Unspecified human immunodeficiency virus [HIV] disease, Sexually Transmitted Diseases, Bacterial, Sexually Transmitted Diseases, Viral
Conditions
Interventions
This is an open-label, single-center, non-randomized pilot study with two parallel arms. The intervention under investigation is post-exposure prophylaxis with doxycycline (active ingredient), an anti
Sponsors
Instituto Nacional de Infectologia Evandro Chagas
Instituto Nacional de Infectologia Evandro Chagas
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Men (cis or trans) who have sex with men, transvestites or trans women; diagnosed with HIV infection or current use of PrEP for at least 6 months; age 18 years or older; laboratory diagnosis or self-reported diagnosis of at least one bacterial sexually transmitted infection (Chlamydia, Gonorrhea or Syphilis) in the last 12 months; consent to participate in the study after receiving adequate information about the study
Exclusion criteria
Exclusion criteria: Allergy to antibiotics of the Tetracycline class; current medications that may impact the metabolism of Doxycycline or that are contraindicated with Doxycycline (Systemic Retinoids, Barbiturates, Carbamazepine and Phenytoin)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that the cumulative incidence of symptomatic bacterial sexually transmitted infections (STIs) — including gonorrhea, chlamydia, and syphilis — over a 48-week period will reflect the efficacy of the proposed intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the cumulative incidence (Poisson model) of symptomatic and asymptomatic sexually transmitted infections (STIs) at week 48; to evaluate the cumulative incidence (Poisson model) of symptomatic and asymptomatic chlamydia at week 48; to evaluate the cumulative incidence (Poisson model) of symptomatic and asymptomatic gonorrhea at week 48; to evaluate the cumulative incidence (Poisson model) of symptomatic and asymptomatic syphilis at week 48; to evaluate the proportions of Neisseria gonorrhoeae strains resistant to tetracycline at baseline and over the 48-week period; to evaluate the proportion of participants with Staphylococcus aureus resistant to methicillin and/or tetracycline in the nasopharynx at baseline and at the end of the 48 weeks; to evaluate the proportion of participants with rectal colonization by extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae at baseline and at the end of the 48 weeks; to evaluate the occurrence of any adverse events (AEs), including grade 3 or 4 AEs, serious adverse events (SAEs), treatment-related AEs, AEs leading to early study discontinuation, drug discontinuation, or death; to evaluate adherence to doxy-PEP, defined by self-reported condomless sexual exposures covered by the use of doxy-PEP and by the proportion of participants with satisfactory levels of doxycycline in hair samples; to evaluate adoption of doxy-PEP, defined as the decision to initiate doxy-PEP in stage 2 of the study | — |
Countries
Brazil
Contacts
Public ContactBeatriz Grinsztejn
Instituto Nacional de Infectologia Evandro Chagas
Outcome results
None listed