Microbicide Delivery System Perceptibility and AcceptabilityProject DRUMNCT02102867

Developing Rectal USPE Measures

A study testing Gel, Cream and Liquid in people with Microbicide Delivery System Perceptibility and Acceptability, run by The Miriam Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Microbicide Delivery System Perceptibility and Acceptability
What is being tested?: Gel, Cream and Liquid
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: Apr 2014to 1 Apr 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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
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

Who cannot join

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,

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

The Miriam Hospital: Centers for Behavioral & Preventive Medicine
Providence, Rhode Island, 02903

Other trials in United States

About this study

Official title: Evaluating User Perceptions and Experiences of Dual Compartment Microbicide Formulations. Project 5.1: Developing Rectal USPE Measures

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.

Read the detailed description

HIV prevention is a global public health priority. Providing efficacious prevention methods that have the greatest likelihood of use will have a profound impact on the public's health. Critical to their use is "acceptability." However, current conceptualizations of adherence and acceptability fail to fully articulate and account for patterns of use and non-use. Formulation properties are critically important to both drug delivery and the user experience. Microbicide developers thus have the opportunity to directly control a formulation's impact on acceptability and adherence to product use, as well as biological product performance. Microbicide products can and should be developed such that they achieve performance standards for both these behavioral (user experience) and biological (efficacy) functions. By incorporating the user experience early on in the product development process, developers will have the greatest chance of providing at-risk individuals with the best prevention methods science can provide. Developing prevention products that can be used in the vagina and/or the rectum and that optimize the user experience in both compartments increases the likelihood that these products will be used consistently and correctly. The impact on global public health has the potential to be far-reaching, decreasing HIV and sexually transmitted infections (STI) incidence and prevalence in both women and men.

Methodology and Data Collection: This is a formative study in which volunteers (N~20-30; ~8-20 males; ~8-20 Females) will first be prescreened for basic study eligibility using a brief questionnaire. Those who are interested in the study and are eligible based on their responses to the prescreen will then complete a STI/HIV screening and pregnancy test (for females).

During the course of the study, participants will evaluate 3 study products (i.e., distinct semi-solid formulations that represent a range of physicochemical and rheological properties). Each participant will be randomly assigned to the order in which they will evaluate the 3 products. After a sexual encounter that includes RAI and study product use, participants will be required to complete a web survey about their experience with the study product.

Conditions: Microbicide Delivery System Perceptibility and Acceptability
Being tested: Gel, Cream, Liquid
Keywords: HIV, STI, Primary Prevention, Topical Microbicides, User Experience, Drug Delivery Systems
Medical subject headings: Sexually Transmitted Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GelOther
Also called Orange
10mL
CreamOther
Also called Green
10mL
LiquidOther
Also called Yellow
10mL

Study groups in NCT02102867
Study group	Role	What they receive
Formulations	Other	Gel, Cream, Liquid Receives: Other: Gel; Other: Cream; Other: Liquid

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 20141 Apr 2022

First posted3 Apr 2014 (estimated)
Study startApr 2014
Primary completionMar 2015
Study completion1 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Microbicide Delivery System Perceptibility and AcceptabilityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02102867
Sponsor's protocol ID: 11968
Other IDs: U19AI101961
Acronym: Project DRUM
Status last verified: Jan 2026
First submitted: 26 Mar 2014
Last updated: 5 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating User Perceptions and Experiences of Dual Compartment Microbicide Formulations. Project 5.1: Developing Rectal USPE Measures
ClinicalTrials.gov ID: NCT02102867
Acronym / sponsor ID: Project DRUM / 11968
Conditions: Microbicide Delivery System Perceptibility and Acceptability
Keywords: HIV, STI, Primary Prevention, Topical Microbicides, User Experience, Drug Delivery Systems
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: The Miriam HospitalUniversity, hospital or other
Collaborators: ImQuest Pharmaceuticals, Inc., National Institute of Allergy and Infectious Diseases (NIAID)
Study start: Apr 2014
Primary completion: Mar 2015 (actual)
Study completion: 1 Apr 2022 (actual)
First posted: 3 Apr 2014 (estimated)
Results: Posted 5 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Formulations	Other	Other: Gel, Other: Cream, Other: LiquidGel, Cream, Liquid

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

All participants must meet all of the inclusion criteria to participate in this study.
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

Key exclusion criteria (14 listed)

Male and female participants will be ineligible if they:
Are pregnant or breastfeeding.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GelAlso: Orange10mL	Other	Formulations
CreamAlso: Green10mL	Other	Formulations
LiquidAlso: Yellow10mL	Other	Formulations

Primary outcome

User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
Time frame: 3 web-based surveys over an average of 6-12 weeks
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

Results and safety

Results posted to the registry on 5 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Females	10	7
Males	8	8

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

Time frame: 3 web-based surveys over an average of 6-12 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Females n = 7	Males n = 8
SEX: Initial Penetration (Green)	3.67 (1.11)	3.29 (1.71)
SEX: Initial Penetration (Orange)	3.86 (1.35)	3.42 (1.32)
SEX: Initial Penetration (Yellow)	3.86 (0.90)	3.50 (1.05)
SEX: Initial Lubrication (Green)	4.03 (0.78)	3.15 (1.81)
SEX: Initial Lubrication (Orange)	3.74 (0.96)	3.78 (1.06)
SEX: Initial Lubrication (Yellow)	4.17 (0.55)	3.23 (1.44)
SEX: Spreading Behavior (Green)	3.62 (1.22)	3.25 (1.19)
SEX: Spreading Behavior (Orange)	3.48 (1.00)	3.50 (1.11)

Population analysed: Numbers analyzed for each scale may differ from overall sample size as a function of sex (and hence opportunity to evaluate) or a non-evaluable scale for a given participant.

Adverse events

Time frame: 6-12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Females	0 of 7 (0%)	1 of 7 (14.3%)	Not reported
Males	0 of 8 (0%)	0 of 8 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kathleen Morrow, PhD principal investigator

The Miriam Hospital: Centers for Behavioral & Preventive Medicine

Robert Buckheit, PhD principal investigator

ImQuest Pharmaceuticals, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Gel, Cream and Liquid in people with Microbicide Delivery System Perceptibility and Acceptability, run by The Miriam Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means (time frame: 3 web-based surveys over an average of 6-12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02102867.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.