A functional performance and acceptability evaluation of  the Miss Liberty female condom  compared to the FC2 female condom.

This study is a cross-over randomized trial to determine the functional performance and acceptability of a 61 mm width synthetic nitrile male  condom in comparison to a 61 mm width standard latex male condom.

This study will  evaluate the functional performance of the Miss Liberty female condom compared to the FC2 female condom.  Primary endpoints will centre on  total clinical failure. In addition, rates of clinical breakage, non-clinical breakage, total breakage, invagination, misdirection and slippage will be calculated for each condom type.  The secondary objectives of the research include safety and acceptability.  The study will start in 2025.

Funder/Sponsors:	Zhejiang Rui Bo 001 High Polymer Co, Ltd
Principal Investigator	Mags Beksinska (Wits MRU)
Co-Investigators	Busi Maphumulo,  Manjeetha Jaggernath
Site:	Wits MRU, Durban

This study is a cross-over randomized trial to determine the functional performance and acceptability of a 61 mm width synthetic nitrile male  condom in comparison to a 61 mm width standard latex male condom.

300 couples will be enrolled in the study- 150 in the USA and 150 at Wits MRU. Each couple will use five of the  new condom type  and compare them to five standard male condoms. The couples will be asked  to complete a condom report at home which collects data  on experience after use of each condom. Function, safety and acceptability will be assessed at two follow-up visits approximately 2 weeks to 1 month apart after enrolment. The study commenced in  2023.

Funder/Sponsors:	Karex Ltd
Principal Investigator	Mags Beksinska (Wits MRU) Fathima Mahomed (Wits MRU)
Co-Investigators	Busi Maphumulo, Naliyum Reddy (Wits MRU)
Site:	Wits MRU, Durban

This study is a cross-over randomized trial to determine the functional performance and acceptability of two synthetic nitrile male  condoms in comparison to a standard latex male condom.

300 couples were enrolled in the study- 150 in the USA and 150 at Wits MRU. Each couple will use five of the  new condom type  and compare them to five standard male condoms. The couples will be asked  to complete a condom report at home which collects data  on experience after use of each condom. Function, safety and acceptability will be assessed at two follow-up visits approximately 2 weeks to 1 month apart after enrolment. The study commenced in June 2023.

Funder/Sponsors:	Karex Ltd
Principal Investigator	Mags Beksinska (Wits MRU) Fathima Mahomed (Wits MRU)
Co-Investigators	Busi Maphumulo, Naliyum Reddy (Wits MRU)
Site:	MRU, Durban

his study was a cross-over randomized trial to determine the functional performance and acceptability of the latex graphene male condom and synthetic nitrile male condom in comparison to the standard latex male condom.

240 couples were enrolled in the study. Each couple was asked to use two new condom types (five of each) and compare them to five standard male condom. The couples were asked to complete a condom log at home which gathered data on experience after use of each condom. Function, safety and acceptability was assessed at three follow-up visits approximately 2 weeks to 1 month apart after enrolment. Data collection was completed in Jan 2022 and data analysis is underway.

 

Funder/Sponsors:	Karex Ltd
Principal Investigator	Mags Beksinska (MRU) Manjeetha Jaggernath (MRU)
Co-Investigators	Jenni Smit (MRU)
Site:	MRU, Durban

Although coloured and scented male condoms have been available for many years in the private and public sector. Female condoms have not been available in different varieties until 2019. Both FC2 and Cupid are available in Strawberry scent (red colour) and Vanilla scent (purple). We conducted   a secondary analysis of choice of scent/colour  of female condoms when female condom users  are offered all types in a condom study. Results will be published  in  2022.

 

Funder/Sponsors:	UNFPA
Principal Investigator	Mags Beksinska (MRU) Jenni Smit (MRU)
Co-Investigators
Site:	MRU, Durban

Male and female condoms are the only available multi-purpose technology (MPT) that provides triple protection,  preventing unintended pregnancy and sexually transmitted infections including HIV.   Rebranding has been shown to be an effective demand-creation strategy for the male condom. Launched in 2015, the Max male condom is now available in four different scents. The female condom has undergone similar branding and is now available as “Maxima”. Now that the rebranded Max/Maxima condoms have been available for several years it would be important to evaluate how these and other brands of condoms are perceived, accessed and used. The aim of this study was to evaluate male and female youth  (16-35 years) condom perceptions with a focus on the perceptions of the Department of Health branded Max/Maxima condoms.  

A  National survey was conducted using an on-line anonymous survey with youth aged 16-35  (male and female) distributed  as a link via  permissions  from collaborating organisations.

Funder/Sponsors:	UNFPA
Principal Investigator	Mags Beksinska (MRU) Jenni Smit (MRU)
Co-Investigators
Site:	MRU, Durban

This randomized comparative prospective follow-up study aims to evaluate contraceptive effectiveness of the Cupid, Cupid 2 and FC2  female condoms.   The contraceptive effectiveness will be determined for 6-12 months. The volunteers will be followed-up monthly for up to twelve months. The primary endpoint will be the occurrence of pregnancy or use of emergency contraception, and the diary information will allow pregnancy rates to be characterised by patterns of condom use and failures (contraceptive efficacy and effectiveness rates).  The study commenced enrolment in November 2019 and a total of 400 women took  part in the study which was completed in November 2021. Analysis is in progress.

 

Funder/Sponsors:	Cupid Ltd & FC2
Principal Investigator	Mags Beksinska (MRU) Jenni Smit (MRU) Ivana Beesham (MRU)
Co-Investigators
Site:	MRU, Durban

Following a pilot function  study in 2017, this main function study was  a two-period, cross-over randomized  trial to determine the functional performance, safety and acceptability of the Wondaleaf female condom in comparison to the FC2 female condom.

220 women were enrolled into the study. Each woman was asked to use five Wondaleaf FCs and five FC2  female condoms  (available in the South African public sector). Women were asked to complete a Condom Log at home which gathered data on experience after use of each condom Function, safety, and acceptability was assessed at two follow-up visits approximately one month apart after enrolment. Data collection was  completed in Oct 2019.

 

Funder/Sponsor:	Twin Catalyst, Malaysia
Principal Investigators:	Dr M Beksinska (MRU) Dr Ivana Beesham (MRU)
Sites:	MRU, Durban

 

The National Female Condom Evaluation was comprised of three complementary components.  Firstly, a national evaluation sample including all STI Sentinel surveillance site in the public sector and a sample of non-public sector sites (NGOs, social marketing, tertiary education and private) participated in a telephone survey and review of distribution statistics. A sub-sample of these sites participated in a more intensive phase involving site visits, client and provider interviews and collection of basic costing data. The second component, a Cohort of approximately 500 new FC acceptors and 60 of their partners, will permit longitudinal assessment of key outcomes related to FC and MC use, HIV-related behaviours, and relationship characteristics. The third component included Key Informant Interviews with policymakers and program managers.   Data collection was completed in 2016 for all components. The study was disseminated in 2017 locally and internationally and is currently being written up for publication.

KEY Publications: Twenty years of the female condom programme in South Africa:  past, present and future.                Beksinska M, Nkosi P, Mabude Z, Smit J, Zulu B, Phungula L, Greener R, Kubeka M, Milford C, Lazarus N, Jali Z, Mantell JE. South African Health Review, 2017.  Chapter 14. In: Padarath A, Barron P, editors. South African Health Review 2017. Durban: Health Systems Trust; 2017. View and download full PDF from their website. 

 

Funder/Sponsor:	USAID Implementation Science Research to Support Programs under PEPFAR
Principal Investigators:	Dr M Beksinska and Prof J Smit (MatCH Research)
Sites:	National Study – all provinces
Collaborators	HIV Centre, University of Columbia, Health Economics and Epidemiology Research Office (HE2RO), University of the Witwatersrand.

In recent years the development of new FC products has become a reality, and several FCs are in various stages of regulatory approval.  Although this has the potential to widen choice and lower product costs, there are other considerations that need to be addressed.

New products vary considerably in design, material and method of insertion and once available, providers and users will need to be trained on the use of new FCs.   Up to 2013, only the FC2 FC was available in South Africa. In 2014, Cupid and the Pleasuremore FC were introduced into some public and non-public sector sites in South Africa. This project commenced in mid-2015.

Funder/Sponsor	Universal Access to Female Condoms Joint Programme (UAFC)
Principal Investigators:	Dr M Beksinska, Prof J Smit (MatCH Research)
Sites:	National

In recent years the development of new FC products has become a reality, and several FCs are in various stages of regulatory approval.  Although this has the potential to widen choice and lower product costs, there are other considerations that need to be addressed.

New products vary considerably in design, material and method of insertion and once available, providers and users will need to be trained on the use of new FCs.   Up to 2013, only the FC2 FC was available in South Africa. In 2014, Cupid and the Pleasuremore FC were introduced into some public and non-public sector sites in South Africa. This project commenced in mid-2015.

Funder/Sponsor:	Bill and Melinda Gates Foundation via Origami Healthcare Products
Principal Investigators:	Dr M Beksinska and Prof J Smit (MatCH Research)
Sites:	MatCH Research Commercial City Site and an NGO in Durban

Following a pilot function  study in 2017, this main function study was  a two-period, cross-over randomized  trial to determine the functional performance, safety and acceptability of the Wondaleaf female condom in comparison to the FC2 female condom.

220 women were enrolled into the study. Each woman was asked to use five Wondaleaf FCs and five FC2  female condoms  (available in the South African public sector). Women were asked to complete a Condom Log at home which gathered data on experience after use of each condom Function, safety, and acceptability was assessed at two follow-up visits approximately one month apart after enrolment. Data collection was  completed in Oct 2019 and data analysis is underway.

Results are expected in the 1^st quarter of 2020

 

Funder/Sponsor:	Twin Catalyst, Malaysia
Principal Investigators:	Dr M Beksinska (MRU) Dr Ivana Beesham (MRU)
Sites:	MRU, Durban

This project will ascertain the functional performance of the adapted Woman’s Condom design (WC2) without the foam dots. The purpose of the proposed research is to conduct and test the WC2 and provide the study results to PATH and the manufacturer for consideration of any potential design changes to the device.  277 urban, sexually-active women who are experienced users of Female Condoms will be recruited from the Commercial City Family Planning Clinic in Durban, where previous studies of the WC/WC2 have been conducted.

Funder/Sponsor:	PATH and UAFC
Principal Investigators:	Dr M Beksinska and Prof J Smit
Sites:	Commercial City Site

The SILCS Diaphragm is a new single-size, reusable cervical barrier. Since diaphragms are used with contraceptive gel to improve effectiveness, researchers are interested in assessing the SILCS Diaphragm as a delivery system for microbicide gel. The SILCS diaphragm has regulatory approval in Europe, and applications for regulatory approval are underway in the United States and Canada.

This study evaluated use and acceptability of the SILCS Diaphragm compared to standard vaginal applicators for delivery of a placebo vaginal gel.  In this randomized crossover study, 115 female participants were randomized to use the SILCS Diaphragm with placebo gel followed by use of vaginal applicators to deliver placebo gel directly into the vagina, or vice versa. The use and acceptability of both methods of gel delivery was assessed. A sub-sample of male partners were recruited to gather issues of partner acceptability. The findings and results have been published in the Aids and Behaviour Scientific Journal and online.

  

Funder/Sponsor:	USAID via Program for Appropriate Technology in Health (PATH)
Principal Investigators:	Dr M Beksinska and Prof J Smit (MatCH Research)
Site:	MatCH Research Commercial City Site

New designs of female condoms (FCs) have been developed to lower cost and/or improve acceptability. To secure regulatory approvals, clinical studies are required to verify performance. This study assessed the functional performance and safety of two new FC types- Velvet, and Cupid2 FC-against the existing FC2 FC.   This was a three-period crossover, randomized non-inferiority clinical trial with 300 women randomized to condom type order in one South African site.  Participants were asked to use 5 of each FC type and interviewed after use of each type. The results found non-inferiority was demonstrated for all condom failure modes for the two new FCs with respect to FC2 within the margin of 3% difference in mean failure, at the 5% significance level. These data are used to support manufacturer dossiers for WHO/UNFPA pre-qualification.  Results of the trial have been recently submitted for publication.

Funder/Sponsor	Universal Access to Female Condoms Joint Programme UAFC, I+Solutions
Principal Investigators:	Dr M Beksinska and Prof J Smit (MatCH Research)
Site:	MatCH Research Commercial City Site

There is no published data on the performance of the Panty Condom (PC). We conducted a pilot study among experienced Female Condom users in Durban, South Africa to assess the functional performance of the PC.  Nineteen participants were recruited and returned for a follow-up survey after five uses of the PC.  Results of the trial have been recently submitted for publication.

Funder/Sponsor	Universal Access to Female Condoms Joint Programme (UAFC), I+Solutions
Principal Investigators:	Dr M Beksinska and Prof J Smit (MatCH Research)
Site:	MatCH Research Commercial City Site

The Woman’s Condom (WC) developed by PATH is an innovative female condom design.  The WC has achieved regulatory approvals in Europe (CE Mark) and China (Shanghai FDA) and has SABS approval in South Africa. This study explored the uptake and acceptability among potential consumer groups and distribution channels. This has helped to inform and identify potential target markets, and collect consumer feedback on the product, packaging, promotion, price, and the feasibility of future distribution channels.   Data was collected from women and men who are potential users or users (as part of this study) of the WC obtained from a range of distribution channels (private companies, NGOs and a university clinic). Findings and results have been published by PATH, download the PDF from their website.

Funder/Sponsor:	Program for Appropriate Technology in Health (PATH)
Principal Investigators:	Prof J Smit (MatCH Research)
Sites:	Durban tertiary Education, NGO and private companies

 

The Woman’s Condom (WC) developed by PATH is an innovative female condom design. We continue to conduct functional performance studies of the Woman’s Condom design.

Funder/ Sponsor:	Program for Appropriate Technology in Health (PATH)
Principal Investigators:	Dr M Beksinska (MatCH Research)
Site:	MatCH Research Commercial City Site