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NOT YET RECRUITING
NCT07884240
PHASE3

A Clinical Study to Assess the Efficacy of Weekly Doxycycline Prophylaxis to Reduce Bacterial Sexually Transmitted Infections (STI) in Young African Women

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

Summary

This study is for people who may get sexually transmitted infections (STIs). Approximately 580 African adolescent and young adult women ages 13-34 in Africa will be included in this study. Study participation is approximately 52 weeks (1 year). Participants will be randomized in a 1:1 ratio to receive doxycycline prophylaxis or standard of care.

Official title: Weekly Doxycycline Prophylaxis for Prevention of Sexually Transmitted Infections Among Young African Women

Key Details

Gender

FEMALE

Age Range

13 Years - 34 Years

Study Type

INTERVENTIONAL

Enrollment

580

Start Date

2026-11-30

Completion Date

2029-07-10

Last Updated

2026-10-20

Healthy Volunteers

No

Interventions

DRUG

Doxycycline hyclate

Two 100 mg doxycycline hyclate immediate-release (IR) tablets (total dose: 200 mg) administered orally once weekly. Weekly dosing for approximately 51 weeks.

DRUG

Standard of Care for STI prevention

No study product. Participants receive local standard of care for STI prevention

Locations (4)

Gaborone CRS (Site ID 12701)

Gaborone, Botswana

Eswatini Prevention Center CRS (Site ID 31994)

Mbabane, Eswatini

Malawi CRS (Site ID 12001)

Lilongwe, Malawi

MU-JHU Research Collaboration (MUJHU CARE LTD) CRS (Site ID 30293)

Kampala, Uganda