Intravaginal Ring Use
Conditions
Keywords
contraception, contraceptive methods, user experience
Brief summary
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?
Detailed description
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.
Interventions
None listed
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The Miriam Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| USPE Scale Scores | Up to 3 months | 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. |
Countries
United States
Participant flow
Recruitment details
Recruited (RI, MA USA) via call-lists, flyers, ads, internet/social media, clinics, CBOs, word-of-mouth.
Participants by arm
| Arm | Count |
|---|---|
| Intravaginal Ring Users Use IVR for 3-month period and report user sensory perceptions and experiences. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Intravaginal Ring Users |
|---|---|
| Age, Customized 18-29 | 6 Participants |
| Age, Customized 30-45 | 2 Participants |
| Health Insurance Coverage Another kind of health care insurance or health coverage plan_Parents' Insurance | 1 Participants |
| Health Insurance Coverage Covered by the Indian Health Service | 0 Participants |
| Health Insurance Coverage Covered by VA healthcare | 0 Participants |
| Health Insurance Coverage Currently do not have health insurance | 2 Participants |
| Health Insurance Coverage Medicaid, medical assistance, or other kind of government assistance plan | 0 Participants |
| Health Insurance Coverage Medicare due to a disability | 0 Participants |
| Health Insurance Coverage Purchased directly from an insurance company | 1 Participants |
| Health Insurance Coverage Through a current or former employer or union | 4 Participants |
| Health Insurance Coverage TRICARE or other military health care | 0 Participants |
| Marital Status Divorced | 1 Participants |
| Marital Status Married | 0 Participants |
| Marital Status Never Married | 7 Participants |
| Marital Status Separated | 0 Participants |
| Marital Status Widowed | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants |
| Race/Ethnicity, Customized Latina or Hispanic | 2 Participants |
| Race/Ethnicity, Customized More than one race | 0 Participants |
| Race/Ethnicity, Customized White | 6 Participants |
| Region of Enrollment United States | 8 Participants |
| Sex/Gender, Customized Female | 8 participants |
| Typical Tampon Use No | 3 Participants |
| Typical Tampon Use Yes | 5 Participants |
| Yearly Income $15,000 to $36,000 a year | 6 Participants |
| Yearly Income $36,000 or more a year | 2 Participants |
| Yearly Income Less than $15,000 a year | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 2 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intravaginal Ring Users | USPE Scale Scores | Initial Penetration & First Strokes (Month 1 IVR) | 3.73 score on a scale | Standard Deviation 1.55 |
| Intravaginal Ring Users | USPE Scale Scores | Initial Penetration & First Strokes (Month 3 IVR) | 3.63 score on a scale | Standard Deviation 1.21 |
| Intravaginal Ring Users | USPE Scale Scores | Discharge (Month 1 IVR) | 1.85 score on a scale | Standard Deviation 1.41 |
| Intravaginal Ring Users | USPE Scale Scores | Discharge (Month 3 IVR) | 2.02 score on a scale | Standard Deviation 1.49 |
| Intravaginal Ring Users | USPE Scale Scores | Discharge Look (Month 1 IVR) | 3.13 score on a scale | Standard Deviation 1.58 |
| Intravaginal Ring Users | USPE Scale Scores | Discharge Look (Month 3 IVR) | 3.07 score on a scale | Standard Deviation 1.59 |
| Intravaginal Ring Users | USPE Scale Scores | Awareness (Month 1 IVR) | 1.84 score on a scale | Standard Deviation 0.86 |
| Intravaginal Ring Users | USPE Scale Scores | Awareness (Month 3 IVR) | 1.82 score on a scale | Standard Deviation 1.02 |
| Intravaginal Ring Users | USPE Scale Scores | Pleasure (Month 1 IVR) | 1.63 score on a scale | Standard Deviation 0.63 |
| Intravaginal Ring Users | USPE Scale Scores | Pleasure (Month 3 IVR) | 2.81 score on a scale | Standard Deviation 1.12 |