A Functional Performance and Acceptability Evaluation of the Miss Liberty Female Condom Compared to the FC2 Female Condom
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 235
- Locations
- 2
- Primary Endpoint
- Clinical slippage
Study Overview
Brief Summary
The purpose of the study is to evaluate the functional performance and acceptability of the Miss Liberty female condom version 1 (Miss Liberty female condom), compared to the FC2 female condom.
The study will be a sequential randomised 2-period cross-over trial comparing five uses of the Miss Liberty female condom, compared to the control FC2 female condom. Each woman will be asked to use five Miss Liberty female condoms, and five FC2 control female condoms in a randomised order. Woman will complete a Condom Use Report after each condom use. Function, safety, and acceptability will be assessed at each of two follow-up visits conducted after using each set of five condoms. The trial will enrol 235 women between 18-45 years old.
The primary objective is to ascertain the functional performance of the Miss Liberty female condom compared to the control FC2 female condom. The secondary objectives are to determine the acceptability and safety (as determined by the number of adverse events) for the Miss Liberty female condom compared to the FC2 female condom.
Detailed Description
The purpose of the study is to evaluate the functional performance and acceptability of the Miss Liberty female condom version 1 (Miss Liberty female condom), compared to the FC2 female condom.
This research study will be a two-period, cross-over randomized controlled trial to compare the functional performance, safety and acceptability of two female condom types. Enrolled women will be asked to use five FC2, or five Miss Liberty female condoms in each study period provided to them in random order according to one of two possible sequences of each condom type. A Condom Use report will be completed after each condom use and a Condom Acceptability Questionnaire will be completed at the end of each study period after use of each set of five study condoms.
If a woman expresses interest in participating, she will be given the study information sheet to read, which will describe the study requirements including her role in the study. If she agrees to take part in the research, she will be invited to the Wits MRU Commercial City site and asked to provide written informed consent.
A physical examination will be undertaken to exclude visible symptoms of sexually transmitted infection. If symptoms are observed the participant will be referred to a Department of Health clinic or their doctor for treatment. A urine pregnancy test will be conducted at screening to exclude pregnancy. Woman will need to provide a copy of HIV testing results which are not older than two months. If HIV testing results are not available, voluntary HIV counselling and testing will be offered and conducted by study staff. Woman will be counselled on Pre Exposure Prophylaxis (PrEP) and referred to a local facility that provides PrEP should they wish to initiate PrEP.
The consent process and all checklists, condom use reports and questionnaires used in the research will be written and conducted in a language that is understandable to the participant, and all relevant documents will be translated into isiZulu.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Masking Description
The statistician preparing the randomization sequences and analyzing the data will remain masked while developing and testing the analysis programs and procedures and drafting the preliminary study report.
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Be between the ages of 18 and 45 years (inclusive);
- •Be of female sex and gender
- •Be literate (able to read a newspaper or letter easily);
- •Have been in an exclusive (monogamous) heterosexual sexual relationship with a male partner partner for at least 3 months; and intend to continue to be an exclusive (monogamous) sexual relationship with their spouse or partner while participating in this research study;
- •Be sexually active (defined as having at least one vaginal coital act per week);
- •Willing to give informed consent;
- •Willing to complete the female condom coital use reports;
- •Willing to use the study condoms as directed;
- •Agree to only use the study condoms sequentially during time of participation
- •Willing to adhere to the follow-up schedule and all study procedures;
- •Willing to provide research study staff with an address, phone number or other locator information while participating in the study;
- •Willing to participate in the study for the duration of 10 condom uses (approximately 2- 3 months);
- •Willing to have a fingerprint scan to exclude co-enrolment in other research projects;
- •Using hormonal or other non-barrier contraception (e.g. Oral Contraceptives, injectables, implant, Intrauterine device (IUD), or have had a tubal sterilization) or male partner vasectomised;
- •Agree to return any unopened condoms;
- •Agree to not bring study condoms in contact with genital or oral piercing jewelry;
- •Able to understand instructions for correct use of female condoms;
- •Agree not to use male condoms when using the female condom in a single sex act.
Exclusion Criteria
- •Woman is pregnant or desires to become pregnant during the time of the research study;
- •Known to be HIV positive by self report;
- •Self-reported history of current sexually transmitted infection (e.g. gonorrhea, syphilis, Chlamydia);
- •Female (or reports her partner) has genital piercing jewelry, uses genital beading or uses sex toys, drugs, medications or non-study devices that can affect sexual performance;
- •Female (or reports her partner) has known sensitivities or allergies to latex, synthetic nitrile, vaginal/sexual lubricants or lubricants used on condoms;
- •Female has symptoms of a sexually transmitted infection (STI).
- •Male partner has known erectile or ejaculatory dysfunction;
- •Is a past or current employee of the University of the Witwatersrand or Miss Liberty Ltd;
Outcomes
Primary Outcomes
Clinical slippage
Time Frame: 2-3 months
Defined as an instance when a female condom slips completely out of the vagina during sexual intercourse. The clinical slippage rate is calculated by dividing the number of female condoms that slipped by the number of female condoms used during sexual intercourse.
Clinical misdirection
Time Frame: 2-3 months
Defined as vaginal penetration whereby the penis is inserted between the female condom and the vaginal wall. The clinical misdirection rate is calculated by dividing the number of reported events of misdirection by the number of female condoms used during sexual intercourse.
Clinical breakage
Time Frame: 2-3 months
Defined as breakage or tearing of the female condom during sexual intercourse or during withdrawal from the vagina. Clinical breakage is breakage with potential adverse clinical consequences. The clinical breakage rate is calculated by dividing the number of female condoms reported to have broken or torn during sexual intercourse or during withdrawal by the number of female condoms used during sexual intercourse.
Clinical invagination
Time Frame: 2-3 months
Defined as an instance when the external retention feature of the female condom is partially or fully pushed into the vagina during sexual intercourse. The clinical invagination rate is calculated by dividing the number of events of invagination by the number of female condoms used during sexual intercourse.
Total clinical failure
Time Frame: 2-3 months
Defined as the sum of female condoms with at least one clinical failure event (clinical breakage, clinical slippage, clinical misdirection, clinical invagination) clinically break or additional failure modes(s) identified in the risk assessment which results in the reduction of the female condom protective function. The total clinical failure rate is calculated by dividing the number of female condoms with a clinical failure by the number of female condoms used during sexual intercourse.
Secondary Outcomes
- Total breakage(2-3 months)
- Non-Clinical breakage(2-3 months)
- Condom Safety(2-3 months)
- Acceptability(2-3 months)
- Non-Clinical slippage(2-3 months)
Investigators
Prof Mags Beksinska
Executive Director
University of Witwatersrand, South Africa