Trials Sponsors Conditions Drugs Pricing

Conditions

Chlamydia Gonorrhea Sexually Transmitted Infection (STI)Syphilis

Keywords

Sexually transmitted infection (STI)GonorrheaChlamydiaAdolescentAdultEarly SyphilisWomenAfrica

Outcome Measures

Primary Outcomes (1)

The Rate of Composite Incident STI events
Nucleic acid amplification test (NAAT) from all sites (vaginal, rectal, oropharyngeal) or newly positive or four-fold rise in RPR titers
Testing will occur at each quarterly visit (week 13, 26, 39 and 52).

Secondary Outcomes (15)

The Rate of Incident Chlamydia Trachomatis (CT) Infection
Testing will occur at each quarterly visit (week 13, 26, 39 and 52).
The Rate of Incident Neisseria Gonorrhoeae (NG) Infection
Testing will occur at each quarterly visit (week 13, 26, 39 and 52).

Study Arms (2)

Doxycycline hyclate 200 mg

EXPERIMENTAL

Participants randomized to the intervention arm will receive doxycycline hyclate 200 mg (2 x 100mg) administered orally once weekly, for the duration of 51 weeks.

Drug: Doxycycline hyclate

Standard of Care

ACTIVE COMPARATOR

Participants randomized to the standard-of-care arm alone will not receive doxycycline prophylaxis and will receive local standard of care for STI prevention per local guidelines.

Drug: Standard of Care for STI prevention

Interventions

Doxycycline hyclateDrug

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

Doxycycline hyclate 200 mg

Standard of Care for STI preventionDrug

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

Standard of Care

Eligibility Criteria

Age13 Years - 34 Years

Sexfemale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

Age 13-34 years, inclusive.
In good health as determined by past medical history, medication use, and targeted physical examination,

Sponsors & Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
NIHlead

Study Sites (4)

Gaborone CRS (Site ID 12701)

Gaborone, Botswana

Unoda Chakalisa, MBBChCONTACT267-3930388 uchakalisa@bhp.org.bw

Eswatini Prevention Center CRS (Site ID 31994)

Mbabane, Eveni H103, Eswatini

Nomxolisi MabuzaCONTACTnm3319@cumc.columbia.edu

Malawi CRS (Site ID 12001)

Lilongwe, A-104, Malawi

Thokozani MakuhungaCONTACT1-265-1755056

MeSH Terms

Conditions

Sexually Transmitted DiseasesGonorrheaSyphilisChlamydia Infections

Interventions

DoxycyclineStandard of Care

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeisseriaceae Infections

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: NIH
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 13, 2026

First Posted

October 20, 2026

Study Start

November 30, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

September 30, 2028

Estimated

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (15)

Study Arms (2)

Doxycycline hyclate 200 mg

Standard of Care

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (15)

Study Arms (2)

Doxycycline hyclate 200 mg

Standard of Care

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations