Developing Rectal USPE Measures

NCT02102867 | Completed Results DMC

• 2 other identifiers: 11968U19AI101961
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Microbicide Delivery System Perceptibility and Acceptability

Keywords

HIV; STI; Primary Prevention; Topical Microbicides; User Experience; Drug Delivery Systems

Outcome Measures

Primary Outcomes (1)

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

  USPE Sum of averaged item means/# items (min:max 1:5); 1=Do not agree at all;2=Agree a little;3=Agree somewhat;4=Agree a lot;5=Agree completely. Products:Gel/Orange, Cream/Green, Liquid/Yellow. Initial Penetration:Smoothness/lubricity; Initial Lubrication:Coating/lubricating; Spreading Behavior:Ease of stroke, product spread; Product Awareness:Feel during sex (movement, felt betw rectal wall-penis); Perceived Wetness:Covering entire rectum, as after orgasm; Stimulating: enhanced pleasure; Messiness:Perceptions of messiness; Leakage:Sensations of leaking during/after sex, in pubic hair, cleanliness; Pre-coital Leakage:Product felt/leakage on body/clothes before sex; Naturalness:Sensation of naturalness, leakage looked like cum; Lubricity:Wetness before sex; slipperiness/lubricity during sex; Effortful:Effort needed at penetration; effort difficulty/dryness; Pleasure: Partner's stimulation; Noticeable: messiness, thickness Higher scores=greater agreement re:product characteristics

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

Study Arms (1)

Formulations

OTHER

Gel, Cream, Liquid

Other: Gel; Other: Cream; Other: Liquid

Interventions

Gel OTHER

10mL

Also known as: Orange

Formulations

Cream OTHER

10mL

Also known as: Green

Formulations

Liquid OTHER

10mL

Also known as: Yellow

Formulations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible male participants must be 18 years of age or older
• Eligible female participants must be 18-45 years of age
• 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

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• The Miriam Hospital: lead
• ImQuest Pharmaceuticals, Inc.: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

The Miriam Hospital: Centers for Behavioral & Preventive Medicine

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Interventions

Gels; Green Or; Fluid Therapy

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Drug Therapy; Therapeutics

Limitations and Caveats

User Sensory Perceptions \& Experience (USPE) scales adapted and were used for the first time to evaluate products used by males for receptive anal sex and females for receptive anal sex.

Results Point of Contact

• Title: Dr Kate Guthrie, Co-Investigator, Project DRUM Lead Investigator
• Organization: The Miriam Hospital

kate.guthrie@brownhealth.org

(401) 793-8180

Study Officials

• Kathleen Morrow, PhD

  The Miriam Hospital: Centers for Behavioral & Preventive Medicine

  PRINCIPAL INVESTIGATOR

• Robert Buckheit, PhD

  ImQuest Pharmaceuticals, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2014
• First Posted: April 3, 2014
• Study Start: April 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: April 1, 2022
• Last Updated: February 5, 2026
• Results First Posted: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)