Sexually Transmitted Infection (STI)Phase 3NCT07884240
A Clinical Study to Assess the Efficacy of Weekly Doxycycline Prophylaxis to Reduce Bacterial Sexually Transmitted Infections (STI) in Young African Women
A Phase 3 study testing Doxycycline hyclate in people with Sexually Transmitted Infection (STI) and Gonorrhea, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 13 to 34 years, women only
- Conditions the study is for
- Sexually Transmitted Infection (STI), Gonorrhea, Syphilis
- What is being tested?
- Doxycycline hyclate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 580 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 30 Nov 2026to 10 Jul 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 34 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- All adolescent and adult young women who meet all the following criteria are eligible for inclusion in this study:
- Age 13-34 years, inclusive.
- In good health as determined by past medical history, medication use, and targeted physical examination,
- If not living with HIV, negative HIV test conducted at screening
- If living with HIV, on an antiretroviral regimen for ≥3 months
- Report at least two of the following:
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- Treatment for a curable STI (not including HIV) in the past 12 months prior to screening.
- Self-report of condomless (oral, vaginal, and/or anal) intercourse at least once in the 30 days prior to screening
- Has had two or more partners in the past 6 months
- ≥ 45 kilograms (99 pounds) in weight
- Anticipate living in the study area for 12 months and no plans for travel away from the study site for a time period that would interfere with product resupply and study participation
- Willing to undergo all required study procedures that may include Directly/Video observed therapy (D/VOT); and
- Provide written informed consent to participate in the study
- If of legal age or otherwise able to provide independent informed consent as determined by local law and consistent with Institutional Review Board (IRB)/Ethics Committee (EC) policies: Willing and able to provide written informed consent for study participation.
- If not of legal age or otherwise not able to provide independent informed consent as determined by local law and consistent with IRB/EC policies: Parent or legal guardian is willing and able to provide written informed consent for study participation and potential participant is willing and able to provide written assent for study participation.
Who cannot join
- All adolescent and adult young women who meet any of the following criteria will be excluded from this study:
- Is male.
- Positive NAAT for CT or NG or with evidence of untreated syphilis infection.
- Documented history of tetracycline allergy or self-reports an allergy to tetracyclines.
- Current (within 30 days of Enrollment) or anticipated use of a medication with a contraindicated interaction to doxycycline (e.g., iron, barbiturates, phenytoin, lithium, carbamazepine, systemic retinoids, warfarin).
- Current or planned use of doxycycline for a prolonged period (> 2 weeks) in the 30 days prior to enrollment, including current prescription for doxycycline for STI prophylaxis.
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- Prolonged antibiotic use (> 2 weeks) within the last 30 days prior to enrollment.
- Pregnant, or breastfeeding.
- Co-enrollment in any other concurrent interventional research or studies that may interfere with this study, unless approved by the Protocol Team in writing.
- Any other medical condition, medical/behavioral intervention, or other conditions that, in the opinion of the clinical site Principal Investigator/Investigator of Record (PI/IoR) or designee, could interfere with adherence to study procedures or compromise interpretation of study results.
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
Botswana1 site
Gaborone CRS (Site ID 12701)
Gaborone
Unoda Chakalisa, MBBCh, 267-3930388, uchakalisa@bhp.org.bw
Eswatini1 site
Eswatini Prevention Center CRS (Site ID 31994)
Mbabane, Eveni H103
Nomxolisi Mabuza, nm3319@cumc.columbia.edu
Malawi1 site
Malawi CRS (Site ID 12001)
Lilongwe, A-104
Thokozani Makuhunga, 1-265-1755056, tmakuhunga@unclilongwe.org
Uganda1 site
MU-JHU Research Collaboration (MUJHU CARE LTD) CRS (Site ID 30293)
Kampala
Deo Wabwire, 256-414-541044, dwabwire@mujhu.org
About this study
Official title: Weekly Doxycycline Prophylaxis for Prevention of Sexually Transmitted Infections Among Young African Women
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.
- Conditions
- Sexually Transmitted Infection (STI), Gonorrhea, Syphilis, Chlamydia
- Being tested
- Doxycycline hyclate, Standard of Care for STI prevention
- Keywords
- Sexually transmitted infection (STI), Gonorrhea, Chlamydia, Adolescent, Adult, Early Syphilis, Women, Africa
- Medical subject headings
- Sexually Transmitted Diseases, Gonorrhea, Syphilis, Chlamydia Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Standard of Care for STI preventionDrug
No study product. Participants receive local standard of care for STI prevention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Standard of Care for STI prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Testing will occur at each quarterly visit (week 13, 26, 39 and 52).
Secondary outcomes (15)
The Rate of Incident Chlamydia Trachomatis (CT) Infection
Nucleic Acid Amplification Test (NAAT) From All Sites (vaginal, rectal, oropharyngeal)
Measured: Testing will occur at each quarterly visit (week 13, 26, 39 and 52).
The Rate of Incident Neisseria Gonorrhoeae (NG) Infection
Nucleic Acid Amplification Test (NAAT) From All Sites (vaginal, rectal, oropharyngeal)
Measured: Testing will occur at each quarterly visit (week 13, 26, 39 and 52).
The Rate of Incident Early Syphilis Infection
Newly Positive or Four-Fold Rise in Rapid Plasma Reagin (RPR) Titers From All Sites (vaginal, rectal, oropharyngeal)
Measured: Testing will occur at each quarterly visit (week 13, 26, 39 and 52).
The Rate of Incident NG Infection
Nucleic Acid Amplification Test (NAAT) From Rectal or Pharyngeal Site
Measured: Testing will occur at each quarterly visit (week 13, 26, 39 and 52).
The Rate of Incident CT Infection
Nucleic Acid Amplification Test (NAAT) From Rectal or Pharyngeal Site
Measured: Testing will occur at each quarterly visit (week 13, 26, 39 and 52).
The Number of Doxycycline-specific Side Effects
Such as gastrointestinal upset, photosensitivity, esophageal irritation, and skin reactions
Measured: Week 0 through Week 52
The Number of Participants who discontinue study due to side effects
Measured: Week 0 through Week 52
Number of Participants with Serious Adverse Events (SAEs)
Measured: Week 0 through Week 52
Number of Participants with Adverse Events (AEs)
Measured: Week 0 through Week 52
Acceptability of Weekly Doxycycline Prophylaxis
The acceptability Likert scale has the following response options: Very acceptable/ Somewhat acceptable/ Neither acceptable nor unacceptable/ Somewhat unacceptable/ Very unacceptable/ Prefer not to answer
Measured: Week 4, 13, 26, 39 and 52
Adherence to Weekly Doxycycline Prophylaxis
Number of directly observed doses
Measured: Up to 52 weeks.
Number of Tetracycline-resistant isolates for CT
Summarized by Randomized Study Arm
Measured: Week 0, Week 26 and Week 52.
Number of Tetracycline-resistant isolates for NG
Summarized by Randomized Study Arm
Measured: Week 0, Week 26 and Week 52.
Number of Tetracycline resistant isolates of M. genitalium
Summarized by Randomized Study Arm
Measured: Week 0, Week 26 and Week 52
Number of Tetracycline resistant isolates of S. aureus
Summarized by Randomized Study Arm
Measured: Week 0, Week 26 and Week 52.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start30 Nov 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion10 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexually Transmitted Infection (STI)Studies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 580 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884240
- Sponsor's protocol ID
- HPTN 119
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No