Developing Rectal USPE Measures for Suppositories (Project DRUM-S)

NCT02744261 | Completed Results DMC

• 2 other identifiers: 30048U19AI101961
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to (a) adapt existing user sensory perception and experience (USPE) items/instruments generated for rectal gel/cream formulations to include USPEs specific to suppository forms for rectal and vaginal use; (b) for both male and female cohorts: to capture the experience of suppository use in the context of receptive anal intercourse (RAI); and (c) for female cohort only: to capture the experience of suppository use in the context of vaginal-penile intercourse (VI), and to compare USPEs of suppository use in the context of RAI to USPEs of suppository use in the context of vaginal-penile intercourse.

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 Perception Scale Scores

  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, Suppository 1/Green, Suppository 2/Yellow. Initial Penetration:Smoothness/lubricity; Initial Lubrication:Coating/lubricating; Spreading Behavior:Ease of stroke, product spread; Product Awareness:Feel during sex (movement, felt betw vaginal/rectal wall-penis); Perceived Wetness:Covering entire vagina/rectum; Stimulating:enhanced pleasure; Messiness:Perceptions of messiness; Leakage:Sensations of leaking during/after sex; Pre-coital Leakage:Product felt/leakage on body or clothes before sex; Naturalness:Sensation of naturalness; leakage looked like vag fluid/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

  Web-based survey (same survey; 3 times; one for each formulation) over an average of 6-12 weeks

Study Arms (1)

Formulations

OTHER

Gel, Suppository 1, Suppository 2

Other: Gel; Other: Suppository 1; Other: Suppository 2

Interventions

Gel OTHER

4 mL

Also known as: Orange

Formulations

Suppository 1 OTHER

Also known as: Green

Formulations

Suppository 2 OTHER

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
• Report vaginal-penile intercourse (VI) at least twice in the past 6 months
• Willing to use each study suppository formulation in conjunction with VI on at least one occasion in each data collection period (resulting in a minimum of 2 vaginal intercourse events during the course of the study)
• Report consistent use of an effective birth control method: e.g., hormonal contraceptive, IUD, bilateral tubal ligation, Essure® or any non-incisional permanent birth control procedure, hysterectomy (partial or total, with/without oophorectomy), partner's vasectomy/salpingectomy

You may not qualify if:

• 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
• Have a sensitivity or allergy to sesame seeds
• Are HIV-positive at baseline, or have a known HIV-positive sexual partner
• Urinary tract infection (UTI)
• 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 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 (including, as determined by medical history, participant self-report, or physical exam: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to prostate gland enlargement; taking psychotropic medications such as monoamine inhibitors, tricyclic antidepressants, SSRIs)
• Are unwilling to refrain from use of nonoxynol-9 (N9) for the duration of the study
• Are currently enrolled in other rectal or vaginal product studies
• Are unable or unwilling to communicate in English, or
• Are unable or unwilling to give written informed consent
• Are pregnant or breastfeeding. Pregnancy testing will be conducted at Visits 1-4 (screening and prior to any product use period)
• Have completed menopause (i.e., at least 12 months without menstrual periods)
• Are currently attempting to get pregnant or have an intention to get pregnant during their participation in the study

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 and Preventive Medicine

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

• Guthrie KM, Rosen RK, Guillen M, Ramirez JJ, Vargas SE, Fava JL, Ham AS, Katz DF, Cu-Uvin S, Tumilty S, Smith KA, Buckheit KW, Buckheit RW , Jr. Designing Dual Compartment HIV Prevention Products: Women's Sensory Perceptions and Experiences of Suppositories for Rectal and Vaginal Use. AIDS Res Hum Retroviruses. 2022 Jul;38(7):601-610. doi: 10.1089/AID.2021.0038. Epub 2021 Oct 18.

  PMID: 34544269 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases

Interventions

Gels; Green Or

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

Limitations and Caveats

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

Results Point of Contact

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

kate.guthrie@brownhealth.org

(401) 793-8180

Study Officials

• Kate Guthrie, 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: April 12, 2016
• First Posted: April 20, 2016
• Study Start: August 11, 2016
• Primary Completion: April 13, 2017
• Study Completion: April 1, 2022
• Last Updated: February 10, 2026
• Results First Posted: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)