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)
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.
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)
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
Parallel
Levonorgesterel Intrauterine system (LNG IUS)
DrugProduct will be used as labeled for approximately 12 months.
Copper T Intrauterine device (Cu-IUD)
DeviceProduct will be used as labeled for approximately 12 months.
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.
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.
Comparisons of host epithelial integrity factors via metaproteomics
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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Seattle Children's Hospital
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
