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.
調査の概要
状態
詳細な説明
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Laura Stueckle, MPH
- 電話番号：1-206-884-1254
- メール：laura.stueckle@seattlechildrens.org
研究連絡先のバックアップ
- 名前：Study PI, Dr. Jaspan, MD, PhD
- メール：heather.jaspan@seattlechildrens.org
研究場所
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Thika、ケニア
- Partners in Health and Research Development
-
コンタクト：
- Prof. Nelly R. Mugo
- 電話番号：+254723914057
- メール：rwamba@uw.edu
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-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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.
他の名前：
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アクティブコンパレータ：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cross-sectional comparisons of vaginal microbial Shannon alpha diversity.
時間枠：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)
時間枠：From enrollment to the end of participation at 12 months
|
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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Comparisons of host epithelial integrity factors via metaproteomics
時間枠：From enrollment to the end of participation at 12 months
|
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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協力者と研究者
捜査官
- 主任研究者：Heather Jaspan, MD, PhD、Seattle Children's Hospital
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- STUDY00005850
- R01HD118913 (米国 NIH グラント/契約)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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