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NCT Number: NCT07500415

Doxi-Rio: Study on the Use of Doxycycline to Prevent Sexually Transmitted Infections in Rio de Janeiro

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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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals assigned male at birth (cisgender or transgender men), transgender women, or travestis who have sex with men
  • Age ≥18 years
  • Living with HIV or currently using HIV pre-exposure prophylaxis (PrEP) for at least 6 months
  • History of at least one bacterial sexually transmitted infection (chlamydia, gonorrhea, or syphilis) in the past 12 months (laboratory-confirmed or self-reported)
  • Willing and able to provide informed consent

Exclusion criteria

  • Known allergy or hypersensitivity to doxycycline or other tetracycline-class antibiotics
  • Current use of medications that may significantly interact with doxycycline or are contraindicated, including systemic retinoids, barbiturates, carbamazepine, or phenytoin

Treatment and study plan

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.

Primary outcomes

  1. Incidence of bacterial sexually transmitted infections (STIs)

    Time frame: Up to 48 weeks

    Cumulative incidence of laboratory-confirmed symptomatic and asymptomatic bacterial STIs (syphilis, gonorrhea, and chlamydia).

Secondary outcomes

  1. Incidence of symptomatic and asymptomatic bacterial STIs

    Time frame: Up to 48 weeks.

    Cumulative incidence of laboratory-confirmed symptomatic and asymptomatic bacterial STIs (syphilis, gonorrhea, and chlamydia).

  2. Incidence of specific STIs (chlamydia, gonorrhea, and syphilis)

    Time frame: Up to 48 weeks

    Cumulative incidence of each STI (chlamydia, gonorrhea, and syphilis), including symptomatic and asymptomatic cases.

  3. Antimicrobial resistance in Neisseria gonorrhoeae

    Time frame: Baseline and up to 48 weeks

    Proportion of Neisseria gonorrhoeae isolates with resistance to tetracycline and other relevant antibiotics over time.

  4. Colonization with antimicrobial-resistant bacteria

    Time frame: Baseline and week 48

    Proportion of participants colonized with methicillin-resistant Staphylococcus aureus (MRSA) and extended-spectrum beta-lactamase (ESBL)-producing enterobacteria.

  5. Adverse events

    Time frame: From enrollment to 48 weeks

    Occurrence of adverse events (AEs), including serious adverse events (SAEs), grade 3 or 4 AEs, and AEs leading to discontinuation of doxy-PEP.

  6. Adherence to doxy-PEP

    Time frame: Up to 48 weeks

    Adherence measured by self-reported coverage of sexual exposures with doxy-PEP and by doxycycline levels in hair samples.

  7. Uptake of doxy-PEP

    Time frame: At enrollment

    Proportion of participants who choose to initiate doxy-PEP after counseling.

  8. Acceptability of doxy-PEP

    Time frame: Up to 48 weeks

    Participant-reported perceptions, experiences, and acceptability of doxy-PEP assessed through questionnaires and qualitative interviews.

Study contacts

Contact information is provided by the study sponsor or research team.

Beatriz Grinsztejn, PhD

CONTACT

[email protected]

+55 2138659128

Sponsors and collaborators

Lead sponsor

Oswaldo Cruz Foundation

Other

Registry information

Official study title

Doxi-Rio: Pilot Implementation of Post-exposure Prophylaxis for Sexually Transmitted Infections With Doxycycline in Rio de Janeiro, Brazil

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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