Trial Outcomes & Findings for Doxycycline PEP for Prevention of Sexually Transmitted Infections Among Kenyan Women Using HIV PrEP (NCT NCT04050540)

Last Updated: 2024-07-10

Results Overview

Combined incidence of N. gonorrhoeae, C. trachomatis, or early syphilis infection by by laboratory-based diagnosis (e.g., positive N. gonorrhoeae or C. trachomatis based on NAAT or syphilis based on four-fold increase in non-treponemal titers).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

449 participants

Primary outcome timeframe

12 months post enrolment

Results posted on

2024-07-10

Participant Flow

Participant milestones

Participant milestones
Measure	dPEP Intervention Arm Participants assigned to dPEP will be instructed to take doxycycline 200 mg (two 100mg capsules) orally within 24 hours and up to 72 hours after each condomless sex act Doxycycline: 200 mg of doxycycline to be taken orally within 24 hours and up to 72 hours after each condomless sex act	Standard of Care Arm Participants assigned to Standard of Care
Overall Study STARTED	224	225
Overall Study COMPLETED	220	222
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Doxycycline PEP for Prevention of Sexually Transmitted Infections Among Kenyan Women Using HIV PrEP

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	dPEP Intervention Arm n=224 Participants Participants assigned to dPEP will be instructed to take doxycycline 200 mg (two 100mg capsules) orally within 24 hours and up to 72 hours after each condomless sex act Doxycycline: 200 mg of doxycycline to be taken orally within 24 hours and up to 72 hours after each condomless sex act	Standard of Care Arm n=225 Participants Participants assigned to Standard of Care	Total n=449 Participants Total of all reporting groups
Age, Categorical <=18 years	15 Participants n=5 Participants	9 Participants n=7 Participants	24 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	209 Participants n=5 Participants	216 Participants n=7 Participants	425 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	24 years n=5 Participants	24 years n=7 Participants	24 years n=5 Participants
Sex: Female, Male Female	224 Participants n=5 Participants	225 Participants n=7 Participants	449 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black/African	224 Participants n=5 Participants	225 Participants n=7 Participants	449 Participants n=5 Participants
Region of Enrollment Kenya	224 Participants n=5 Participants	225 Participants n=7 Participants	449 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months post enrolment

Population: Intention to treat, STI incidence events per 100 person-years

Outcome measures

Outcome measures
Measure	dPEP Intervention Arm n=224 Participants Participants assigned to dPEP will be instructed to take doxycycline 200 mg (two 100mg capsules) orally within 24 hours and up to 72 hours after each condomless sex act Doxycycline: 200 mg of doxycycline to be taken orally within 24 hours and up to 72 hours after each condomless sex act	Standard of Care Arm n=225 Participants Participants assigned to Standard of Care
Incidence of N. Gonorrhoeae, C. Trachomatis, or Early Syphilis Infection by Laboratory-based Diagnosis	25.1 Events per 100 person-years	29.0 Events per 100 person-years

Adverse Events

dPEP Intervention Arm

Serious events: 0 serious events

Other events: 40 other events

Deaths: 0 deaths

Standard of Care Arm

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Jenell Stewart

University of Washington, Department of Global Health

Phone: 206 520 3866

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	dPEP Intervention Arm n=224 participants at risk Participants assigned to dPEP will be instructed to take doxycycline 200 mg (two 100mg capsules) orally within 24 hours and up to 72 hours after each condomless sex act Doxycycline: 200 mg of doxycycline to be taken orally within 24 hours and up to 72 hours after each condomless sex act	Standard of Care Arm n=225 participants at risk Participants assigned to Standard of Care
Gastrointestinal disorders Nausea	1.3% 3/224 • Number of events 3 • 12 months AEs, SAEs and social harms were recorded.	0.00% 0/225 • 12 months AEs, SAEs and social harms were recorded.
Gastrointestinal disorders Diarrhea	0.89% 2/224 • Number of events 2 • 12 months AEs, SAEs and social harms were recorded.	0.00% 0/225 • 12 months AEs, SAEs and social harms were recorded.
Skin and subcutaneous tissue disorders Rash	0.45% 1/224 • Number of events 1 • 12 months AEs, SAEs and social harms were recorded.	0.00% 0/225 • 12 months AEs, SAEs and social harms were recorded.
Social circumstances Social Harm	1.8% 4/224 • Number of events 6 • 12 months AEs, SAEs and social harms were recorded.	0.00% 0/225 • 12 months AEs, SAEs and social harms were recorded.
Nervous system disorders Dizziness	1.3% 3/224 • Number of events 3 • 12 months AEs, SAEs and social harms were recorded.	0.00% 0/225 • 12 months AEs, SAEs and social harms were recorded.
Gastrointestinal disorders Gastrointestinal Irritation	1.3% 3/224 • Number of events 3 • 12 months AEs, SAEs and social harms were recorded.	0.00% 0/225 • 12 months AEs, SAEs and social harms were recorded.
Nervous system disorders Headache	0.89% 2/224 • Number of events 2 • 12 months AEs, SAEs and social harms were recorded.	0.00% 0/225 • 12 months AEs, SAEs and social harms were recorded.
Skin and subcutaneous tissue disorders Lipoma	0.45% 1/224 • Number of events 1 • 12 months AEs, SAEs and social harms were recorded.	0.00% 0/225 • 12 months AEs, SAEs and social harms were recorded.
Infections and infestations Malaria	3.1% 7/224 • Number of events 8 • 12 months AEs, SAEs and social harms were recorded.	3.1% 7/225 • Number of events 8 • 12 months AEs, SAEs and social harms were recorded.
Infections and infestations Oral Yeast Infection	0.89% 2/224 • Number of events 2 • 12 months AEs, SAEs and social harms were recorded.	0.00% 0/225 • 12 months AEs, SAEs and social harms were recorded.
Gastrointestinal disorders Peptic Ulcers	0.89% 2/224 • Number of events 2 • 12 months AEs, SAEs and social harms were recorded.	0.00% 0/225 • 12 months AEs, SAEs and social harms were recorded.
Skin and subcutaneous tissue disorders Photosensitivity	1.3% 3/224 • Number of events 3 • 12 months AEs, SAEs and social harms were recorded.	0.00% 0/225 • 12 months AEs, SAEs and social harms were recorded.
Pregnancy, puerperium and perinatal conditions Preterm Rupture of Membranes	0.45% 1/224 • Number of events 1 • 12 months AEs, SAEs and social harms were recorded.	0.00% 0/225 • 12 months AEs, SAEs and social harms were recorded.
Pregnancy, puerperium and perinatal conditions Preterm Twin Cesarean Delivery	0.45% 1/224 • Number of events 1 • 12 months AEs, SAEs and social harms were recorded.	0.00% 0/225 • 12 months AEs, SAEs and social harms were recorded.
Pregnancy, puerperium and perinatal conditions Spontaneous Abortion	0.89% 2/224 • Number of events 2 • 12 months AEs, SAEs and social harms were recorded.	0.00% 0/225 • 12 months AEs, SAEs and social harms were recorded.
Gastrointestinal disorders Vomiting	4.0% 9/224 • Number of events 9 • 12 months AEs, SAEs and social harms were recorded.	0.00% 0/225 • 12 months AEs, SAEs and social harms were recorded.
Musculoskeletal and connective tissue disorders Achilles Tendon Injury	0.00% 0/224 • 12 months AEs, SAEs and social harms were recorded.	0.44% 1/225 • Number of events 2 • 12 months AEs, SAEs and social harms were recorded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hemorrhagic Ovarian Cyst	0.00% 0/224 • 12 months AEs, SAEs and social harms were recorded.	0.44% 1/225 • Number of events 1 • 12 months AEs, SAEs and social harms were recorded.
Pregnancy, puerperium and perinatal conditions Hyperemesis Gravidarum	0.00% 0/224 • 12 months AEs, SAEs and social harms were recorded.	0.44% 1/225 • Number of events 1 • 12 months AEs, SAEs and social harms were recorded.
Pregnancy, puerperium and perinatal conditions Nuchal Cord	0.00% 0/224 • 12 months AEs, SAEs and social harms were recorded.	0.44% 1/225 • Number of events 1 • 12 months AEs, SAEs and social harms were recorded.
Pregnancy, puerperium and perinatal conditions Placental Abruption	0.00% 0/224 • 12 months AEs, SAEs and social harms were recorded.	0.44% 1/225 • Number of events 1 • 12 months AEs, SAEs and social harms were recorded.
Infections and infestations Pneumonia	0.00% 0/224 • 12 months AEs, SAEs and social harms were recorded.	0.44% 1/225 • Number of events 1 • 12 months AEs, SAEs and social harms were recorded.
Pregnancy, puerperium and perinatal conditions Preeclampsia	0.00% 0/224 • 12 months AEs, SAEs and social harms were recorded.	0.44% 1/225 • Number of events 1 • 12 months AEs, SAEs and social harms were recorded.
Renal and urinary disorders Renal Stones	0.00% 0/224 • 12 months AEs, SAEs and social harms were recorded.	0.44% 1/225 • Number of events 1 • 12 months AEs, SAEs and social harms were recorded.