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.

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.

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.

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.

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.

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.

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. 

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.

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.

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

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.

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.