Impact of the Daily Doxycycline Pre-exposure Prophylaxis (PrEP) on the Incidence of Syphilis, Gonorrhoea and Chlamydia

NCT03709459 | Unknown

• 1 other identifier: PHIRG1901
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 4

Brief Summary

1\. This study is a non-randomized observational cohort trial using before and after comparison to evaluate intervention 2. It would mimic the conditions that would occur outside a clinical trial. 2. After consent and enrolment, all procedures will be guided by the Australian STI Management Guidelines. 3\. All enrolling participants will be offered daily doxycycline 100mg 4. All participants will be invited to complete a survey in every 3 months time for 12 months dated from participation. 5\. All follow-up information will be collected through electronic data capture to allow accurate and timely analyses. 6\. Data collection will be from (i) medical records (ii) online self-completed questionnaire

Conditions

STIs Prevention

Keywords

Syphilis, Gonorrhea, Chlamydia, Doxycycline, PrEP, Syphilaxis

Outcome Measures

Primary Outcomes (2)

• Incidence of STI (gonorrhoea, chlamydia and infectious syphilis) per 100 person years among study participants

  measured using data collected by the ACCESS study

  1 year after the last participant complete their last follow-up visit

• Patterns of daily doxycycline use and adherence to the medication schedule

  measured among participants consenting to the adherence and behavioural online survey

  1 year after the last participant complete their last follow-up visit

Secondary Outcomes (2)

• Evidence of clinically significant antibiotic resistance in in a subset of participants

  1 year after the last participant who's recruited from the Melbourne site

• Behavioural risk practices among study participants

  1 year after the last participant complete their last follow-up visit

Interventions

Doxycycline DRUG

Participants will be asked to take Doxycycline 100mg/day for 12months duration

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Men who report male to male sex in the last 3 months and who have had at least two screening for syphilis, chlamydia and gonorrhoea in the last 12 months, and at least once incidence of syphilis in the last two years, are eligible for the study.

You may qualify if:

• Male or transgender
• Aged 18 years or over
• Reports sex with men in last 3 months
• At least two screenings for syphilis, gonorrhoea and chlamydia in the past 12 months
• A diagnosis of syphilis within the last 12 months, OR a diagnosis of any 2 STIs within the last 12 months and syphilis within the last 24 months.
• HIV +ve, OR HIV -ve and on PrEP for at least 6 months.

You may not qualify if:

• Documented or self-reported hypersensitivity to doxycycline or antimicrobial agents from tetracycline family
• A known diagnosis of myasthenia gravis
• Factors or conditions that may compromise a participant's access to health services for follow-up (incarceration or planned relocation that would impact upon proximity to a trial site).

Sponsors & Collaborators

• Kirby Institute: lead
• South Australian Health and Medical Research Institute: collaborator
• Monash University: collaborator

Study Sites (4)

Royal Prince Alfred Hospital Sexual Health Medicine

Camperdown, New South Wales, 2050, Australia

Location

Sydney Sexual Health Centre

Sydney, New South Wales, 2000, Australia

Location

Kirketon Road Centre

Sydney, New South Wales, 2010, Australia

Location

Melbourne Sexual Health Centre

Melbourne, Victoria, 3053, Australia

Location

Biospecimen

Retention: SAMPLES WITH DNA

oropharynx and rectum swab

MeSH Terms

Conditions

Syphilis; Gonorrhea; Chlamydia Infections

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Neisseriaceae Infections; Chlamydiaceae Infections

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Bridget Haire, PhD

  Kirby Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2018
• First Posted: October 17, 2018
• Study Start: December 17, 2019
• Primary Completion: July 17, 2024
• Study Completion: December 17, 2024
• Last Updated: October 5, 2023

Record last verified: 2023-10

Locations

AU (4)