeks

    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. Recommend to friends, at the end of the baseline assessment

    Time frame: 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.

  3. Recommend to friends, follow-up

    Time frame: 2-4 weeks

    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.

  4. Credibility of inoculated exposure #1

    Time frame: At the end of the baseline assessment

    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.

  5. Credibility of inoculated exposure #2

    Time frame: At the end of the baseline assessment

    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.

  6. Credibility of inoculated exposure #3

    Time frame: At the end of the baseline assessment

    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.

  7. Credibility of inoculated exposure #4

    Time frame: At the end of the baseline assessment

    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.

  8. Credibility of inoculated exposure #5

    Time frame: At the end of the baseline assessment

    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.

  9. Credibility of inoculated exposure #6

    Time frame: At the end of the baseline assessment

    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.

  10. Credibility of inoculated exposure #7,follow-up

    Time frame: 2-4 weeks

    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.

  11. Credibility of inoculated exposure #8,follow-up

    Time frame: 2-4 weeks

    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.

  12. Credibility of inoculated exposure #9,follow-up

    Time frame: 2-4 weeks

    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.

  13. Credibility of inoculated exposure #10,follow-up

    Time frame: 2-4 weeks

    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.

  14. Anxiousness of inoculated exposure #1

    Time frame: At the end of the baseline assessment

    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.

  15. Anxiousness of inoculated exposure #2

    Time frame: At the end of the baseline assessment

    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.

  16. Anxiousness of inoculated exposure #3

    Time frame: At the end of the baseline assessment

    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.

  17. Anxiousness of inoculated exposure #4

    Time frame: At the end of the baseline assessment

    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.

  18. Anxiousness of inoculated exposure #5

    Time frame: At the end of the baseline assessment

    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.

  19. Anxiousness of inoculated exposure #6

    Time frame: At the end of the baseline assessment

    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.

  20. Anxiousness of inoculated exposure #7,follow-up

    Time frame: 2-4 weeks

    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.

  21. Anxiousness of inoculated exposure #8,follow-up

    Time frame: 2-4 weeks

    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.

  22. Anxiousness of inoculated exposure #9,follow-up

    Time frame: 2-4 weeks

    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.

  23. Anxiousness of inoculated exposure #10,follow-up

    Time frame: 2-4 weeks

    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.

  24. Shareability of inoculated exposure #1

    Time frame: At the end of the baseline assessment

    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.

  25. Shareability of inoculated exposure #2

    Time frame: At the end of the baseline assessment

    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.

  26. Shareability of inoculated exposure #3

    Time frame: At the end of the baseline assessment

    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.

  27. Shareability of inoculated exposure #4

    Time frame: At the end of the baseline assessment

    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.

  28. Shareability of inoculated exposure #5

    Time frame: At the end of the baseline assessment

    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.

  29. Shareability of inoculated exposure #6

    Time frame: At the end of the baseline assessment

    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.

  30. Shareability of inoculated exposure #7,follow-up

    Time frame: 2-4 weeks

    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.

  31. Shareability of inoculated exposure #8,follow-up

    Time frame: 2-4 weeks

    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.

  32. Shareability of inoculated exposure #9,follow-up

    Time frame: 2-4 weeks

    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.

  33. Shareability of inoculated exposure #10,follow-up

    Time frame: 2-4 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alison Buttenheim, PhD

CONTACT

[email protected]

Teniola Egbe, MPH, MBE

CONTACT

[email protected]

215-898-2939

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Health Economics and Epidemiology Research Office, University of the Witwatersrand
  • University of Cape Town

Registry information

Official study title

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

Acronym: PROTECT-L

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Apr 9, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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