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Objectives: New designs of female condoms have been developed to lower cost and/or improve acceptability. To secure regulatory approvals, clinical studies are required to verify performance. We aimed to assess the functional performance and safety of two new female condom types - Velvet and Cupid2 female condom - against the existing FC2 female condom.
Study Design: This was a three-period crossover, randomized noninferiority clinical trial with 300 women randomized to condom-type order in one South African site. Primary end points were total clinical failure and total female condom failure. Noninferiority of component modes, clinical breakage, nonclinical breakage, slippage, misdirection and invagination were also determined. Safety data were also assessed for each female condom. Participants were asked to use five of each female condom type and to collect information on use in a condom diary at home and were interviewed after use of each type. Frequencies and percentages were calculated by condom type for each failure mode, and differences in performance of the three female condoms using FC2 as reference, with 95% confidence intervals, were estimated using generalized estimating equation models.
Results: A total of 282 (94%) participants completed follow-up, using at least one condom of each type. Total clinical failure (clinical breakage, invagination, misdirection, slippage) was <5% for all female condoms: FC2 (4.50%), Cupid2 (4.79%) and Velvet (3.93%). Noninferiority was demonstrated for all condom failure modes for the two new female condoms with respect to FC2, within the margin of 3% difference in mean failure, at the 5% significance level.
Conclusion: Noninferiority for the two new female condoms was demonstrated with respect to the marketed FC2. These data are used to support manufacturer dossiers for World Health Organization (WHO)/United Nations Population Fund (UNFPA) prequalification.
Implications: Data from this study have been submitted to WHO/UNFPA and will contribute to the prequalification submission requirements for the Cupid2 and Velvet female condoms.
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http://dx.doi.org/10.1016/j.contraception.2015.05.008 | DOI Listing |
Reprod Health
December 2024
Department of Epidemiology and Biostatistics, University of California, San Francisco, USA.
Introduction: Although the Government of Nepal has developed strategies to integrate contraceptive services with abortion care to better meet the contraceptive needs of women, data indicate that significant gaps in services remain. This paper assessed post-abortion contraceptive use, trends over 36 -months, and factors influencing usage.
Methods: Data from this paper came from an ongoing cohort study of 1831 women who sought an abortion from one of the sampled 22 government-approved health facilities across Nepal.
China CDC Wkly
November 2024
National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.
What Is Already Known About This Topic?: A substantial proportion of people living with human immunodeficiency virus (PLWH) remain unaware of their infection status. Contact tracing serves as an effective public health tool for identifying human immunodeficiency virus (HIV) infections and supports progress toward achieving the 95-95-95-95 goals.
What Is Added By This Report?: An egocentric contact tracing study conducted in Yunnan, China, between January 2022 and June 2024 enrolled 1,981 index cases, of whom 314 (15.
Int J Equity Health
December 2024
Community Health Sciences Department, College of Applied Medical Sciences, King Saud University, 11433, Riyadh, Saudi Arabia.
Background: Awareness of Human Immunodeficiency Virus (HIV) is limited in Muslim countries, even among high-risk populations. Several factors contribute to the misunderstandings and stigma surrounding HIV, including socio-cultural and religious aspects. This study explored people's experiences and perceptions of HIV awareness campaigns in the Gulf Cooperation Council (GCC) region.
View Article and Find Full Text PDFBMC Infect Dis
December 2024
Department of Population, Family and Reproductive Health, School of Public Health, University of Ghana, Legon, Ghana.
Background: There is currently limited knowledge about HIV prevention and treatment cascades among female sex workers (FSW) in Ghana. This study sought to use the 2020 bio-behavioural survey (BBS) among FSWs to identify gaps and priorities in HIV treatment and prevention cascades to help achieve the 95-95-95 fast track targets.
Method: The study used a cross-sectional design with Time Location Sampling (TLS) technique in all regions of Ghana.
Ther Adv Infect Dis
December 2024
Section of Infectious Diseases & Global Health, University of Chicago Medicine, 5841 S. Maryland Avenue, MC5065, Chicago, IL 60637, USA.
Introduction: Despite escalating rates of sexually transmitted infections (STIs) in the United States (US), there has been progressive divestment of sexual health services leading to the reliance on emergency departments (EDs) for sexual healthcare, particularly among vulnerable populations. The Sexual Wellness Clinic (SWC), a novel care delivery model operating in collaboration with the ED, offers comprehensive sexual health services.
Objectives: This study aims to analyze the demographics, STI positivity, and HIV Pre-Exposure Prophylaxis (PrEP) uptake among patients accessing the SWC.
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