GonorrheaPhase 4NCT03980223
Evaluation of Doxycycline Post-exposure Prophylaxis to Reduce Sexually Transmitted Infections in PrEP Users and HIV-infected Men Who Have Sex With Men
A Phase 4 study testing Doxycycline Hyclate Delayed-Release 200 mg in people with Gonorrhea and Chlamydia, run by University of California, San Francisco at 3 sites in United States.
Trial summary
The purpose of this study is to understand if taking an antibiotic called doxycycline by mouth as soon as possible after sexual contact without a condom can reduce the risk of sexually transmitted infections (STIs), including gonorrhea, chlamydia and syphilis. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- What is being tested?
- Doxycycline Hyclate Delayed-Release 200 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 641 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Nov 2019to 12 Jun 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing and able to give written informed consent
- Age ≥ 18 years
- Male sex at birth
- Previously HIV-diagnosed OR HIV-seronegative at the time of last test within the past month and a current prescription for PrEP (both daily or event-driven permitted) or plan to start PrEP within 30 days after the enrollment visit
- Condomless anal or oral sexual contact with ≥ 1 male sex-at-birth partners in the past 12 months
- Diagnosed with GC, CT or early syphilis (primary, secondary or early latent) in the past 12 months. Note: self report of STI is acceptable if documentation not available. If the participant reports an incident STI in the past year at the same clinic where the participant will be enrolled, this diagnosis should be confirmed by chart review prior to enrollment. If the diagnosis from this clinic cannot be confirmed, the participant should not be enrolled. If the STI was reported at a clinical site that is not the study site, and records cannot be obtained, self-report will suffice.
- Note: Syphilis diagnosis within the last year refers to primary syphilis, secondary syphilis, and documented early latent syphilis (< 1 year since last syphilis diagnosis or negative test). Known late latent syphilis or latent syphilis of unknown duration would not qualify. Positive syphilis titers which represent serofast status and not active disease do not qualify as a syphilis diagnosis. Clinician judgement regarding qualifying syphilis diagnosis should be sought when the diagnosis of syphilis in the past year is not clear or if there is a question about serofast status vs. active infection.
Who cannot join
- Allergy to tetracycline class
- Current medications which may impact doxycycline metabolism or that are contraindicated with doxycycline, as per the prescribing information. These include systemic retinoids, barbiturates, carbamazepine, and phenytoin.
- Current use of warfarin, as intermittent doxycycling use can lead to an unpredictable impact on INR
- Anticipated use of doxycycline during the coming 12 months for non-STI prevention (e.g., acne treatment).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
San Francisco City Clinic / San Francisco Department of Public Health
San Francisco, California, 94103
University of California, San Francisco / Zuckerberg San Francisco General Hospital/UCSF
San Francisco, California, 94110
University of Washington
Seattle, Washington, 98195
About this study
The purpose of this study is to understand if taking an antibiotic called doxycycline by mouth as soon as possible after sexual contact without a condom can reduce the risk of sexually transmitted infections (STIs), including gonorrhea, chlamydia and syphilis. The study will also look at the safety of doxycycline PEP and the impact that PEP may have on the bacteria that cause STIs as well as on bacteria that normally live on the body. While doxycycline is approved by the Food and Drug Administration (FDA), taking doxycycline immediately after sexual contact to prevent infection is investigational and is not approved by the FDA for this use. Participants will take part in the study for 1 year.
Read the detailed description
The overarching goal is to assess the effectiveness of doxycycline PEP on incidence of STIs and tetracycline resistance among STIs and commensal bacteria to inform public health policy. Participants will be randomized 2:1, with a greater number receiving doxycycline PEP compared with the standard of care control, to maximize data on safety, tolerability, adherence coverage of sexual acts, and resistance data in participants randomized to doxycycline PEP, without negatively impacting power to measure effectiveness. Participants will be counseled about the preliminary effectiveness data from IPERGAY, and the potential for antimicrobial resistance (AMR) in STIs or other bacteria. Possibility of unreported doxycycline us in the control arm (contamination) will be monitored through retrospective batch testing of doxycycline metabolites in hair, to detect doxycycline use in the prior 3 months. 53
Eligible participants randomized 2:1 to receive PEP will receive open-label doxycycline 200 mg to be taken ideally within 24 hours but no later than 72 hours after condomless sexual contact (oral or anal). 200 mg of doxycycline will be taken at most once per 24 hour period regardless of the number of sexual acts occurring during this time period. Sexual activity will be recorded for both arms of the study (doxycycline PEP and control condition) by the participant using a smartphone application that will be adapted for study use; this will enable comparable assessment of risk in the two arms. PEP pill-taking will also be measured by the app to enable assessment of coverage of sex acts by PEP. Sexual activity and adherence will also be assessed in person at quarterly visits. STI testing will be conducted quarterly from three anatomic sites (pharyngeal, rectal and urinary) and blood for syphilis testing. Participants with a positive STI test will return for STI treatment and for swabs of the affected site for resistance testing; culture based for gonorrhea (GC) and molecular methods for CT and syphilis. Those with a serologic test that indicates a new syphilis infection will have swabs of any current active lesion as well as mucosal swabs from the oropharynx. Nares and oropharyngeal swabs will be obtained at baseline, 6 and 12 months to evaluate tetracycline resistance in S. aureus among carriers and in commensal Neisseria species.
Stool samples from 100 participants on the doxycycline PEP arm - 50 MSM living with HIV and 50 HIV uninfected MSM on pre-exposure prophylaxis (PrEP) - will be collected at baseline, 6 and 12 months to evaluate effects of intermittent doxycycline on the gut resistome, using 16s ribosomal RNA amplification to study tetracycline resistance genes. Rectal swabs will be collected and archived in all participants at baseline, 6, and 12 months for future studies of the impact of doxycycline PEP on the enteric microbiome and resistome.
Study population: This study will enroll 390 HIV-infected participants and 390 persons taking PrEP, for a total sample size of 780. An approximately equal number of participants in each of these cohorts (and in each study arm) will be enrolled in San Francisco and Seattle.
Current or planned initiation of PrEP use is an eligibility criterion for enrollment, because this population of MSM has high rates of STIs and are typically seen quarterly for PrEP visits. However, participants may opt to stop PrEP use at any time during the study without affecting their involvement in the study. Any HIV-uninfected participants who subsequently seroconvert will be managed clinically by the study site according to local practice (appropriate counseling, clinical evaluation and immediate linkage to clinical and psychosocial services). These participants will also be retained in the study unless they choose to discontinue study participation.
- Being tested
- Doxycycline Hyclate Delayed-Release 200 mg
- Keywords
- HIV, Post-Exposure Prophylaxis, Men who have sex with men (MSM), Doxycycline, HIV Pre-Exposure Prophylaxis, Sexually transmitted infection
- Medical subject headings
- Gonorrhea, Chlamydia Infections, Syphilis, Homosexuality, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxycycline Hyclate Delayed-Release 200 mgDrug
200 mg of doxycycline taken by mouth after condomless sexual contact as post exposure prophylaxis (PEP)
| Study group | Role | What they receive |
|---|---|---|
| Doxy PEP | Experimental | Doxycycline 200mg in addition to standard of care STI testing and treatment Receives: Drug: Doxycycline Hyclate Delayed-Release 200 mg |
| Control | No intervention | The control arm will consist of standard of care STI testing and treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Quarterly Visits In Which an STI Was Detected
Number of quarterly visits with an STI event detected.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start26 Nov 2019
- Primary completion12 Jun 2023
- Study completion12 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for GonorrheaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Open-label randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 641 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, National Institute of Allergy and Infectious Diseases (NIAID), Mayne Pharma International Pty Ltd, San Francisco Department of Public Health
- Responsible party
- Sponsor
- Investigators
- Anne Luetkemeyer, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980223
- Sponsor's protocol ID
- DoxyPEP
- Other IDs
- R01AI143439
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2019
- Last updated
- 12 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers outside of the study team
Publications
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 29229440The Lancet Hiv. U=U taking off in 2017. Lancet HIV. 2017 Nov;4(11):e475. doi: 10.1016/S2352-3018(17)30183-2. No abstract available.
PubMed 29096785Harrison WO, Hooper RR, Wiesner PJ, Campbell AF, Karney WW, Reynolds GH, Jones OG, Holmes KK. A trial of minocycline given after exposure to prevent gonorrhea. N Engl J Med. 1979 May 10;300(19):1074-8. doi: 10.1056/NEJM197905103001903.
PubMed 107450Steen R, Chersich M, Gerbase A, Neilsen G, Wendland A, Ndowa F, Akl EA, Lo YR, de Vlas SJ. Periodic presumptive treatment of curable sexually transmitted infections among sex workers: a systematic review. AIDS. 2012 Feb 20;26(4):437-45. doi: 10.1097/QAD.0b013e32834ed991.
PubMed 22095197Bolan RK, Beymer MR, Weiss RE, Flynn RP, Leibowitz AA, Klausner JD. Doxycycline prophylaxis to reduce incident syphilis among HIV-infected men who have sex with men who continue to engage in high-risk sex: a randomized, controlled pilot study. Sex Transm Dis. 2015 Feb;42(2):98-103. doi: 10.1097/OLQ.0000000000000216.
PubMed 25585069Sloan B, Scheinfeld N. The use and safety of doxycycline hyclate and other second-generation tetracyclines. Expert Opin Drug Saf. 2008 Sep;7(5):571-7. doi: 10.1517/14740338.7.5.571.
PubMed 18759709Turner RB, Smith CB, Martello JL, Slain D. Role of doxycycline in Clostridium difficile infection acquisition. Ann Pharmacother. 2014 Jun;48(6):772-6. doi: 10.1177/1060028014528792. Epub 2014 Mar 28.
PubMed 24682682Nadelman RB, Nowakowski J, Fish D, Falco RC, Freeman K, McKenna D, Welch P, Marcus R, Aguero-Rosenfeld ME, Dennis DT, Wormser GP; Tick Bite Study Group. Prophylaxis with single-dose doxycycline for the prevention of Lyme disease after an Ixodes scapularis tick bite. N Engl J Med. 2001 Jul 12;345(2):79-84. doi: 10.1056/NEJM200107123450201.
PubMed 11450675Angelakis E, Armstrong N, Nappez C, Richez M, Chabriere E, Raoult D. Doxycycline assay hair samples for testing long-term compliance treatment. J Infect. 2015 Nov;71(5):511-7. doi: 10.1016/j.jinf.2015.08.003. Epub 2015 Aug 20.
PubMed 26299894Perkins R, Fredericksen RJ, Christopoulos KA, Beima-Sofie K, Cohen SE, Dombrowski JC, Dright A, Gardner S, Kohler P, Luetkemeyer AF, Pintye J, Celum C. "It's Been a Very Liberating Experience": Doxycycline Postexposure Prophylaxis for Sexually Transmitted Infection Prevention and Experiences With Sexual Pleasure by Men Who Have Sex With Men. Sex Transm Dis. 2025 Dec 1;52(12):728-733. doi: 10.1097/OLQ.0000000000002220. Epub 2025 Jul 10.
PubMed 40637301Luetkemeyer AF, Donnell D, Cohen SE, Dombrowski JC, Grabow C, Haser G, Brown C, Cannon C, Malinski C, Perkins R, Nasser M, Lopez C, Suchland RJ, Vittinghoff E, Buchbinder SP, Scott H, Charlebois ED, Havlir DV, Soge OO, Celum C. Doxycycline to prevent bacterial sexually transmitted infections in the USA: final results from the DoxyPEP multicentre, open-label, randomised controlled trial and open-label extension. Lancet Infect Dis. 2025 Aug;25(8):873-883. doi: 10.1016/S1473-3099(25)00085-4. Epub 2025 Mar 24.
PubMed 40147465Chu VT, Glascock A, Donnell D, Grabow C, Brown CE, Ward R, Love C, Kalantar KL, Cohen SE, Cannon C, Woodworth MH, Kelley CF, Celum C, Luetkemeyer AF, Langelier CR. Impact of doxycycline post-exposure prophylaxis for sexually transmitted infections on the gut microbiome and antimicrobial resistome. Nat Med. 2025 Jan;31(1):207-217. doi: 10.1038/s41591-024-03274-2. Epub 2024 Oct 3.
PubMed 39363100Fredericksen RJ, Perkins R, Brown CE, Cannon C, Lopez C, Cohee A, Dombrowski JC, Cohen S, Malinski C, Powell M, Luetkemeyer AF, Celum C, Christopoulos K. Doxycycline as Postsexual Exposure Prophylaxis: Use, Acceptability, and Associated Sexual Health Behaviors Among a Multi-Site Sample of Clinical Trial Participants. AIDS Patient Care STDS. 2024 Apr;38(4):155-167. doi: 10.1089/apc.2023.0289.
PubMed 38656217Luetkemeyer 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Doxycycline Post-exposure Prophylaxis to Reduce Sexually Transmitted Infections in PrEP Users and HIV-infected Men Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT03980223
- Acronym / sponsor ID
- DoxyPEP
- Keywords
- HIV, Post-Exposure Prophylaxis, Men who have sex with men (MSM), Doxycycline, HIV Pre-Exposure Prophylaxis, Sexually transmitted infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 641 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of Washington, National Institute of Allergy and Infectious Diseases (NIAID), Mayne Pharma International Pty Ltd, San Francisco Department of Public Health
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 12 Jun 2023 (actual)
- First posted
- 10 Jun 2019 (actual)
- Results
- Posted 12 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to understand if taking an antibiotic called doxycycline by mouth as soon as possible after sexual contact without a condom can reduce the risk of sexually transmitted infections (STIs), including gonorrhea, chlamydia and syphilis. The study will also look at the safety of doxycycline PEP and the impact that PEP may have on the bacteria that cause STIs as well as on bacteria that normally live on the body. While doxycycline is approved by the Food and Drug Administration (FDA), taking doxycycline immediately after sexual contact to prevent infection is investigational and is not approved by the FDA for this use. Participants will take part in the study for 1 year.
Detailed description
The overarching goal is to assess the effectiveness of doxycycline PEP on incidence of STIs and tetracycline resistance among STIs and commensal bacteria to inform public health policy. Participants will be randomized 2:1, with a greater number receiving doxycycline PEP compared with the standard of care control, to maximize data on safety, tolerability, adherence coverage of sexual acts, and resistance data in participants randomized to doxycycline PEP, without negatively impacting power to measure effectiveness. Participants will be counseled about the preliminary effectiveness data from IPERGAY, and the potential for antimicrobial resistance (AMR) in STIs or other bacteria. Possibility of unreported doxycycline us in the control arm (contamination) will be monitored through retrospective batch testing of doxycycline metabolites in hair, to detect doxycycline use in the prior 3 months. 53
Eligible participants randomized 2:1 to receive PEP will receive open-label doxycycline 200 mg to be taken ideally within 24 hours but no later than 72 hours after condomless sexual contact (oral or anal). 200 mg of doxycycline will be taken at most once per 24 hour period regardless of the number of sexual acts occurring during this time period. Sexual activity will be recorded for both arms of the study (doxycycline PEP and control condition) by the participant using a smartphone application that will be adapted for study use; this will enable comparable assessment of risk in the two arms. PEP pill-taking will also be measured by the app to enable assessment of coverage of sex acts by PEP. Sexual activity and adherence will also be assessed in person at quarterly visits. STI testing will be conducted quarterly from three anatomic sites (pharyngeal, rectal and urinary) and blood for syphilis testing. Participants with a positive STI test will return for STI treatment and for swabs of the affected site for resistance testing; culture based for gonorrhea (GC) and molecular methods for CT and syphilis. Those with a serologic test that indicates a new syphilis infection will have swabs of any current active lesion as well as mucosal swabs from the oropharynx. Nares and oropharyngeal swabs will be obtained at baseline, 6 and 12 months to evaluate tetracycline resistance in S. aureus among carriers and in commensal Neisseria species.
Stool samples from 100 participants on the doxycycline PEP arm - 50 MSM living with HIV and 50 HIV uninfected MSM on pre-exposure prophylaxis (PrEP) - will be collected at baseline, 6 and 12 months to evaluate effects of intermittent doxycycline on the gut resistome, using 16s ribosomal RNA amplification to study tetracycline resistance genes. Rectal swabs will be collected and archived in all participants at baseline, 6, and 12 months for future studies of the impact of doxycycline PEP on the enteric microbiome and resistome.
Study population: This study will enroll 390 HIV-infected participants and 390 persons taking PrEP, for a total sample size of 780. An approximately equal number of participants in each of these cohorts (and in each study arm) will be enrolled in San Francisco and Seattle.
Current or planned initiation of PrEP use is an eligibility criterion for enrollment, because this population of MSM has high rates of STIs and are typically seen quarterly for PrEP visits. However, participants may opt to stop PrEP use at any time during the study without affecting their involvement in the study. Any HIV-uninfected participants who subsequently seroconvert will be managed clinically by the study site according to local practice (appropriate counseling, clinical evaluation and immediate linkage to clinical and psychosocial services). These participants will also be retained in the study unless they choose to discontinue study participation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Doxy PEP | Experimental | Drug: Doxycycline Hyclate Delayed-Release 200 mgDoxycycline 200mg in addition to standard of care STI testing and treatment |
| Control | No intervention | –The control arm will consist of standard of care STI testing and treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Willing and able to give written informed consent
- Age ≥ 18 years
- Male sex at birth
- Previously HIV-diagnosed OR HIV-seronegative at the time of last test within the past month and a current prescription for PrEP (both daily or event-driven permitted) or plan to start PrEP within 30 days after the enrollment visit
- Condomless anal or oral sexual contact with ≥ 1 male sex-at-birth partners in the past 12 months
Key exclusion criteria (4 listed)
- Allergy to tetracycline class
- Current medications which may impact doxycycline metabolism or that are contraindicated with doxycycline, as per the prescribing information. These include systemic retinoids, barbiturates, carbamazepine, and phenytoin.
- Current use of warfarin, as intermittent doxycycling use can lead to an unpredictable impact on INR
- Anticipated use of doxycycline during the coming 12 months for non-STI prevention (e.g., acne treatment).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doxycycline Hyclate Delayed-Release 200 mg200 mg of doxycycline taken by mouth after condomless sexual contact as post exposure prophylaxis (PEP) | Drug | Doxy PEP |
Primary outcome
Number of Quarterly Visits In Which an STI Was Detected
Time frame: 1 year
Number of quarterly visits with an STI event detected.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29229440Molina 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.
- Background: PubMed 29096785The Lancet Hiv. U=U taking off in 2017. Lancet HIV. 2017 Nov;4(11):e475. doi: 10.1016/S2352-3018(17)30183-2. No abstract available.
- Background: PubMed 107450Harrison WO, Hooper RR, Wiesner PJ, Campbell AF, Karney WW, Reynolds GH, Jones OG, Holmes KK. A trial of minocycline given after exposure to prevent gonorrhea. N Engl J Med. 1979 May 10;300(19):1074-8. doi: 10.1056/NEJM197905103001903.
- Background: PubMed 22095197Steen R, Chersich M, Gerbase A, Neilsen G, Wendland A, Ndowa F, Akl EA, Lo YR, de Vlas SJ. Periodic presumptive treatment of curable sexually transmitted infections among sex workers: a systematic review. AIDS. 2012 Feb 20;26(4):437-45. doi: 10.1097/QAD.0b013e32834ed991.
- Background: PubMed 25585069Bolan RK, Beymer MR, Weiss RE, Flynn RP, Leibowitz AA, Klausner JD. Doxycycline prophylaxis to reduce incident syphilis among HIV-infected men who have sex with men who continue to engage in high-risk sex: a randomized, controlled pilot study. Sex Transm Dis. 2015 Feb;42(2):98-103. doi: 10.1097/OLQ.0000000000000216.
- Background: PubMed 18759709Sloan B, Scheinfeld N. The use and safety of doxycycline hyclate and other second-generation tetracyclines. Expert Opin Drug Saf. 2008 Sep;7(5):571-7. doi: 10.1517/14740338.7.5.571.
- Background: PubMed 24682682Turner RB, Smith CB, Martello JL, Slain D. Role of doxycycline in Clostridium difficile infection acquisition. Ann Pharmacother. 2014 Jun;48(6):772-6. doi: 10.1177/1060028014528792. Epub 2014 Mar 28.
- Background: PubMed 11450675Nadelman RB, Nowakowski J, Fish D, Falco RC, Freeman K, McKenna D, Welch P, Marcus R, Aguero-Rosenfeld ME, Dennis DT, Wormser GP; Tick Bite Study Group. Prophylaxis with single-dose doxycycline for the prevention of Lyme disease after an Ixodes scapularis tick bite. N Engl J Med. 2001 Jul 12;345(2):79-84. doi: 10.1056/NEJM200107123450201.
- Background: PubMed 26299894Angelakis E, Armstrong N, Nappez C, Richez M, Chabriere E, Raoult D. Doxycycline assay hair samples for testing long-term compliance treatment. J Infect. 2015 Nov;71(5):511-7. doi: 10.1016/j.jinf.2015.08.003. Epub 2015 Aug 20.
- Derived from this study: PubMed 40637301Perkins R, Fredericksen RJ, Christopoulos KA, Beima-Sofie K, Cohen SE, Dombrowski JC, Dright A, Gardner S, Kohler P, Luetkemeyer AF, Pintye J, Celum C. "It's Been a Very Liberating Experience": Doxycycline Postexposure Prophylaxis for Sexually Transmitted Infection Prevention and Experiences With Sexual Pleasure by Men Who Have Sex With Men. Sex Transm Dis. 2025 Dec 1;52(12):728-733. doi: 10.1097/OLQ.0000000000002220. Epub 2025 Jul 10.
- Derived from this study: PubMed 40147465Luetkemeyer AF, Donnell D, Cohen SE, Dombrowski JC, Grabow C, Haser G, Brown C, Cannon C, Malinski C, Perkins R, Nasser M, Lopez C, Suchland RJ, Vittinghoff E, Buchbinder SP, Scott H, Charlebois ED, Havlir DV, Soge OO, Celum C. Doxycycline to prevent bacterial sexually transmitted infections in the USA: final results from the DoxyPEP multicentre, open-label, randomised controlled trial and open-label extension. Lancet Infect Dis. 2025 Aug;25(8):873-883. doi: 10.1016/S1473-3099(25)00085-4. Epub 2025 Mar 24.
- Derived from this study: PubMed 39363100Chu VT, Glascock A, Donnell D, Grabow C, Brown CE, Ward R, Love C, Kalantar KL, Cohen SE, Cannon C, Woodworth MH, Kelley CF, Celum C, Luetkemeyer AF, Langelier CR. Impact of doxycycline post-exposure prophylaxis for sexually transmitted infections on the gut microbiome and antimicrobial resistome. Nat Med. 2025 Jan;31(1):207-217. doi: 10.1038/s41591-024-03274-2. Epub 2024 Oct 3.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers outside of the study team
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Luetkemeyer, MD principal investigator
University of California, San Francisco
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Doxycycline Hyclate Delayed-Release 200 mg in people with Gonorrhea and Chlamydia, run by University of California, San Francisco at 3 sites in United States.
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 7 inclusion and 4 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: finished, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Yes. Results are posted in the registry (first posted 12 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Quarterly Visits In Which an STI Was Detected (time frame: 1 year). 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 NCT03980223, which also lists 14 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 12 Jul 2024.