CompletedNot Applicable

Developing Rectal USPE Measures

United States18 participantsStarted 2014-04

Plain-language summary

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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means

Timeframe: 3 web-based surveys over an average of 6-12 weeks

Trial details

NCT IDNCT02102867

SponsorThe Miriam Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-03

Results submitted2025-10-07

View on ClinicalTrials.gov More Microbicide Delivery System Perceptibility and Acceptability trials