Clinical trial NCT02102867: Developing Rectal USPE Measures
Official title: Evaluating User Perceptions and Experiences of Dual Compartment Microbicide Formulations. Project 5.1: Developing Rectal USPE Measures
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: 2014-04-03
Enrollment: 30
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 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.

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; \~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. Participants will be required to complete a brief phone survey (\<5 minutes) every day, beginning the day after they start their first product evaluation period and continuing until they complete their final study visit (approximately 12-24 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 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 and a cognitive interview with study staff about their experiences with the study product and the USPE scale items being developed.

Eligibility criteria: 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 and cognitive interviews

Exclusion Criteria:

* 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,
  * 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.

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