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The goal of this clinical trial is to learn if doxycycline post-exposure prophylaxis (doxy-PEP) can help prevent bacterial sexually transmitted infections (STIs) among sexual and gender minorities in Rio de Janeiro, Brazil, including men who have sex with men, transgender women, and travestis who are living with HIV or using HIV pre-exposure prophylaxis (PrEP). Bacterial STIs such as syphilis, gonorrhea, and chlamydia remain common in these populations, even with existing prevention strategies.
This study aims to answer the following questions: whether doxy-PEP can reduce the number of new STIs, whether it is safe and well tolerated, whether participants use it as recommended, and whether its use may contribute to antibiotic resistance or changes in the body's natural bacteria. Doxy-PEP involves taking a dose of doxycycline, an antibiotic, shortly after sexual activity to reduce the risk of acquiring STIs.
Participants will first receive information and counseling about doxy-PEP, including its possible benefits and risks, and will then choose whether or not to use this prevention strategy. Those who choose to use doxy-PEP will take doxycycline after sex as instructed and will be followed for up to 48 weeks, with clinic visits approximately every three months. During these visits, participants will be tested for STIs, monitored for side effects, and asked about medication use, sexual health, and overall well-being.
Researchers will collect information on new STI diagnoses, safety, and how consistently participants use doxy-PEP. The study will also explore participants' experiences and perceptions of this strategy. The results of this study will help determine whether doxy-PEP is a practical and acceptable approach for STI prevention in Brazil and may inform future public health strategies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doxycycline Post-Exposure Prophylaxis (Doxy-PEP) | Experimental | Participants who choose to initiate doxycycline post-exposure prophylaxis (doxy-PEP) after receiving counseling on its risks and benefits. Participants will take doxycycline after sexual activity as instructed and will be followed for up to 48 weeks with regular clinical visits, including testing for sexually transmitted infections, safety assessments, and adherence evaluation. Participants who initially decline doxy-PEP may choose to initiate it at any time during the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxycycline | Drug | Doxycycline 200 mg taken orally within 72 hours after sexual activity, not exceeding one dose per 24 hours and a maximum of three doses per week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of bacterial sexually transmitted infections (STIs) | Cumulative incidence of laboratory-confirmed symptomatic and asymptomatic bacterial STIs (syphilis, gonorrhea, and chlamydia). | Up to 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of symptomatic and asymptomatic bacterial STIs | Cumulative incidence of laboratory-confirmed symptomatic and asymptomatic bacterial STIs (syphilis, gonorrhea, and chlamydia). | Up to 48 weeks. |
| Incidence of specific STIs (chlamydia, gonorrhea, and syphilis) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Beatriz Grinsztejn, PhD | Contact | +55 2138659128 | beatriz.grinsztejn@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Infectologia Evandro Chagas | Recruiting | Rio de Janeiro | Rio de Janeiro | 21040-360 | Brazil |
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| ID | Term |
|---|---|
| D012749 | Sexually Transmitted Diseases |
| D013587 | Syphilis |
| D006069 | Gonorrhea |
| D002690 | Chlamydia Infections |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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This is an open-label, single-group, pilot implementation study evaluating doxycycline post-exposure prophylaxis (doxy-PEP) for the prevention of bacterial sexually transmitted infections. All eligible participants receive counseling and are offered the option to initiate doxy-PEP. Participants who choose to initiate doxy-PEP are followed prospectively for up to 48 weeks, with regular clinical and laboratory assessments, including testing for sexually transmitted infections, safety monitoring, and adherence evaluation. Participants who initially decline doxy-PEP may opt to initiate it at any time during the study. The study aims to assess feasibility, acceptability, safety, adherence, and impact on STI incidence and antimicrobial resistance in a real-world setting.
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Cumulative incidence of each STI (chlamydia, gonorrhea, and syphilis), including symptomatic and asymptomatic cases. |
| Up to 48 weeks |
| Antimicrobial resistance in Neisseria gonorrhoeae | Proportion of Neisseria gonorrhoeae isolates with resistance to tetracycline and other relevant antibiotics over time. | Baseline and up to 48 weeks |
| Colonization with antimicrobial-resistant bacteria | Proportion of participants colonized with methicillin-resistant Staphylococcus aureus (MRSA) and extended-spectrum beta-lactamase (ESBL)-producing enterobacteria. | Baseline and week 48 |
| Adverse events | Occurrence of adverse events (AEs), including serious adverse events (SAEs), grade 3 or 4 AEs, and AEs leading to discontinuation of doxy-PEP. | From enrollment to 48 weeks |
| Adherence to doxy-PEP | Adherence measured by self-reported coverage of sexual exposures with doxy-PEP and by doxycycline levels in hair samples. | Up to 48 weeks |
| Uptake of doxy-PEP | Proportion of participants who choose to initiate doxy-PEP after counseling. | At enrollment |
| Acceptability of doxy-PEP | Participant-reported perceptions, experiences, and acceptability of doxy-PEP assessed through questionnaires and qualitative interviews. | Up to 48 weeks |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014211 | Treponemal Infections |
| D013145 | Spirochaetales Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D016870 | Neisseriaceae Infections |
| D002694 | Chlamydiaceae Infections |
| D000086982 | Blood-Borne Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |