Doxy-Post-exposure Prophylaxis

Status Recruiting

Clinical Trial Summary

The goal of this project is to collect data regarding the ability of various oral doses of doxycycline to penetrate mucosal tissues in men and women to inform the combination of doxycycline with antiretrovirals (ARVs) for the development of single-dose event-driven multipurpose prevention strategies to protect against HIV and sexually transmitted infections (STIs). This study is of importance in the field of research because it allows the exploration of new dosing strategies that would permit a single event-driven oral dose of medications that could provide protection from HIV as well as other STIs. The study population that this study seeks to enroll are healthy people assigned male or female sex at birth and not using gender-affirming hormone therapy and are willing to undergo study procedures. Recruitment: Both face-to-face and online engagements will be conducted to recruit study participants. Face-to-face locations include bars and nightclubs, community organizations serving study populations, sports events, and community venues, and online engagements include dating sites, social networks, and craigslist, amongst other social medial platforms.

Clinical Trial Description

The incidence of bacterial STIs is increasing and studies have recently shown that Doxy-PEP can reduce the incidence of bacterial STIs among men who have sex with men (MSM) and Doxy-PEP is being explored for STI prevention among women. A better understanding of mucosal drug penetration of doxycycline will inform the design of future studies to prevent STIs in various populations. The purpose of this study is to understand how well doxycycline taken by mouth gets to the tissues of the rectum and vagina. Researchers think doxycycline could be used to treat sexually transmitted infections (STIs) caused by bacteria. To understand better, they want to see how well doxycycline reaches the tissues affected by STIs. The study procedures include the collection of past and present medical history, and biological specimen sampling such as blood, rectal and vaginal fluids, tissue biopsies, and urine. Study participants will also be administered an investigational agent (doxycycline not yet approved for this indication). The duration of this clinical trial for study participants will be approximately 8 weeks. ;

Study Design

Related Conditions & MeSH terms

Sexually Transmitted Diseases

Clinical Trial Details

NCT number	NCT05853120
Study type	Interventional
Source	Emory University
Contact	Colleen Kelley, MD, MPH
Phone	404-712-1823
Email	colleen.kelley@emory.edu
Status	Recruiting
Phase	Phase 4
Start date	May 31, 2023
Completion date	September 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02579135` - Reducing HIV Risk Among Adolescents: Evaluating Project HEART	N/A
Enrolling by invitation	`NCT06127277` - Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care	N/A
Recruiting	`NCT05889689` - Evaluation of an Adolescent Pregnancy Prevention Program; Relationship Smarts+ With Lessons From Mind Matters	N/A
Completed	`NCT02516930` - A Non-inferiority Randomized Controlled Trial to Evaluate Promoting Condom Use Among MSM and Transgender Individuals in China	N/A
Completed	`NCT03063385` - Puerto Rico Cuidalos Parent-adolescent Program	N/A
Completed	`NCT01411878` - Louisville Teen Pregnancy Prevention Project	N/A
Completed	`NCT02009046` - Randomized Evaluation of a Multi-Component, Rights-Based Sexuality Education Initiative for High School Students	N/A
Completed	`NCT01303575` - Internet-Based Sexual Health Education for Middle School Native American Youth	N/A
Completed	`NCT00167505` - All About Youth: Evaluation of Sexual Risk Avoidance and Risk Reduction Programs for Middle School Students	N/A
Completed	`NCT00183456` - A Peer-Oriented HIV Prevention Outreach Program for Individuals at High Risk for HIV and Other STIs	Phase 2
Completed	`NCT00336180` - Adolescent Drug and HIV Prevention in South Africa	Phase 2/Phase 3
Completed	`NCT00710060` - Effectiveness of a Community-level HIV/STD Prevention Intervention in Promoting Safer Sexual Behaviors in High-risk Populations	Phase 3
Completed	`NCT01084395` - Reducing HIV Risk Among Mexican Youth	N/A
Completed	`NCT00161382` - Development and Evaluation of an HIV, STD, and Pregnancy Prevention Program for Middle School Students	N/A
Completed	`NCT00640653` - Efficacy of an Abstinence-Only HIV Risk-Reduction Intervention for Young African-American Adolescents	N/A
Completed	`NCT00289939` - Reducing HIV & Domestic Violence Risk in Women Offenders	Phase 3
Completed	`NCT00137943` - Parents Matter!: Interventions to Promote Effective Parent-Child Communication	Phase 1
Completed	`NCT03408743` - Engineering an Online STI Prevention Program: CSE2	N/A
Completed	`NCT06104813` - Evaluation of Deaf Men's Knowledge About Sexual Health
Not yet recruiting	`NCT05910580` - Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Doxy-Post-exposure Prophylaxis — DOXY-PEP

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms