PrEP feasibility study in Tokyo

Phase 3

• Conditions: HIV

• Registration Number: JPRN-jRCTs031180134
• Lead Sponsor: Mizushima Daisuke

Brief Summary

The present study showed that the prophylactic effect against HIV infection and the retention and adherence rates of PrEP were high, although PrEP initiation increased the incidence of STI among Japanese MSM. The use of PrEP in Japan is feasible, and therefore, the implementation of PrEP is highly recommended, combined with safer sex promotion.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-19
• Study Completion: 2021-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 124

Inclusion Criteria

1. Non HIV-infected MSM who have anal sexual intercouse.
2. Aged 20 years or over
3. At high risk for acquiring HIV infection as below
Had STI within one year
Had anal sexual intercouse without condome use within 6 months
Have sex partners with HIV infection
Had use of stimulants within 6 months
4. Live in Japan and understand Japanese
5. Participate in a MSM cohort study Sexual Health Clinic and continue to
attend the cohort for one year and understand importance and significance of
HIV prevention by PrEP.
6. Willing and able to provide informed consent

Exclusion Criteria

1. Suspected acute HIV infected
2. Having severe hepatic disorder or renal dysfunction(eGFR<60ml/min/1.73m2)
3. Concurrently taking a nephrotoxic agent (e.g.high-dose non-stroidal antiinflammatory drugs/NSAIDs)
4. Allergic to TDF and/or FTC
5. Concurrently taking prescribed products containing TDF or FTC
6. Possiblity to be unable to continue taking truvada during the study period
7. Considered to be inadequate for PrEP due to other factors

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of HIV infection among MSM on PrEP (/100 person-year)

Secondary Outcome Measures

Name	Time	Method
1. Incidence of STI among MSM on PrEP<br>2. Incidence of adverse event related to use of Truvada(TDF/FTC)<br>3. Frecuency of high-risk sexual activity<br>4. Rate of lost to follow-up and adherence for medication