Female condom color and scent preference in Durban, South Africa.

Objectives: To assess preferences for female condom (FC) colors and scents. Study design: Women aged 18-40 years were randomized to one of three FCs (FC2, Cupid1, Cupid2) two of which offered a choice of color and scent (red/strawberry, purple/vanilla, natural/unscented). Women could choose any variety within condom types while participating in an FC contraceptive efficacy study in South Africa. Results: One hundred and thirty-three women were allocated to each FC type. Strawberry was the most popular variety for both FC2 and Cupid1 (60.9%, 78.3% respectively). Some women chose more than one variety but few chose the natural. Conclusions: Data support a clear preference for colored and scented FCs. Implications: These data can inform FC programme managers to predict demand for different varieties of FC and can adjust supply of FCs accordingly.

Functional performance of the Wondaleaf condom: A crossover, noninferiority, randomized clinical trial.

BACKGROUND: New female condom (FC) products wishing to apply for United Nations Population Fund/World Health Organisation (UNFPA/WHO) prequalification are required to conduct a randomized, controlled clinical investigation comparing the new FC to the marketed FC, in order to comply with UNFPA/WHO and International Organization for Standardization (ISO) specifications. We aimed to assess the functional performance, acceptability and safety of the Wondaleaf female condom compared to the control FC2 female condom. METHODS: This randomized clinical trial enrolled 220 women in one South African site. The primary outcome of the study was the rate of female condom (FC) failure. Participants were asked to use five of each FC type and to collect information on use in a condom diary at home, and were interviewed after use of each FC type. RESULTS: Noninferiority was demonstrated for the Wondaleaf with respect to the reference FC2 for all condom functions. The Wondaleaf was found to be superior to the FC2 reference condom for invagination (p > .000), misdirection (p > .000) and clinical failure (p > .000). Acceptability ratings for a range of features were similar between the two FCs. Few safety events were reported for either device. CONCLUSION: The Wondaleaf performs as well as the FC2, and is equally acceptable. Results from this study will inform further refinement of this FC design. Trial registrations: ClinicalTrials.gov Identifier: NCT04076774 https://clinicaltrials.gov/. South African National Clinical Trials Database (SANCTR) number DOH-27-0319-6020.

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.

End-user preference for and choice of four vaginally delivered HIV prevention methods among young women in South Africa and Zimbabwe: the Quatro Clinical Crossover Study.

INTRODUCTION: Adherence to HIV prevention methods is a challenge, particularly for young women in Sub-Saharan Africa. End-user research during product development can inform modifiable factors to increase future uptake and adherence. METHODS: Preferences for four vaginally inserted placebo HIV prevention methods were assessed among Zimbabwean and South African young women using a crossover clinical design. For each of months 1 to 4, participants were asked to use a pre-coitally inserted film, insert (vaginal tablet) and gel once/week for a month, and a monthly ring in a randomly assigned sequence. Participants subsequently chose one preferred product to use as directed for the final study month. Women ranked the four products from most preferred to least preferred at enrolment and after trying all products. RESULTS: A total of 200 women aged 18 to 30 (mean 23) were enrolled; 178 (89%) completed follow-up. At baseline, 41% of participants selected the gel as their most preferred product and 61% selected the ring as least preferred. During the crossover period, most (82% to 85%) self-reported using each product at least once a week, although only half the time with sex. Objective biomarker data confirmed adequate use of all products. After trying each product, rankings changed with the film, ring, insert and gel being selected by 29%, 28%, 26% and 16% respectively. Choice varied significantly by country (p < 0.001): More Zimbabweans chose the film (45%), and more South Africans chose the insert (34%). Among women choosing the ring, 88% reported using it every time with sex. By contrast, self-reported adherence was lower for "on-demand" (coitally associated) products, with 40% to 55% using them every time during sex (p < 0.001). CONCLUSIONS: Preferences for these four dosage forms varied before and after use, and both within and across countries - there was no clear favourite - indicating the need for a range of options for end-users The ring's popularity increased the most with use, was the second most preferred delivery system, and per self-report, provided more coverage during sex. These end-user perspectives provide important information to product developers and funding agencies.

A Randomized Crossover Study Evaluating the Use and Acceptability of the SILCS Diaphragm Compared to Vaginal Applicators for Vaginal Gel Delivery.

INTRODUCTION: This study aimed to assess acceptability and preferences for the SILCS diaphragm for vaginal gel delivery compared to a prefilled applicator. METHODS: A randomized crossover study among 115 women in South Africa, using both methods during five sex acts. RESULTS: We found no significant differences in acceptability between the two products. Experience of gel leakage after sex was greater when inserted via applicator. More women were interested in SILCS/gel for multipurpose protection (68%) than in either SILCS alone (17%) or microbicide gel alone (14%). CONCLUSIONS: A SILCS gel delivery system for multipurpose prevention seems feasible and acceptable.