Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2026-01-23 @ 3:40 AM
Study NCT ID:
NCT02744261
Status:
COMPLETED
Last Update Posted:
2022-04-08
First Post:
2016-04-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developing Rectal USPE Measures for Suppositories (Project DRUM-S)
Sponsor:
The Miriam Hospital
Organization:
Study Overview
Official Title:
Evaluating User Perceptions and Experiences of Dual Compartment Microbicide Formulations. Project 5.3: Developing Rectal USPE Measures for Suppositories (Project DRUM-S)
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DRUM-S
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U19AI101961 | NIH | None | https://reporter.nih.gov/quic… | View |