Randomized controlled clinical pilot-study to evaluate the feasibility, acceptability, and ergonomics of an in-tegrative, telemedicine approach in the use case of HIV prevention with HIV Pre-Exposure Prophylaxis (PrEP) as compared to standard of care

Randomized controlled clinical pilot-study to evaluate the feasibility, acceptability, and ergonomics of an in-tegrative, telemedicine approach in the use case of HIV prevention with HIV Pre-Exposure Prophylaxis (PrEP) as compared to standard of care - 2MINF03

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00029258

Enrollment

100

Registered

2022-06-30

Start date

2023-08-19

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Z29.22 Z20.6

Interventions

Group 1: Participants will be offered a fully telemedicine approach to HIV PrEP that includes self-collection of required biomaterials, reporting of findings/results, counseling, and self-service. Spe

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Subjects who are able to provide written informed consent and comply with study-specific procedures - Age 18 years or older - HIV-PrEP care for at least 3 months at the study center

Exclusion criteria

Exclusion criteria: - Any reason why a physician believes PrEP should be discontinued within the next 12 months. - Lack of an Android/Apple iOS smartphone or inability to use a web browser.

Design outcomes

Primary

Measure	Time frame
1) Rate of study termination due to any reason (criterion for success: < 50% until month 12 in intervention group), rate of recruitment 2) User satisfaction and user-assessed usability on (e.g., adapted MAUQ-7-point Likert Scale [1] or Telemedicine Satisfaction Questionnaire) every three months. Recommen-dation rate by using net promotor score (NPS) 3) Physician satisfaction regarding telemedical approach, using rating scales (e.g., Likert Scales) by month 0, 3, 6, 9 and 12 4) PRO: Participant-assessed treatment quality (e.g., GPAQ [2]), evaluation of preference of self-sampling using a rating scale, average travel/visit time, PrEP adherence rate and stigma regarding PrEP by month 0, 3, 6, 9 and 12, as compared to standard of care approach using rating scales (e.g., Likert Scales) by month 0, 3, 6, 9 and 12 5) Economic analysis (provided within a Piggyback study) 6) PrEP retention rate compared to standard of care 7) Descriptive Demographics of study population	—

Measure

Time frame

1) Rate of study termination due to any reason (criterion for success: < 50% until month 12 in intervention group), rate of recruitment 2) User satisfaction and user-assessed usability on (e.g., adapted MAUQ-7-point Likert Scale [1] or Telemedicine Satisfaction Questionnaire) every three months. Recommen-dation rate by using net promotor score (NPS) 3) Physician satisfaction regarding telemedical approach, using rating scales (e.g., Likert Scales) by month 0, 3, 6, 9 and 12 4) PRO: Participant-assessed treatment quality (e.g., GPAQ [2]), evaluation of preference of self-sampling using a rating scale, average travel/visit time, PrEP adherence rate and stigma regarding PrEP by month 0, 3, 6, 9 and 12, as compared to standard of care approach using rating scales (e.g., Likert Scales) by month 0, 3, 6, 9 and 12 5) Economic analysis (provided within a Piggyback study) 6) PrEP retention rate compared to standard of care 7) Descriptive Demographics of study population

—

Countries

Germany

Contacts

Public ContactFlorian Maximilian Voit

Klinikum rechts der Isar, Technische Universität München

florian.voit@mri.tum.de+498941408274

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026