Effects of Copper Versus Levonorgestrel Intrauterine Devices on Mucosal Microbiota and Barrier Function Among Young African Women
Effects of Copper Versus Levonorgestrel Intrauterine Devices on Mucosal Microbiota and Barrier Function: a Randomized Trial Among Young African Women
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:
- Whether women assigned to copper IUD vs hormonal IUS have differences in vaginal microbial diversity after 1 year of use
- Whether women randomized to Copper IUD have reduced genital mucosal barrier integrity as indicated by proteomic signatures
- Whether women randomized to Copper IUD have greater incidence of high-risk HPV or curable STIs (Ct, Ng, Tv)
Participants will be assigned to have either the copper IUD or the hormonal IUS inserted as contraception. After that, they will have blood and vaginal fluids collected every 3 months for one year to look at the bacteria in their vagina, test for sexually transmitted infections, and examine markers of vaginal health.
After enrolment, each participant will be followed for 12 months, and at the end of the trial, the participant can continue to use the IUD/IUS or the study clinician can remove it.
연구 개요
상태
상세 설명
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Laura Stueckle, MPH
- 전화번호: 1-206-884-1254
- 이메일: laura.stueckle@seattlechildrens.org
연구 연락처 백업
- 이름: Study PI, Dr. Jaspan, MD, PhD
- 이메일: heather.jaspan@seattlechildrens.org
연구 장소
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Thika, 케냐
- Partners in Health and Research Development
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연락하다:
- Prof. Nelly R. Mugo
- 전화번호: +254723914057
- 이메일: rwamba@uw.edu
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 0-6 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
- A recent septic abortion
- Untreated mucopurulent cervicitis on exam, untreated pelvic inflammatory disease (PID), or untreated known gonorrhoea or chlamydia
- Has any condition (social or medical), which in the opinion of the investigator, would make study participation unsafe or complicate data interpretation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Copper T-380 intrauterine device (Cu-IUD)
The 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. |
Product will be used as labeled for approximately 12 months.
다른 이름들:
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활성 비교기: Levonorgestrel intrauterine system (LNG IUS)
The 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 |
Product will be used as labeled for approximately 12 months.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cross-sectional comparisons of vaginal microbial Shannon alpha diversity.
기간: From enrollment to the end of participation at 12 months
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Cross-sectional differences at month-12 in Shannon diversity will be compared using Mann-Whitney U.
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From enrollment to the end of participation at 12 months
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Cross-sectional comparisons of Bray-Curtis distances (Beta diversity)
기간: From enrollment to the end of participation at 12 months
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Cross-sectional differences at 12 months of Bray-Curtis distances (ß diversity) will be assessed using PERMANOVAs.
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From enrollment to the end of participation at 12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Comparisons of host epithelial integrity factors via metaproteomics
기간: From enrollment to the end of participation at 12 months
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Differential abundance of host proteins will be evaluated using the limma package in R, for each arm, adjusting for potential confounders, and functional enrichment analysis conducted using DAVID.
Evaluation of proteomic changes using the MEFISTO R package will be used.
The mixOmics R package will be used to identify the minimum protein signature most associated with different contraceptives will be evaluated using sparse PLSDA and Data Integration Analysis and Biomarker discovery using Latent cOmponents (DIABLO).
Microbial functional changes will be investigated by aggregation of proteins with the same Gene Ontology.
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From enrollment to the end of participation at 12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Heather Jaspan, MD, PhD, Seattle Children's Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- STUDY00005850
- R01HD118913 (미국 NIH 보조금/계약)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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