Barrier methods current projects

Female Condom Contraceptive (CoCo) Study

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 months. The volunteers will be followed-up monthly for up to seven 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 780 women will take part in the study.

Funder/Sponsors: Cupid Ltd & FC2
Principal Investigator Mags Beksinska (MRU)
Jenni Smit (MRU)
Ivana Beesham (MRU)
Co-Investigators
Site: MRU, Durban
A Randomized Crossover Trial of the Functional Performance, Safety and Acceptability of the Wonderleaf Condom

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 1st quarter of 2020

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

Dr Ivana Beesham (MRU)

Sites: MRU, Durban

 

Completed Studies

Evaluation of the National South African Female Condom Program: Investigating Factors Associated with Uptake and Sustained Use

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. 

 

National Female COndom Evaluation site

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.

Completed Barrier Method Projects

Introduction of New Female Condom Products: Lessons from Dual Programming in South Africa.

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

A Randomized Crossover Trial of the Functional Performance, Safety and Acceptability of the Origami Internal Condom

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

A Functional Performance Study of The Wondaleaf Female Condom

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 1st quarter of 2020

 

Funder/Sponsor: Twin Catalyst, Malaysia
Principal Investigators: Dr M Beksinska (MRU)
Dr Ivana Beesham (MRU)
Sites: MRU, Durban
A Functional Performance Study of the Woman's Condom 2: An adapted design of the Woman's Condom

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

SILCS Diaphragm: A Randomized Cross-over Study Evaluating the Use and Acceptability of SILCS Diaphragm Compared to Vaginal Applicators for Placebo Gel Delivery

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.

BarrierMethods black

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

A Randomized Controlled Trial of the Functional Performance and Safety of the Velvet, FC2 and Cupid2 Female Condoms.

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

A Pilot Study Evaluating the Functionality of the Panty Condom

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.

Panty condom

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

Potential Distribution Channels for the Woman's Condom

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.

Womens-Condom-Distribution-day

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

 

Functional Performance Study of The Woman’s Condom

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