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| ID | Type | Description | Link |
|---|---|---|---|
| K24HD062645 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravaginal Ring Users | Use IVR for 3-month period and report user sensory perceptions and experiences. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Females who are 18-45 years old, HIV negative or unknown (self report), non-pregnant (urine test) and not intending to get pregnant (self-report), report vaginal sex with a man in the past month, and present with a need/desire for contraception.
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| Name | Affiliation | Role |
|---|---|---|
| Kate Guthrie, PhD | The Miriam Hospital: Centers for Behavioral & Preventive Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Miriam Hospital: Centers for Behavioral & Preventive Medicine | Providence | Rhode Island | 02906 | United States |
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Recruited (RI, MA USA) via call-lists, flyers, ads, internet/social media, clinics, CBOs, word-of-mouth.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intravaginal Ring Users | Use IVR for 3-month period and report user sensory perceptions and experiences. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Female participants using IVR for a period of 3 months
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| ID | Title | Description |
|---|---|---|
| BG000 | Intravaginal Ring Users | Use IVR for 3-month period and report user sensory perceptions and experiences. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 3 months |
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3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intravaginal Ring Users | Use IVR for 3-month period and report user sensory perceptions and experiences. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased Vaginal Discharge | Reproductive system and breast disorders | Non-systematic Assessment | Ppt noticed thick white chunks in her vagina when she went to feel for the ring. There was no odor and no other symptoms. Pt saw her PCP about a week and a half after the onset of symptoms. PCP believes chunks were not related to IVR use. |
User Sensory Perceptions & Experience (USPE) scales adapted and were used for the first time to evaluate IVR use in Project WISH.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Kate Guthrie, Principal Investigator, Project WISH Lead Investigator | The Miriam Hospital | 401-793-8180 | kate.guthrie@brownhealth.org |
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| Participants |
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| Sex/Gender, Customized | Number | participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Marital Status | Count of Participants | Participants |
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| Yearly Income | Count of Participants | Participants |
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| Health Insurance Coverage | Count of Participants | Participants |
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| Typical Tampon Use | Count of Participants | Participants |
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| Units | Counts |
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| Participants |
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| 0 |
| 8 |
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| 8 |
| 2 |
| 8 |
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| Tooth Infection | Infections and infestations | Non-systematic Assessment | Pt noted during final visit after completion of 3-month use of IVR that she saw her PCP regarding a tooth infection. Pt was prescribed antibiotics and made plan for tooth extraction. Pt's symptoms did not affect her participation in the study. |
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