COMPLETED

Daily Doxycycline to Inform Sexually Transmitted Infection Prophylaxis Regimens

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this project is to collect data regarding the concentrations of doxycycline in mucosal tissues after daily dosing for 7 days in people assigned male sex at birth (AMAB) and assigned female sex at birth (AFAB) to inform future studies of doxycycline to protect against bacterial sexually transmitted infections (STIs).

Official Title

Daily Doxy: Study of Persons Receiving Daily Doxycycline to Inform Sexually Transmitted Infection Prophylaxis Regimens

Quick Facts

Study Start:2024-09-13

Study Completion:2025-04-29

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06545656

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 59 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Assigned male sex or female sex at birth * In good general health * Not currently taking doxycycline or other tetracycline-derived antibiotics and no plans to initiate during the study * For HIV positive people, on stable antiretroviral therapy with an undetectable viral load and cluster of differentiation 4 (CD4) count\> 300ul/ml * Willing to use condoms consistently for the duration of the study * Able to provide informed consent * No plans for relocation in the next 4 months * Not pregnant and does not plan on getting pregnant for the duration of the study * Willing to undergo peripheral blood, urine, rectal or vaginal secretion collection, and a rectal or vaginal and cervical biopsy procedure * Willing to use study products as directed	* Current or chronic history of liver disease * Continued need for, or use during the 90 days prior to enrollment, of the following medications: * Systemic immunomodulatory agents * Supraphysiologic doses of steroids (short course steroids less than 7 days duration, allowable at the discretion of the investigators) * Chemotherapy or radiation for treatment of malignancy * Experimental medications, vaccines, or biologicals * Intent to use doxycycline or other tetracycline-derived antibiotics during the course of the study, outside of the study procedures * Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements * Known allergic reaction to study drugs * Significant laboratory abnormalities at baseline visit for rectal biopsies, including but not limited to: * Hemoglobin (Hgb) ≤ 10 g/dL * Partial thromboplastin time (PTT) \> 1.5x upper limit of normal (ULN) or international normalised ratio (INR) \> 1.5x ULN * Platelet count \<100,000

Inclusion Criteria

Exclusion Criteria

* Assigned male sex or female sex at birth
* In good general health
* Not currently taking doxycycline or other tetracycline-derived antibiotics and no plans to initiate during the study
* For HIV positive people, on stable antiretroviral therapy with an undetectable viral load and cluster of differentiation 4 (CD4) count\> 300ul/ml
* Willing to use condoms consistently for the duration of the study
* Able to provide informed consent
* No plans for relocation in the next 4 months
* Not pregnant and does not plan on getting pregnant for the duration of the study
* Willing to undergo peripheral blood, urine, rectal or vaginal secretion collection, and a rectal or vaginal and cervical biopsy procedure
* Willing to use study products as directed

* Current or chronic history of liver disease
* Continued need for, or use during the 90 days prior to enrollment, of the following medications:
* Systemic immunomodulatory agents
* Supraphysiologic doses of steroids (short course steroids less than 7 days duration, allowable at the discretion of the investigators)
* Chemotherapy or radiation for treatment of malignancy
* Experimental medications, vaccines, or biologicals
* Intent to use doxycycline or other tetracycline-derived antibiotics during the course of the study, outside of the study procedures
* Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements
* Known allergic reaction to study drugs
* Significant laboratory abnormalities at baseline visit for rectal biopsies, including but not limited to:
* Hemoglobin (Hgb) ≤ 10 g/dL
* Partial thromboplastin time (PTT) \> 1.5x upper limit of normal (ULN) or international normalised ratio (INR) \> 1.5x ULN
* Platelet count \<100,000

Contacts and Locations

Principal Investigator

Colleen Kelley, MD, MPH

PRINCIPAL_INVESTIGATOR

Emory University

Study Locations (Sites)

Hope Clinic

Atlanta, Georgia, 30322

United States

Collaborators and Investigators

Sponsor: Emory University

Colleen Kelley, MD, MPH, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-13

Study Completion Date2025-04-29

Study Record Updates

Study Start Date2024-09-13

Study Completion Date2025-04-29

Terms related to this study

Additional Relevant MeSH Terms

Sexually Transmitted Infection