Trial Outcomes & Findings for Weekly Doxycycline DOT for STI Prevention Among Cisgender Women Taking HIV PrEP in Kisumu, Kenya (NCT NCT06582966)

Last Updated: 2026-04-13

Results Overview

Confirmation of weekly doxyPEP DOT dosing each week will be recorded on weekly CRFs and quarterly surveys on acceptability will be completed.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

6 months

Results posted on

2026-04-13

Participant milestones
Measure	DoxyDOT Single Arm Open label, single-arm, pilot study of 60 cisgender women taking HIV PrEP in Kisumu, Kenya will be given doxycycline 200 mg orally once weekly with clinical follow-up including quarterly STI testing and treatment for six months.
Overall Study STARTED	60
Overall Study COMPLETED	56
Overall Study NOT COMPLETED	4

Reasons for withdrawal
Measure	DoxyDOT Single Arm Open label, single-arm, pilot study of 60 cisgender women taking HIV PrEP in Kisumu, Kenya will be given doxycycline 200 mg orally once weekly with clinical follow-up including quarterly STI testing and treatment for six months.
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	1
Overall Study declined study procedures	1
Overall Study Lost to Follow-up	1

Weekly Doxycycline DOT for STI Prevention Among Cisgender Women Taking HIV PrEP in Kisumu, Kenya

Baseline characteristics by cohort
Measure	DoxyDOT Single Arm n=60 Participants Open label, single-arm, pilot study of 60 cisgender women taking HIV PrEP in Kisumu, Kenya will be given doxycycline 200 mg orally once weekly with clinical follow-up including quarterly STI testing and treatment for six months.
Age, Categorical <=18 years	1 Participants n=193 Participants
Age, Categorical Between 18 and 65 years	59 Participants n=193 Participants
Age, Categorical >=65 years	0 Participants n=193 Participants
Sex: Female, Male Female	60 Participants n=193 Participants
Sex: Female, Male Male	0 Participants n=193 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=193 Participants
Race (NIH/OMB) Asian	0 Participants n=193 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=193 Participants
Race (NIH/OMB) Black or African American	60 Participants n=193 Participants
Race (NIH/OMB) White	0 Participants n=193 Participants
Race (NIH/OMB) More than one race	0 Participants n=193 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=193 Participants
Region of Enrollment Kenya	60 Participants n=193 Participants

Timeframe: 6 months

Confirmation of weekly doxyPEP DOT dosing each week will be recorded on weekly CRFs and quarterly surveys on acceptability will be completed.

Outcome measures
Measure	DoxyDOT Single Arm n=1560 Doses Open label, single-arm, pilot study of 60 cisgender women taking HIV PrEP in Kisumu, Kenya will be given doxycycline 200 mg orally once weekly with clinical follow-up including quarterly STI testing and treatment for six months.
doxyPEP DOT Adherence	1417 Doses

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	DoxyDOT Single Arm n=60 participants at risk Open label, single-arm, pilot study of 60 cisgender women taking HIV PrEP in Kisumu, Kenya will be given doxycycline 200 mg orally once weekly with clinical follow-up including quarterly STI testing and treatment for six months.
Social circumstances Social harm	3.3% 2/60 • Adverse Events collected from enrollment up to 6 months post-enrollment.
Infections and infestations Malaria	1.7% 1/60 • Adverse Events collected from enrollment up to 6 months post-enrollment.
Hepatobiliary disorders Jaundice	1.7% 1/60 • Adverse Events collected from enrollment up to 6 months post-enrollment.
Social circumstances Physical assault	1.7% 1/60 • Adverse Events collected from enrollment up to 6 months post-enrollment.

University of Minnesota, Hennepin Healthcare

Phone: (612)8735271