A Crossover Study Evaluating 3 Non-medicated Silicone IVRs
Condition: Hiv; Pregnancy Related
Study type: Interventional

Summary: 
      The overall aim of this study is to assess different external diameters of intravaginal rings
      (IVRs) for adherence, preference, and acceptability. To assess these domains, women in
      male-partnered relationships will use three different size IVRs.
    

Detailed description: 
      The study design is a randomized, open-label, parallel group 3-way crossover study comparing
      adherence, preference and overall acceptability of 3 different-sized placebo IVRs (IVRs A, B
      and C) in 24 US couples. At enrollment, each couple will be randomly assigned to 1 of 6
      sequences of IVR use: A-B-C, A-C-B, B-A-C, B-C-A, C-A-B or C-B-A. Each couple will use each
      of the 3 IVRs (IVRs A, B and C) for 30 days per IVR, 90 days total. Each couple will
      participate for approximately 4 months, including screening. After providing written informed
      consent at screening, females and their male partners will be evaluated against the inclusion
      and exclusion criteria by providing their medical, contraceptive, and sexual history as well
      as undergoing a clinical exam. The exam will include a visual inspection of the genitalia
      (men) and a speculum exam (women). Potential participants will be recruited by Emory
      University (Atlanta, GA) and Einstein College of Medicine (Bronx, NY) by contacting prior
      research participants who've consented to be contacted for new studies; advertising; and
      distribution of flyers in the study communities. All recruitment materials will be approved
      by the relevant IRBs prior to use. After screening, women will have an additional 4 visits
      and their male partners will have 1 additional in-person visit for enrollment and 3 remote
      visits. Before and after using each IVR, women will have a pelvic exam. If women report
      symptoms during interim visits, they will have a pelvic exam and will restart IVR use based
      on the clinical judgement of the site investigator. After enrollment, men who report symptoms
      possibly related to IVR use will be asked to attend the clinic for an examination. Follow-up
      visits (in-person for women and remote for men) will include counseling on protocol
      adherence, contraception, HIV risk reduction counseling. Women will be shown how to use the
      IVR at Visit 1/Enrollment and will be able to practice ring insertion and removal at that
      first visit. At monthly visits, women will be examined to check that the IVR is in place.

      ADHERENCE: The primary adherence measure will be assessed via daily SMS text messages to
      women in which they will report if the IVR was out of the vagina in the previous 24h and if
      so, for how long. At monthly visits, women will respond to a computer assisted self-interview
      (CASI) questionnaire asking them to rate their adherence in terms of how well they feel they
      adhered to the IVR instructions for use. They will also be asked to report in more detail
      about expulsions and removals and the context in which those happen; feeling the ring during
      daily activities and during sex; and any symptoms experienced in the previous month.

      PREFERENCE: We will ask women and their male partners to choose the IVR they think they will
      prefer at baseline -- before using any IVRs -- and then ask them to state their preference
      after using all 3 IVRs. Preferences at baseline and endline, and between males and females
      within each couple, will be compared.

      ACCEPTABILITY: Acceptability will be assessed via the monthly CASI interviews according to an
      adapted version of the Merkatz et al IVR acceptability model.

      SAFETY: Safety will be assessed by recording AEs.
    

Intervention name(s): Impact of ring size on adherence
Intervention type(s): Device
Intervention description(s): The study design is a randomized, open-label, parallel group 3-way crossover study comparing adherence, preference and overall acceptability of 3 different-sized placebo IVRs (IVRs A, B and C) in 24 US couples. At enrollment, each couple will be randomly assigned to 1 of 6 sequences of IVR use: A-B-C, A-C-B, B-A-C, B-C-A, C-A-B or C-B-A. Each couple will use each of the 3 IVRs (IVRs A, B and C) for 30 days per IVR, 90 days total.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other