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Women's Input on Sexual Health (WISH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by The Miriam Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT02057419
First received: January 31, 2014
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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?


Condition Phase
Sexual and Reproductive Health
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: K24: Advancing Reproductive Health: Women's Input on Sexual Health (Project WISH)

Resource links provided by NLM:


Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • Product Use [ Time Frame: up to an average of 8-9 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • USPE Scale Scores [ Time Frame: up to an average of 8-9 months ] [ Designated as safety issue: No ]
    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


Other Outcome Measures:
  • Experience and Adherence Narratives [ Time Frame: average of 9-10 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 24
Study Start Date: April 2014
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Contraceptive Method
3-month use period for each of 3 contraceptive methods, randomly ordered. intravaginal ring, oral contraceptive pill, spermicide+condom; dosage and frequency as instructed
Sexual Lubricant Method
3-month use period for each of 3 sexual lubricant methods, randomly ordered. gel formulation, film formulation, insert formulation; dosage and frequency as instructed

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. Each participant will use 3 different SRH products for 3 months each. 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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02057419

Contacts
Contact: Research Assistant 401.793.8143 reprohealthteam@lifespan.org
Contact: Research Assistant 401.793.8123 reprohealthteam@lifespan.org

Locations
United States, Rhode Island
The Miriam Hospital: Centers for Behavioral & Preventive Medicine Recruiting
Providence, Rhode Island, United States, 02906
Principal Investigator: Kathleen Morrow, PhD         
Sponsors and Collaborators
The Miriam Hospital
Investigators
Principal Investigator: Kathleen Morrow, PhD The Miriam Hospital: Centers for Behavioral & Preventive Medicine
  More Information

No publications provided

Responsible Party: The Miriam Hospital
ClinicalTrials.gov Identifier: NCT02057419     History of Changes
Other Study ID Numbers: TMH-506070, K24HD062645
Study First Received: January 31, 2014
Last Updated: April 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The Miriam Hospital:
contraception
contraceptive methods
sexual lubricant
user experience
adherence
User experience: impact on use of contraceptive methods
User experience: impact on use of sexual lubricants

Additional relevant MeSH terms:
Contraceptive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014