Health Trials

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

ConditionsMisinformationLenacapavir
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-29
SponsorUniversity of Pennsylvania

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

1,500 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: Enhanced inoculation messageOther 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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University of Pennsylvania

Lead sponsor

Health Economics and Epidemiology Research Office, University of the Witwatersrand

Collaborator

University of Cape Town

Collaborator

Source ClinicalTrials.gov
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