← Back to Search

Placebo Intravaginal Rings for Acceptability and Safety (MATRIX-003 Trial)

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

Must not have

Clinically apparent Grade 2 or higher pelvic exam finding at Enrollment

Prior use of post-exposure prophylaxis or oral pre-exposure prophylaxis in the past 4 weeks or any prior use of long-acting systemic pre-exposure prophylaxis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, approximately 11 weeks

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My pelvic exam showed a noticeable issue of Grade 2 or higher.

Select...

I have used HIV prevention medication recently or in the past.

Select...

I haven't taken antibiotics, steroids, or antifungals in the last 14 days.

Select...

I have had a hysterectomy.

Select...

My blood tests show high levels of liver enzymes or creatinine, or low hemoglobin.

Select...

I am currently being treated for a urinary or reproductive tract infection.

Select...

I have a serious ongoing illness or infection that is not under control.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Satisfaction with Placebo Intravaginal Ring Use

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

Secondary study objectives

Number of Participants with Genitourinary Grade 2 or Higher Adverse Events

Other study objectives

Mean Change in Nugent Score

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 / 11Eligibility criteria met