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

NCT07518914 | Recruiting

• 1 other identifier: 859478
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Misinformation; Lenacapavir

Keywords

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

Outcome Measures

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 0-10 scale. Higher score meaning you are extremely likely to do the action.

  At the end of the baseline assessment

Secondary Outcomes (33)

• Lenacapavir intention, follow-up

  2-4 weeks

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

  At the end of the baseline assessment

• Recommend to friends, follow-up

  2-4 weeks

• Credibility of inoculated exposure #1

  At the end of the baseline assessment

• Credibility of inoculated exposure #2

  At the end of the baseline assessment

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Enhanced inoculation message

OTHER

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

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

Control

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.

Enhanced inoculation message

Eligibility Criteria

• Age: 18 Years - 29 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Unwilling or unable to provide consent for study participation.

Sponsors & Collaborators

• Health Economics and Epidemiology Research Office, University of the Witwatersrand: collaborator
• University of Cape Town: collaborator
• University of Pennsylvania: lead

Study Sites (1)

Health Economics and Epidemiology Research Office, University of the Witwatersrand

Johannesburg, South Africa

RECRUITING

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Teniola Egbe, MPH, MBE

CONTACT

215-898-2939; tegbe@pennmedicine.upenn.edu

Alison Buttenheim, PhD

CONTACT

butt@nursing.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 9, 2026
• Study Start: May 19, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: June 26, 2026

Record last verified: 2026-06

Locations

ZA (1)