Safety of a condom uterine balloon tamponade (ESM-UBT) device for uncontrolled primary postpartum hemorrhage among facilities in Kenya and Sierra Leone.

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.

Cost-utility analysis of a female condom promotion program in Washington, DC.

A retrospective economic evaluation of a female condom distribution and education program in Washington, DC. was conducted. Standard methods of cost, threshold and cost-utility analysis were utilized as recommended by the U.S. Panel on cost-effectiveness in health and medicine. The overall cost of the program that distributed 200,000 female condoms and provided educational services was $414,186 (at a total gross cost per condom used during sex of $3.19, including educational services). The number of HIV infections that would have to be averted in order for the program to be cost-saving was 1.13 in the societal perspective and 1.50 in the public sector payor perspective. The cost-effectiveness threshold of HIV infections to be averted was 0.46. Overall, mathematical modeling analyses estimated that the intervention averted approximately 23 HIV infections (even with the uncertainty inherent in this estimate, this value appears to well exceed the necessary thresholds), and the intervention resulted in a substantial net cost savings.

Can medicaid reimbursement help give female condoms a second chance in the United States?

The female condom is the only other barrier contraception method besides the male condom, and it is the only "woman-initiated" device for prevention of sexually transmitted infections. Although studies demonstrate high acceptability and effectiveness for this device, overall use in the United States remains low. The female condom has been available through Medicaid in many states since 1994. We provide the first published summary of data on Medicaid reimbursement for the female condom. Our findings demonstrate low rates of claims for female condoms but high rates of reimbursement. In light of the 2009 approval of a new, cheaper female condom and the recent passage of comprehensive health care reform, we call for research examining how health care providers can best promote consumer use of Medicaid reimbursement to obtain this important infection-prevention device.

The female condom: the international denial of a strong potential.

The female condom has received surprisingly little serious attention since its introduction in 1984. Given the numbers of women with HIV globally, international support for women's reproductive and sexual health and rights and the empowerment of women, and, not least, due to the demand expressed by users, one would have expected the female condom to be widely accessible 16 years after it first appeared. This expectation has not materialised; instead, the female condom has been marginalised in the international response to HIV and AIDS. This paper asks why and analyses the views and actions of users, providers, national governments and international public policymakers, using an analytical framework specifically designed to evaluate access to new health technologies in poor countries. We argue that universal access to female condoms is not primarily hampered by obstacles on the users' side, as is often alleged, nor by unwilling governments in developing countries, but that acceptability of the female condom is problematic mainly at the international policy level. This view is based on an extensive review of the literature, interviews with representatives of UNAIDS, UNFPA and other organisations, and a series of observations made during the International AIDS Conference in Mexico in August 2008.

Costs of HIV prevention among out-of-treatment drug-using women: results of a randomized controlled trial.

OBJECTIVES: We developed a micro-costing methodology to estimate the real resource costs consumed by delivery of the National Institute on Drug Abuse (NIDA) Cooperative Agreement Standard Intervention (SI) for human immunodeficiency virus (HIV) prevention, plus two enhanced modules, in a three-arm randomized controlled trial (RCT) among drug-using women. To our knowledge, this is the first micro-costing study of the SI and enhanced modules and the first of its kind targeting drug-using women. METHODS: We conducted a micro-costing study alongside a three-arm RCT to estimate costs of (1) the modified NIDA SI; (2) the SI and a well woman exam (SI+WWE); and (3) the SI, WWE, and four educational sessions (SI+WWE+4ES) to prevent HIV and sexually transmitted diseases in at-risk, drug-using women in St. Louis, Missouri. RESULTS: The cost of the SI that all 501 participants received was approximately $227 per person. The additional costs for the WWE and 4ES were approximately $145 and $942 per person, respectively. Total program costs for the SI (n = 501) were $113,869; additional costs for the SI+WWE (n = 342) were $49,403 and for the SI+WWE+4ES (n = 170) were $160,189. The main cost component for the SI (64% of total costs) was testing costs, whereas building and facilities costs were the main cost component for the SI+WWE+4ES (75% of total costs). CONCLUSIONS: This study provides accurate estimates of the real costs for standard and enhanced HIV interventions for policy makers seeking to implement targeted HIV-prevention programs with scarce resources.

The evaluation of the Woman's Condom marketing approach: What value did peer-led interpersonal communication add to the promotion of a new female condom in urban Lusaka?

During a mass media campaign accompanying the launch of the Maximum Diva Woman's Condom (WC) in Lusaka, Zambia, a cluster-randomized evaluation was implemented to measure the added impact of a peer-led interpersonal communication (IPC) intervention on the awareness and uptake of the new female condom (FC). The WC and mass media campaign were introduced simultaneously in 40 urban wards in April 2016; half of the wards were randomly assigned to the treatment (IPC intervention) with cross-sectional surveys conducted before (n = 2,364) and one year after (n = 2,430) the start of the intervention. A pre-specified intention-to-treat (ITT) analysis measured the impact of randomization to IPC at the community level. In adjusted ITT models, there were no statistically significant differences between intervention and control groups. Due to significant implementation challenges, we also conducted exploratory secondary analyses to estimate effects among those who attended an IPC event (n = 66) using instrumental variable and inverse probability weighting analyses. In addition to increases in FC identification (IPC attendees had higher reported use of any condom, improved perceptions of FC's, and were more likely to have discussed contraceptive use with their partner as compared to non-attendees). The introduction of a new FC product combined with an IPC intervention significantly increased general knowledge and awareness in the community as compared to media alone, but did not lead to detectable community level impacts on other primary outcomes of interest. Observational evidence from our study suggests that IPC attendance is associated with increased use and negotiation. Future studies should explore the intensity and duration of IPC programming necessary to achieve detectable community level impacts on behavior. Trial Registration: AEARCTR-0000899.

Country-wide distribution of the nitrile female condom (FC2) in Brazil and South Africa: a cost-effectiveness analysis.

OBJECTIVE: To evaluate the cost-effectiveness and potential impact of expanded female condom distribution. DESIGN: Cost-effectiveness analysis assessing HIV infections averted annually and incremental cost per HIV infection averted for country-wide distribution of the nitrile female condom (FC2) among sexually active individuals, 15-49 years, with access to publicly distributed condoms in Brazil and South Africa. RESULTS: In Brazil, expansion of FC2 distribution to 10% of current male condom use would avert an estimated 604 (5-95th percentiles, 412-831) HIV infections at 20,683 US dollars (5-95th percentiles, 13,497-29,521) per infection averted. In South Africa, 9577 (5-95th percentiles, 6539-13,270) infections could be averted, at 985 US dollars (5-95th percentiles, 633-1412) per infection averted. The estimated cost of treating one HIV-infected individual is 21,970 US dollars (5-95th percentiles, 18,369-25,719) in Brazil and 1503 US dollars (5-95th percentiles, 1245-1769) in South Africa, indicating potential cost savings. The incremental cost of expanded distribution would be reduced to 8930 US dollars (5-95th percentiles, 5864-13,163) per infection averted in Brazil and 374 US dollars (5-95th percentiles, 237-553) in South Africa by acquiring FC2s through a global purchasing mechanism and increasing distribution threefold. Sensitivity analyses show model estimates to be most sensitive to the estimated prevalence of sexually transmitted infections, total sexual activity, and fraction of FC2s properly used. CONCLUSIONS: Expanded distribution of FC2 in Brazil and South Africa could avert substantial numbers of HIV infections at little or no net cost to donor or government agencies. FC2 may be a useful and cost-effective supplement to the male condom for preventing HIV.

Sex, life and the female condom: some views of HIV positive women.

This article offers some insights into the experiences of HIV positive women with the female condom, drawing on my own personal experience and responses of 18 members of the International Community of Women Living with HIV/AIDS to an e-mail survey conducted in 2005. Major barriers reported to female condom use were cost and sporadic or very limited access. All respondents talked about needing to negotiate the use of female condoms with their male sex partners. Most felt more in control and more confident during sex when using the female condom than with the male condom or unprotected sex. Concerns about female condoms appear to be common, especially among women who have never used one; those who had used the female condom for long periods of time said good things about it. Women reclaiming our bodies is a central part of the joy and the challenge of promoting the female condom. For HIV positive women and girls, using a condom is more than protection against pregnancy, but a matter of life and death greater than the risks pregnancy can bring. Female condoms could make a critically important contribution to protecting HIV positive women's sexuality and continued sexual activity, as a fundamental part of our sexual and reproductive rights, if only they were more widely available and affordable.

Assessing the potential of the Woman's Condom for vaginal drug delivery.

BACKGROUND: The Woman's Condom is a new female condom that uses a dissolvable polyvinyl alcohol capsule to simplify vaginal insertion. This preclinical study assessed the feasibility to incorporate an antiviral drug, UC781, into the Woman's Condom capsule, offering a unique drug delivery platform. STUDY DESIGN: UC781 capsules were fabricated using methods from the development of the Woman's Condom capsules as well as those used in vaginal film development. Capsules were characterized to evaluate physical/chemical attributes, Lactobacillus compatibility, in vitro safety and bioactivity, and condom compatibility. RESULTS: Two UC781 capsule platforms were assessed. Capsule masses (mg; mean±SD) for platforms 1 and 2 were 116.50±18.22 and 93.80±8.49, respectively. Thicknesses were 0.0034±0.0004 in and 0.0033±0.0004 in. Disintegration times were 11±3 s and 5±1 s. Puncture strengths were 21.72±3.30 N and 4.02±0.83 N. Water content measured 6.98±1.17% and 7.04±1.92%. UC781 content was 0.59±0.05 mg and 0.77±0.11 mg. Both platforms retained in vitro bioactivity and were nontoxic to TZM-bl cells and Lactobacillus. Short-term storage of UC781 capsules with the Woman's Condom pouch did not decrease condom mechanical integrity. CONCLUSIONS: UC781 was loaded into a polymeric capsule similar to that of the Woman's Condom product. This study highlights the potential use of the Woman's Condom as a platform for vaginal delivery of drugs relevant to sexual/reproductive health, including those for short- or long-acting HIV prevention. IMPLICATIONS: We determined the proof-of-concept feasibility of incorporation of an HIV-preventative microbicide into the Woman's Condom capsule. This study highlights various in vitro physical and chemical evaluations as well as bioactivity and safety assessments necessary for vaginal product development related to female sexual and reproductive health.

"It's some kind of women's empowerment": the ambiguity of the female condom as a marker of female empowerment.

The female condom is the latest in a series of sexual and reproductive technologies to be imported into the third world, following the contraceptive pill, the Depo-Provera injection, the latex male condom, and others. It is an example of "traveling technology", which accrues different meanings and connotations in the different settings into which it is introduced in its journey through the circuits of international technological diffusion, from the headquarters of international NGOs and bilateral aid programs, through the bureaucracies of national ministries of health to the communities in urban and rural settings where the condoms are distributed. The female condom almost always carries connotations of women's empowerment, and the possibility of greater sexual autonomy for women. This association is a result of the female condom being the first new "post-Cairo" technology, the diffusion of which was spurred by the consensus reached at the 1994 International Conference on Population and Development in Cairo, at which the need to promote women's empowerment was moved to the center of international family planning and population movements. However, I demonstrate that "empowerment" is an ambiguous term, interpreted in different ways in different contexts. I illustrate this through interviews conducted in 1998 and 1999 with stakeholders in the female condom in Cape Town, Nairobi, and in rural western Kenya. These stakeholders range from directors of US-based development programs to heads of national AIDS-prevention efforts to community-based distributors and primary health care nurses at the village level. I argue that three different notions of empowerment are being articulated with respect to the female condom--two which correspond to Maxine Molyneux's typology of strategic and practical gender interests, and a third in which women's empowerment is conceived of as something which diminished the power of men. I argue further that the disjunctures between these three different notions of what "empowerment" means will pose a challenge for people at all levels which are seeking to make the female condom more widely accessible to women at risk of HIV/AIDS.

Cost-effectiveness of the female condom in preventing HIV and STDs in commercial sex workers in rural South Africa.

We assessed the cost-effectiveness of the female condom (FC) in preventing HIV infection and other STDs among commercial sex workers (CSWs) and their clients in the Mpumulanga Province of South Africa. The health and economic outcomes of current levels of male condom (MC) use in 1000 CSWs who average 25 partners per year and have an HIV prevalence of 50.3% was compared with the expected outcomes resulting from the additional provision of FCs to these CSWs. A simulation model calculated health and public sector cost outcomes assuming 5 years of HIV infectivity, 1 month of syphilis and gonorrhea infectivity, and FC use in 12% of episodes of vaginal intercourse. Delayed infections and interactions between STDs and HIV were modeled. The simulation was extended to non-CSWs with as few as one casual partner per year. We conducted multiple sensitivity analyses. The program would distribute 6000 FCs annually at a cost of $4002 and would avert 5.9 HIV, 38 syphilis, and 33 gonorrhea cases. This would save the public sector health payer $12,090 in averted HIV/AIDS treatment costs, and $1,074 in averted syphilis and gonorrhea treatment costs for a net saving of $9163. Sensitivity analyses indicate that the economic findings are robust across a wide range of values for key inputs. The program generates net savings of $5421 if HIV prevalence in CSWs is 25% rather than 50.3% and savings of S3591 if each CSW has an average of 10 clients per year rather than 25. A program focusing on non-CSWs with only one casual partner would save $199. We conclude that a well-designed FC program oriented to CSWs and other women with casual partners is likely to be highly cost-effective and can save public sector health funds in rural South Africa.

Making the female condom a "reality" for adolescents.

Alarming rates of pregnancy, sexually transmitted diseases, and human immunodeficiency virus infection among adolescents point to the need for expanding contraceptive options for adolescents. The female condom-a female-controlled barrier method that protects both partners from sexually transmitted diseases-marks an important breakthrough in contraceptive technology. This report reviews current research on the efficacy and acceptability of the female condom and considers the feasibility of its use in the adolescent population. Specifically, the authors first consider the factors that affect teenage condom (and other contraceptive) use (efficacy, cost and availability, and acceptability) and then apply the mechanics of the female condom to these issues. Based on this analysis, recommendations for future steps to be taken by researchers, adolescent health practitioners, and the manufacturer of the female condom are presented.

The female condom: acceptability and perception among rural women in Zimbabwe.

This study was conducted to generate data for developing an action plan for accessing the female condom through primary health care centres in Zimbabwe. It used both quantitative and qualitative methods to gather information from sexually active women and men on the perception and acceptability of the female condom among users in rural areas of Zimbabwe. The findings show that very few women had used the female condom prior to the survey. Several women (93%) liked the condom especially young women aged 20-39 years (83%), compared to older women aged 40 years and above (11%). Both women and men liked the dual role of contraception and protection against STIs including HIV/AIDS played by the female condom. Most women (98%) felt that it is important for women to have their own condom. However, both men and women pointed out that it will be difficult to introduce the female condom in married situations due to the stigma associated with condoms in general. Over 80% of women said they will have to seek permission from their partners to use the female condom. Women had problems with inserting the condom and were concerned with lubrication, size and appearance, and how to dispose of used condom. Regarding cost, 77% felt that the female condom is too expensive given that the male condom can be obtained free from health centres. The cost of the female condom could hinder its continued use and would encourage women, especially commercial sex workers, to re-use it. Respondents still require more information relating to side effects (45%), effectiveness in STIs prevention including HIV/AIDS (44%), proper use (43%) and cost (32%).

The female condom.

BACKGROUND: The female condom has been available in numerous countries for some years. It was launched in Australia on March 8th, 2000 and is an important addition to the range of barrier contraceptives. OBJECTIVE: This article aims to provide an overview of the female condom to enable GPs and nurse practitioners to advise clients and provide information about its use. DISCUSSION: The female condom is an effective form of contraception. When used correctly it has a failure rate of about 5%, which compares favourably with other forms of barrier contraception. It is important that users are instructed on insertion, in particular the need to guide the penis into the condom. Evidence shows that it reduces the incidence of sexually transmitted infections. There may also be additional benefit in reducing wart virus and herpes transmission, as there is greater protection to the vulva and the base of the penis, when compared with the male condom. The female condom has high user acceptability, and offers advantages in terms of sensitivity and also ease of use by men with erectile dysfunction. It is the only barrier protection under a woman's control, giving protection to the vagina and vulva as well as the cervix.

[Current status of the female condom in Africa]. / Actualité du préservatif féminin en Afrique.

The female condom was developed in the 1980s. It is a contraceptive device used by women that protects against both pregnancy and sexually-transmitted diseases (STDs) including HIV infection. Two studies have investigated the contraceptive effectiveness of the female condom, and it was found to be as effective as other barrier methods. It has been shown to be effective against STD and HIV transmission in vitro but there is only limited evidence of its efficacy in vivo. No serious local side effects or allergies have been reported and the female condom can be used with any type of lubricant, spermicidal cream or foam. The female condom is the only device other than the male condom that has been shown to prevent HIV transmission. The female condom has been marketed in 13 countries since the summer of 1996. Most of these countries are industrialized and the selling price in these countries is too high for developing countries. Sub-Saharan Africa has very high prevalence rates for HIV infection, at least 30% of the general population in Eastern and Central regions. The epidemic is also spreading fast in some parts of the Western region. In Ivory Coast for example, 12 to 15% of pregnant women are infected. African women are subordinate to men in many aspects of their lives, politically, educationally, socially and sexually. This sexual inequality makes them highly vulnerable to STDs, including HIV, and unwanted pregnancies. This paper reviews 10 of the 15 studies carried out in sub-Saharan African countries between 1990 and 1996 and compiled by the World Health Organization. Recruitment methods, education of subjects, methodology and assessment of acceptability differed between studies. Despite these limitations, most studies concluded that the women who participated in the trials generally found the female condom acceptable. Acceptability was established quicker among prostitutes than among other women and men found the female condom less acceptable than did women. However, the sample size is too small to draw any firm conclusions. Commercial sex workers in the studies reviewed were very interested in this new method because it gave them an additional method of safer protection during sex. However, they were occasionally faced with difficult negotiations with some clients, refusal to use the female condom and sexual violence. Reuse of the device was reported in four studies, but the term reuse is seldom defined. In cases where it was defined, the frequency of reuse, with washing of the device, accounted for no more than 1% of the total number of uses. The acceptability of the female condom among women other than prostitutes faces two obstacles, the reaction of the woman's regular partner and attitudes to the device itself (appearance, difficulties or uneasiness concerning its use). However, some women liked it because it provided dual protection against pregnancy and STDs and sexual pleasure. The moderate level of acceptability to male partners may be overestimated because women whose partners disliked the device would be more likely to discontinue its use. The studies of acceptability reviewed here show that use of the female condom in Africa is realistic and that it provides women with more independent protection. Initial negative perceptions of the device are often replaced with a more positive reaction after several uses. The experience gained with use reduces the technical problems. We need to overcome the stereotypes, simplifications and strong opinions that threaten to damage the acceptance of this new method and efforts to encourage women to adopt it. However, we still require further clinical data on the effectiveness of the female condom at preventing pregnancy and HIV transmission. Availability of the female condom is improving in Africa. Pilot marketing studies were launched in 1996 in Guinea, Zambia, South Africa, followed by Uganda and Tanzania. There are local initiatives in Ivory Coast and Zimbabwe. (ABSTRACT TRUNC

PIP: This work discusses the female condom and the context of women's lives in sub-Saharan Africa, analyzes results of studies on acceptability conducted in Africa, and assesses the prospects for future use of the method in Africa. Studies have been conducted throughout the world on the efficacy, tolerance, and acceptability of the female condom. The two studies of contraceptive effectiveness, carried out in England, the US, and Latin America, showed it to be about as effective as other barrier methods. Both studies had high dropout rates. The female condom has been demonstrated to be effective in vitro against transmission of HIV and sexually transmitted diseases, but evidence of efficacy in vivo remains limited. The high prevalence of HIV infection in eastern and central Africa and its rapid spread in parts of western Africa, and the growing desire of African women to space or limit births, indicate a need for protection that could be met by the female condom. The subordinate position of African women at all levels limits their ability to negotiate on sexual topics, including contraception. 10 of the 15 studies of acceptability of the female condom, carried out in 9 sub-Saharan African countries between 1990 and 1996 and compiled by the World Health Organization, were reviewed. The studies were limited by small sample size, selective recruiting, lack of consistency in methods and analysis, and a tendency to ignore dropout rates and motives. Despite the limitations, the studies found female condoms to be acceptable to certain groups of women, especially prostitutes. Acceptability was established more rapidly among prostitutes, although large proportions reported the method to be unacceptable to some of their clients. Results of acceptability studies were more variable among non-prostitutes. Acceptability among men has been insufficiently documented. Stereotypes and oversimplifications must not be allowed to hamper promotion of the female condom. It is recommended that further study of the contraceptive and disease prevention efficacy of the female condom be conducted and that availability and accessibility of the method be increased for African women.

Silencing women's sexuality: global AIDS policies and the case of the female condom.

INTRODUCTION: The female condom is the only evidence-based AIDS prevention technology that has been designed for the female body; yet, most women do not have access to it. This is remarkable since women constitute the majority of all HIV-positive people living in sub-Saharan Africa, and gender inequality is seen as a driving force of the AIDS epidemic. In this study, we analyze how major actors in the AIDS prevention field frame the AIDS problem, in particular the female condom in comparison to other prevention technologies, in their discourse and policy formulations. Our aim is to gain insight into the discursive power mechanisms that underlie the thinking about AIDS prevention and women's sexual agency. METHODS: We analyze the AIDS policies of 16 agencies that constitute the most influential actors in the global response to AIDS. Our study unravels the discursive power of these global AIDS policy actors, when promoting and making choices between AIDS prevention technologies. We conducted both a quantitative and qualitative analysis of how the global AIDS epidemic is being addressed by them, in framing the AIDS problem, labelling of different categories of people for targeting AIDS prevention programmes and in gender marking of AIDS prevention technologies. RESULTS: We found that global AIDS policy actors frame the AIDS problem predominantly in the context of gender and reproductive health, rather than that of sexuality and sexual rights. Men's sexual agency is treated differently from women's sexual agency. An example of such differentiation and of gender marking is shown by contrasting the framing and labelling of male circumcision as an intervention aimed at the prevention of HIV with that of the female condom. CONCLUSIONS: The gender-stereotyped global AIDS policy discourse negates women's agency in sexuality and their sexual rights. This could be an important factor in limiting the scale-up of female condom programmes and hampering universal access to female condoms.