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MisinformationPROTECT-LNCT07518914

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

A study testing Diabetes information and Enhanced inoculation message in people with Misinformation and Lenacapavir, run by University of Pennsylvania at 1 site in South Africa.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 29 years, women onlyHealthy volunteers can take part
Conditions the study is for
Misinformation, Lenacapavir
What is being tested?
Diabetes information and Enhanced inoculation message
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,500 participants
Where
1 siteSouth Africa
Study dates
19 May 2026to Apr 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 29 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Unwilling or unable to provide consent for study participation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Teniola Egbe, MPH, MBE contact

215-898-2939

tegbe@pennmedicine.upenn.edu

Alison Buttenheim, PhD contact

butt@nursing.upenn.edu

South Africa1 site, 1 recruiting
  • Health Economics and Epidemiology Research Office, University of the Witwatersrand

    Johannesburg

    Candice Chetty-Makkan, PhD, +27 (0) 10 001 7941, cchetty@heroza.org

    Recruiting

Other trials in South Africa

About this study

Official title: 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.

Being tested
Diabetes information, Enhanced inoculation message
Keywords
South Africa, Lenacapavir, Adolescent Girls and Young WOmen, PrEP
Medical subject headings
Communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diabetes informationBehavioural

    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 messageBehavioural

    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.

Study groups in NCT07518914
Study groupRoleWhat they receive
ControlActive comparatorParticipants 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
Receives: Behavioral: Diabetes information
Enhanced inoculation messageOtherParticipants 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
Receives: Behavioral: Enhanced inoculation message

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 1-10 scale. Higher score meaning you are extremely likely to do the action.

    Measured: At the end of the baseline assessment

Secondary outcomes (33)
  1. Lenacapavir intention, follow-up

    Intention 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.

    Measured: 2-4 weeks

  2. 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 1-10 scale. Higher score meaning you are extremely likely to do the action.

    Measured: At the end of the baseline assessment

  3. 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 1-10 scale. Higher score meaning you are extremely likely to do the action.

    Measured: 2-4 weeks

  4. 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.

    Measured: At the end of the baseline assessment

  5. 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.

    Measured: At the end of the baseline assessment

  6. 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.

    Measured: At the end of the baseline assessment

  7. 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.

    Measured: At the end of the baseline assessment

  8. 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.

    Measured: At the end of the baseline assessment

  9. 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.

    Measured: At the end of the baseline assessment

  10. 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.

    Measured: 2-4 weeks

  11. 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.

    Measured: 2-4 weeks

  12. 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.

    Measured: 2-4 weeks

  13. 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.

    Measured: 2-4 weeks

  14. 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.

    Measured: At the end of the baseline assessment

  15. 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.

    Measured: At the end of the baseline assessment

  16. 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.

    Measured: At the end of the baseline assessment

  17. 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.

    Measured: At the end of the baseline assessment

  18. 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.

    Measured: At the end of the baseline assessment

  19. 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.

    Measured: At the end of the baseline assessment

  20. 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.

    Measured: 2-4 weeks

  21. 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.

    Measured: 2-4 weeks

  22. 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.

    Measured: 2-4 weeks

  23. 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.

    Measured: 2-4 weeks

  24. 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.

    Measured: At the end of the baseline assessment

  25. 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.

    Measured: At the end of the baseline assessment

  26. 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.

    Measured: At the end of the baseline assessment

  27. 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.

    Measured: At the end of the baseline assessment

  28. 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.

    Measured: At the end of the baseline assessment

  29. 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.

    Measured: At the end of the baseline assessment

  30. 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.

    Measured: 2-4 weeks

  31. 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.

    Measured: 2-4 weeks

  32. 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.

    Measured: 2-4 weeks

  33. 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.

    Measured: 2-4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2026
  2. Study start19 May 2026
  3. Primary completionApr 2028 (estimated)
  4. Study completionApr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07518914
Sponsor's protocol ID
859478
Acronym
PROTECT-L
Status last verified
Oct 2026
First submitted
1 Apr 2026
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The investigators are still determining the data sharing plan and if we will be sharing IPD yet

Questions about this trial

What is this clinical trial studying?

A study testing Diabetes information and Enhanced inoculation message in people with Misinformation and Lenacapavir, run by University of Pennsylvania at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Teniola Egbe, MPH, MBE (215-898-2939, tegbe@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lenacapavir intention, at the end of the baseline assessment (time frame: At the end of the baseline assessment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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