ClinicalTrials.gg
RecruitingNCT07518914PROTECT-LUpdated Oct 6, 2026

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

An interventional study of Diabetes information and Enhanced inoculation message in Misinformation and Lenacapavir, sponsored by University of Pennsylvania. Recruiting at 1 site in South Africa. Open to female participants aged 18 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Updated Oct 6, 2026Study documents postedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
1,500
Allocation
Randomized
Ages
18 Years to 29 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 15 studies in Communication by University of Pennsylvania — 5 open to participants now, 6 under way, none of them phase 3. Communication · University of Pennsylvania.

Planned enrollment
5th of 15
1,500 · median 523
Started
2026
with 4 others
No phase
15 of 15
5 open now
Registered
12th of 15
by date

Among the 15 studies in Communication by University of Pennsylvania, this one is the 5th largest by planned enrollment, is one of 5 that started in 2026, is one of 15 with no phase, and was the 12th registered.

By phase

15 studies; the count open now beside each. This study's row is marked.

No phasethis study15 · 5 open

By the year they started

First in 2013; this study’s year is marked. 5 started in 2026.

Size and results

Median enrollment 523 across the 15 interventional studies. Of the 8 that completed or were terminated, 5 (63%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 15 studies in Communication by University of Pennsylvania, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Misinformation
  • Lenacapavir

Browse trials for

Keywords

  • South Africa
  • Lenacapavir
  • Adolescent Girls and Young WOmen
  • PrEP
04

Who can participate

Ages eligible
18 Years to 29 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female (cisgender or transgender)
  • Age 18-29 years
  • Self-reported history of sexual activity in the past 12 months
  • Self-reported -negative status or unknown HIV status at enrolment
  • Willing and able to provide consent
  • Able to read and understand English

Exclusion criteria

Exclusion Criteria:

Unwilling or unable to provide consent for study participation.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1,500 participants (estimated)

Study arms

  • 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

  • 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

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

  • BehavioralEnhanced 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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: At the end of the baseline assessment

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 2-4 weeks

07

Study locations

1 of 1 sites recruiting
  • Health Economics and Epidemiology Research Office, University of the Witwatersrand
    Johannesburg, South Africa
    Recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided — The investigators are still determining the data sharing plan and if we will be sharing IPD yet

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for Apr 2028, 23 months after the start.

Of 390 non-industry interventional studies with no phase under Communication, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 23 months is above that.

Counting every sponsor, half of 394 studies reached it within 18 months; a quarter within 6 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 1, 2026
First posted
Apr 9, 2026
StartActual
May 19, 2026
Primary completionEst.
Apr 2028
CompletionEst.
Apr 2029
Last update
Oct 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Documents
Show all 1 update
  1. Oct 6, 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07518914
Collaborators
Health Economics and Epidemiology Research Office, University of the Witwatersrand, University of Cape Town
Responsible party
Sponsor
First posted
Apr 9, 2026
Start date
May 19, 2026
Primary completion
Apr 2028 (estimated)
Completion
Apr 2029 (estimated)
Last update
Oct 6, 2026

Study contacts

Teniola Egbe, MPH, MBE
Contact
tegbe@pennmedicine.upenn.edu
215-898-2939
Alison Buttenheim, PhD
Contact
butt@nursing.upenn.edu

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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