Women's Input on Sexual Health
Condition: Sexual and Reproductive Health
Study type: Observational

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.
    

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.
      
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