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Prevention study for Gonorrhea
Official title Doxycycline Prophylaxis for Prevention of Sexually Transmitted Infections
ClinicalTrials.gov ID: NCT06738407
What this study is testing
What is Doxycycline hyclate delayed released 200 mg?
Doxycycline hyclate delayed released 200 mg is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for gonorrhea.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this open-label, randomized trial is to assess the efficacy of doxycycline prophylaxis in reducing incidences of bacterial sexually transmitted infections (STIs) among adolescent and young adult females while also evaluating acceptability and antimicrobial resistance in order to inform public health policy.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 13 to 29, women only
You may be able to join if
- Age 13-29 years, inclusive;
- Self-reports GC, CT, and/or early syphilis diagnosis in the 12 months prior to screening;
- Self-reports condomless (oral, vaginal, and/or anal) intercourse at least once in the 30 days prior to screening
- Is at least 45 kilograms (99.2 pounds) in weight
- Fluent in English (able to read, speak, and understand English);
You likely can't join if
- Is male;
- Is pregnant, breastfeeding, or planning to become pregnant in the next 12 months;
- Documented history of tetracycline allergy or self-reports an allergy to tetracyclines;
- Current or anticipated use of a medication (e.g., barbiturates, phenytoin, lithium, carbamazepine, systemic retinoids, warfarin) with a...
- Current or planned use of doxycycline for a prolonged period (\> 2 weeks) in the 30 days prior to enrollment, including current prescription for...
- Prolonged antibiotic use (\> 2 weeks) within the last 30 days prior to enrollment;
See the full eligibility criteria
- Age 13-29 years, inclusive;
- Self-reports GC, CT, and/or early syphilis diagnosis in the 12 months prior to screening;
- Self-reports condomless (oral, vaginal, and/or anal) intercourse at least once in the 30 days prior to screening
- Is at least 45 kilograms (99.2 pounds) in weight
- Fluent in English (able to read, speak, and understand English);
- Willing to undergo all required study procedures; and
- Willing to provide written informed consent to participate in the study.
- Is male;
- Is pregnant, breastfeeding, or planning to become pregnant in the next 12 months;
- Documented history of tetracycline allergy or self-reports an allergy to tetracyclines;
- Current or anticipated use of a medication (e.g., barbiturates, phenytoin, lithium, carbamazepine, systemic retinoids, warfarin) with a contraindicated interaction to doxycycline ;
- Current or planned use of doxycycline for a prolonged period (\> 2 weeks) in the 30 days prior to enrollment, including current prescription for doxycycline for STI prophylaxis;
- Prolonged antibiotic use (\> 2 weeks) within the last 30 days prior to enrollment;
- Co-enrollment in any other concurrent treatment research or studies that may interfere with this study, such as an STI prevention trial, unless approved by Protocol Team in writing;
- Does not have consistent access (or anticipated weekly access for 52 weeks of survey completion) to smartphone that can access the HMP app; or
- Any other medical condition, medical/behavioral intervention, or other conditions that, in the opinion of the clinical site Project Lead (PL)/Investigator of Record (IoR) or designee, could interfere with adherence to...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- San Francisco, California, United States
- Washington D.C., District of Columbia, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- New Orleans, Louisiana, United States
- Baltimore, Maryland, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Memphis, Tennessee, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 13 years to 29 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; San Francisco, California, United States; Washington D.C., District of Columbia, United States; Tampa, Florida, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.