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

Not Applicable

Recruiting

Conditions: Z29.22
Z20.6
Contact with and exposure to human immunodeficiency virus [HIV]

Registration Number: DRKS00029258

Lead Sponsor: TUM, Fakultät für Medizin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 100

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

- 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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Rate of study termination due to any reason (criterion for success: < 50% until month 12 in intervention group), rate of recruitment<br>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)<br>3) Physician satisfaction regarding telemedical approach, using rating scales (e.g., Likert Scales) by month 0, 3, 6, 9 and 12<br>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<br>5) Economic analysis (provided within a Piggyback study)<br>6) PrEP retention rate compared to standard of care<br>7) Descriptive Demographics of study population

Secondary Outcome Measures