Internal/Female Condom Bibliography December 1, 2020
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Internal/Female Condom Bibliography December 1, 2020 The articles listed below represent a bibliography of research on the internal/female condom that was created by the Cervical Barrier Advancement Society (CBAS). To update the bibliography, we searched PubMed for the terms “internal condom” and “female condom” in titles and abstracts from articles published through December 1, 2020. 2020 Nel A, Malherbe M, van Niekerk N, Beksinska M, Greener R, Smit J, Frezieres R, Walsh T. Performance and Acceptability of the FC2 Female Condom When Used With and Without a Silicone Placebo Vaginal Ring-A Randomized, Crossover Trial. J Acquir Immune Defic Syndr. 2020 Sep 1;85(1):58-65. doi: 10.1097/QAI.0000000000002408. BACKGROUND: The silicone Dapivirine Vaginal Ring 25 mg, has been developed to provide an additional HIV prevention option for women. If approved for use, women will always be counselled to use condoms when using the vaginal ring for maximum protection. This paper evaluates the compatibility of female condoms with the ring. METHODS: This was a 2-period crossover, randomized noninferiority trial. Couples in 2 sites in the United States of America were randomized to FC2 Female Condom (FC2) with and without a placebo silicone ring and asked to use 4 female condoms in each period. The primary noninferiority endpoint was the clinical failure rate during intercourse or withdrawal (self-reported clinical breakage, slippage, misdirection, and invagination). Frequencies and percentages were calculated for each failure mode and differences in performance of the 2 periods, using the female condom without the ring as reference. Noninferiority was defined using an 8% margin at the 5% significance level. Safety and tolerability were also assessed. RESULTS: Eighty-one couples were enrolled and 79 completed the trial using a total of 596 female condoms (297 and 299 with/without a ring inserted, respectively). Total female condom clinical failure was 14.1% and 15.7% in the presence and absence of a ring, respectively, with a difference of -2.1% (95% confidence interval: -7.8% to 3.6%), thereby demonstrating noninferiority when used with the ring. There were no differences in safety and tolerability between the 2 periods. DISCUSSION: Concurrent use of the placebo silicone vaginal ring had no significant effect on female condom functionality or safety outcomes. Burton J, Bedford R, Graham C, Nadarzynski T. Perceived barriers and facilitators to female condoms among UK based healthcare professionals. Eur J Contracept Reprod Health Care. 2020 Aug;25(4):299-304. doi: 10.1080/13625187.2020.1777966. Epub 2020 Jun 22. OBJECTIVES: The female condom (FC) is an effective strategy against sexually transmitted infections (STIs) in susceptible women and men who have sex with men. FCs are the only female-initiated dual protection method that protects against both STIs and unintended pregnancy. As healthcare professionals (HCPs) are a key element in the promotion of contraceptive use, it is important to examine attitudes towards FCs among this group. Study participants: 15 male and female HCPs aged between 22 and 57 years recruited from sexual and reproductive health settings located in Brighton, London, and Glasgow. Sampling method: Purposive sampling with targeted advertisements (newsletters and bulletins). Study design: face-to-face and telephone interviews with sexual health HCPs. Main outcome measure: potential barriers and facilitators to FCs in the UK. Data were analysed thematically to identify common views and perspectives. RESULTS: FCs were thought to be unacceptable to most women due to stigma, design, negative visual appeal, insertion difficulties and lack of familiarity. The perceived unavailability and higher cost of FCs, in comparison to male condoms, are major barriers to their use. CONCLUSIONS: HCPs are reluctant to promote FCs, often due to the perceived social stigma surrounding FCs. Cervical Barrier Advancement Society www.cervicalbarriers.org Further education and promotion are needed to increase acceptability and correct usage. Future research needs to explore strategies to increase the acceptability of FCs among women, men who have sex with men and HCPs. Beksinska M, Nkosi P, Mabude Z, Mantell JE, Zulu B, Milford C, Smit JA. Lessons from the evaluation of the South African National Female Condom Programme. PLoS One. 2020 Aug 13;15(8):e0236984. Background Understanding of the facilitators and challenges to female condom (FC) uptake has been limited due to lack of evaluation of national FC programmes. Setting The FC has been an integral component of South Africa’s (SA) HIV prevention programme for 20 years and is the largest government-funded FC programme worldwide. Methods The national FC evaluation used a mixed-methods approach and consisted of key informant interviews and a telephone survey in a national sample of public and non-public sites. A sub-sample of sites participated in client and provider interviews, and a self-administered client survey. A review of distribution statistics from South Africa’s District Health Information System was also conducted. Results All 256 public-sector and 28 non-public-sector facilities reported having ever distributed FCs. Less than 5% of these facilities reported stock-outs and less than 3% reported they had a supply of expired female condoms. Systems for male condom (MC) and FC distribution were complementary, with similar ordering, delivery and reporting processes. FC promotion by providers (n = 278) varied with regard to FC training, whether attitudes about FCs influenced providers offer of FCs, and how they counselled clients about FCs. Of the 4442 self- administered client surveys in 133 facilities, similar proportions of women (15.4%) and men (15.2%) had ever used FCs. Although FCs were available at almost all sites surveyed, only two-thirds of clients were aware of their availability. Conclusion Data highlight the role of providers as gatekeepers to FC access in public and non-public sectors and provide support for further FC programme expansion in SA and globally. Mantell JE, Exner TM, Bai D, Leu CS, Beksinska M, Mabude Z, Hoffman S, Smit JA. Perceived male partner attitudes toward the female condom predict female university students' use of the female condom. Int J STD AIDS. 2020 Jul;31(8):753-762. doi: 10.1177/0956462420912986. Female and male condoms are the only methods that prevent both sexually transmitted infections (STIs), including HIV, and unintended pregnancy. Despite continuing high STI rates, few studies investigate factors predicting whether women initiating female condom (FC) use sustain use. Using data from a randomized trial, we examined predictors of sustained FC use at five-month follow-up (FU2) among female university students in South Africa who participated in either a one-session, information-only, group-delivered Minimal Intervention or a two-session, group-delivered Enhanced Intervention. In the final multiple logistic regression model, believing one's partner holds positive attitudes toward the FC (aOR = 1.40; p = 0.028), and greater FC use for vaginal sex at previous assessment (aOR) = 1.19; p = 0.008) were associated with greater odds of FC use at FU2. Excluding number of FC-protected occasions at FU1 from the analysis, discussing FC use with partner (aOR = 2.89; p = 0.071) and believing one's partner holds positive attitudes toward the FC (aOR = 1.63; p < 0.001) were associated with greater odds of use at FU2. The FC empowers women to protect themselves from both STIs and Cervical Barrier Advancement Society www.cervicalbarriers.org unintended pregnancy, but targeted interventions are needed to address men's negative attitudes toward the device. Engaging men as FC champions to support and promote FC use, along with marketing campaigns targeted to men, may expand FC coverage and enhance uptake. Beksinska M, Wong R, Smit J. Male and female condoms: Their key role in pregnancy and STI/HIV prevention. Best Pract Res Clin Obstet Gynaecol. 2020 Jul;66:55-67. doi: 10.1016/j.bpobgyn.2019.12.001. Epub 2019 Dec 14. Male and female condoms are the only available Multipurpose Prevention Technologies (MPTs) that can prevent unintended pregnancy and sexually transmitted infections including HIV. If used correctly and consistently, condoms can provide levels of pregnancy protection similar to many hormonal methods. Condoms remain one of the most common methods used at first sexual intercourse and are relied on as a current use of contraception by adolescents in many regions of the world. Male and female condoms are safe and require no prescription; in particular male condoms are generally easy to access at low cost. Female condoms are more expensive than male condoms and less accessible; however, they have the advantage of being a female-initiated method. Condom users may experience some common challenges; however, recent advances in condom technology have led to new designs and modifications of existing products to improve quality and make them more attractive, acceptable and pleasurable for consumers and increase its use. Wiyeh AB, Mome RKB, Mahasha PW, Kongnyuy EJ, Wiysonge CS. Effectiveness of the female condom in preventing HIV and sexually transmitted infections: a systematic review and meta-analysis. BMC Public Health. 2020 Mar 12;20(1):319. doi: 10.1186/s12889-020-8384-7. BACKGROUND: The effectiveness of female condoms for preventing HIV and sexually transmitted infections (STIs) remains inconclusive. We examined the effects of female condoms on the acquisition of HIV and STIs. METHODS: We searched four databases, two trial registries, and reference lists of relevant publications in October 2018 and updated our search in February 2020. We screened search output, evaluated study eligibility, and extracted data in duplicate; resolving differences through discussion. We calculated the effective sample size of cluster randomised trials using an intra-cluster correlation coefficient of 0·03. Data from similar studies were combined in a meta-analysis. We performed a non-inferiority analysis of new condoms relative to marketed ones using a non-inferiority margin of 3%.