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Developing Rectal USPE Measures

CompletedNA

Sponsor: The Miriam Hospital

Conditions: Microbicide Delivery System Perceptibility and Acceptability

Interventions: Gel, Cream, Liquid

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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 not an exclusion criterion, since treatment is not required), chancroid, genital sores or ulcers, and, if clinically indicated, genital warts,
  * Have current inflammatory bowel disease (IBD) or history of active IBD within last 3 months,
  * Have any other significant colorectal symptom(s) as determined by medical history, participant self-report , or physical exam (including but not limited to presence of any unresolved injury, infectious or inflammatory condition of the local mucosa, presence of symptomatic external hemorrhoids, and presence of any painful anorectal conditions that would be tender to manipulation),
  * Have a nontreatable sexually transmitted disease that could, in the opinion of the investigator/study clinician, make the patient unsuitable for the study or unable to comply with study requirements
  * Have any other clinical condition or prior therapy that, in the opinion of the investigator/study clinician, would make the patient unsuitable for the study or unable to comply with the study requirements,
  * Are unwilling to refrain from use of nonoxynol-9 (N9) for the duration of the study,
  * Are unable or unwilling to communicate in English, or
  * Are unable or unwilling to give written informed consent.

Additionally, female participants will be ineligible if they:

• Are pregnant or breastfeeding.

Locations (1)

Providence, Rhode Island, United States