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Placebo Vaginal Films for HIV Prevention Acceptability

Q: Does this clinical research offer enrollment to individuals aged 70 and above?

Participants for this trial must be aged 18 years or above, and below the age of 45.

Q: What are the prerequisites for joining this scientific experiment?

To be eligible, those participating must demonstrate a suitable level of safety and fall in the age range between 18 to 45. 100 people are allowed to take part in this experiment.

Q: Is this research endeavor actively seeking participants?

According to the clinicaltrials.gov database, this particular trial is no longer recruiting patients. It was posted on October 1st, 2023 and last edited on September 20th, 2023; however there are 28 other medical studies actively looking for participants at present.

Q: Are there any institutes in the US currently conducting this trial?

There are 5 participating clinical trials, located at the Kenya Medical Research Institute in Nairobi, Wits Reproductive Health and <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a> Institute in Hillbrow, The Aurum Institute in Klerksdorp and two other sites.

Phase < 1

Recruiting

Led By Katherine Bunge, MD

Research Sponsored by Rohan, Lisa, PhD

Eligibility Criteria Checklist

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

Must have

Assigned female sex at birth

-- Hormonal methods except vaginal rings

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, approximately 9 weeks

Awards & highlights

Study Summary

This trial studies how safe & acceptable two placebo vaginal films (no active medicine, same size but different shape) are for HIV prevention in 100 people from the US, Kenya, SA & Zimbabwe. Involves 10 visits/calls & in-depth interviews with participants & partners over 9 weeks.

Who is the study for?

The MATRIX-002 trial is for HIV-negative individuals, aged 18-45, assigned female at birth. Participants must be sterilized or use effective contraception, abstain from sexual activity in the first month and avoid other vaginal products. They should not have a history of significant health issues or drug abuse that could affect the study.Check my eligibility

What is being tested?

This trial tests the acceptability and safety of two placebo vaginal films (without active medication), differing only by having square or rounded corners. Participants will self-insert these films twice over two months and attend ten visits including interviews about their experience.See study design

What are the potential side effects?

Since both vaginal films are placebos without any active medication, they are expected to have minimal side effects. However, participants may experience discomfort or mild reactions related to film insertion which will be closely monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

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

Select...

I was assigned female at birth.

Select...

I use birth control methods other than vaginal rings.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, approximately 9 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, approximately 9 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approximately 9 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 Vaginal Film Use

Secondary outcome measures

Number of Participants that Correctly Inserted Vaginal Film

Number of Participants with Genitourinary Grade 2 or Higher Adverse Events

Other outcome measures

Mean Change in Nugent Score

Mean Change in Vaginal pH

Trial Design

2Treatment groups

Experimental Treatment

Group I: Placebo Vaginal Film with Square CornersExperimental Treatment1 Intervention

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

Group II: Placebo Vaginal Film with Rounded CornersExperimental Treatment1 Intervention

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

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Rohan, Lisa, PhDLead Sponsor

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

Katherine Bunge, MDPrincipal InvestigatorUniversity of Pittsburgh

7 Previous Clinical Trials

696 Total Patients Enrolled

2 Trials studying Safety

67 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.

Does this clinical research offer enrollment to individuals aged 70 and above?

"Participants for this trial must be aged 18 years or above, and below the age of 45."

Answered by AI

What are the prerequisites for joining this scientific experiment?

"To be eligible, those participating must demonstrate a suitable level of safety and fall in the age range between 18 to 45. 100 people are allowed to take part in this experiment."

Answered by AI

Is this research endeavor actively seeking participants?

"According to the clinicaltrials.gov database, this particular trial is no longer recruiting patients. It was posted on October 1st, 2023 and last edited on September 20th, 2023; however there are 28 other medical studies actively looking for participants at present."

Answered by AI

Are there any institutes in the US currently conducting this trial?

"There are 5 participating clinical trials, located at the Kenya Medical Research Institute in Nairobi, Wits Reproductive Health and HIV Institute in Hillbrow, The Aurum Institute in Klerksdorp and two other sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Katherine Bunge 2023. "MATRIX-002: Trial to Assess Acceptability and Safety of Two Placebo Vaginal Films". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06046053.