Doxycycline pre-exposure prophylaxis against sexually transmitted infections

JRCT ID: jRCTs031240520

Registered date:03/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Sexuall Transmitted Disease
• Date of first enrollment: 05/12/2024
• Target sample size: 220
• Study type: Interventional

Intervention(s)

Study group: Single 200 mg dose of Vibramycin 2 to 24 hours prior to sexual intercourse, administered each time of sexual intercourse
Control group: Single 200 mg dose of Vibramycin within 72 hours after sexual intercourse, administered each time of sexual intercourse
Follow-up will be conducted for 1 year after the start of the intervention.
Subjects who have given consent will be randomly assigned to each group at baseline (day 1) to begin the intervention. Follow-up will be conducted every 3 months from baseline to check for gonorrhea, chlamydia, genitalium, and syphilis, as well as side effects/adverse events and medication compliance rates.

Outcome(s)

• Primary Outcome: the occurrence of a first STI (gonorrhoea, chlamydia, or syphilis) during the follow-up period.

Secondary Outcome

The occurrence of a first each sexually transmitted infection (chlamydia, gonorrhea, syphilis, genitalium).
Incidence rate of any of chlamydia, gonorrhea, or syphilis.
Incidence rate of each sexually transmitted infection (chlamydia, gonorrhea, syphilis, and genitalium).
Adherence to medications.
Percentage of adverse events.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

The applicant must meet all of the following conditions (1) through (4).
(1) Persons aged 18 or older who are attending our sexual health (SH) clinic.
(2) Persons with a history of sexually transmitted infections while attending the SH clinic.
(3) Those who are on PrEP (pre-exposure prophylaxis) for HIV
(4) Persons who have given written consent to participate in the study.

Exclude criteria

(1) Those who are allergic to any of the study drugs
(2) Other cases in which the physician in charge determines that participation in the study is inappropriate.

Related Information

• Primary Sponsor: Mizushima Daisuke
• Source(s) of Monetary Support: National Center for Global Health and Medicine