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

NCT06046053 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-12-19

No results posted yet for this study

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

Interventions

DRUG

Placebo Vaginal Film with Square Corners

2" x 2" placebo vaginal film with square corners

DRUG

Placebo Vaginal Film with Rounded Corners

2" x 2" placebo vaginal film with rounded corners

Sponsors & Collaborators

  • United States Agency for International Development (USAID)

    collaborator FED

  • Rohan, Lisa, PhD

    lead OTHER

Principal Investigators

  • Katherine Bunge, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-18
Primary Completion
2024-12-10
Completion
2024-12-10
FDA Drug
Yes

Countries

  • United States
  • Kenya
  • South Africa
  • Zimbabwe

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06046053 on ClinicalTrials.gov