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

NCT06046053 | Completed Early Phase 1 FDA Drug

• 1 other identifier: STUDY23040051
• Study Type: interventional
• Target: 100
• Locations: 4 countries
• Sites: 5

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.

Conditions

Safety; Acceptability; Usability

Keywords

Vagina; Film; Placebo

Outcome Measures

Primary Outcomes (1)

• Mean Satisfaction with Placebo Vaginal Film Use

  Satisfaction will be assessed using a 10-point Likert scale with 0 being the least satisfied and 10 being the most satisfied

  Through study completion, approximately 9 weeks

Secondary Outcomes (2)

• 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

Other Outcomes (2)

• Mean Change in Vaginal pH

  Through study completion, approximately 9 weeks

• Mean Change in Nugent Score

  Through study completion, approximately 9 weeks

Study Arms (2)

Placebo Vaginal Film with Square Corners

EXPERIMENTAL

A single 2" x 2" placebo vaginal film with square corners, inserted intravaginally once monthly for two months.

Drug: Placebo Vaginal Film with Square Corners

Placebo Vaginal Film with Rounded Corners

EXPERIMENTAL

A single 2" x 2" placebo vaginal film with rounded corners, inserted intravaginally once monthly for two months

Drug: Placebo Vaginal Film with Rounded Corners

Interventions

Placebo Vaginal Film with Square Corners DRUG

2" x 2" placebo vaginal film with square corners

Placebo Vaginal Film with Square Corners

Placebo Vaginal Film with Rounded Corners DRUG

2" x 2" placebo vaginal film with rounded corners

Placebo Vaginal Film with Rounded Corners

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rohan, Lisa, PhD: lead
• United States Agency for International Development (USAID): collaborator

Study Sites (5)

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Kenya Medical Research Institute

Nairobi, Kenya

Location

Wits Reproductive Health and HIV Institute

Hillbrow, Johannesburg, 2038, South Africa

Location

The Aurum Institute

Klerksdorp, North West, South Africa

Location

Harare Health and Research Consortium

Chitungwiza, Zimbabwe

Location

Related Publications (3)

• Acceptability Study of Vaginal Films for HIV Prevention (FACE). https://clinicaltrials.gov/ct2/show/NCT01231763?term=NCT01231763&draw=2&rank=1. Accessed February 23, 2023.

  BACKGROUND

• Musara P, Milford C, Shapley-Quinn MK, Weinrib R, Mutero P, Odoom E, Mgodi NM, Chirenje ZM, Hanif H, Clark MR, Smit J, van der Straten A, Montgomery ET; Quatro Study Team. Preferences and Acceptability of Vaginal Delivery Forms for HIV Prevention Among Women, Male Partners and Key Informants in South Africa and Zimbabwe: Qualitative Findings. AIDS Behav. 2021 Jan;25(1):124-138. doi: 10.1007/s10461-020-02949-4.

  PMID: 32588257 BACKGROUND

• Guthrie KM, Rohan L, Rosen RK, Vargas SE, Shaw JG, Katz D, Kojic EM, Ham AS, Friend D, Buckheit KW, Buckheit RW Jr. Vaginal film for prevention of HIV: using visual and tactile evaluations among potential users to inform product design. Pharm Dev Technol. 2018 Mar;23(3):311-314. doi: 10.1080/10837450.2017.1339085. Epub 2017 Jun 21.

  PMID: 28592183 BACKGROUND

Study Officials

• Katherine Bunge, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Since the two films will differ by shape, masking is not possible once the product is removed from packaging for the participant and clinicians assessing the clinical outcomes. However, the assessors of the vaginal microenvironment endpoints will be masked as to product assignment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomized (1:1) to insert either placebo vaginal film A or placebo vaginal film B once monthly for two months. Films A and B are 2" x 2" in size and differ only by shape (square versus rounded corners).

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 21, 2023
• Study Start: October 18, 2023
• Primary Completion: December 10, 2024
• Study Completion: December 10, 2024
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); ZI (1); ZA (2); KE (1)