Microbicide Delivery System Perceptibility and AcceptabilityDRUM-SNCT02744261
Developing Rectal USPE Measures for Suppositories (Project DRUM-S)
A study testing Gel, Suppository 1 and Suppository 2 in people with Microbicide Delivery System Perceptibility and Acceptability, run by The Miriam Hospital at 1 site in United States.
Trial 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… Read more about this study
- 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, Suppository 1 and Suppository 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2016to 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
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- Additional Inclusion Criteria for Female Volunteers:
- 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
Who cannot join
- 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
- Have an active rectal or reproductive tract infection requiring treatment per current CDC guidelines or have other condition that, in the opinion of the investigator/study clinician, make the patient unsuitable for the study or unable to comply with study requirements (Note: HSV seropositivity without active genital lesions is not an exclusion criteria)
- Urinary tract infection (UTI)
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- 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
- Additional Exclusion Criteria for Female Volunteers:
- 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
- Are unwilling to refrain from use of any vaginal product (inclusive of douching; exclusive of tampons during menses) other than study products
- Have clinically significant abnormal pelvic findings and/or findings requiring therapy as a function of clinical exam at Visit 1
- Report being within 30 days of their last pregnancy outcome or gynecologic surgical procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
The Miriam Hospital Centers for Behavioral and Preventive Medicine
Providence, Rhode Island, 02903
About this study
Official title: Evaluating User Perceptions and Experiences of Dual Compartment Microbicide Formulations. Project 5.3: Developing Rectal USPE Measures for Suppositories (Project DRUM-S)
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.
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 mixed methods design in which volunteers (N~20-30; ~10-15 males; ~10-15 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 products: 2 distinct suppository formulations and 1 gel formulation that represent a range of rheological and other biophysical properties of potential microbicides being designed for rectal/dual compartment use. Participants will evaluate the experience of suppository use (as compared to gel use) in the context of receptive anal intercourse (RAI) among males and females, and in the context of vaginal intercourse (VI) (females). Each participant will be randomly assigned to the order in which they will evaluate the 3 products. After a sexual encounter that includes RAI/VI and study product use, participants will be required to complete a web survey about their experience with the study product.
- Being tested
- Gel, Suppository 1, Suppository 2
- 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
4 mL
Suppository 1Other
Also called Green
Suppository 2Other
Also called Yellow
| Study group | Role | What they receive |
|---|---|---|
| Formulations | Other | Gel, Suppository 1, Suppository 2 Receives: Other: Gel; Other: Suppository 1; Other: Suppository 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Web-based survey (same survey; 3 times; one for each formulation) 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.
- First posted20 Apr 2016 (estimated)
- Study start11 Aug 2016
- Primary completion13 Apr 2017
- 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ImQuest Pharmaceuticals, Inc., National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Kate Guthrie, PhD, Principal investigator, The Miriam Hospital: Centers for Behavioral & Preventive MedicineRobert Buckheit, PhD, Principal investigator, ImQuest Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744261
- Sponsor's protocol ID
- 30048
- Other IDs
- U19AI101961
- Acronym
- DRUM-S
- Status last verified
- Feb 2026
- First submitted
- 12 Apr 2016
- Last updated
- 10 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: as per individual agreement, provided data safety/confidentiality agreements are met
Publications
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.
PubMed 34544269
Study at a glance
From the registry record, last updated by the sponsor on 10 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 5.3: Developing Rectal USPE Measures for Suppositories (Project DRUM-S)
- ClinicalTrials.gov ID
- NCT02744261
- Acronym / sponsor ID
- DRUM-S / 30048
- Keywords
- HIV, STI, Primary Prevention, Topical Microbicides, User Experience, Drug Delivery Systems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- ImQuest Pharmaceuticals, Inc., National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 11 Aug 2016 (actual)
- Primary completion
- 13 Apr 2017 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Posted 10 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 mixed methods design in which volunteers (N~20-30; ~10-15 males; ~10-15 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 products: 2 distinct suppository formulations and 1 gel formulation that represent a range of rheological and other biophysical properties of potential microbicides being designed for rectal/dual compartment use. Participants will evaluate the experience of suppository use (as compared to gel use) in the context of receptive anal intercourse (RAI) among males and females, and in the context of vaginal intercourse (VI) (females). Each participant will be randomly assigned to the order in which they will evaluate the 3 products. After a sexual encounter that includes RAI/VI and study product use, participants will be required to complete a web survey about their experience with the study product.
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: Suppository 1, Other: Suppository 2Gel, Suppository 1, Suppository 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (20 listed)
- 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
- Have an active rectal or reproductive tract infection requiring treatment per current CDC guidelines or have other condition that, in the opinion of the investigator/study clinician, make the patient unsuitable for the study or unable to comply with study requirements (Note: HSV seropositivity without active genital lesions is not an exclusion criteria)
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: Orange4 mL | Other | Formulations |
| Suppository 1Also: Green | Other | Formulations |
| Suppository 2Also: Yellow | Other | Formulations |
Primary outcome
User Perception Scale Scores
Time frame: Web-based survey (same survey; 3 times; one for each formulation) 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, 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34544269Guthrie 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.
- Individual participant dataSharing planned: No. as per individual agreement, provided data safety/confidentiality agreements are met
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.
Kate Guthrie, 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, Suppository 1 and Suppository 2 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 10 inclusion and 20 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 10 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 10 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 Perception Scale Scores (time frame: Web-based survey (same survey; 3 times; one for each formulation) 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 NCT02744261, which also lists 1 linked publication.
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 10 Feb 2026; AzTrials last refreshed its copy on 27 Oct 2026.