MATRIX-002: Trial to Assess Acceptability and Safety of Two Placebo Prototype Vaginal Films
Overview
- Phase
- Early Phase 1
- Intervention
- Placebo Vaginal Film with Square Corners
- Conditions
- Safety
- Sponsor
- Rohan, Lisa, PhD
- Enrollment
- 100
- Locations
- 5
- Primary Endpoint
- Mean Satisfaction with Placebo Vaginal Film Use
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This study will enroll approximately 100 HIV-negative persons, aged18-45 years, and assigned female sex at birth from sites in the United States, Kenya, South Africa, and Zimbabwe. The study will assess the acceptability and safety of two placebo vaginal films. The placebo films do not contain any active medication, are the same size, but differ by shape (square versus rounded corners). Participants will be randomly assigned to one of the two films and asked to use (self-insert) the assigned film two times (approximately one month apart). Participants will be asked to refrain from sexual activity during the first month of use and may resume usual sexual activity during the second month of use. The study involves answering questions, undergoing pelvic examinations, and collecting blood and vaginal fluid samples. The study involves a total of 10 visits/contacts, including in person visits and telephone calls over approximately 9 weeks. In addition, both participants and approximately 30 of their sexual partners will be asked to take part in in depth interviews to further assess acceptability, attitudes, and experiences with film use to gauge interest in the future use of vaginal films as a HIV prevention option.
Detailed Description
The goal of this randomized, clinical trial is to compare two placebo vaginal films in HIV seronegative adult (18-45 years old) persons assigned female sex at birth who are at low risk of acquiring HIV infection, and sexual partners of evaluable participants. Participants will be recruited from five sites, one in the US and four is sub-Saharan Africa. Approximately 100 participants will be randomized (1:1), stratified by site, to insert either placebo vaginal film A or placebo vaginal film B, which differ only by shape, once monthly for two months. Participants will be asked to refrain from sexual activity during the first month of use and may resume usual sexual activity during the second month of use after insertion of the second film which will be the same film they were assigned to use during the first month. Differences in safety, acceptability, usability, social harms and benefits, and vaginal microenvironment between the two films and the two study phases (i.e., with and without sexual abstinence requirement) will be assessed. In addition, both participants and approximately 30 sexual partners of evaluable participants will be asked to take part in in depth interviews to further assess acceptability, attitudes, and experiences with film use to gauge interest in the future use of vaginal films as a HIV prevention option.
Investigators
Katherine Bunge
Associate Professor
University of Pittsburgh
Eligibility Criteria
Inclusion Criteria
- •Assigned female sex at birth.
- •Able and willing to provide written informed consent to be screened for and enrolled in MATRIX-002 in one of the study languages.
- •Able and willing to provide adequate contact/locator information.
- •Able and willing to comply with all protocol requirements, including:
- •Abstaining from all receptive sexual intercourse (vaginal, anal, digital, oral) for the first month of product use.
- •Abstaining from using other intravaginal products for the first month of product use.
- •Abstaining from engaging in intravaginal practices for the first month of product use.
- •Refraining from participation in other research studies for the duration of the study unless approved by the Protocol Safety Review Team.
- •Responding to scheduled phone/short message service contacts.
- •Attending all clinic follow-up visits.
Exclusion Criteria
- •Per participant report at Screening and Enrollment, intends to do any of the following during the study participation period:
- •Become pregnant.
- •Breastfeed.
- •Relocate away from the study site.
- •Travel away from the study site for a time period that would interfere with product resupply and/or study participation.
- •Positive HIV test at Screening or Enrollment.
- •Positive test for Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis, or Treponema pallidum (Syphilis) at Screening or (per participant report) treated for potential sexually transmitted infection within past 12 months.
- •Diagnosed with urinary tract infection, pelvic inflammatory disease, or reproductive tract infection requiring treatment per WHO guidelines at Enrollment.
- •Clinically apparent Grade 2 or higher pelvic exam finding per the DAIDS Table for Grading Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 and/or Addenda 1 (Female Genital Grading Table for Use in Microbicide Studies \[Dated November 2007\]) at Enrollment.
- •Participant report and/or clinical evidence of any of the following:
Arms & Interventions
Placebo Vaginal Film with Square Corners
A single 2" x 2" placebo vaginal film with square corners, inserted intravaginally once monthly for two months.
Intervention: Placebo Vaginal Film with Square Corners
Placebo Vaginal Film with Rounded Corners
A single 2" x 2" placebo vaginal film with rounded corners, inserted intravaginally once monthly for two months
Intervention: Placebo Vaginal Film with Rounded Corners
Outcomes
Primary Outcomes
Mean Satisfaction with Placebo Vaginal Film Use
Time Frame: Through study completion, approximately 9 weeks
Satisfaction will be assessed using a 10-point Likert scale with 0 being the least satisfied and 10 being the most satisfied
Secondary Outcomes
- Number of Participants with Genitourinary Grade 2 or Higher Adverse Events(Through study completion, approximately 9 weeks)
- Number of Participants that Correctly Inserted Vaginal Film(Through study completion, approximately 9 weeks)