COMPLETED

MATRIX-002: Trial to Assess Acceptability and Safety of Two Placebo Vaginal Films

Conditions

Safety Acceptability Usability Vagina Film Placebo

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

MATRIX-002: Trial to Assess Acceptability and Safety of Two Placebo Prototype Vaginal Films

Quick Facts

Study Start:2023-10-18

Study Completion:2024-12-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06046053

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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. * HIV-uninfected based on testing performed at Screening and Enrollment. * Per participant report, if in a relationship, must be in a mutually monogamous relationship with a partner who is not known to be HIV positive or to currently have a sexually transmitted infection. * Negative urine pregnancy test at Screening and Enrollment. * Participants over the age of 21 (inclusive) must have documentation of a Grade 0 Pap smear within the past 3 years prior to Enrollment, or a Grade 1 Pap smear at Screening with no treatment required, per the Female Genital Grading Table for Use in Microbicide Studies Addendum 1 (Dated November 2007) to the DAIDS Table for Grading Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. * Protected from pregnancy starting two weeks before Screening and continuing for the duration of study participation by an effective contraceptive method; effective methods include: * Hormonal methods except vaginal rings * Copper intrauterine device * Sterilization of participant * Correct and consistent condom use (for US site only) * Abstinence from penile-vaginal intercourse * Identifies as a sexual partner of a MATRIX-002 participant. * Identified by participant as a sexual partner during MATRIX-002 for whom the participant has given permission to contact. * Able and willing to provide written informed consent in one of the study languages. * Able and willing to complete the required study procedures. * Must be 18 years old or above at the time of their study participation.	* 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: * Known adverse reaction to any of the study product materials (ever). * Hysterectomy. * Surgical procedure involving the pelvis in the 30 days prior to Enrollment. * Use of diaphragm, NuvaRing, or (for African sites only) spermicide for contraception in the two weeks prior to Screening. * Antibiotic or antifungal (oral or intravaginal) therapy within 7 days of Enrollment. * Prior use of post-exposure prophylaxis or oral pre-exposure prophylaxis (including emtricitabine/disoproxil fumarate) in the 4 weeks prior to Screening or any prior use of long-acting systemic pre-exposure prophylaxis (including cabotegravir or islatravir). * Use of any of the following in the 12 months prior to Screening: stimulants (cocaine \[including crack\], methamphetamine, or non-physician prescribed pharmaceutical-grade stimulants), or inhaled nitrates, or illicit injection drug use of any kind. * At Screening or Enrollment, as determined by the Investigator of Record/designee, has any significant uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or infectious disease. * Has any of the following laboratory abnormalities at Screening: * Grade 2 or higher Aspartate aminotransferase, alanine transaminase, creatinine, or Hemoglobin per the DAIDS Table for Grading Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. * Has any other condition that, in the opinion of the Investigator of record/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Inclusion Criteria

Exclusion 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.
* HIV-uninfected based on testing performed at Screening and Enrollment.
* Per participant report, if in a relationship, must be in a mutually monogamous relationship with a partner who is not known to be HIV positive or to currently have a sexually transmitted infection.
* Negative urine pregnancy test at Screening and Enrollment.
* Participants over the age of 21 (inclusive) must have documentation of a Grade 0 Pap smear within the past 3 years prior to Enrollment, or a Grade 1 Pap smear at Screening with no treatment required, per the Female Genital Grading Table for Use in Microbicide Studies Addendum 1 (Dated November 2007) to the DAIDS Table for Grading Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017.
* Protected from pregnancy starting two weeks before Screening and continuing for the duration of study participation by an effective contraceptive method; effective methods include:
* Hormonal methods except vaginal rings
* Copper intrauterine device
* Sterilization of participant
* Correct and consistent condom use (for US site only)
* Abstinence from penile-vaginal intercourse
* Identifies as a sexual partner of a MATRIX-002 participant.
* Identified by participant as a sexual partner during MATRIX-002 for whom the participant has given permission to contact.
* Able and willing to provide written informed consent in one of the study languages.
* Able and willing to complete the required study procedures.
* Must be 18 years old or above at the time of their study participation.

* 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:
* Known adverse reaction to any of the study product materials (ever).
* Hysterectomy.
* Surgical procedure involving the pelvis in the 30 days prior to Enrollment.
* Use of diaphragm, NuvaRing, or (for African sites only) spermicide for contraception in the two weeks prior to Screening.
* Antibiotic or antifungal (oral or intravaginal) therapy within 7 days of Enrollment.
* Prior use of post-exposure prophylaxis or oral pre-exposure prophylaxis (including emtricitabine/disoproxil fumarate) in the 4 weeks prior to Screening or any prior use of long-acting systemic pre-exposure prophylaxis (including cabotegravir or islatravir).
* Use of any of the following in the 12 months prior to Screening: stimulants (cocaine \[including crack\], methamphetamine, or non-physician prescribed pharmaceutical-grade stimulants), or inhaled nitrates, or illicit injection drug use of any kind.
* At Screening or Enrollment, as determined by the Investigator of Record/designee, has any significant uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or infectious disease.
* Has any of the following laboratory abnormalities at Screening:
* Grade 2 or higher Aspartate aminotransferase, alanine transaminase, creatinine, or Hemoglobin per the DAIDS Table for Grading Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017.
* Has any other condition that, in the opinion of the Investigator of record/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Contacts and Locations

Principal Investigator

Katherine Bunge, MD

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Study Locations (Sites)

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213

United States

Collaborators and Investigators

Sponsor: Rohan, Lisa, PhD

Katherine Bunge, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-18

Study Completion Date2024-12-10

Study Record Updates

Study Start Date2023-10-18

Study Completion Date2024-12-10

Terms related to this study

Keywords Provided by Researchers

Vagina
Film
Placebo

Additional Relevant MeSH Terms

Safety
Acceptability
Usability