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When scientific constraints and real-world implementation collide: Lessons from a hybrid type 3 study of a digital,
Kathryn R Macapagal1, Krystal L Madkins1, Ashley Knapp1
1Northwestern University.
Research Square
|May 4, 2026
Summary
Implementing digital HIV prevention interventions directly to consumers requires adapting strategies for recruitment and retention. Lessons learned from a hybrid study highlight the need for flexible eligibility, incentives, and nationwide reach to improve public health practice.
Area of Science:
- Public Health
- Digital Health Interventions
- Implementation Science
Background:
- Digital HIV prevention interventions (DHIs) are effective but face challenges in translation to public health practice.
- Direct-to-consumer (DTC) delivery models expand DHI reach, yet rigorous testing in real-world settings is limited.
- Hybrid type 3 studies offer a framework for accelerating the translation of research into practice.
Purpose of the Study:
- To describe lessons learned from a hybrid type 3 study of a DTC DHI for young men who have sex with men (YMSM).
- To evaluate the implementation and effectiveness of the Keep It Up! (KIU!) 3.0 DTC DHI.
- To identify challenges and adaptations in recruiting and retaining participants in a DTC DHI.
Main Methods:
- A cluster-randomized hybrid type 3 implementation-effectiveness study of the KIU! 3.0 DTC DHI.
- Four major implementation adaptations were made over the trial period in response to recruitment and retention issues.
- Data included enrollment logs, advertising costs, participant communications, and internal documentation to analyze recruitment patterns and costs.
Main Results:
- Implementation adaptations included streamlining enrollment, modifying eligibility criteria, increasing financial incentives, and shifting to nationwide recruitment.
- Nationwide recruitment led to a 301% increase in enrollment and a decrease in cost per participant.
- Participant retention and return of at-home STI test kits remained challenging; incentives increased 'imposter' participants.
Conclusions:
- Implementing DTC DHIs in hybrid studies necessitates balancing pragmatic goals with effectiveness measurement.
- Future hybrid studies should carefully consider eligibility, incentives, and outcome measurement for better alignment with real-world contexts.
- Distinguishing research components from service delivery is crucial for successful translation of digital health interventions.
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