Evaluation of the National South African Female Condom Program: Investigating Factors Associated with Uptake and Sustained Use
The National Female Condom Evaluation is 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) is participating in a telephone survey and review of distribution statistics. A sub-sample of these sites is participating 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 includes Key Informant Interviews with policymakers and program managers. Data collection is progressing well. Telephonic interviews were completed in 2015. In-depth facility audits are ongoing and will be completed by July 2016.
The cohort of FC users and a sub-set of their partners is ongoing and all participants will have completed this component by August 2016.
Preliminary data was presented at the Global FC Conference held in December 2015.
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 was introduced into some public and non-public sector sites in South Africa. This project is in the planning phase and will assess the introduction of new FC products in South Africa through interviews with providers and clients, commencing in mid-2015.
Universal Access to Female Condoms Joint Programme (UAFC)
A Randomized Crossover Trial of the Functional Performance, Safety and Acceptability of the Origami Internal Condom
The Origami Internal Condom is a new condom that has been designed to be used for either anal or vaginal sexual intercourse. This randomized comparative cross-over trial will evaluate functional performance, safety and acceptability of the Origami internal condom compared to FC2. The study will enrol 28 couples (14 heterosexual for vaginal use and 14 homosexual for anal use) agreeing to use 5 each of the 2 condom types. The fieldwork will commence in mid-2015.
Bill and Melinda Gates Foundation via Origami Healthcare Products
Dr M Beksinska and Prof J Smit (MatCH Research)
MatCH Research Commercial City Site and an NGO in 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.
A Functional Performance Study of The Wondaleaf Female Condom
The purpose is to ascertain the functional performance of the Wondaleaf FC. The study will enrol 55 women, anticipating that 50 women complete the study. 55 Urban, sexually-active women who are experienced users of FCs will be recruited from the Commercial City MatCH Research Unit site, where previous studies have been conducted.
Each woman will be asked to use 5 Wondaleaf FCs and 5 FC2 female condoms( available in the South African public sector). Function, safety and acceptability will be assessed at two follow-up visits approximately one month after enrolment. Women will complete a Condom Log at home which gathers data on experience after use of each condom.
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.
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. Fieldwork is now complete and data analysis is in progress.
USAID via Program for Appropriate Technology in Health (PATH)
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.
Universal Access to Female Condoms Joint Programme UAFC, I+Solutions
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.
Universal Access to Female Condoms Joint Programme (UAFC), I+Solutions
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 will explore uptake and acceptability among potential consumer groups and distribution channels. This will help inform and identify potential target markets, and collect consumer feedback on the product, packaging, promotion, price, and the feasibility of future distribution channels. Data is being 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). Fieldwork is currently in progress.
Program for Appropriate Technology in Health (PATH)
Prof J Smit (MatCH Research)
Durban tertiary Education, NGO and private companies