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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOswaldo Cruz Foundation

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Doxycycline Post-Exposure Prophylaxis (Doxy-PEP)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of bacterial sexually transmitted infections (STIs)

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

Time frame
Up to 48 weeks

Secondary outcomes

1

Incidence of symptomatic and asymptomatic bacterial STIs

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

Time frame
Up to 48 weeks.
2

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

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

Time frame
Up to 48 weeks
3

Antimicrobial resistance in Neisseria gonorrhoeae

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

Time frame
Baseline and up to 48 weeks
4

Colonization with antimicrobial-resistant bacteria

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

Time frame
Baseline and week 48

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.