The purpose of this study is to: (a) adapt existing vaginal USPE items/instruments for evaluation of similar elements of rectal compartment use; (b) develop these scales using 3 distinct semi-solid formulations that represent a range of physicochemical and rheological properties of microbicides that are currently being designed for dual compartment use; and (c) develop novel USPE instruments to capture the experience of product use in the context of receptive anal intercourse (RAI) in both male and female cohorts.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* All participants must meet all of the inclusion criteria to participate in this study.
* Eligible male participants must be 18 years of age or older
* Eligible female participants must be 18-45 years of age
Inclusion criteria include men and women who:
* Report receptive anal intercourse (RAI) at least twice in the past 6 months,
* Are willing to use each study product in conjunction with RAI on at least one occasion in each data collection period (resulting in a minimum of 3 RAI events during each product evaluation period; on average every 2 weeks, all 3 products across an average of 6 -12 weeks))
* Are willing and able to respond to study data collection systems via phone and internet, attend all study visits, and participate in in-depth qualitative interviews
Exclusion Criteria:
* Male and female participants will be ineligible if they:
* Have a sensitivity or allergy to vaginal, anal, or rectal products,
* Have a sensitivity or allergy to any of the ingredients contained in the study products,
* Are HIV positive at baseline, or have a known HIV-positive sexual partner,
* Have an active rectal or reproductive tract infection requiring treatment per current Centers for Disease Control (CDC) guidelines or symptomatic urinary tract infection (UTI). Infections requiring treatment include Chlamydia (CT)\*, gonorrhea (GC)\*, syphilis, active herpes simplex virus (HSV) lesions (note: HSV seropositivity with no active genital lesions is no…
What they're measuring
1
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
Timeframe: 3 web-based surveys over an average of 6-12 weeks