Clinical trial NCT02744261: Developing Rectal USPE Measures for Suppositories (Project DRUM-S)
Official title: Evaluating User Perceptions and Experiences of Dual Compartment Microbicide Formulations. Project 5.3: Developing Rectal USPE Measures for Suppositories (Project DRUM-S)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Microbicide Delivery System Perceptibility and Acceptability
Keywords: HIV
STI
Primary Prevention
Topical Microbicides
User Experience
Drug Delivery Systems
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: ImQuest Pharmaceuticals, Inc.
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2016-04-20
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals residing in the greater Providence, RI and southeastern, MA metropolitan areas

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.

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. Participants will be required to complete a brief phone survey (\<3 minutes) every day, beginning the day after they start their first product evaluation period and continuing until they complete their final study visit (approximately 10-20 weeks). The phone survey includes a short set of questions about sexual behavior and product use during the time since the last phone survey (about 24 hours). 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. After a participant has evaluated all three products, participants complete an individual in-depth interview with study staff about their experiences with the study products.

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

Inclusion Criteria:

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

Inclusion criteria include men and women who:

* 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

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

Exclusion Criteria:

* 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)
* 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

Primary outcomes:
measure: User Perception Qualitative Interview
timeFrame: at completion of user evaluation of all 3 products (approximately 6-12 weeks post-enrollment)
Secondary outcomes:
measure: User Perception Scale Scores
timeFrame: Web-based survey (same survey; 3 times; one for each formulation) over an average of 6-12 weeks
Other outcomes:
measure: Daily Product Use and Sexual Behavior Survey
timeFrame: daily over an average of 6-12 weeks
Locations:
city: Providence
country: United States
facility: The Miriam Hospital Centers for Behavioral and Preventive Medicine
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital: Centers for Behavioral & Preventive Medicine
name: Kate Guthrie, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: ImQuest Pharmaceuticals, Inc.
name: Robert Buckheit, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.