Effects of Copper Versus Levonorgestrel Intrauterine Devices on Mucosal Microbiota and Barrier Function Among Young African Women
2 other identifiers
interventional
120
1 country
1
Brief Summary
The goal of this clinical trial is to definitively determine whether copper intrauterine device (IUD) or hormonal intrauterine system (IUS) results in greater vaginal microbial diversity after 1 year in women (n= approximately 120) aged 18-40 years, who desire to use a copper IUD or hormonal IUS as contraception, are HIV-negative and could benefit from STI prevention. The main questions it aims to answer are:
- 1.Whether women assigned to copper IUD vs hormonal IUS have differences in vaginal microbial diversity after 1 year of use
- 2.Whether women randomized to Copper IUD have reduced genital mucosal barrier integrity as indicated by proteomic signatures
- 3.Whether women randomized to Copper IUD have greater incidence of high-risk HPV or curable STIs (Ct, Ng, Tv)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2026
CompletedFirst Posted
Study publicly available on registry
June 4, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2029
Study Completion
Last participant's last visit for all outcomes
July 1, 2030
June 4, 2026
May 1, 2026
3 years
April 29, 2026
June 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cross-sectional comparisons of vaginal microbial Shannon alpha diversity.
Cross-sectional differences at month-12 in Shannon diversity will be compared using Mann-Whitney U.
From enrollment to the end of participation at 12 months
Cross-sectional comparisons of Bray-Curtis distances (Beta diversity)
Cross-sectional differences at 12 months of Bray-Curtis distances (ß diversity) will be assessed using PERMANOVAs.
From enrollment to the end of participation at 12 months
Secondary Outcomes (1)
Comparisons of host epithelial integrity factors via metaproteomics
From enrollment to the end of participation at 12 months
Study Arms (2)
Copper T-380 intrauterine device (Cu-IUD)
ACTIVE COMPARATORThe Cu-IUD will be Model TCu 380A used in public sector services in Kiambu County. Each T-shaped plastic frame has 176 mg of copper wire coiled around its vertical arm and a copper collar of 68 mg of copper on each of its transverse arms for a total copper surface area on the device of 380 mm2. The product will be sterile and will be inserted as described in the package insert.
Levonorgestrel intrauterine system (LNG IUS)
ACTIVE COMPARATORThe LNG-IUD consists of a T-shaped polyethylene frame with a steroid reservoir containing 52 mg levonorgestrel packaged with a sterile inserter. The product will be sterile and will be inserted as described in the package insert
Interventions
Product will be used as labeled for approximately 12 months.
Product will be used as labeled for approximately 12 months.
Eligibility Criteria
You may qualify if:
- Willing and able to provide written informed consent for screening and trial participation
- Desire and willingness to use either IUD or IUS for contraception for at least one year
- Clear understanding of study randomization and commitment to use the assigned IUD
- Between 18 and 40 years of age (inclusive)
- Willing and able to actively participate in the study for 12 months
- Willing to be tested for HIV
- Sexually active
- HIV-negative
- Would benefit from STI prevention
You may not qualify if:
- Living with HIV or HIV screening results that are not definitively negative
- Currently pregnant or planning to become pregnant within the next 12 months
- Documented or known history of infertility or sterilization
- Prior history of ectopic pregnancy
- Use of contraceptive implant, IUD or injectable progestin in the past 3 months
- Use of oral contraceptives in the past 30 days
- Planning to use alternative contraception except condoms for the trial duration
- weeks postpartum
- Has had a hysterectomy or sterilization
- History of challenges using and IUD/IUS, including frequent expulsion
- Medical contraindications (Category 3 or 4 criteria as detailed in the WHO MEC1 to copper IUDs or LNG-IUS, including:
- Endometrial, ovarian, or cervical cancer
- Unexplained vaginal bleeding between menstrual periods or bleeding after intercourse
- History of pelvic tuberculosis
- Anatomical abnormality of the uterus incompatible with IUD insertion
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Partners in Health and Research Development
Thika, Kenya
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heather Jaspan, MD, PhD
Seattle Children's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
April 29, 2026
First Posted
June 4, 2026
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
July 1, 2029
Study Completion (Estimated)
July 1, 2030
Last Updated
June 4, 2026
Record last verified: 2026-05