Microbicide Delivery System AcceptabilityProject-MISTNCT01334827
A Formative Study to Explore the Sensory Perceptions of Vaginal Product Users
A study testing high volume gel, low volume gel and vaginal film in people with Microbicide Delivery System Acceptability, run by The Miriam Hospital at 1 site in United States.
Trial summary
The purpose of the study is to compare, contrast, and characterize the range of user perceptions and potential acceptability of three (3) topical vaginal microbicide dosage forms. 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 Acceptability
- What is being tested?
- high volume gel, low volume gel and vaginal film
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jun 2012
- 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
- Women who:
- are between the ages of 18 and 45
- report vaginal sex with their male sexual partner in the past 6 months
- report being in a monogamous sexual relationship with their male partner
- 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
- are able to tolerate film use, as measured by pelvic exam at Visit 1B
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- are willing to refrain from any vaginal product use (inclusive of douching) for 48 hours before Visit 1B and until they complete all study activities (except for study-related products)
- are willing to refrain from having vaginal intercourse 24 hours before Visit 1B and Visits 2-4
- are willing to use condoms for vaginal-penile sex between all study visits (Visits 1A - 4)
- are willing to refrain from any non-penile vaginal penetration during dosage form evaluation visits (Visits 2-4)
- are willing to undergo HIV testing and receive test results and counseling.
- Men who:
- are at least 18 years of age
- report vaginal sex with their female sexual partner in the past 6 months
- report being in a monogamous sexual relationship with their female sexual partner
- are willing to refrain from having vaginal intercourse 24 hours before Visit 1B and Visits 2-4
- are willing to use condoms for vaginal-penile sex between all of study visits (Visits 1A-4)
- are willing to refrain from any non-penile vaginal penetration during dosage form evaluation visits (Visits 2-4)
- are willing to use a non-lubricated latex condom (provided) for penile-vaginal intercourse during dosage form evaluation visits (Visits 2-4)
- are willing to undergo HIV testing and receive test results and counseling.
Who cannot join
- Women and men will be ineligible if:
- they are unable or unwilling to give informed consent
- their partner is unable or unwilling to give informed consent
- they are currently enrolled in other vaginal product study/studies
- they are STI (Neisseria gonorrhea, Chlamydia trachomatis, bacterial vaginosis, trichomoniasis, syphilis), HIV positive upon screening (Visit 1A), or pregnant (females) at any study visit
- they are breastfeeding, or have completed menopause (i.e., at least 12 months without menstrual periods) (female participants only)
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- they are currently attempting to get pregnant or have an intention to get pregnant during their participation in the study
- they have clinically significant abnormal pelvic findings and/or findings requiring therapy as a function of clinical exam at Visits 1A and/or 1B (female participants only)
- they report being within 30 days of their last pregnancy outcome or gynecologic surgical procedure
- they have known, or suspected, allergies to any component of the study products or similar ingredients in other products
- they have known, or suspected, allergies to latex
- they have any condition that, in the opinion of the study clinician or principle investigator, would compromise the participant´s ability to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rational Development of Combination Microbicide Therapies: A Formative Study to Explore the Sensory Perceptions of Vaginal Product Users (Project MIST)
The purpose of the study is to compare, contrast, and characterize the range of user perceptions and potential acceptability of three (3) topical vaginal microbicide dosage forms.
Read the detailed description
The success of microbicide products will derive from the synergy of their biological functionality and user acceptability. Biological functionality is the integrated result of safe and effective anti-HIV compounds incorporated into dosage forms or devices that successfully deliver those compounds to target tissues, fluids, and pathogens. Acceptability is a multi-factorial phenomenon that accounts for the personal, dyadic, product-related, and social contexts that potentiate - or not - a woman's decision to use a microbicide. Acceptability (assessed, in part, by the users' sensory perceptions of products during use) depends strongly upon dosage forms and/or delivery systems with biophysical functions and/or mechanical and materials properties that are most conducive to human use. Without both, microbicides' potential to decisively alter the public health impact of HIV/AIDS and other sexually transmitted infections will be largely limited. The current protocol will specifically study the impact of gel volume on user perceptions, as well as extend user perception scale development to include those properties and product "behaviors" experienced when using a vaginal film.
- Being tested
- high volume gel, low volume gel, vaginal film
- Keywords
- topical microbicide, primary prevention, HIV, drug delivery systems
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high volume gelOther
Also called Gray
4 mL HEC
low volume gelOther
Also called Red
2 mL HEC
vaginal filmOther
Also called Blue
1" x 2" intravaginal quick-dissolving film
| Study group | Role | What they receive |
|---|---|---|
| Formulations | Other | high volume gel; low volume gel; vaginal film Receives: Other: high volume gel; Other: low volume gel; Other: vaginal film |
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:Low volume gel, high volume gel, film.Initial Penetration:Smoothness/lubricity; Initial Lubrication:Coating/lubricating; Spreading Behavior:Ease of stroke, product spread; Product Awareness:Feel intravaginally during sex (movement, felt betw vaginal wall-penis); Perceived Wetness:Covering entire vagina; as after orgasm; Stimulating: enhanced pleasure; Messiness:Perceptions of watery/messiness; Leakage:Sensations of leaking during/after sex; in pubic hair; need to clean; Pre-coital Leakage:Product felt/leakage noticed on panty liner before sex; Naturalness:Sensation of naturalness; leakage looked like vaginal fluid; Lubricity:Wetness before sex; slipperiness/lubricity during sex; Effortful:Effort needed at penetration; effort difficulty/dryness; Pleasure:Partner's stimulation; Noticeable:Male sensation during sex, messiness, thickness
Measured: 4-5 visits over an average of 8-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2012
- Study completionJun 2012
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 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
- Model description
- Mixed Methods Measurement Development study
- Masking
- None (open label)
- Enrolment
- 48 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
- Robert Buckheit, PhD, Principal investigator, ImQuest PharmaceuticalsKathleen Morrow, PhD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334827
- Sponsor's protocol ID
- 11800
- Other IDs
- R33AI076967
- Acronym
- Project-MIST
- Status last verified
- Oct 2025
- First submitted
- 11 Apr 2011
- Last updated
- 15 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rational Development of Combination Microbicide Therapies: A Formative Study to Explore the Sensory Perceptions of Vaginal Product Users (Project MIST)
- ClinicalTrials.gov ID
- NCT01334827
- Acronym / sponsor ID
- Project-MIST / 11800
- Keywords
- topical microbicide, primary prevention, HIV, drug delivery systems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 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 2011 (actual)
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 13 Apr 2011 (estimated)
- Results
- Posted 8 Dec 2020
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 the study is to compare, contrast, and characterize the range of user perceptions and potential acceptability of three (3) topical vaginal microbicide dosage forms.
Detailed description
The success of microbicide products will derive from the synergy of their biological functionality and user acceptability. Biological functionality is the integrated result of safe and effective anti-HIV compounds incorporated into dosage forms or devices that successfully deliver those compounds to target tissues, fluids, and pathogens. Acceptability is a multi-factorial phenomenon that accounts for the personal, dyadic, product-related, and social contexts that potentiate - or not - a woman's decision to use a microbicide. Acceptability (assessed, in part, by the users' sensory perceptions of products during use) depends strongly upon dosage forms and/or delivery systems with biophysical functions and/or mechanical and materials properties that are most conducive to human use. Without both, microbicides' potential to decisively alter the public health impact of HIV/AIDS and other sexually transmitted infections will be largely limited. The current protocol will specifically study the impact of gel volume on user perceptions, as well as extend user perception scale development to include those properties and product "behaviors" experienced when using a vaginal film.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Mixed Methods Measurement Development study
| Arm | Type | Receives |
|---|---|---|
| Formulations | Other | Other: high volume gel, Other: low volume gel, Other: vaginal filmhigh volume gel; low volume gel; vaginal film |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- are between the ages of 18 and 45
- report vaginal sex with their male sexual partner in the past 6 months
- report being in a monogamous sexual relationship with their male partner
- 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
- are able to tolerate film use, as measured by pelvic exam at Visit 1B
Key exclusion criteria (12 listed)
- they are unable or unwilling to give informed consent
- their partner is unable or unwilling to give informed consent
- they are currently enrolled in other vaginal product study/studies
- they are STI (Neisseria gonorrhea, Chlamydia trachomatis, bacterial vaginosis, trichomoniasis, syphilis), HIV positive upon screening (Visit 1A), or pregnant (females) at any study visit
- they are breastfeeding, or have completed menopause (i.e., at least 12 months without menstrual periods) (female participants only)
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 |
|---|---|---|
| high volume gelAlso: Gray4 mL HEC | Other | Formulations |
| low volume gelAlso: Red2 mL HEC | Other | Formulations |
| vaginal filmAlso: Blue1" x 2" intravaginal quick-dissolving film | Other | Formulations |
Primary outcome
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
Time frame: 4-5 visits over an average of 8-12 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:Low volume gel, high volume gel, film.Initial Penetration:Smoothness/lubricity; Initial Lubrication:Coating/lubricating; Spreading Behavior:Ease of stroke, product spread; Product Awareness:Feel intravaginally during sex (movement, felt betw vaginal wall-penis); Perceived Wetness:Covering entire vagina; as after orgasm; Stimulating: enhanced pleasure; Messiness:Perceptions of watery/messiness; Leakage:Sensations of leaking during/after sex; in pubic hair; need to clean; Pre-coital Leakage:Product felt/leakage noticed on panty liner before sex; Naturalness:Sensation of naturalness; leakage looked like vaginal fluid; Lubricity:Wetness before sex; slipperiness/lubricity during sex; Effortful:Effort needed at penetration; effort difficulty/dryness; Pleasure:Partner's stimulation; Noticeable:Male sensation during sex, messiness, thickness
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- 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.
Robert Buckheit, PhD principal investigator
ImQuest Pharmaceuticals
Kathleen Morrow, PhD principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high volume gel, low volume gel and vaginal film in people with Microbicide Delivery System 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 20 inclusion and 12 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 15 Oct 2025. 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 8 Dec 2020). 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: 4-5 visits over an average of 8-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2025.