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.

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.

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.

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.

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.

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.

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.

A prospective study assessing the effects of introducing the female condom in a sex worker population in Mombasa, Kenya.

OBJECTIVE: To assess the impact and costs of adding female condoms to a male condom promotion and distribution peer education programme for sex workers in Mombasa, Kenya. DESIGN: A 12 month, prospective study of 210 female sex workers. METHODS: We interviewed participants about their sexual behaviour every 2 months for a total of seven times and introduced female condoms after the third interview. We also collected cost data and calculated the cost and cost effectiveness of adding the female condom component to the existing programme. RESULTS: Introduction of the female condom in an HIV/AIDS prevention project targeting sex workers led to small, but significant, increases in consistent condom use with all sexual partners. However, there was a high degree of substitution of the female condom for male condoms. The cost per additional consistent condom user at a programme level is estimated to be 2160 dollars (1169 pounds sterling, 1711 euros) (95% CI: 1338 to 11 179). CONCLUSIONS: The female condom has some potential for reducing unprotected sex among sex workers. However, given its high cost, and the marginal improvements seen here, governments should limit promotion of the female condom in populations that are already successfully using the male condom. More research is needed to identify effective methods of encouraging sex workers to practise safer sex with their boyfriends.

Expanding safer sex options: introducing the female condom into national programmes.

Although the female condom has been introduced into over 90 countries since 1997, it has only been accepted in sexual and reproductive health programmes as a mainstream method in a few. This paper describes introductory strategies developed by Ministries of Health and non-governmental organisations in Brazil, Ghana, Zimbabwe and South Africa, supported by UNAIDS, and the manufacturers of the female condom, which have significantly expanded the number of female condoms being used. These projects have several key similarities: a focus on training for providers and peer educators, face-to-face communication with potential users to equip them with information and skills, an identified target audience, a consistent supply, a long assessment period to gauge actual use beyond the initial novelty phase, and a mix of public and private sector distribution. Female condom programmes require the sanction, leadership and funding of governments and donors. However, the non-governmental and private sectors have also played a major role in programme implementation. To ensure successful introduction of the female condom, it is crucial to involve a range of decision-makers, programme managers, service providers, community leaders and women's and youth groups. The rising cost of inaction and unprotected sex in the spread of HIV and AIDS force us to recognise the high cost of not providing female condoms alongside male condoms in family planning and AIDS prevention programmes.

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%).

Intention to use the female condom following a mass-marketing campaign in Lusaka, Zambia.

OBJECTIVES: This report examines intention to use the female condom among men and women in Lusaka, Zambia, who were exposed to mass-marketing of the female condom. METHODS: The study used data from a representative sample of consumers at outlets that sell or distribute the female condom and the male condom. RESULTS: In spite of a high level of awareness of the female condom, use of this method in the last year was considerably lower than use of the male condom. Intention to use the female condom in the future was highest among respondents who had used only the female condom in the last year. CONCLUSIONS: The female condom is likely to be most important for persons who are unable or unwilling to use the male condom.

"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.