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Syphilis InfectionPhase 4ThaiDoxyPEPNCT07397403

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

A Phase 4 study testing Doxycycline (200mg/day) in people with Syphilis Infection and Gonorrhea, run by Bangrak STIs Center at 1 site in Thailand.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 60 days, men onlyHealthy volunteers can take part
Conditions the study is for
Syphilis Infection, Gonorrhea, Chlamydia
What is being tested?
Doxycycline (200mg/day)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteThailand
Study dates
6 Oct 2025to 31 May 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 days
  • Men only
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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
Show all 11Show fewer
  • 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
  • -

Who cannot join

  • 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)
Show all 16Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rossapnorn Kittiyaowamarn, MD contact

+66814501066

rossaphorn@gmail.com

Kittipoom Chinhiran, MD contact

+66863583077

x_destiny_war@hotmail.com

Thailand1 site, 1 recruiting
  • Bangrak STIs Center

    Sathorn, Bangkok, 10120

    Rossaphorn Kittiyaowamarn, MD, +66814501066, rossaphorn@gmail.com

    Kittipoom Chinhiran, MD, x_destiny_war@hotmail.com

    Recruiting

Other trials in Thailand

About this study

Official title: 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.

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.

Being tested
Doxycycline (200mg/day)
Keywords
DoxyPEP, MSM, Syphilis, gonorrhea, Chlamydia, Prevention
Medical subject headings
Gonorrhea, Chlamydia Infections, Syphilis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Doxycycline (200mg/day)Drug

    Doxycycline 200 mg single dose after unprotected sex within 24-72 hours

Study groups in NCT07397403
Study groupRoleWhat they receive
DoxyPEP armExperimentalParticipants will receive DoxyPEP for STIs prophylaxis in this arm
Receives: Drug: Doxycycline (200mg/day)
Control armNo interventionParticipants will receive standard STIs prevention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the efficacy of doxycycline in preventing sexually transmitted infections (gonorrhea, chlamydia, and syphilis) among men who have sex with men in Thailand.

    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.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2026
  2. Study start6 Oct 2025
  3. Primary completion5 Oct 2026 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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. The 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. All 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. Before 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
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07397403
Sponsor's protocol ID
1/2568
Acronym
ThaiDoxyPEP
Status last verified
Oct 2025
First submitted
2 Feb 2026
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 17533217
  • 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.

    PubMed 30486854
  • 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.

    PubMed 28099363
  • 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.

    PubMed 29182717
  • 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.

    PubMed 38118022
  • 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.

    PubMed 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.

    PubMed 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 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.

    PubMed 29229440
  • 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.

    PubMed 33835852
  • 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.

    PubMed 34852691
  • 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.

    PubMed 34392717
  • 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.

    PubMed 34143341

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Doxycycline (200mg/day) in people with Syphilis Infection and Gonorrhea, run by Bangrak STIs Center at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rossapnorn Kittiyaowamarn, MD (+66814501066, rossaphorn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07397403, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.

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