Oral Doxycycline for the Prevention of Syphilis in Men Who Have Sex with Men (DaDHS)

NCT02864550 | Completed Phase 4 DMC

• 1 other identifier: BritishCCDC2
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Syphilis is a sexually transmitted infection (STI) disproportionately affecting gay, bisexual and other men who have sex with men (gbMSM), with the potential for significant sequelae - particularly in those who are Human Immunodeficiency Virus (HIV)-positive. Rising rates of this STI have prompted a search for novel prevention solutions. A recent pilot study of daily doxycycline prophylaxis demonstrated promise as a novel STI prevention tool. This innovative approach to STI prevention has solid clinical precedent, both from the HIV pre-exposure prophylaxis (PrEP) literature, as well as doxycycline's use as prophylaxis for other infections. The overarching goal of this project is to determine whether the daily use of doxycycline is an efficacious and acceptable intervention for syphilis prevention in high-risk, HIV-positive gbMSM.

Conditions

Syphilis; Sexually Transmitted Infections

Keywords

Men who have sex with men; Human immunodeficiency virus; Doxycycline; Tetracycline

Outcome Measures

Primary Outcomes (5)

• To assess the proportion of participants who are eligible and consent to participate amongst those approached.

  To determine the feasibility of daily syphilis PrEP

  15 months

• To assess the proportion of participants reporting > 95% adherence to study drug, according to self-report and pill counts.

  To determine the feasibility of daily syphilis PrEP

  15 months

• To assess the proportion of individuals with therapeutic doxycycline drug level (defined at ≥ 1000 ng/mL) at each study time point.

  To determine the feasibility of daily syphilis PrEP

  15 months

• To assess the proportion of individuals reporting grade 3 or 4 adverse events in each study arm.

  To determine the feasibility of daily syphilis PrEP

  15 months

• Proportion of individuals with adverse event-related study drug discontinuation in each study arm.

  To determine the feasibility of daily syphilis PrEP

  15 months

Secondary Outcomes (4)

• To assess the proportion of individuals with evidence of tetracycline class resistance in common flora (Staphylococcus aureus, Streptococcus pyogene and Streptococcus pneumoniae)

  At 6 and 12 months

• To assess the changes in sexual risk behaviour will be calculated by comparing risk parameters (i.e. number partners, number of anal sexual encounters that were condomless) from pre-PrEP initiation to the study period.

  15 months

• To assess the incidence of early syphilis infection

  15 months

• To assess the incidence of gonorrhea or chlamydia infection

  15 months

Other Outcomes (1)

• To assess changes in the bacterial populations found in the rectal microbiome.

  15 months

Study Arms (2)

Doxycycline arm

EXPERIMENTAL

Participants in this intervention group will receive doxycycline 100mg orally daily, which is available as a 100mg capsule. This single daily dose was chosen to maximize adherence, given the common use of once-daily Human Immunodeficiency Virus (HIV) pre-exposure prophylaxis (PrEP), as well as its efficacy as once-daily prophylaxis against malaria and its utility as dosing as infrequent as once weekly for another spirochete infection, leptospirosis.

Drug: Doxycycline

Placebo arm

PLACEBO COMPARATOR

Participants in this control group will receive a placebo capsule identical in appearance, taste, and size to the capsule provided to the intervention group.

Other: Placebo

Interventions

Doxycycline DRUG

doxycycline 100mg orally daily

Doxycycline arm

Placebo OTHER

placebo capsule identical in appearance, taste, and size to the capsule provided to the intervention group

Placebo arm

Eligibility Criteria

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

You may qualify if:

• Males, ≥ 18 years of age at baseline;
• Self-reported MSM status;
• Self-report condomless anal sex with a man within the last 6 months;
• Laboratory documentation of HIV-1 infection;
• Prior diagnosis of early/infectious syphilis (i.e. primary, secondary or early latent) within preceding 36 months (defined on the basis of a new positive serum rapid plasma reagin (RPR) test, or ≥2-dilution rise in titre if previous syphilis, or positive darkfield microscopy result or T. pallidum direct fluorescent antibody test or PCR from a primary lesion);
• Able to provide informed consent.

You may not qualify if:

• Known allergy or intolerance to doxycycline or tetracyclines;
• A known diagnosis of myasthenia gravis;
• Use of medications which could lower doxycycline levels, including barbiturates, phenytoin and carbamazepine;
• Individuals using isotretinoin;
• Any individual capable of getting pregnant.

Sponsors & Collaborators

• British Columbia Centre for Disease Control: lead

Study Sites (1)

British Columbia Centre for Disease Control

Vancouver, British Columbia, V5Z 4R4, Canada

Location

Related Publications (25)

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MeSH Terms

Conditions

Syphilis; Sexually Transmitted Diseases; Homosexuality; Acquired Immunodeficiency Syndrome

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Communicable Diseases; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sexuality; Sexual Behavior; Behavior; HIV Infections; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Troy Grennan, MD

  BC Centre for Disease Control

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician Lead, HIV/STI program, BCCDC

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 12, 2016
• Study Start: August 15, 2019
• Primary Completion: April 5, 2024
• Study Completion: December 31, 2024
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)