Single Arm Trial of Menstrual Cups Among Economically Vulnerable Women to Reduce Bacterial Vaginosis and STIs (POWWERHealth)
Bacterial Vaginosis, Vaginal Microbiome, Chlamydia Trachomatis Infection
About this trial
This is an interventional prevention trial for Bacterial Vaginosis focused on measuring Menstrual Cup, Menstrual Health, Menstrual Hygiene, Bacterial vaginosis, Vaginal microbiome, Sexually transmitted infections, Kenya
Eligibility Criteria
Inclusion Criteria: age 15-35 years, able to provide informed consent, residing in Kisumu County, not currently pregnant, has experienced a menstrual period in the past 2 months, and dependent on sex for livelihood as defined above. Exclusion Criteria: pregnancy, post-natal (within 6 months), post-menopausal, amenorrhea, IUD in situ.
Sites / Locations
- Rush University Medical Center
- Nyanza Reproductive Health SocietyRecruiting
Arms of the Study
Arm 1
Other
Intervention Arm
After completing 12 months observation of usual practices of menstrual hygiene management, all participants will be provided reusable menstrual cups that can be worn during sex. The menstrual cup training is comprised of a 2 hour group session that covers basic information on reproductive health, menstrual health, and menstrual hygiene, cup use (insertion/removal), storage, cleaning. In the first three months after intervention delivery, there are monthly phone calls to assess usage and for trouble shooting. There are 12 months of observation in the menstrual cup arm, with Bacterial vaginosis (BV) and vaginal microbiome (VMB) assessment at the beginning of the 12-month period, at 6 months, and at 12 months. Sexually transmitted infection (STI) is measured at the beginning of the 12- month intervention period, and then at 12 months.