Functional performance study of an adapted design of the woman’s condom: a crossover,noninferiority, randomized clinical trial

Objectives: We aimed to assess the functional performance and safety of a modified Woman’s Condom (WC2) against the existing FC2 female condom.

Study design: This randomized clinical trial enrolled 287 women in one South African site. The primary outcome of the study was the rate of female condom failure. Participants were asked to use five of each female condom type and to collect information on use in a condom log at home and were interviewed after use of each FC type.

Results: Noninferiority was demonstrated for the WC2 with respect to the reference condom FC2 for all condom functions. The WC2 was found to be superior to the FC2 reference condom for clinical failure (p?=?.000), total female condom failure (p?=?.001), misdirection (p?=?.000) and slippage (p?=?.004).

Conclusion: The WC2 female condom performs as well as the FC2 female condom and offers good stability during use.

Implications: Results from this study will inform further refinement of this female condom design, resulting in a new and potentially less expensive Woman’s Condom.     

Missed opportunities: emergency contraception utilisation by young south African women

Although contraceptives, including emergency contraceptives, are widely available free at public health facilities in South Africa, rates of teenage and unintended pregnancy are high. This paper analyses awareness and utilisation of emergency contraception amongst 193 young women (aged 15-24 years) attending public sector health facilities. Structured interviews were held at 17 and 14 primary health clinics in an urban and a rural area respectively. Respondents were asked about their knowledge of contraceptive methods and use, and specifically about emergency contraceptive utilisation. More sexually active young urban women (76%) were currently using a method of contraception, compared to the young rural women (53%). Only 17% had ever heard of emergency contraception, although significantly more in the urban area (p = 0.005) had heard of it. Only one woman from each site had ever used emergency contraception, although 39% had had unprotected intercourse in the previous year when they did not wish to conceive. Young South African women should be the focus of interventions aimed at improving awareness of the availability of emergency contraception and knowledge about its correct utilisation.     

Structural integrity of the female condom after multiple uses, washing, drying, and re-lubrication

Establishing the safety of re-using the female condom could significantly increase women's access to barrier methods especially in poorer countries. In this study, the structural integrity of female condoms was tested (n = 295) after multiple acts of vaginal intercourse. Fifty women were recruited to the study. Each woman re-used one condom up to eight times and washed, dried, and re-lubricated between each use. Structural integrity was measured using standard quality control testing; water-leakage, air-burst, and seam tensile strength. All results were compared to the United States Food and Drug Administration (US FDA) standards for an unused female condom. The results of the structural integrity tests for all cycles were above the FDA minimum standards for seam strength and burst tests. There was no deterioration detected in condoms used 8 times when compared to new female condoms in these tests. Five holes were detected by the water leakage test across all cycles, of which three were detected by the subjects themselves and reported to the investigators, therefore, giving a breakage rate of 1.7%. The holes were not associated with increased number of uses. This study provides further evidence that suggests the structural integrity of the female condom after multiple use is still within FDA minimum standards, although random holes resulting from handling occur infrequently with the re-use procedure.     

Use of modern and traditional products to self-treat symptoms of sexually transmitted infections in South African women

The objective of the study is to investigate products used by women self-treating symptoms of reproductive tract infections (RTIs), including sexually transmitted infections (STIs), and their methods of administration. A household survey using a multi-stage cluster sample design was undertaken in KwaZulu-Natal, South Africa. Women aged 18-60 years were interviewed (n = 867) and information was collected on demographics, reproductive health and sexual behaviours. A fifth of women reported having RTI/STI symptoms (20.5%), of whom 41.9% were treating these symptoms (mostly discharge [79.1%], ulcers [6.8%] and itching [7.7%]). Only three women were using medication prescribed by a health provider, while the remainder were self-treating using traditional medicines and modern products, including antiseptics, soaps, petroleum jelly, menthol creams and alum. Products were administered in various ways. Although RTI/STI treatment is widely available and free in public health facilities, many women are still self-treating. Potential harm of products for self-treatment requires further investigation and efforts should be made to improve STI service uptake.     

Standardized definitions of failure modes for female condoms

Definitions of male condom failure modes are now well documented, and failure events are usually reported as the proportion of the total number of condoms used and the proportion of men/couples who experience an event. The lack of standardized definitions for female condom (FC) failure has led to variability in reporting and hence difficulties in making comparisons across studies. As a result, the World Health Organization convened a technical review committee meeting in January 2006 through which the members compiled and agreed to a standard list of terms and definitions for each of the failure modes. These failure modes apply to FCs currently marketed or in advanced stages of clinical testing. They were designed to assist in the review and comparative assessment of different FCs.     

Predictors of vaginal practices for sex and hygiene in KwaZulu-Natal, South Africa: findings of a household survey and qualitative inquiry

Vaginal practices in sub-Saharan Africa may increase HIV transmission and have important implications for development of microbicides and future HIV prevention technologies. It remains unclear which women undertake vaginal practices and what factors predict prevalence, practice type and choice of products. Using cross-sectional data from mixed research methods, we identify factors associated with vaginal practices among women in KwaZulu-Natal, South Africa. Data were gathered through focus group discussions, in-depth and key-informant interviews, followed by a province-wide, multi-stage cluster household survey, using structured questionnaires in face-to-face interviews with 867 women. This paper details six types of vaginal practices, which--despite their individual distinctiveness and diverse motivations--may be clustered into two broad groups: those undertaken for purposes of 'hygiene' (genital washing, douching and application) and those for 'sexual motivations' (application, insertion, ingestion and incisions). Multivariate analysis found significant associations between 'hygiene' practices and media access, religiosity and transactional sex. 'Sexual' practices were associated with partner concurrency, religiosity and use of injectable hormonal contraceptives. Future interventions relating to vaginal practices as well as microbicides need to reflect this characterisation of practices as sexual- and/or hygiene-related.     

Placing contraception at the centre of the HIV prevention agenda

Over the past decade, the global response to the HIV epidemic has been unprecedented, and enormous progress has been made. Significant investment in the roll out of antiretroviral treatment (ART) and efforts to increase treatment coverage have greatly reduced the number of AIDS-related deaths worldwide. There are a growing number of promising innovations to expand the HIV prevention mix. However, the reach of these interventions is still very limited in adolescent girls and young women (15–24 years) and the full realisation of the intervention mandates has not yet been achieved. The HIV prevention field has been criticised for the tendency to adopt a narrow focus. The Fast-Track Strategy offers a unique opportunity for the HIV prevention field to broaden its gaze and to begin to identify synergies (and efficiencies) with prevention approaches from other global development priorities, namely sexual and reproductive health and rights (SRHR). This paper applies a SRHR lens to HIV prevention by highlighting the critical relationship between unintended pregnancy and HIV, and seeks to expand on earlier debates that prevention of HIV and prevention of unintended pregnancy are inextricably linked, complementary activities with interrelated and common goals. We call for the prioritisation of prevention of unintended pregnancy amongst two overlapping population groups — girls and young women (15–24 years old) and women living with HIV — as a key tactic to accomplish the Joint United Nations Programme on HIV/AIDS (UNAIDS) Fast-Track Strategy and as a way to fully realise existing HIV prevention efforts. We discuss the intersecting pathways between HIV prevention and unintended pregnancy prevention and build a case for contraception to be placed at the centre of the HIV prevention agenda.     

The acceptability of reuse of the female condom among urban South African women

This study assessed whether reuse of the female condom was acceptable among two groups of women in central Johannesburg, South Africa, who were taking part in two separate studies of female condom reuse. The first group consisted of women (aged 17 to 43years) attending a family planning/sexually transmitted infections (STIs) clinic who were participating in a cross-sectional survey of the acceptability of female condoms reuse (n=100). The second group included women (aged 18–40 years) at high risk for STI (80% self-declared sex workers) who were taking part in an ongoing cohort study to investigate the safety of reuse of the female condom through a structural integrity and microbial retention study (n=50). Among women participating in the acceptability study, 83% said that they would be willing to reuse the female condom, and 91% thought the idea of reuse, of the female condom was acceptable. All women taking part in the safety of reuse study and who reused the female condom up to seven time (n=49) reported that the steps involved in reusing the device were easy to perform and acceptable. All 49 women said they would reuse the female condom at least once, while 45% said they would use it a maximum of seven or eight times. From the results of the interviews with both study groups, it can be concluded that, among women in a South African urban environment who have used a male and/or female condom, the concept of reuse of the female condom is acceptable and thought to be a good idea.