Sexual and Reproductive Health Clinical Trial
— WISHOfficial title:
K24: Advancing Reproductive Health: Women's Input on Sexual Health (Project WISH)
Verified date | August 2019 |
Source | The Miriam Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to answer the following questions: (a) how do sexual and reproductive health (SRH) delivery method characteristics play a role in user preference for specific SRH methods; (b) can we understand the interplay between salient SRH product characteristics and effective use; (c) does effective use differ by indication (e.g., whether the product is for contraception or lubrication); and (d) can this knowledge help product developers better understand how to design new SRH products and develop behavioral (or point-of-care) interventions to optimize use?
Status | Completed |
Enrollment | 44 |
Est. completion date | March 31, 2018 |
Est. primary completion date | June 24, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - are between the ages of 18 and 45 at prescreening, - report vaginal sex with a man in the past month at prescreening, - are not pregnant (self-report, confirmed at V1, V2, and V3 by urine HcG test) and report no intention to become pregnant during the course of the study, - report negative or unknown HIV status, - report a need for contraceptive products and/or sexual lubricants (primary presenting need determines study condition), and - are willing and able to provide informed consent. Exclusion Criteria: - self-report pregnancy, have a positive urine pregnancy test at Visits 1, 2, or 3, or intend to become pregnant during the course of the study, - self-report breast feeding, - self-report a vaginal delivery or other reproductive surgical procedure in the past 30 days, - self-report being HIV-positive, - self-report being diagnosed with or having an active sexually transmitted infection (STI) in the past 12 months, - self-report an allergy or sensitivity to any of the study products, - do not have a cell phone or internet access, - are unable or unwilling to give informed consent, or - have any condition that, in the opinion of the study clinician(s) or principle investigator, would compromise the participant's ability to participate in the study |
Country | Name | City | State |
---|---|---|---|
United States | The Miriam Hospital: Centers for Behavioral & Preventive Medicine | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
The Miriam Hospital | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Experience and Adherence Narratives | Participants will complete an in-depth qualitative interview (IDI) about their experiences with the study products following each 3 month use period. There are 3 use periods, therefore, the final IDI will occur approximately 9-10 months from enrollment | average of 9-10 months | |
Primary | Product Use | Product use will be assessed on a daily basis, whether products are daily use regimens or pericoital regimens. There are 3 3-month use periods; therefore, daily product use measures will be collected, on average, through 9-10 months of use. | up to an average of 8-9 months | |
Secondary | USPE Scale Scores | User sensory perceptions and experiences (USPEs) with study products will be captured approximately monthly over a 90 day use period for each product evaluated. There are 3 use periods, therefore, the final USPE results will occur approximately 8-9 months following enrollment | up to an average of 8-9 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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