Carol Joanis

Can condom users likely to experience condom failure be identified

A study based on a convenience sample of 177 couples who each used 11 condoms found that 103 condoms (5.3%) broke before or during intercourse and 67 condoms (3.5%) slipped off during sex. Couples who had not used a condom in the past year were almost twice as likely to experience condom failure as were couples who had used at least one during that period (p < .001). Of the couples who had used a condom in the previous year, the failure rate among those who reported at least one condom break during that period was more than twice the failure rate among those who reported no breaks (p < .001). Among couples who had used condoms in the past year without breaking any, those who did not live with their partner and those who had a high school education or less were at increased risk of condom failure (adjusted odds ratios of 3.2 and 2.7, respectively).

The Impact of Lubricants on Latex Condoms during Vaginal Intercourse

The objective was to evaluate the impact of additional lubricant on condom breakage and slippage. Two hundred and sixty-eight couples used 6 new and 6 aged condoms during vaginal intercourse and were instructed to use 2 of each type with either water-based lubricant, oil-based lubricant or no additional lubricant. The use of either oil-based or water-based lubricant increased slippage rates of new and aged condoms, although only one pairwise comparison (oil-based lubricant vs. no additional lubricant) was statistically significant (8.5% vs. 3.8%, P=0.004). The use of oil-based lubricant increased breakage, although not statistically significantly, in both new and aged condoms. Water-based lubricant did not impact the breakage rate of the new condoms and decreased the breakage rate of the aged condoms (no additional lubricant 4.5% vs. water-based lubricant 2.1%, P=0.029). From a functional perspective, this study suggests that condom users should be told not to use oil-based lubricants. The negative impact of water-based lubricant on slippage may be outweighed by the protective influence on breakage, especially for aged condoms. Over three-quarters of the couples (76%) had at least some incorrect knowledge, according to current condom instructions, of the type of lubricant that should be used with condoms.

Acceptability of Spermicidal Film and Foaming Tablets Among Women in Three Countries

75 participants in four community-based distribution programs of the Family Planning Association of Kenya 65 clients of two Profamilia clinics in Santo Domingo Dominican Republic and 60 clients of a research and family planning clinic associated with the University of Juarez in Durango Mexico completed a questionnaire and agreed to use spermicidal films and foaming tablets along with a latex condom during each act of intercourse for 14 days in Kenya and 21 days in the Latin American countries. The women were each given 15 foaming tablets 15 pieces of contraceptive film and 15 condoms. The investigators aimed to evaluate the acceptability of these two vaginal spermicides which may also protect against sexually transmitted diseases including HIV infection. The women preferred the spermicidal film over the foaming tablet: in Kenya 86% vs. 35% p < 0.001; in the Dominican Republic 60% vs. 46% p = 0.265; and in Mexico 97% vs. 73% p < 0.001. Their partners also had a preference for the spermicidal film: in Kenya 84% vs. 31% p < 0.001; in the Dominican Republic 29% vs. 21% p = 0.261; and in Mexico 59% vs. 46% p = 0.046. All the women in Kenya 69% of those in the Dominican Republic and 88% in Mexico mentioned something they liked about the film. The leading positive attributes were ease of use general feel or comfort and lack of side effects. On the other hand 25-33% of all women reported no positive attributes of foaming tablets. The most reported negative attributes of foaming tablets were that they were messy or too wet. Women in the Latin American countries were more likely to find that the film stuck to their finger during insertion than those in Kenya. They found the foaming tablets to be easier to insert than the film while women in Kenya found the film easier to insert (p < 0.001).

Condom Breakage and Slippage Rates Among Study Participants in Eight Countries

Family Health International staff used data from six studies (5711 condoms used by 1758 couples during vaginal intercourse at 13 sites) in the Dominican Republic Ghana Kenya Mali Mexico Nepal Sri Lanka and the US to examine slippage breakage and total failure rates. The 52-mm lubricated latex condoms were all manufactured by the same US company and came from six different manufacturing lots all of which passed the tensile test of the American Society for Testing and Materials and the airburst test of the International Standards Organization. Most couples (75-100%) at seven of the nine sites where marital status data were collected were married or living in union with their partner. Only 39% of those in the Dominican Republic and 46% of those in Mali were married or living in union with their partner. Breakage rates ranged from 0.6% in Sri Lanka to 13.3% in Ghana. At 11 sites breakage rates were less than 5%. Qualitative research identified four types of behavior associated with condom breakage: incorrect method of putting on the condom use of oil-based lubricants reuse of condoms and the duration and intensity of intercourse. Slippage rates ranged from 0 in Ghana to 9.3% in Kenya. About 66% of condom breaks occurred during intercourse or removal. 47% of the condoms that broke were broken at the tip or the closed end. 26% broke along the shaft. 27% broke near the open end. A secondary analysis conducted as part of one of the US studies revealed that a small portion of condom users comprise a disproportionate of condom failures. The factors linked to condom breakage were: couples with no condom experience in the last 12 months couples who did not live together at least one condom broke in the last year and couples with no more than 12 years of education. These findings suggest that most condom users use condoms correctly and therefore condoms protect them from pregnancy and sexually transmitted diseases.

Performance and safety of the second-generation female condom (FC2) versus the Woman's, the VA worn-of-women, and the Cupid female condoms: a randomised controlled non-inferiority crossover trial

BACKGROUND New designs of female condom have been developed to reduce costs and improve acceptability. To secure regulatory approvals, clinical studies are needed to verify performance. We aimed to assess the functional performance and safety of three new condom types-the Womans Condom, the VA worn-of-women (wow) Condom Feminine, and the Cupid female condom-against the existing second-generation female condom (FC2). METHODS We did a randomised controlled, non-inferiority, four-period crossover trial at three sites in Shanghai, China, and one site in Durban, South Africa, between May 1, 2011, and Jan 31, 2012. Participants aged 18-45 years who were sexually active, monogamous, not pregnant, and not sex workers, were eligible for inclusion if they were literate, had no known allergies to the study products; used a reliable, non-barrier method of contraception, and had no visible or reported sexually transmitted infections. We used a computer-generated randomisation sequence with a Williams square design of size four to assign patients (1:1:1:1) to the FC2 control device, or the Womans, VA wow, or Cupid condoms, with 12 potential allocations. Randomisation was stratified by site. Participants were not masked to condom type, but allocation was concealed from study investigators. The primary non-inferiority endpoints were total clinical failure and total female condom failure, with a non-inferiority margin of 3%. Women were asked to use five of each condom type and were interviewed after use of each type. We also assessed safety data for each type. We did both per-protocol and intention-to-treat analyses. We calculated frequencies and percentages for each failure event and estimated differences in performance with a generalised estimating equation model. This study is registered, number DOH-27-0113-4271. FINDINGS 616 women were assessed for eligibility, of whom 600 were randomly assigned to condom-type order (30, 120, and 150 women in the three sites in China, and 300 women in the site in South Africa). 572 women completed follow-up, with at least one condom of each type. Total female condom failure was 3·43% for FC2, 3·85% for the Womans Condom (difference 0·42%, 90% CI -1·42 to 2·26), 3·02% for VA wow (-0·42%, -1·86 to 1·32), and 4·52% for Cupid (1·09%, -0·60 to 2·78); total clinical failure was 2·88%, 3·05% (0·17%, -1·48 to 1·81), 2·49% (-0·25%, -1·75 to 1·26), and 3·87% (0·99%, -0·55 to 2·52), respectively. Only two (<1%) participants, in South Africa, reported serious adverse events, unrelated to use of the study products. INTERPRETATION Non-inferiority was shown for all condom failure events for the three new devices versus the FC2, within the predefined margin. FUNDING Universal Access to Female Condoms (UAFC).

Female condom technology: new products and regulatory issues

Like male condoms, female condoms (FCs) provide protection against unplanned pregnancy and most sexually transmitted infections including HIV. The first FC made by the Female Health Company was approved by the US Food and Drug Administration (USFDA) in 1993. Since 2000, several different types of FCs have become available or are in development to lower the cost and/or improve acceptability. Although similar in function, new FCs often differ in design and materials. Classified as Class III medical devices by the USFDA, FCs have a regulatory process that is more complex than that for male condoms. This, coupled with the lack of an international standard to verify the quality of new devices, has hindered new products gaining regulatory approvals and entering the market. We review the existing regulatory pathway for FCs, the progress made in developing standards specifically for FCs and the FCs available now or in development, including their current status regarding approval.

Practice makes perfect: reduction in female condom failures and user problems with short-term experience in a randomized trial

BACKGROUND Female condom (FC) failure (breakage, slippage, invagination and misdirection) declines with user experience. Participants in FC performance trials are commonly novice users, and failure rates may be inflated related to inexperience. STUDY DESIGN This was a randomized, crossover study assessing preference, safety, acceptability and function of three new FCs (WC, FC2 and V-Amour) among 170 women in Durban, South Africa. FC failure by condom type use period was investigated in women using five FCs of each type. RESULTS Of the 2411 condoms used during intercourse, 96 failures (breakage, slippage, invagination and misdirection) occurred in 86 condoms (77 condoms had one failure, 8 condoms had two failures, and 1 condom had three failures). Total clinical failure was comparable across FC types. The number of failures in the first condom use period was 58 (7.0%), and this decreased to 21 events (2.6%) in the second and, finally, 17 (2.1%) in the last condom use period. No failures were reported in the last use of the FC in the final condom use period. CONCLUSIONS FC failure rates decreased markedly after use of the first five condoms, regardless of FC type, and stabilized in the second and third use periods. Consideration should be given to the number of condoms used in trials to ensure that failure rates are not inflated by limiting the numbers of condoms used by novice users.

Structural integrity of the female condom after a single use, washing, and disinfection

The Reality(R) female condom is approved for use during a single act of intercourse, but is expensive relative to other barrier methods. Re-use is a potential strategy to reduce its per-use cost. We tested the structural integrity of female condoms (n = 318) after a single act of vaginal intercourse. We also measured the impact of laboratory washing (1, 5, or 10 times) with and without disinfection on the structural integrity of unused condoms. Structural integrity was measured via 5 tests: seam tensile strength, water leakage, air-burst, tear propagation, and device dimensions. No degradation in device structural integrity occurred after a single use when compared to control for seam tensile (16.0 vs.15.7 mPa; p = 0.558); water leakage (1.9% vs. 0.9%; p = 0.618); air burst (3.9 vs. 3.6 kPa; p <0.001); or tear propagation (344.6 vs. 336.8 psi; p = 0.313). Mean length was slightly increased [single use vs. control (177.9 vs. 172.5 mm; p <0.001)]. No consistent pattern of structural degradation emerged across all wash/disinfection groups. Our data suggest the structural integrity of the female condom remains intact after a single use and cleaning.

Using scratch card technology for random allocation concealment in a clinical trial with a crossover design

Background To avoid selection bias in clinical trials, random allocation concealment is crucial to ensure that participants and or researchers remain unaware of assignments. Purpose We aimed to design an allocation concealment method that reduced the possibility of selection bias for a randomized, open-label, crossover trial to evaluate device function of four female condom (FC) types. Methods Using scratch card technology, we devised a simple method of concealment, whereby the treatment sequence was printed on a single card for each participant, and the codes for each treatment in the sequence were concealed beneath foil squares on a stiff A6-sized card. On the first and subsequent follow-up visits, the foil corresponding to that visit was scratched from the square to reveal the condom type allocation for the next condom-use period. Staff in the South African and Chinese trial sites were trained in use and care of the card, and on completion of the study completed a questionnaire on their experience of use. Results Research staff in both countries found the card easy to use and those who had previously used the sequentially numbered, opaque, sealed envelopes (SNOSE) system for random allocation reported the scratch card easier to use. Research staff most commonly used a coin to remove the foil square and some used their fingernails. In both South Africa and China, no errors in allocation sequence were found during study monitoring. Limitations Scratch card system of allocation cannot be printed in-house. Conclusions This novel, effective method of concealment for a crossover random allocation was well liked by study staff. The most important advantage of this method is the ability to conceal consecutive allocations of a crossover design using a single card, thus eliminating the need for multiple envelopes per participant. While we used this method in a clinical trial of FCs, it could be employed in a range of other clinical trials and other randomized studies.

The effects of condom choice on self-reported condom use among men in Ghana, Kenya and South Africa: a randomized trial☆

BACKGROUND Male condoms are readily available and affordable in many settings, but risky sexual acts still go unprotected. STUDY DESIGN This unblinded randomized trial, conducted in Ghana, Kenya and South Africa, was designed to assess the impact of providing a choice of condoms on self-reported use and uptake over 6 months. RESULTS We enrolled 1,274 men. The mean subject-specific proportion of protected acts with all partners increased from baseline to 6 months by 0.07 in the control group compared to 0.03 in the choice group (p=.025). The observed results were largely consistent across all three countries. In the choice group, men clearly preferred one condom type over the others, and this preference was consistent across all three countries. CONCLUSIONS Providing one type of male condom in public sector programs appears justified. Programs should not focus on the number of brands available, but should encourage effective promotion and consistent and correct use of available brands.