## Protocol Section
### Identification Module
**NCT ID:** NCT06414408

**Acronym:** DOT-Doxy-PEP

**Brief Title:** Randomized Directly Observed Therapy Study to Interpret Clinical Trials of Doxy-PEP

**Official Title:** Randomized Directly Observed Therapy Study to Interpret Clinical Trials of Doxy-PEP

#### Organization Study ID Info
**ID:** AI186641
#### Organization
**Class:** OTHER
**Full Name:** University of California, San Francisco
### Status Module
#### Completion Date
**Date:** 2028-09-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-09-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-09-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of California, San Francisco

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Rates of bacterial sexually transmitted infections (STIs) are rising globally, demanding innovative interventions beyond the scope of current efforts to prevent STIs. The United States Doxycycline Post-exposure Prophylaxis (DoxyPEP) Study has demonstrated the efficacy of doxycycline post-exposure prophylaxis (PEP) among men who have sex with men and transgender women; but puzzlingly, doxycycline PEP was found ineffective in cisgender women in the Kenyan doxycycline Post-Exposure Prophylaxis (dPEP) study, with preliminary data suggesting the low medication adherence may explain the null result. By study end, the investigators will have developed adherence measurement methods for doxycycline in hair, blood, and urine, and will use these techniques to help interpret the Kenyan dPEP study, and to examine the relative performance of these methods within the United States DoxyPEP trial, establishing adherence metrics for current and future rollout studies of doxycycline post-exposure prophylaxis

### Conditions Module

**Conditions:**

- Sexually Transmitted Diseases, Bacterial

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

**Intervention Model Description:** Participants will be randomized to one of 4 doxycycline dosing patterns (daily, 3x weekly, weekly, every other week) and then will crossover to an alternate pattern once during the study.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 48

**Type:** ESTIMATED

**Phases:**

- EARLY_PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will be randomized to take once daily doxycycline 200mg for six weeks.

**Intervention Names:**

- Drug: Doxycycline Pill

**Label:** Daily Dosing

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Participants will be randomized to take one doxycycline 200mg dose three times a week (Monday, Wednesday, and Friday) for six weeks.

**Intervention Names:**

- Drug: Doxycycline Pill

**Label:** Three-times Weekly Dosing

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** Participants will be randomized to take one doxycycline 200mg dose once week.

**Intervention Names:**

- Drug: Doxycycline Pill

**Label:** Weekly Dosing

**Type:** ACTIVE_COMPARATOR

#### Arm Group 4

**Description:** Participants will be randomized to take one doxycycline 200mg dose every other week.

**Intervention Names:**

- Drug: Doxycycline Pill

**Label:** Every Other Week Dosing

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Daily Dosing

- Every Other Week Dosing

- Three-times Weekly Dosing

- Weekly Dosing

**Description:** 200mg Dose

**Name:** Doxycycline Pill

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Doxycycline concentrations will be measured using liquid chromatography tandem mass spectrometry within hair samples for each of the four dosing patterns within an intensive washout pharmacokinetic phase following initial dosing.

**Measure:** Hair Doxycycline Concentration

**Time Frame:** 4 weeks

**Description:** Doxycycline concentrations will be measured using liquid chromatography tandem mass spectrometry within plasma samples for each of the four dosing patterns within an intensive washout pharmacokinetic phase following initial dosing.

**Measure:** Plasma Doxycycline Concentration

**Time Frame:** 4 weeks

**Description:** Doxycycline concentrations will be measured using liquid chromatography tandem mass spectrometry within urine samples for each of the four dosing patterns within an intensive washout pharmacokinetic phase following initial dosing.

**Measure:** Urine Doxycycline Concentration

**Time Frame:** 4 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* not currently at risk of a sexually transmitted infection (no STI in the last 2 years and no partner with an STI in the last year);
* willing to provide hair, blood, and urine samples;
* not currently enrolled in other STI prevention studies;
* able to speak English or Spanish; and
* transgender women participants should be currently using estrogen gender affirming hormone therapy with blood estrogen levels demonstrating consistent use
* transgender men participants should be currently using testosterone gender affirming hormone therapy with blood testosterone levels demonstrating consistent use

Exclusion Criteria:

* any health condition that may interfere with participation or the ability to provide informed consent, including any debilitating or life-threatening conditions;
* pregnancy or plans to become pregnant;
* liver cirrhosis or fulminant liver disease;
* known hypersensitivity reaction to doxycycline.
* detectable doxycycline in hair at enrollment.

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** DOTDoxyPEP@ucsf.edu

**Name:** Kevin Sassaman

**Phone:** 415-878-6384

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** San Francisco

**Country:** United States

**Facility:** University of California, San Francisco/San Francisco General Hospital

**State:** California

**Zip:** 94110

#### Overall Officials

**Official 1:**

**Affiliation:** University of California, San Francisco

**Name:** Matthew Spinelli, MD, MAS

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003141

- Term: Communicable Diseases

- ID: D000007239

- Term: Infections

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000001424

- Term: Bacterial Infections

- ID: D000001423

- Term: Bacterial Infections and Mycoses

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M15558

- Name: Sexually Transmitted Diseases

- Relevance: HIGH

- As Found: Sexually Transmitted Diseases

- ID: M17935

- Name: Sexually Transmitted Diseases, Bacterial

- Relevance: HIGH

- As Found: Sexually Transmitted Diseases, Bacterial

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M4722

- Name: Bacterial Infections

- Relevance: LOW

- As Found: Unknown

- ID: M12136

- Name: Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: M4721

- Name: Bacterial Infections and Mycoses

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012749

- Term: Sexually Transmitted Diseases

- ID: D000015231

- Term: Sexually Transmitted Diseases, Bacterial

### Intervention Browse Module - Ancestors

- ID: D000000900

- Term: Anti-Bacterial Agents

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000000962

- Term: Antimalarials

- ID: D000000981

- Term: Antiprotozoal Agents

- ID: D000000977

- Term: Antiparasitic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M7493

- Name: Doxycycline

- Relevance: HIGH

- As Found: Open-Label Study

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4280

- Name: Antimalarials

- Relevance: LOW

- As Found: Unknown

- ID: M4298

- Name: Antiprotozoal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4294

- Name: Antiparasitic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000004318

- Term: Doxycycline

### Misc Info Module

- Version Holder: 2024-05-31
