Women's Input on Sexual Health

N/ACompletedNCT02057419

The Miriam Hospital8 enrolled

Overview

The purpose of this study is to answer the following question: How do user sensory perceptions and experiences (USPEs) for IVRS differ between initial and continued use and how can this knowledge help product developers better understand how to design new IVR products and develop behavioral (or point-of-care) interventions to optimize use?

Background: Sexual and reproductive health (SRH) is a global public health priority. Providing efficacious SRH technologies that have the greatest likelihood of use will have the greatest impact on women's health. Critical to use is "acceptability." However, current conceptualizations of adherence and acceptability fail to fully articulate and account for the user experience. Given the recent development of various IVR technologies and the potential for multipurpose technologies, the impact on global public health would be far-reaching, affecting reproductive health in women and men: decreasing STI incidence, minimizing unplanned pregnancies, and decreasing morbidity and mortality due to a range of other reproductive health conditions. Condition: Participants will use an IVR for a period of three months and report sensory perceptions and use experiences. Methodology and Data Collection: Volunteers (N\~6-10) will first be screened for the study using a brief questionnaire. Those who are interested in contraception and are eligible based on their responses to the prescreen will then complete a clinical screening visit and pregnancy test. Once enrolled participants will complete a survey that asks questions about demographics and sexual and reproductive history. During the course of the study, participants will evaluate their use of an IVR. IVRs will be used for three consecutive months. They will be given a three-month supply of the product at the beginning of the use period. About once a month, each participant will be required to complete a web survey about their experience with the study product. All participants complete a final survey that will ask about their experiences with the study product.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Intravaginal Ring Use

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 * 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

Locations (1)

The Miriam Hospital: Centers for Behavioral & Preventive Medicine

Providence, Rhode Island, United States

Outcomes

Primary Outcomes

USPE Scale Scores

User sensory perceptions and experiences (USPEs) with the IVR will be captured approximately monthly over a 90 day use period. USPE Sum of averaged item means/# items (min:max 1:5); 1=Do not agree at all;2=Agree a little;3=Agree somewhat;4=Agree a lot;5=Agree completely. Product: IVR USPE Scales: Initial Penetration and First Strokes: Smoothness/lubricity; Awareness: Feel (not) intravaginally during sex; Discharge Look: Appearance of discharge; Discharge: Sensations of discharge during and after sex inside and outside body; Pleasure: Participant and partner's stimulation A higher score indicates greater agreement with subscale characteristics being reported on.

Time frame: Up to 3 months

Data from ClinicalTrials.gov

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