The Efficacy of Doxycycline Post Exposure Prophylaxis for Preventing STIs Among MSM in Bangkok, Thailand.

Официальное название

The Efficacy of Doxycycline Post Exposure Prophylaxis for Preventing Sexually Transmitted Diseases (Gonorrhea, Chlamydia, Syphilis) Among Men Who Have Sex With Men in Bangkok, Thailand.

Обзор

The objective of this research is to evaluate the efficacy and safety of doxycycline in MSM for preventing sexually transmitted infections (gonorrhea, chlamydia, and syphilis) in Thailand Participation in this study will last approximately 12 weeks and will include 2-3 clinic visits, along with 10-11 follow-up phone contacts over a period of 11 weeks.

Вмешательства

• Препарат Doxycycline (200mg/day)
  Doxycycline 200 mg single dose after unprotected sex within 24-72 hours

Первичные конечные точки

• To evaluate the efficacy of doxycycline in preventing sexually transmitted infections (gonorrhea, chlamydia, and syphilis) among men who have sex with men in Thailand. [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

Biological male, aged not over 60 years

Thai nationality

Able to read, communicate, and understand the Thai language

Men who have sex with men (MSM), aged 18 years or older and not over 60 years

Having at least one of the following risk factors:

A history of condomless sex, or condom failure (breakage, leakage, or slippage), via any sexual route with at least two sexual partners within the past 3 months

A diagnosis of gonorrhea, chlamydia, or syphilis within the past 6 months

Current use of HIV pre-exposure prophylaxis (PrEP)

Willing and able to participate in study procedures (e.g., able to return to the clinic for scheduled testing for gonorrhea, chlamydia, and syphilis; able to complete doxycycline use records; and able to receive follow-up phone calls from the research team)

Willing and able to provide written informed consent to participate in the study

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Критерии исключения

• History of allergy to tetracycline-class antibiotics

Diagnosed with syphilis and not yet treated, or currently receiving treatment with benzathine penicillin G or doxycycline

Receipt of benzathine penicillin G within the past 12 weeks

Prior receipt of a gonorrhea vaccine

Current use of medications or products that may interact with doxycycline, including:

Vitamin A derivatives (e.g., isotretinoin, acitretin)

Antiepileptic drugs (e.g., phenytoin, carbamazepine, phenobarbital)

Immunosuppressive agents (e.g., methotrexate)

Medications for heart failure or cardiac arrhythmias (e.g., digoxin)

Anticoagulants (e.g., warfarin)

Use of oral or injectable medications that affect blood cells, such as anticancer drugs, chemotherapy, systemic corticosteroids, or targeted therapies

History of renal impairment (eGFR < 60 mL/min/1.73 m²) or hepatic impairment (AST or ALT > 3 times the upper limit of normal)

Uncontrolled or unstable underlying diseases, such as hematologic disorders, cancer, autoimmune diseases, or neurological disorders

Severe medical or psychiatric conditions that, in the investigator's judgment, may increase study-related risk or impair the participant's ability to provide informed consent

Alcohol dependence (inability to control alcohol consumption, withdrawal symptoms upon reduction or cessation, or continued use despite harm) or illicit drug dependence (regular, uncontrolled use) within the past 12 months prior to enrollment, which may affect doxycycline use for STI prevention

Previous participation in this study with prior randomization

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Таиланд · 1 центр

• Bangrak STIs Center — Sathorn

Публикации

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• Molina JM, Bercot B, Assoumou L, Rubenstein E, Algarte-Genin M, Pialoux G, Katlama C, Surgers L, Bebear C, Dupin N, Ouattara M, Slama L, Pavie J, Duvivier C, Loze B, Goldwirt L, Gibowski S, Ollivier M, Ghosn J, Costagliola D; ANRS 174 DOXYVAC Study Group. Doxycycline prophylaxis and meningococcal group B vaccine to prevent bacterial sexually transmitted infections in France (ANRS 174 DOXYVAC): a m PMID 38797183
• Luetkemeyer AF, Donnell D, Dombrowski JC, Cohen S, Grabow C, Brown CE, Malinski C, Perkins R, Nasser M, Lopez C, Vittinghoff E, Buchbinder SP, Scott H, Charlebois ED, Havlir DV, Soge OO, Celum C; DoxyPEP Study Team. Postexposure Doxycycline to Prevent Bacterial Sexually Transmitted Infections. N Engl J Med. 2023 Apr 6;388(14):1296-1306. doi: 10.1056/NEJMoa2211934. PMID 37018493
• Molina JM, Charreau I, Chidiac C, Pialoux G, Cua E, Delaugerre C, Capitant C, Rojas-Castro D, Fonsart J, Bercot B, Bebear C, Cotte L, Robineau O, Raffi F, Charbonneau P, Aslan A, Chas J, Niedbalski L, Spire B, Sagaon-Teyssier L, Carette D, Mestre SL, Dore V, Meyer L; ANRS IPERGAY Study Group. Post-exposure prophylaxis with doxycycline to prevent sexually transmitted infections in men who have sex PMID 29229440

Идентификаторы

NCT: NCT07397403 · 1/2568

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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