AzTrials
AzTrials

SafetyEarly Phase 1NCT06046053

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

A Early Phase 1 study of Safety and Acceptability, run by Rohan, Lisa, PhD at 5 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Safety, Acceptability, Usability
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
5 sitesin 4 countries
Study dates
18 Oct 2023to 10 Dec 2024
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
Show all 25Show fewer
  • 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.

Who cannot join

  • 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.
Show all 21Show fewer
  • 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.

Trial locations and contacts

5 sites in 4 countries.

5 sites in 4 countries

South Africa2 sites

  • Wits Reproductive Health and HIV Institute

    Hillbrow, Johannesburg, 2038

  • The Aurum Institute

    Klerksdorp, North West

Other trials in South Africa

United States1 site

  • Magee-Womens Hospital

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

Kenya1 site

  • Kenya Medical Research Institute

    Nairobi

Other trials in Kenya

Zimbabwe1 site

  • Harare Health and Research Consortium

    Chitungwiza

Other trials in Zimbabwe

About this study

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

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.

Read the 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.

Being tested
Placebo Vaginal Film with Square Corners, Placebo Vaginal Film with Rounded Corners
Keywords
Vagina, Film, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo Vaginal Film with Square CornersDrug

    2" x 2" placebo vaginal film with square corners

  • Placebo Vaginal Film with Rounded CornersDrug

    2" x 2" placebo vaginal film with rounded corners

Study groups in NCT06046053
Study groupRoleWhat they receive
Placebo Vaginal Film with Square CornersExperimentalA single 2" x 2" placebo vaginal film with square corners, inserted intravaginally once monthly for two months.
Receives: Drug: Placebo Vaginal Film with Square Corners
Placebo Vaginal Film with Rounded CornersExperimentalA single 2" x 2" placebo vaginal film with rounded corners, inserted intravaginally once monthly for two months
Receives: Drug: Placebo Vaginal Film with Rounded Corners

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Through study completion, approximately 9 weeks

Secondary outcomes (2)

  1. Number of Participants with Genitourinary Grade 2 or Higher Adverse Events

    Number of participants with genitourinary Grade 2 or higher Adverse Events deemed related to placebo vaginal film use

    Measured: Through study completion, approximately 9 weeks

  2. Number of Participants that Correctly Inserted Vaginal Film

    Number of participants with clinically assessed proper insertion (more than half of the vaginal film proximal to introitus).

    Measured: Through study completion, approximately 9 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2023
  2. Study start18 Oct 2023
  3. Primary completion10 Dec 2024
  4. Study completion10 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06046053
Sponsor's protocol ID
STUDY23040051
Status last verified
Dec 2024
First submitted
13 Sep 2023
Last updated
19 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

  • 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.

    PubMed 32588257

  • 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.

    PubMed 28592183

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study of Safety and Acceptability, run by Rohan, Lisa, PhD at 5 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in South Africa, United States, Kenya, Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Satisfaction with Placebo Vaginal Film Use (time frame: Through study completion, approximately 9 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06046053, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in