Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:27 AM
Study NCT ID:
NCT07397403
Status:
RECRUITING
Last Update Posted:
2026-02-09
First Post:
2026-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Doxycycline Post Exposure Prophylaxis for Preventing STIs Among MSM in Bangkok, Thailand.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006069', 'term': 'Gonorrhea'}, {'id': 'D002690', 'term': 'Chlamydia Infections'}, {'id': 'D013587', 'term': 'Syphilis'}], 'ancestors': [{'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015231', 'term': 'Sexually Transmitted Diseases, Bacterial'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D002694', 'term': 'Chlamydiaceae Infections'}, {'id': 'D014211', 'term': 'Treponemal Infections'}, {'id': 'D013145', 'term': 'Spirochaetales Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004318', 'term': 'Doxycycline'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Labotatory staffs'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is designed as a randomized controlled trial (RCT). Participants will be randomly assigned to either the intervention group or the control group in a 2:1 ratio using simple randomization.\n\nThe intervention group will receive doxycycline for the prevention of sexually transmitted infections (gonorrhea, chlamydia, and syphilis) for a period of 3 months. The control group will receive standard-of-care services and a brief educational session on sexually transmitted infection prevention at the start of the study.\n\nAll participants will be tested for bacterial sexually transmitted infections (syphilis, gonorrhea, and chlamydia) at baseline and again at the end of the study after completing 12 weeks of follow-up.\n\nBefore randomization, eligible participants will complete a questionnaire assessing knowledge, attitudes, and preventive behaviors related to sexually transmitted infections. In-depth interviews will also be conducted among men who have sex with men (MSM) at risk due'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-02', 'studyFirstSubmitDate': '2026-02-02', 'studyFirstSubmitQcDate': '2026-02-02', 'lastUpdatePostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the efficacy of doxycycline in preventing sexually transmitted infections (gonorrhea, chlamydia, and syphilis) among men who have sex with men in Thailand.', 'timeFrame': '12 weeks', 'description': 'Measure the proportion of participants who test positive by NAAT for gonorrhea or chlamydia at any anatomical site (genital, pharyngeal, or rectal), or who are diagnosed with syphilis during the study period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DoxyPEP', 'MSM', 'Syphilis', 'gonorrhea', 'Chlamydia', 'Prevention'], 'conditions': ['Syphilis Infection', 'Gonorrhea', 'Chlamydia']}, 'referencesModule': {'references': [{'pmid': '17533217', 'type': 'BACKGROUND', 'citation': 'Frederiks WM, Kummerlin IP, Bosch KS, Vreeling-Sindelarova H, Jonker A, Van Noorden CJ. NADPH production by the pentose phosphate pathway in the zona fasciculata of rat adrenal gland. J Histochem Cytochem. 2007 Sep;55(9):975-80. doi: 10.1369/jhc.7A7222.2007. Epub 2007 May 28.'}, {'pmid': '30486854', 'type': 'BACKGROUND', 'citation': 'Ren Z, Zhang P, Wang H, Wang H. Qualitative research investigating the mental health care service gap in Chinese burn injury patients. BMC Health Serv Res. 2018 Nov 28;18(1):902. doi: 10.1186/s12913-018-3724-3.'}, {'pmid': '28099363', 'type': 'BACKGROUND', 'citation': 'Liu Q, Tong D, Yuan W, Liu G, Yuan G, Lan W, Zhang D, Zhang J, Huang Z, Zhang Y, Jiang J. Different RET gene mutation-induced multiple endocrine neoplasia type 2A in 3 Chinese families. Medicine (Baltimore). 2017 Jan;96(3):e5967. doi: 10.1097/MD.0000000000005967.'}, {'pmid': '29182717', 'type': 'BACKGROUND', 'citation': 'Peyriere H, Makinson A, Marchandin H, Reynes J. Doxycycline in the management of sexually transmitted infections. J Antimicrob Chemother. 2018 Mar 1;73(3):553-563. doi: 10.1093/jac/dkx420.'}, {'pmid': '38118022', 'type': 'RESULT', 'citation': 'Stewart J, Oware K, Donnell D, Violette LR, Odoyo J, Soge OO, Scoville CW, Omollo V, Mogaka FO, Sesay FA, McClelland RS, Spinelli M, Gandhi M, Bukusi EA, Baeten JM; dPEP Kenya Study Team. Doxycycline Prophylaxis to Prevent Sexually Transmitted Infections in Women. N Engl J Med. 2023 Dec 21;389(25):2331-2340. doi: 10.1056/NEJMoa2304007.'}, {'pmid': '38797183', 'type': 'RESULT', 'citation': '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 multicentre, open-label, randomised trial with a 2 x 2 factorial design. Lancet Infect Dis. 2024 Oct;24(10):1093-1104. doi: 10.1016/S1473-3099(24)00236-6. Epub 2024 May 23.'}, {'pmid': '37018493', 'type': 'RESULT', 'citation': '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': '29229440', 'type': 'RESULT', 'citation': '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 with men: an open-label randomised substudy of the ANRS IPERGAY trial. Lancet Infect Dis. 2018 Mar;18(3):308-317. doi: 10.1016/S1473-3099(17)30725-9. Epub 2017 Dec 8.'}, {'pmid': '33835852', 'type': 'RESULT', 'citation': 'Nanthaprut P, Manojai N, Chanlearn P, Mattawanon N, Chiawkhun P, Homkham N, Traisathit P. Comparison of HIV-Positive Incidence Among Transgender Women and Men Who Have Sex with Men at Stand-Alone and Mobile Voluntary Counseling and Testing Facilities in Chiang Mai Province, Thailand. AIDS Patient Care STDS. 2021 Apr;35(4):116-125. doi: 10.1089/apc.2020.0258.'}, {'pmid': '34852691', 'type': 'RESULT', 'citation': 'Chen JS, Levintow SN, Tran HV, Sripaipan T, Nguyen MX, Nguyen SM, Miller WC, Go VF, Giang LM. HIV and STI prevalence and testing history among men who have sex with men in Hanoi, Vietnam. Int J STD AIDS. 2022 Feb;33(2):193-201. doi: 10.1177/09564624211060185. Epub 2021 Dec 1.'}, {'pmid': '34392717', 'type': 'RESULT', 'citation': 'Nguyen TV, Tran HP, Khuu NV, Nguyen PD, Le TN, Hoang CD, Tran T, Le TQ, Pham QD, Phan LT. Increases in both HIV and syphilis among men who have sex with men in Vietnam: Urgent need for comprehensive responses. Int J STD AIDS. 2021 Dec;32(14):1298-1307. doi: 10.1177/09564624211036421. Epub 2021 Aug 14.'}, {'pmid': '34143341', 'type': 'RESULT', 'citation': 'Johnston LG, Soe P, Widihastuti AS, Camellia A, Putri TA, Rakhmat FF, Nurwandani RA, Prabhu SM, Sulaiman N, Pronyk PM. Alarmingly High HIV Prevalence Among Adolescent and Young Men Who have Sex with Men (MSM) in Urban Indonesia. AIDS Behav. 2021 Nov;25(11):3687-3694. doi: 10.1007/s10461-021-03347-0. Epub 2021 Jun 18.'}], 'seeAlsoLinks': [{'url': 'https://www.who.int/news-room/fact-sheets/detail/sexually-transmitted-infections-(stis)', 'label': 'Sexually transmitted infections (STIs) \\[Internet\\]. Who.int. \\[cited 2024 Sep 24\\].'}, {'url': 'https://www.cdc.gov/sti/about/index.html', 'label': 'Center for Disease Control and Prevention. Sexually transmitted infections (STIs). \\[cited 2024 Sep 24\\]'}, {'url': 'http://dx.doi.org/10.15585/mmwr.rr7302a1', 'label': 'CDC clinical guidelines on the use of doxycycline postexposure prophylaxis for bacterial sexually transmitted infection prevention, United States, 2024'}]}, 'descriptionModule': {'briefSummary': '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\n\nParticipation 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '60 Days', 'minimumAge': '18 Days', 'genderBased': True, 'genderDescription': 'Men who have sex with men', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nBiological male, aged not over 60 years\n\nThai nationality\n\nAble to read, communicate, and understand the Thai language\n\nMen who have sex with men (MSM), aged 18 years or older and not over 60 years\n\nHaving at least one of the following risk factors:\n\nA 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\n\nA diagnosis of gonorrhea, chlamydia, or syphilis within the past 6 months\n\nCurrent use of HIV pre-exposure prophylaxis (PrEP)\n\nWilling 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)\n\nWilling and able to provide written informed consent to participate in the study\n\n\\-\n\nExclusion Criteria:\n\n* History of allergy to tetracycline-class antibiotics\n\nDiagnosed with syphilis and not yet treated, or currently receiving treatment with benzathine penicillin G or doxycycline\n\nReceipt of benzathine penicillin G within the past 12 weeks\n\nPrior receipt of a gonorrhea vaccine\n\nCurrent use of medications or products that may interact with doxycycline, including:\n\nVitamin A derivatives (e.g., isotretinoin, acitretin)\n\nAntiepileptic drugs (e.g., phenytoin, carbamazepine, phenobarbital)\n\nImmunosuppressive agents (e.g., methotrexate)\n\nMedications for heart failure or cardiac arrhythmias (e.g., digoxin)\n\nAnticoagulants (e.g., warfarin)\n\nUse of oral or injectable medications that affect blood cells, such as anticancer drugs, chemotherapy, systemic corticosteroids, or targeted therapies\n\nHistory of renal impairment (eGFR \\< 60 mL/min/1.73 m²) or hepatic impairment (AST or ALT \\> 3 times the upper limit of normal)\n\nUncontrolled or unstable underlying diseases, such as hematologic disorders, cancer, autoimmune diseases, or neurological disorders\n\nSevere 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\n\nAlcohol 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\n\nPrevious participation in this study with prior randomization"}, 'identificationModule': {'nctId': 'NCT07397403', 'acronym': 'ThaiDoxyPEP', 'briefTitle': 'The Efficacy of Doxycycline Post Exposure Prophylaxis for Preventing STIs Among MSM in Bangkok, Thailand.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bangrak STIs Center'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': '1/2568'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DoxyPEP arm', 'description': 'Participants will receive DoxyPEP for STIs prophylaxis in this arm', 'interventionNames': ['Drug: Doxycycline (200mg/day)']}, {'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'Participants will receive standard STIs prevention'}], 'interventions': [{'name': 'Doxycycline (200mg/day)', 'type': 'DRUG', 'description': 'Doxycycline 200 mg single dose after unprotected sex within 24-72 hours', 'armGroupLabels': ['DoxyPEP arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10120', 'city': 'Sathorn', 'state': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Rossaphorn Kittiyaowamarn, MD', 'role': 'CONTACT', 'email': 'rossaphorn@gmail.com', 'phone': '+66814501066'}, {'name': 'Kittipoom Chinhiran, MD', 'role': 'CONTACT', 'email': 'x_destiny_war@hotmail.com'}, {'name': 'Rossaphorn Kittiyoawamarn, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bangrak STIs Center', 'geoPoint': {'lat': 13.74998, 'lon': 100.51682}}], 'centralContacts': [{'name': 'Rossapnorn Kittiyaowamarn, MD', 'role': 'CONTACT', 'email': 'rossaphorn@gmail.com', 'phone': '+66814501066'}, {'name': 'Kittipoom Chinhiran, MD', 'role': 'CONTACT', 'email': 'x_destiny_war@hotmail.com', 'phone': '+66863583077'}], 'overallOfficials': [{'name': 'Rossaphorn KITTIYAOWAMARN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bangrak STIs Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) from this study will not be publicly shared due to ethical and legal considerations. The study involves sensitive sexual health information from key populations, and even de-identified datasets may carry a risk of re-identification. Data sharing is also subject to Thai data protection regulations and the conditions approved by the institutional ethics committee and participant informed consent.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bangrak STIs Center', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Mahidol University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Bangrak STIs Center', 'investigatorFullName': 'Rossaphorn Kittiyaowamarn', 'investigatorAffiliation': 'Bangrak STIs Center'}}}}