Clinical trial NCT02057419: Women's Input on Sexual Health
Official title: K24: Advancing Reproductive Health: Women's Input on Sexual Health (Project WISH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sexual and Reproductive Health
Keywords: contraception
contraceptive methods
sexual lubricant
user experience
adherence
User experience: impact on use of contraceptive methods
User experience: impact on use of sexual lubricants
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2014-02-07
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 sexual lubrication and/or contraception.

Brief summary: 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?

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 patterns of use and non-use. This research hypothesizes that a new model of use, Effective Use, is required. If correct, and if developers utilize an Effective Use model, a shift from the current "acceptability = adherence" paradigm would offer new insights in the development of SRH technologies that will result in increased use and improved SRH outcomes. If the model can be fully realized, women will have the best reproductive health technologies science can provide. 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.

Conditions: There will be 2 experimental conditions: sexual lubricant use and contraceptive use. \[NOTE: The protocol has been revised. Protocol 1 is no longer recruiting - Protocol 1: Each participant will use 3 different SRH products for 3 months each. Recruitment for Protocol 2 is ongoing for the contraceptive use condition only. - Protocol 2: Each participant will use 1 product for 6 months, or 2 products, each for 3 months. This will be dependent on the user's choice.\] The sexual lubricant use condition will include gel, film, and capsule. The contraceptive use condition will include gel, intravaginal ring, and oral contraceptive pill. The order in which participants experience each delivery method will be randomized.

Methodology and Data Collection: Volunteers (N\~20-30) 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 (contraceptive arm only) and pregnancy test. Those who are interested in lubricants and are eligible based on their responses to the prescreen, and those who are eligible after clinical screening (contraception arm), will complete a survey that asks questions about demographics and sexual and reproductive history.

During the course of the study, participants will evaluate three study products (contraceptives OR sexual lubricants). Each product will be used for three consecutive months. Participants will be randomly assigned to the order in which they will try the three products. They will be given (lubricants), or prescribed (contraceptives) a three month supply of the product at the beginning of each use period. Participants will be required to complete a brief phone survey (\<5 minutes) every day, beginning the day after they start their first product evaluation period and continuing until they complete their final study visit (approximately 9 months). The phone survey includes a short set of questions about sexual behavior and product use during the time since the last phone survey (about 24 hours). About once a month, each participant will be required to complete a web survey about their experience with the study product.

Every three months, participants will meet with research staff and, if necessary, the study clinician. All participants will be tested for pregnancy, and will be given, or prescribed, the next study product. Participants will also complete an individual in-depth interview with study staff about their experiences in the study. Participants will repeat these steps for the final (third) study product. After a participant has tried all three products, she will meet with a clinician (contraceptive arm only) to follow up clinically about her contraception options post-study participation. All participants complete a final survey that will ask about their experiences with all three study products, and about what kinds of products, if any, they might be interested in using in the future. Participants will also complete a final in-depth interview.

Eligibility criteria: 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

Primary outcomes:
measure: Product Use
timeFrame: up to an average of 8-9 months
Secondary outcomes:
measure: USPE Scale Scores
timeFrame: up to an average of 8-9 months
Other outcomes:
measure: Experience and Adherence Narratives
timeFrame: average of 9-10 months
Locations:
city: Providence
country: United States
facility: The Miriam Hospital: Centers for Behavioral & Preventive Medicine
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital: Centers for Behavioral & Preventive Medicine
name: Kate Guthrie, PhD
role: PRINCIPAL_INVESTIGATOR
References: