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Placebo Intravaginal Ring B for Safety (MATRIX-003 Trial)

Q: Is enrollment in this research endeavor open to me?

To be considered for inclusion, potential candidates must meet safety requirements and fall within the 18-45 age range. In total, 100 individuals are needed to complete this experiment.

Q: Is the age criterion for this clinical trial exceeding fifty-five years?

To be eligible for this trial, applicants must fall within the age range of 18 to 45. Furthermore, there are three studies designated specifically for patients below 18 and 19 trials dedicated to those above 65 years old.

Q: How many locations are currently managing this clinical investigation?

At present, this clinical trial is occuring in 5 different sites: Hillbrow, Pittsburgh and Chitungwiza to name a few. Picking the site closest to you can help reduce travel burden if you decide to enrol.

Q: Is this clinical experiment actively recruiting participants?

Reportedly, the clinical trial posted on January 1st 2024 is not currently recruiting. The last update occurred at the end of November 2023. Nevertheless, there are 25 other studies that have open recruitment periods at this time.

Phase < 1

Recruiting

Led By Catherine A Chappell, MD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must be either not currently sexually active or in a mutually monogamous relationship with only one partner who is not known to be HIV positive or to currently have a sexually transmitted infection

Able and willing to comply with all protocol requirements including abstaining from other intravaginal products or practices for the duration of the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, approximately 11 weeks

Awards & highlights

MATRIX-003 Trial Summary

This trial is researching two types of rings to see if they are easy, comfortable, and safe for women to use. It includes 100 participants from the US, SA, and Zimbabwe. It involves 7 visits and 2 calls over 9-11 weeks. Participants and partners are interviewed to assess acceptability.

Who is the study for?

This trial is for HIV-negative women aged 18-45, who are not pregnant or planning to become so, and are either not sexually active or in a monogamous relationship. They must be willing to avoid other vaginal products and abstain from sex for the first two weeks of each ring use period.Check my eligibility

What is being tested?

The study tests the comfort and safety of two non-medicated intravaginal rings that differ in flexibility. Participants will try each ring for four weeks with a break between uses, while also providing feedback through interviews and undergoing health checks.See study design

What are the potential side effects?

Since both rings are placebos without medication, major side effects aren't expected. However, participants may experience discomfort or minor reactions related to the physical presence of the ring.

MATRIX-003 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am not sexually active or only have one sexual partner who does not have HIV or any STIs.

Select...

I can follow all study rules and avoid using other vaginal products or practices.

Select...

I was assigned female at birth.

Select...

I am 18 years old or older.

MATRIX-003 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, approximately 11 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, approximately 11 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approximately 11 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean Satisfaction with Placebo Intravaginal Ring Use

Number of Participants Preferring to Use Placebo Intravaginal Ring A versus Ring B

Secondary outcome measures

Number of Participants with Genitourinary Grade 2 or Higher Adverse Events

Other outcome measures

Mean Change in Nugent Score

MATRIX-003 Trial Design

2Treatment groups

Experimental Treatment

Group I: Sequence: Placebo Intravaginal Ring B followed by Placebo Intravaginal Ring AExperimental Treatment2 Interventions

Placebo Intravaginal Ring B will be inserted and used for 28 days, Ring B will be removed and followed by no intravaginal ring use for 7-21 days. Then Placebo Intravaginal Ring A will be inserted and used for 28 days.

Group II: Sequence: Placebo Intravaginal Ring A followed by Placebo Intravaginal Ring BExperimental Treatment2 Interventions

Placebo Intravaginal Ring A will be inserted and used for 28 days, Ring A will be removed and followed by no intravaginal ring use for 7-21 days. Then Placebo Intravaginal Ring B will be inserted and used for 28 days.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Oak Crest Institute of ScienceOTHER

2 Previous Clinical Trials

25 Total Patients Enrolled

University of PittsburghLead Sponsor

1,723 Previous Clinical Trials

16,342,856 Total Patients Enrolled

United States Agency for International Development (USAID)FED

202 Previous Clinical Trials

1,477,344 Total Patients Enrolled

1 Trials studying Safety

100 Patients Enrolled for Safety

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment in this research endeavor open to me?

"To be considered for inclusion, potential candidates must meet safety requirements and fall within the 18-45 age range. In total, 100 individuals are needed to complete this experiment."

Answered by AI

Is the age criterion for this clinical trial exceeding fifty-five years?

"To be eligible for this trial, applicants must fall within the age range of 18 to 45. Furthermore, there are three studies designated specifically for patients below 18 and 19 trials dedicated to those above 65 years old."

Answered by AI

How many locations are currently managing this clinical investigation?

"At present, this clinical trial is occuring in 5 different sites: Hillbrow, Pittsburgh and Chitungwiza to name a few. Picking the site closest to you can help reduce travel burden if you decide to enrol."

Answered by AI

Is this clinical experiment actively recruiting participants?

"Reportedly, the clinical trial posted on January 1st 2024 is not currently recruiting. The last update occurred at the end of November 2023. Nevertheless, there are 25 other studies that have open recruitment periods at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial to Assess Acceptability and Safety of Two Placebo Intravaginal Rings

Catherine Anne Chappell 2024. "Trial to Assess Acceptability and Safety of Two Placebo Intravaginal Rings". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06163274.

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