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1.
BMC Health Serv Res ; 24(1): 35, 2024 Jan 05.
Artículo en Inglés | MEDLINE | ID: mdl-38183015

RESUMEN

BACKGROUND: Female condoms protect against unplanned pregnancies and sexually transmitted infections (STIs) including HIV; however, their uptake is very low in South Africa. Nurses are frontline healthcare workers and are uniquely positioned to promote their use to their clients. This study assesses nurses' knowledge of, attitudes to, and practices regarding the promotion of female condoms at selected primary healthcare facilities in the King Sabata Dalindyebo sub-district of the Eastern Cape, South Africa. METHODS: A descriptive cross-sectional study was conducted from April to May 2021 at five community health centres in the King Sabata Dalindyebo sub-district, South Africa. A total of 139 nurses completed a self-administered questionnaire. Data were analysed using simple descriptive statistics. RESULTS: The majority of the participants (82.7%) were knowledgeable about the female condom. Some participants did not have a good attitude and willingness to promote female condom use to their clients. Junior nurses (enrolled nursing assistants and newly qualified professional nurses) were less knowledgeable about the female condom than more qualified and older nurses. There was no significant association between level of knowledge and attitude or willingness to promote the use of the female condom. CONCLUSION: This study found good knowledge of the female condom among the nurses; however, the knowledge did not translate into a willingness to promote the device at their health facilities. Capacity building of the junior nurses will fill the knowledge gaps identified. Studies exploring the sociocultural issues around the female condom are needed in the region.


Asunto(s)
Condones Femeninos , Embarazo , Humanos , Femenino , Sudáfrica , Competencia Clínica , Estudios Transversales , Atención Primaria de Salud
2.
BMC Public Health ; 22(1): 1675, 2022 09 05.
Artículo en Inglés | MEDLINE | ID: mdl-36064344

RESUMEN

BACKGROUND: With overpopulation contributing to the depletion of planetary resources, the high rates of unintended pregnancies in India are a cause for concern. Despite the free supply of contraception options within India's national family planning initiatives, women are generally offered hormonal options as temporary spacing methods. However, female condoms, a much neglected but potent woman initiated, non-hormonal multipurpose prevention device, are yet to be considered for inclusion in India's contraceptive cafeteria. Thus, we aim to examine the place of female condoms among the contraceptive options, by analysing the perceptions of key stakeholders regarding its advantages and disadvantages, along with their opinions on how female condoms should be promoted. METHODS: We used purposive sampling to recruit and interview potential users and dispensers of the female condom. The interview participants visited or worked at family planning clinics in Pune at Smt. Kashibai Navale Medical College and General Hospital (SKNMC-GH), its urban and rural outreach clinics, and at Saheli (a non-governmental organisation for female sex workers). We conducted semi-structured interviews and coded our data inductively. RESULTS: We interviewed 5 rural women, 20 urban women (including 10 female sex workers), 5 male partners of female sex workers, and 5 family planning healthcare providers. Nearly half (12/25) of the women we interviewed, said that they were eager to use female condoms in the future. Many participants perceived female condoms to be an instrument to empower women to be in control of their sexual and reproductive lives (15/35), and that it provided user comfort and confidence (4/35). Their perceived disadvantages are that they are relatively more expensive (6/35), users have limited experience (9/35), and women who buy or use them may be stigmatised and feel embarrassed (4/35). Yet, nearly three-quarters of potential users (21/30) and most healthcare providers (4/5), were confident that female condoms could become popular following extensive promotional campaigns, interventions to improve availability and access, and initiatives to enhance the knowledge of female users. CONCLUSIONS: Female condoms have garnered support from both users and dispensers and have the potential to be widely adopted in India if family planning initiatives which increase awareness, knowledge, and access are systematically undertaken as with other contraceptive options.


Asunto(s)
Condones Femeninos , Trabajadores Sexuales , Condones , Anticoncepción , Anticonceptivos , Servicios de Planificación Familiar , Femenino , Conocimientos, Actitudes y Práctica en Salud , Humanos , India , Masculino , Embarazo , Conducta Sexual
3.
Health Promot J Austr ; 33(1): 117-125, 2022 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-33522029

RESUMEN

BACKGROUND: The female condom is a barrier method for the prevention of sexually transmissible infections and unintended pregnancy. Uptake of this method remains low in Australia, although little research has been undertaken to explore this. METHODS: An interventional cross-sectional study was undertaken in 2019 to explore the views and experiences of women in New South Wales. After trying the female condom, they were invited to complete an online survey and/or structured interview. Training in the use of the female condom was not provided. This paper reports on qualitative findings from open-ended survey responses and interviews. RESULTS: In total, 284 participants completed the survey and 20 participated in an interview. Most were aware of the female condom prior to participating in the study, but few had used it previously. Four broad themes were identified from the data: (i) accessibility of the female condom, including cost and availability, (ii) supporting choice in different circumstances, (iii) aspects of empowerment and control and (iv) use of gendered language. CONCLUSIONS: The female condom may be an acceptable option for many women in Australia. To support the choice of method and promote uptake, it will be important to increase the accessibility of the female condom by raising awareness and addressing the issues of cost and availability. Further exploration of issues regarding inclusive language and messaging in health promotion campaigns and marketing is warranted to ensure that this product is accessible for all people who may wish to use it, regardless of gender or sexuality. Similar research could be undertaken with men/partners and members of the LGBTQ+ community to explore their perspectives of the female condom. SO WHAT?: To support contraceptive choice and promote the uptake of the female condom for those who desire this method, it will be important to address the issues of cost and availability. Accessibility will also be enhanced through the consideration of inclusive language and messaging in health promotion campaigns and marketing of the female condom.


Asunto(s)
Condones Femeninos , Australia , Condones , Estudios Transversales , Femenino , Humanos , Masculino , Embarazo , Conducta Sexual , Encuestas y Cuestionarios
4.
BMC Pregnancy Childbirth ; 20(1): 34, 2020 Jan 13.
Artículo en Inglés | MEDLINE | ID: mdl-31931785

RESUMEN

BACKGROUND: Postpartum hemorrhage (PPH) is the leading cause of maternal death in Tanzania. The Every Second Matters for Mothers and Babies- Uterine Balloon Tamponade (ESM-UBT) device was developed to address this problem in women with atonic uterus. The objective of this study was to understand the barriers and facilitators to optimal use of the device, in Dar es Salaam Tanzania 1 year after implementation. METHODS: Semi-structured interviews of skilled-birth attendants were conducted between May and July 2017. Interviews were recorded, coded and analyzed for emergent themes. RESULTS: Among the participants, overall there was a positive perception of the ESM-UBT device. More than half of participants reported the device was readily available and more than 1/3 described ease and success with initial use. Barriers included fear and lack of refresher training. Finally, participants expressed a need for training and device availability at peripheral hospitals. CONCLUSION: The implementation and progression to optimal use of the ESM-UBT device in Tanzania is quite complex. Ease of use and the prospect of saving a life/preserving fertility strongly promoted use while fear and lack of high-level buy-in hindered utilization of the device. A thorough understanding and investigation of these facilitators and barriers are required to increase uptake of the ESM-UBT device.


Asunto(s)
Condones Femeninos , Servicios de Salud Materna/estadística & datos numéricos , Hemorragia Posparto/terapia , Taponamiento Uterino con Balón/instrumentación , Inercia Uterina/terapia , Adulto , Femenino , Implementación de Plan de Salud , Accesibilidad a los Servicios de Salud , Humanos , Mortalidad Materna/tendencias , Hemorragia Posparto/mortalidad , Embarazo , Derivación y Consulta , Tanzanía/epidemiología , Taponamiento Uterino con Balón/mortalidad , Inercia Uterina/mortalidad
5.
BMC Public Health ; 20(1): 319, 2020 Mar 12.
Artículo en Inglés | MEDLINE | ID: mdl-32164652

RESUMEN

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%. We assessed the certainty of evidence using GRADE. RESULTS: We included fifteen studies of 6921 women. We found that polyurethane female condoms (FC1) plus male condoms may be as effective as male condoms only in reducing HIV acquisition (1 trial, n = 149 women, RR 0.07, 95%CI 0.00-1.38; low-certainty evidence). However, the use of FC1 plus male condoms is superior to male condoms alone in reducing the acquisition of gonorrhoea (2 trials, n = 790, RR 0.59, 95%CI 0.41-0.86; high-certainty evidence) and chlamydia (2 trials, n = 790, RR 0.67, 95%CI 0.47-0.94; high-certainty evidence). Adverse events and failure rates of FC1 were very low and decreased during follow up. Although the functionality of newer female condoms (Woman's, Cupid, Pheonurse, Velvet, and Reddy) may be non-inferior to FC2, there were no available studies assessing their efficacy in preventing HIV and STIs. CONCLUSION: The use of female plus male condoms is more effective than use of male condoms only in preventing STIs and may be as effective as the male condom only in preventing HIV. There is a need for well conducted studies assessing the effects of newer female condoms on HIV and STIs. PROSPERO REGISTRATION NUMBER: CRD42018090710.


Asunto(s)
Infecciones por VIH/prevención & control , Enfermedades de Transmisión Sexual/prevención & control , Condones Femeninos , Femenino , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto
6.
Eur J Contracept Reprod Health Care ; 25(4): 299-304, 2020 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-32567987

RESUMEN

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. 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.


Asunto(s)
Actitud del Personal de Salud , Condones Femeninos , Conducta Anticonceptiva/psicología , Conocimientos, Actitudes y Práctica en Salud , Personal de Salud/psicología , Adulto , Servicios de Planificación Familiar , Femenino , Promoción de la Salud , Accesibilidad a los Servicios de Salud , Humanos , Persona de Mediana Edad , Embarazo , Embarazo no Planeado , Minorías Sexuales y de Género/psicología , Enfermedades de Transmisión Sexual/prevención & control , Estigma Social , Reino Unido , Adulto Joven
7.
Health Care Women Int ; 41(5): 600-618, 2020 05.
Artículo en Inglés | MEDLINE | ID: mdl-31385750

RESUMEN

Female sex workers (FSW) are high-risk for HIV infection. The authors conducted a quasi-experimental study by providing peer education on 110 FSWs, and routine HIV education on 120 controls, in Surakarta Indonesia. An additional qualitative study was performed to explain the contextual factors contributing to the effectiveness of peer education. The difference in difference approach showed that peer education improved knowledge, acceptance, and utilization of female condom. The improvements were related to the clients' perceptions, access, and available interactive communication with the peer educator. The peer education program should be enhanced to support the prevention of HIV/AIDS.


Asunto(s)
Condones Femeninos/estadística & datos numéricos , Infecciones por VIH/prevención & control , Conocimientos, Actitudes y Práctica en Salud , Grupo Paritario , Trabajadores Sexuales/psicología , Adulto , Comunicación , Femenino , Educación en Salud , Humanos , Indonesia , Persona de Mediana Edad , Sexo Seguro , Trabajo Sexual , Trabajadores Sexuales/estadística & datos numéricos
8.
BMC Womens Health ; 19(1): 128, 2019 10 28.
Artículo en Inglés | MEDLINE | ID: mdl-31660933

RESUMEN

BACKGROUND: Infection by HIV and other STIs and unplanned pregnancies are among the most serious problems associated with sexuality. Male and female condoms are the only dual-purpose devices to control both unplanned pregnancies and STIs, and studying people's attitudes toward the use of these devices are excellent ways to predict their use. Therefore, the purpose of the present study was to adapt and validate the Female Condom Attitude Scale for Spanish language and to evaluate the use of female condoms in Colombian population. METHODS: For that purpose, a total of 387 Colombian women aged 23.68 years in average were asked to respond to the Female Condom Attitude Scale, the Sexual Opinion Survey, and the UCLA Multidimensional Condom Attitudes Scale. RESULTS: The use of female condom in Colombia is very low; only 5.10% of the surveyed women had used it at least once. On the other hand, results revealed a five-factor dimensionality (Sexual pleasure enhancement, Inconvenience, Improved prophylaxis, Sexual pleasure inhibition, and Insertion reluctance) with alphas between .81 and .96. The scale also showed adequate psychometric properties and criterion validity. No relationship was found between attitudes toward female condom and attitudes toward male condom. CONCLUSIONS: The Spanish adaptation of the Female Condom Attitude Scale was found to be reliable and valid in a sample of young women.


Asunto(s)
Condones Femeninos/estadística & datos numéricos , Conducta Anticonceptiva/psicología , Aceptación de la Atención de Salud/psicología , Conducta Sexual/psicología , Encuestas y Cuestionarios/normas , Adulto , Actitud Frente a la Salud , Colombia , Femenino , Humanos , Lenguaje , Psicometría , Reproducibilidad de los Resultados , Enfermedades de Transmisión Sexual/prevención & control , Enfermedades de Transmisión Sexual/psicología , Traducciones , Adulto Joven
9.
BMC Womens Health ; 19(1): 77, 2019 06 14.
Artículo en Inglés | MEDLINE | ID: mdl-31200702

RESUMEN

BACKGROUND: Low-fee female sex workers (FSW) lack power to effectively negotiate male condom use with clients. Female condoms (FCs) may provide an alternative strategy. This study was conducted to assess the acceptability of FC use among low-fee FSWs, and to identify appropriate candidates for future FC promotion. METHODS: A one-month follow-up study was conducted. At entry into the study, eligible participants completed a baseline questionnaire and were given 10 FCs. At the one-month follow up encounter, the number of used FC packages were counted and each participant completed a follow-up questionnaire. Logistic regression was used to identify variables associated with more frequent use of FCs (> 2 times). RESULTS: A total of 312 low-fee FSWs were enrolled at baseline and all participants completed the follow-up evaluation. Among them, 123 (39.4%) participants had used more than two FCs. Participants who were illiterate or had completed at most primary school education (OR: 2.4, 95% CI: 1.4-7.2), charged ≤30 RMB per client (≤30 vs. 51-80 RMB, OR: 3.8, 95% CI: 1.9-7.6), or had consistently used condoms with regular clients in the past month (OR: 2.4, 95%CI: 1.4-4.2) were more likely to use FCs. CONCLUSION: Low-fee FSWs charging ≤30 RMB per client, and those who are less educated may be appropriate initial candidates for FC promotion in China. Strategies to consider include teaching FSWs tactics for negotiation of FC use that can initially be applied with regular clients, and providing education to maximize ease-of use, and minimize discomfort with FC usage.


Asunto(s)
Condones Femeninos/estadística & datos numéricos , Infecciones por VIH/prevención & control , Trabajadores Sexuales/psicología , Sexo Inseguro/psicología , Adulto , China , Estudios Transversales , Femenino , Estudios de Seguimiento , Infecciones por VIH/psicología , Humanos , Negociación , Sexo Seguro/psicología , Trabajadores Sexuales/estadística & datos numéricos , Encuestas y Cuestionarios , Sexo Inseguro/prevención & control , Adulto Joven
10.
BMC Public Health ; 19(1): 1410, 2019 Oct 29.
Artículo en Inglés | MEDLINE | ID: mdl-31664963

RESUMEN

BACKGROUND: The Woman's Condom, a newly designed condom for women, has obtained market approval in China, but it remains relatively unfamiliar to the migrant population. The aim of this study is to evaluate the short-term acceptability of the Woman's Condom and influencing factors among internal migrants. METHODS: A longitudinal study was conducted among 1800 migrants in Beijing, Chongqing, and Shanghai in China between August 2013 and August 2014.Three-level model was implemented with the Statistical Analysis System software (v.9.4 SAS Institute) to analyze within-individual changes, between-individuals effects, and between-group effects. RESULTS: Three-level model analysis revealed statistically higher short-term acceptability of the Woman's Condom among subjects who lived in Shanghai (ß = 6.50, t = 2.76, p < 0.01), unmarried and not in a cohabiting relationship (ß = 3.05, t = 2.76, p < 0.01) than those who lived in Beijing, married and in a cohabiting relationship. Female (ß = - 1.69, t = - 7.55, p < 0.01) and lower educational attainment (ß = - 2.30, t = - 1.94, p = 0.05) were negatively related, while occupations of education, health, and civil staff (ß = 1.50, t = 2.92, p < 0.01) were positively related to acceptability. It was predicted that migrants' acceptability of the Woman's Condom would significantly increase over time (ß = 1.09, t = 5.54, p < 0.01). CONCLUSIONS: The findings indicate that the Woman's Condom enjoyed relatively high short-term acceptability among migrants in China. In order to popularize the Women's Condoms in migrants, more publicity, consultation and training in open and prosperous areas should be strengthened.


Asunto(s)
Condones Femeninos/estadística & datos numéricos , Conducta Sexual/psicología , Migrantes/psicología , Adulto , Beijing , China , Femenino , Humanos , Relaciones Interpersonales , Estudios Longitudinales , Estado Civil/estadística & datos numéricos , Persona de Mediana Edad , Características de la Residencia/estadística & datos numéricos , Migrantes/estadística & datos numéricos , Adulto Joven
11.
Reprod Health ; 16(1): 175, 2019 Dec 03.
Artículo en Inglés | MEDLINE | ID: mdl-31796046

RESUMEN

BACKGROUND: Expanding contraceptive method choices for sexually active youth is critical to prevent STIs/HIV and unintended pregnancies. However, preferences and decision making around contraception among young adults are not well understood. A new female condom (FC), the Woman's Condom (WC), features an improved design and is marketed as a premium product at a higher price point. We conducted a qualitative study to examine the underlying knowledge, attitudes, and perceptions around the FC generally, the WC specifically, and to explore the opportunities and challenges of introducing the WC to young adults in urban Zambia. METHODS: Thirty focus group discussions comprised of 245 men and women aged 18-24 years were facilitated by local moderators in Lusaka, Zambia between August and December 2016. Data were analyzed using thematic content analysis using ATLAS.ti (Version 7.5.17). RESULTS: While interest in the newly launched WC was high, few participants recognized it, so discussion was framed around FCs more generally. The decision to use a FC is challenged by misconceptions regarding safety and correct use, cost, and women's limited power over decision making in relationships. Participants also reported low availability of the product. Several opportunities for FC uptake were discussed, including the perception that FCs provide better sensation during intercourse compared with male condoms, and women reported enthusiasm for the opportunity to be the partner responsible for contraception. Some women expressed interest in the WC in order to ensure it was not tampered with by their partner, a practice commonly reported by both genders that reflects high levels of mistrust. CONCLUSIONS: Findings suggest the FC, including the new WC, has potential to increase gender equity by giving women a product they are comfortable buying and being able to control to ensure correct use; however, future programming should address high perceived cost of the WC and women's limited decision making power in relationships. Findings also highlight the need for interventions that include product demonstration and promote the WC as a method that provides better sensation during sex than male condoms. To increase voluntary uptake, the challenges identified here should be incorporated into future social marketing campaigns.


Asunto(s)
Condones Femeninos/estadística & datos numéricos , Conducta Anticonceptiva/psicología , Educación en Salud , Conocimientos, Actitudes y Práctica en Salud , Parejas Sexuales/psicología , Enfermedades de Transmisión Sexual/prevención & control , Adolescente , Adulto , Femenino , Humanos , Masculino , Embarazo , Enfermedades de Transmisión Sexual/epidemiología , Adulto Joven , Zambia/epidemiología
12.
Eur J Contracept Reprod Health Care ; 24(3): 233-239, 2019 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-31112062

RESUMEN

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.


Asunto(s)
Condones Femeninos , Diseño de Equipo , Adolescente , Adulto , Condones Femeninos/efectos adversos , Comportamiento del Consumidor , Estudios Cruzados , Falla de Equipo , Femenino , Humanos , Persona de Mediana Edad , Adulto Joven
13.
BMC Pregnancy Childbirth ; 18(1): 168, 2018 May 15.
Artículo en Inglés | MEDLINE | ID: mdl-29764416

RESUMEN

BACKGROUND: Postpartum hemorrhage is the leading cause of maternal mortality in low- and middle-income countries. While evidence on uterine balloon tamponade efficacy for severe hemorrhage is encouraging, little is known about safety of this intervention. The objective of this study was to evaluate the safety of an ultra-low-cost uterine balloon tamponade package (named ESM-UBT) for facility-based management of uncontrolled postpartum hemorrhage (PPH) in Kenya and Sierra Leone. METHODS: Data were collected on complications/adverse events in all women who had an ESM-UBT device placed among 92 facilities in Sierra Leone and Kenya, between September 2012 and December 2015, as part of a multi-country study. Three expert maternal health investigator physicians analyzed each complication/adverse event and developed consensus on whether there was a potential causal relationship associated with use of the ESM-UBT device. Adverse events/complications specifically investigated included death, hysterectomy, uterine rupture, perineal or cervical injury, serious or minor infection, and latex allergy/anaphylaxis. RESULTS: Of the 201 women treated with an ESM-UBT device in Kenya and Sierra Leone, 189 (94.0%) survived. Six-week or longer follow-up was recorded in 156 of the 189 (82.5%). A causal relationship between use of an ESM-UBT device and one death, three perineal injuries and one case of mild endometritis could not be completely excluded. Three experts found a potential association between these injuries and an ESM-UBT device highly unlikely. CONCLUSION: The ESM-UBT device appears safe for use in women with uncontrolled PPH. TRIAL REGISTRATION: Trial registration was not completed as data was collected as a quality assurance measure for the ESM-UBT kit.


Asunto(s)
Condones Femeninos , Técnicas Hemostáticas/instrumentación , Hemorragia Posparto/terapia , Taponamiento Uterino con Balón/métodos , Adolescente , Adulto , Condones Femeninos/economía , Costos y Análisis de Costo , Femenino , Instituciones de Salud/estadística & datos numéricos , Técnicas Hemostáticas/economía , Humanos , Kenia , Hemorragia Posparto/economía , Embarazo , Estudios Retrospectivos , Sierra Leona , Resultado del Tratamiento , Taponamiento Uterino con Balón/economía , Taponamiento Uterino con Balón/estadística & datos numéricos , Adulto Joven
14.
Fed Regist ; 83(188): 48711-3, 2018 Sep 27.
Artículo en Inglés | MEDLINE | ID: mdl-30272398

RESUMEN

The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify single-use female condoms, renaming the device to "single-use internal condom," a postamendments class III device (regulated under product code MBU), into class II (special controls) subject to premarket notification (510(k)). FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is finalizing this reclassification on its own initiative based on new information. FDA is also amending the existing device identification for "female condom," a preamendments class III device (product code OBY), by renaming the device "multiple-use female condom," to distinguish it from the "single-use internal condom." This order reclassifies single-use internal condoms from class III to class II and reduces regulatory burden because these types of devices will no longer be required to submit a premarket approval application (PMA), but can instead submit a less burdensome 510(k) before marketing their device.


Asunto(s)
Condones Femeninos/clasificación , Equipos Desechables/clasificación , Femenino , Humanos , Terminología como Asunto , Estados Unidos , United States Food and Drug Administration
15.
Am J Public Health ; 107(10): 1633-1635, 2017 10.
Artículo en Inglés | MEDLINE | ID: mdl-28817319

RESUMEN

OBJECTIVES: To examine state-level female condom use through Medicaid from 2004 to 2014, because in 2010, the Patient Protection and Affordable Care Act (ACA) allowed for expanded Medicaid coverage in many states, extending requirements for contraceptive care to more of the poorest women in the United States and to most women with private insurance. METHODS: We collected data via brief survey of Medicaid offices in all 50 states between March 2015 and March 2016. RESULTS: The number of states providing Medicaid reimbursement for the female condom increased 33% (from 25 to 36) since 2007. Twenty-nine states provided data showing low numbers of claims for female condoms but high rates of reimbursement. CONCLUSIONS: This period of heightened access demands that the public health community seize the moment to increase awareness about and promote the female condom among health care professionals and consumers. The pending repeal of the ACA may thwart important gains in access; policies promoting women's reproductive health must be implemented immediately.


Asunto(s)
Condones Femeninos/estadística & datos numéricos , Cobertura del Seguro/estadística & datos numéricos , Seguro de Salud/estadística & datos numéricos , Medicaid/estadística & datos numéricos , Humanos , Patient Protection and Affordable Care Act , Estados Unidos
16.
Qual Health Res ; 27(9): 1302-1315, 2017 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-27811288

RESUMEN

New interventions to reduce HIV and sexually transmitted infections (STI) among female sex workers are introduced into the context of women's existing prevention beliefs and practices. These indigenous practices affected implementation of our program to introduce female condoms to women in sex-work establishments in southern China. We used ethnographic field observations and in-depth interviews to document common prevention methods women reported using to protect themselves before and during intervention implementation. Individual, sex-work establishment, and other contextual factors, including sources of information and social and economic pressures to use or reject prevention options, shaped their perceptions and selection of these methods and affected adoption of female condoms as an additional tool. Efforts to improve uptake of effective prevention methods among low-income sex workers require attention to the context and spectrum of women's HIV/STI prevention practices when introducing innovations such as female condoms, microbicides, pre-exposure prophylaxis pills, and others, as they become available.


Asunto(s)
Condones Femeninos/estadística & datos numéricos , Infecciones por VIH/prevención & control , Conocimientos, Actitudes y Práctica en Salud , Pobreza , Trabajadores Sexuales/psicología , Adulto , Antropología Cultural , Antibacterianos/administración & dosificación , China/epidemiología , Información de Salud al Consumidor/métodos , Femenino , Infecciones por VIH/etnología , Humanos , Medicina Tradicional China/estadística & datos numéricos , Persona de Mediana Edad , Investigación Cualitativa , Medición de Riesgo , Factores de Riesgo , Enfermedades de Transmisión Sexual/prevención & control , Factores Socioeconómicos , Abuso de Sustancias por Vía Intravenosa/epidemiología , Ducha Vaginal/estadística & datos numéricos
17.
AIDS Behav ; 20(12): 2845-2849, 2016 12.
Artículo en Inglés | MEDLINE | ID: mdl-26864690

RESUMEN

This study assessed and mapped the availability of the female condom in relation to the male condom and HIV prevalence in the Philadelphia metropolitan area, which has a high density of HIV. One percent of the 1228 service providers contacted sold/provided the female condom and 77 % sold/provided the male condom. The lack of availability of the female condom suggests this product will have no public health impact on reducing HIV and that interventions that promote use of the female condom are not sustainable in this high-risk area. Our findings may help policy makers increase female condom availability in this area.


Asunto(s)
Condones Femeninos/provisión & distribución , Infecciones por VIH/prevención & control , Infecciones por VIH/transmisión , Accesibilidad a los Servicios de Salud/estadística & datos numéricos , Población Urbana/estadística & datos numéricos , Adulto , Condones/provisión & distribución , Estudios Transversales , Femenino , Predicción , Infecciones por VIH/epidemiología , Política de Salud/tendencias , Humanos , Masculino , Philadelphia , Prevalencia
18.
Health Educ Res ; 31(2): 260-72, 2016 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-26956041

RESUMEN

Partner negotiation and insertion difficulties are key barriers to female condom (FC) use in sub-Saharan Africa. Few FC interventions have provided comprehensive training in both negotiation and insertion skills, or focused on university students. In this study we explored whether training in FC insertion and partner negotiation influenced young women's FC use. 296 female students at a South African university were randomized to a one-session didactic information-only minimal intervention (n= 149) or a two-session cognitive-behavioral enhanced intervention (n= 147), which received additional information specific to partner negotiation and FC insertion. Both groups received FCs. We report the 'experiences of' 39 randomly selected female students who participated in post-intervention qualitative interviews. Two-thirds of women reported FC use. Most women (n= 30/39) applied information learned during the interventions to negotiate with partners. Women reported that FC insertion practice increased their confidence. Twelve women failed to convince male partners to use the FC, often due to its physical attributes or partners' lack of knowledge about insertion. FC educational and skills training can help facilitate use, improve attitudes toward the device and help women to successfully negotiate safer sex with partners. Innovative strategies and tailored interventions are needed to increase widespread FC adoption.


Asunto(s)
Condones Femeninos/estadística & datos numéricos , Educación en Salud/organización & administración , Conocimientos, Actitudes y Práctica en Salud , Negociación , Parejas Sexuales/psicología , Femenino , Humanos , Embarazo , Embarazo no Planeado , Sexo Seguro , Enfermedades de Transmisión Sexual/prevención & control , Sudáfrica , Universidades , Adulto Joven
19.
J Obstet Gynaecol Can ; 38(2): 182-222, 2016 Feb.
Artículo en Inglés, Francés | MEDLINE | ID: mdl-27032746

RESUMEN

OBJECTIVE: To provide guidelines for health care providers on the use of contraceptive methods to prevent pregnancy and on the promotion of healthy sexuality. OUTCOMES: Overall efficacy of cited contraceptive methods, assessing reduction in pregnancy rate, safety, ease of use, and side effects; the effect of cited contraceptive methods on sexual health and general well-being; and the relative cost and availability of cited contraceptive methods in Canada. EVIDENCE: Published literature was retrieved through searches of Medline and The Cochrane Database from January 1994 to January 2015 using appropriate controlled vocabulary (e.g., contraception, sexuality, sexual health) and key words (e.g., contraception, family planning, hormonal contraception, emergency contraception). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies published in English from January 1994 to January 2015. Searches were updated on a regular basis in incorporated in the guideline to June 2015. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. VALUES: The quality of the evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table 1). CHAPTER 7: INTRAUTERINE CONTRACEPTION: SUMMARY STATEMENTS: 1. Intrauterine contraceptives are as effective as permanent contraception methods. (II-2) 2. The use of levonorgestrel-releasing intrauterine system (LNG-IUS) 52 mg by patients taking tamoxifen is not associated with recurrence of breast cancer. (I) 3. Intrauterine contraceptives have a number of noncontraceptive benefits. The levonorgestrel-releasing intrauterine system (LNG-IUS) 52 mg significantly decreases menstrual blood loss (I) and dysmenorrhea. (II-2) Both the copper intrauterine device and the LNG-IUS significantly decrease the risk of endometrial cancer. (II-2) 4. The risk of uterine perforation decreases with inserter experience but is higher in postpartum and breastfeeding women. (II-2) 5. The risk of pelvic inflammatory disease (PID) is increased slightly in the first month after intrauterine contraceptive (IUC) insertion, but the absolute risk is low. Exposure to sexually transmitted infections and not the IUC itself is responsible for PID occurring after the first month of use. (II-2) 6. Nulliparity is not associated with an increased risk of intrauterine contraceptive expulsion. (II-2) 7. Ectopic pregnancy with an intrauterine contraceptive (IUC) is rare, but when a pregnancy occurs with an IUC in situ, it is an ectopic pregnancy in 15% to 50% of the cases. (II-2) 8. In women who conceive with an intrauterine contraceptive (IUC) in place, early IUC removal improves outcomes but does not entirely eliminate risks. (II-2) 9. Intrauterine contraceptives do not increase the risk of infertility. (II-2) 10. Immediate insertion of an intrauterine contraceptive (10 minutes postplacental to 48 hours) postpartum or post-Caesarean section is associated with a higher continuation rate compared with insertion at 6 weeks postpartum. (I) 11. Immediate insertion of an intrauterine contraceptive (IUC; 10 minutes postplacental to 48 hours) postpartum or post-Caesarean section is associated with a higher risk of expulsion. (I) The benefit of inserting an IUC immediately postpartum or post-Caesarean section outweighs the disadvantages of increased risk of perforation and expulsion. (II-C) 12. Insertion of an intrauterine contraceptive in breastfeeding women is associated with a higher risk of uterine perforation in the first postpartum year. (II-2) 13. Immediate insertion of an intrauterine contraceptive (IUC) post-abortion significantly reduces the risk of repeat abortion (II-2) and increases IUC continuation rates at 6 months. (I) 14. Antibiotic prophylaxis for intrauterine contraceptive insertion does not significantly reduce postinsertion pelvic infection. (I) RECOMMENDATIONS: 1. Health care professionals should be careful not to restrict access to intrauterine contraceptives (IUC) owing to theoretical or unproven risks. (III-A) Health care professionals should offer IUCs as a first-line method of contraception to both nulliparous and multiparous women. (II-2A) 2. In women seeking intrauterine contraception (IUC) and presenting with heavy menstrual bleeding and/or dysmenorrhea, health care professionals should consider the use of the levonorgestrel intrauterine system 52 mg over other IUCs. (I-A) 3. Patients with breast cancer taking tamoxifen may consider a levonorgestrel-releasing intrauterine system 52 mg after consultation with their oncologist. (I-A) 4. Women requesting a levonorgestrel-releasing intrauterine system or a copper-intrauterine device should be counseled regarding changes in bleeding patterns, sexually transmitted infection risk, and duration of use. (III-A) 5. A health care professional should be reasonably certain that the woman is not pregnant prior to inserting an intrauterine contraceptive at any time during the menstrual cycle. (III-A) 6. Health care providers should consider inserting an intrauterine contraceptive immediately after an induced abortion rather than waiting for an interval insertion. (I-B) 7. In women who conceive with an intrauterine contraceptive (IUC) in place, the diagnosis of ectopic pregnancy should be excluded as arly as possible. (II-2A) Once an ectopic pregnancy has been excluded, the IUC should be removed without an invasive procedure. The IUC may be removed at the time of a surgical termination. (II-2B) 8. In the case of pelvic inflammatory disease, it is not necessary to remove the intrauterine contraceptive unless there is no clinical improvement after 48 to 72 hours of appropriate antibiotic treatment. (II-2B) 9. Routine antibiotic prophylaxis for intrauterine contraceptive (IUC) insertion is not indicated. (I-B) Health care providers should perform sexually transmitted infection (STI) testing in women at high risk of STI at the time of IUC insertion. If the test is positive for chlamydia and/or gonorrhea, the woman should be appropriately treated postinsertion and the IUC can remain in situ. (II-2B) 10. Unscheduled bleeding in intrauterine contraception users, when persistent or associated with pelvic pain, should be investigated to rule out infection, pregnancy, gynecological pathology, expulsion or malposition. (III-A)


Asunto(s)
Condones Femeninos , Consenso , Anticonceptivos Hormonales Orales , Dispositivos Intrauterinos , Canadá , Femenino , Humanos , Embarazo , Salud Reproductiva
20.
J Obstet Gynaecol Res ; 42(11): 1567-1574, 2016 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-27444262

RESUMEN

AIM: To compare the acceptability of Phoenurse female condom (PFC) and second-generation Femidom female condom (FC2) among Chinese women. METHODS: A randomized, cross-over clinical trial was carried out in women aged 20-49 years seeking family service in Qingdao, China, between April and October 2013. Women were classified into two groups using a computer-generated randomized sequence. Participants completed questionnaires at baseline and after using 10 of each type of female condom (FC). RESULTS: Of 290 women, 247 (85.2%) believed that FC could protect against sexually transmitted diseases and HIV. A total of 152 (52.5%) thought that the female condom (FC) contraceptive failure rate was higher, and 107 (36.9%) thought that FC could be reused before they participated in this study. After the study, 135 (46.6%) and 39 women (13.4%) would have been happy to use FC2 and PFC, respectively. Significant difference was noted between PFC and FC2 for the features color, lubrication and overall fit, rather than length, appearance, smell and application method. A total of 68 (23.5%) and 140 women (49.5%) liked FC2's color and lubrication better than PFC (44, 15.2%; 99, 34.6%). Also, 158 women (54.5%) preferred the overall fit of FC2 compared with PFC (143, 49.5%; P < 0.05). CONCLUSION: Participants did not have sufficient knowledge about the contraceptive effect and use of FC. Lubrication means the smooth degree of using FC. Length means the size of FC. Appearance means the users' overall impression of the FC.


Asunto(s)
Condones Femeninos , Conocimientos, Actitudes y Práctica en Salud , Adulto , China , Comportamiento del Consumidor , Estudios Cruzados , Femenino , Humanos , Persona de Mediana Edad , Enfermedades de Transmisión Sexual/prevención & control , Adulto Joven
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