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Technical Update on the Female Condom
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Meeting Summary ReportThe Bureau for Africa/Office of Sustainable Development (OSD), U.S. Agency for International Development (USAID) sponsored a December 18, 2001 Technical Update on the Female Condom as a forum for sharing the latest scientific and programmatic information on the female condom. Family Health International (FHI) organized the meeting, working in collaboration with Population Council, Population Services International (PSI), and the Female Health Company. The meeting was part of an information dissemination initiative on the female condom, supported by OSD. Participants included representatives from agencies responsible for family planning service delivery, sexually transmitted infection (STI)/HIV control, women's advocacy, public health research, and reproductive health service policymaking. The participant packet included research briefs prepared by FHI on critical issues and other background information. This report tracks the agenda of the meeting (Appendix.) In recent years USAID has been actively assessing whether to include the female condom among the commodities supported through mission activities around the world. USAID formed a Female Condom Working Group in 1997, made up of representatives from both the Office of Health and Nutrition (HIV/AIDS Division), and the Office of Population (Research and Logistics Management Divisions). Members were interested in exchanging information and collaborating with other partners interested in female condom research and programming. The Working Group initiated a small-scale trial female condom procurement in 1997, and polled missions about interest in learning more about the female condom or participating in research. Missions interested in hosting studies in their countries received a limited stock of female condoms. In 1998 a core group from the Female Condom Working Group established priorities for research that USAID would sponsor to address key scientific and programmatic issues. USAID was interested in focusing support on research that would produce answers to key questions of global significance. Since 1997, FHI, Population Council, and PSI have conducted numerous USAID-sponsored studies to examine issues surrounding female condom programming. PSI and its country affiliates have also implemented female condom social marketing programs, compiling rich programmatic data. Investigators from other countries are also studying similar issues of global significance and contributing to the international literature. Today the body of knowledge on the female condom is dynamic, expanding, yet far from complete. Gaps in knowledge leave policymakers and program planners feeling uncertain about the appropriate role of the female condom in reproductive health programs. USAID'S goal in sponsoring the Technical Update on the Female Condom, summarized in this report, was to take inventory of what is now known about female condom programming, to note remaining unanswered questions, and to identify key policy and programmatic issues to be resolved through additional research and activities. Meeting participants were also provided an opportunity to share their views on existing data and to discuss implications for female condom policymaking and program planning. Scientific Update Jeff Spieler, USAID Global Bureau, chaired the session. He explained that the purpose of this session was to review findings from research that has examined the efficacy, effectiveness, acceptability, and re-use of the female condom. The objective of this session was to permit participants to review information reflecting the viability of the female condom as a method for family planning and STI protection. Effectiveness. Dr. Paul Feldblum of FHI discussed female condom effectiveness for preventing pregnancy and sexually transmitted infections. Rates of contraceptive effectiveness for all barrier methods, including the female condom, vary according to how well they are used. The 12-month pregnancy rate for perfect (consistent and correct) use of the female condom is five percent, compared to the male condom at three percent, and the diaphragm at six percent. The 12-month pregnancy rate for typical use (an average experience of all users) is about the same as the diaphragm at around 21 percent but not as effective as the male condom at 14 percent. The female condom is approximately as effective a contraceptive method as the male condom, and seems more effective than vaginal spermicidal methods. For disease prevention, the polyurethane material of the female condom is impermeable to various pathogens, including HIV. But for the efficacy of the method to be translated into a beneficial health effect in populations, it must be used broadly and consistently; the level of protected sex must increase; and female condom use must augment but not replace the level of protection already achieved by male condoms. Two cluster-randomized trials that have examined the impact of female condom introduction on disease rates have produced conflicting results. One study conducted among sex workers in Thailand found that STI rates were lower among women who had been given the option of using either the female condom or the male condom, than among women who had been instructed to use male condoms consistently as usual. But another cluster-randomized trial, conducted in Kenya with 1,929 women of reproductive age employed at tea, coffee, and flower plantations, found no difference in the STI rates between women who received female and male condoms and women who received only male condoms. One other cohort study looked at the impact of alternative counselling messages and female condom introduction on levels of protection. The study, conducted with female patients in a Philadelphia STI clinic, showed slight evidence of higher rates of protected sex acts among women counselled on female condom use than among women who received counselling on male-condom use or women who received "hierarchy" counselling which promoted the use of male and female condoms, the diaphragm and cervical cap, spermicides, and withdrawal, in descending order of effectiveness against STIs (see Table 1). Dr. Feldblum concluded that the female condom is an efficacious contraceptive and prophylactic method, depending on consistency and correctness as with any barrier method. But recommendations that it be made more widely available are based on slender evidence. More research is needed to confirm the method's effectiveness in general populations. Table 1. Prospective Female Condom (FC) Studies
Acceptability. Ellen Weiss, Horizons Project, International Center for Research on Women, presented highlights from studies in Brazil and Zimbabwe that provide insight on female condom acceptability and use dynamics. She began by referencing a 1997 WHO/UNAIDS-sponsored review of female condom research. This report indicated that among 41 acceptability studies, the female condom was considered "acceptable" to 41 to 95 percent of study participants. Users reported repeatedly that it is more durable than the male condom, provides more control for women, is less disruptive to sexual intimacy, permits more time for withdrawal after ejaculation, and is more comfortable for men. Still, important questions remain: Who continues to use the female condom beyond the initial trial and why? What impact does female condom availability have on overall incidence of protected sex? The Zimbabwe study was conducted approximately one year after the start of a female condom social marketing program coordinated by PSI. Marketed as a "contraceptive sheath," the female condom was sold through selected pharmacies at a heavily subsidized price. Interviews were conducted with men and women exiting urban sales outlets that sold male and female condoms. Interviews were conducted with 493 female condom users (256 males and 237 females), who represented less than two percent of all pharmacy clients approached. This study indicated that female condom users were most apt to be in their mid-to-late-20s, with higher levels of education and access to household resources. More female users were unmarried, while more male users were married. The vast majority had used the male condom prior to trying the female condom. Users perceived it to be effective and reliable for pregnancy and STI/HIV prevention. Women (57 percent) were more likely to report some difficulty with female condom use than men (30 percent). The interviews revealed that women more often than men initiate dialogue, decide on its use, and procure the female condom, but many males and females report joint decision-making. Although there were no concrete findings on the proportion of sex acts protected by either male or female condoms, there was some indication that protection may have increased with female condom introduction. Specifically, 27 percent of married women female condom users had never used male condoms, and 13 out of 65 (20 percent) consistent female condom users were not consistent male condom users. The Horizons Project study in Brazil focused on sex workers. The project began by making the female condom available at a stable and affordable price through outlets located near sex worker sites. Promotional and educational activities were also offered. A cross-sectional baseline survey (n=211) and follow-up survey (n=216) were conducted six months apart with convenience samples of sex workers drawn from four sites (street and brothel-based). Additionally, 20 in-depth interviews were conducted with follow-up survey respondents who had used the female condom more than four times in the previous six months. Results from Brazil indicated that sex workers used the female condom for curiosity or as an alternative when a client or partner did not want to use the male condom. Between the baseline and follow-up surveys, the proportion of respondents who had ever used the female condom increased from 17 percent to 51 percent. It was used more often with regular clients and boyfriends than new clients. Yet the female condom's impact on overall use of protection was not impressive. Only 35 percent of sex workers who tried the female condom were using it at the time of the follow-up survey, and 73 percent had not used the female condom during the last five sex acts. Moreover, consistent use of protection (male or female condom) for the two weeks preceding the survey decreased from 83.3 percent at baseline to 69.5 percent at follow-up. These two Horizons studies suggest that the female condom offers some but not an overwhelming amount of added value over the male condom, concluded Weiss. It is uncertain whether limitations are rooted in the product or the intervention or both. Re-use. Carol Joanis of FHI explained that research into the feasibility of re-using the female condom has been in progress for about six years, conducted primarily by FHI and the Reproductive Health Research Unit (RHRU) of Baragwanath Hospital, Johannesburg, South Africa. In June 2000, the World Health Organization (WHO) convened an expert meeting to evaluate data from this research. Experts in the fields of microbiology, epidemiology, materials, quality control and assurance, and policy and programs participated in the evaluation of the data. The panel decided that insufficient data existed to support a recommendation for female condom re-use. Additional research needs were identified. These included: (1) a study to assess the effect of disinfection, washing, drying and re-lubrication on the structural properties (durability) of the female condom; (2) a safety study to assess the impact of re-use on human tissue (penis, vagina and cervix) of those who used the female condom as labeled (i.e. a single use versus those who re-used the condom five times); and (3) a microbial study to evaluate whether the disinfect/wash/dry/re-lubrication protocol is sufficient to remove STI pathogens including gonorrhea, HIV, chlamydia and herpes. A disinfect/wash/dry/re-lubrication protocol was developed for use in the above studies. Joanis reported that a second meeting would be held at WHO in January 2002. Results of the new research studies will be presented. The advisability of female condom re-use will be evaluated based on science and programmatic implications. From these discussions, one of two possible outcomes is expected. Either a policy statement on re-use (i.e. a hierarchal approach to risk minimization) will be issued or there will be a request for more research. Audience Discussion. Meeting participants raised a number of questions about study designs and protocols, including sample sizes and number of users in studies, self-reports, and the types of STIs measured. The presenters explained the rationale for the various study designs, including how some things could be done in much more expensive and time-consuming studies. A vigorous discussion over research issues regarding the female and male condom ensued, with some questioning whether the female condom was being held to a higher standard of efficacy and other measurements than the male condom. Finally, various participants and presenters pointed out that research on programmatic issues and the female condom remains in its infancy, and that much more is needed. Field Experiences/Lessons Learned Khadijat Mojidi of USAID, Bureau for Africa/Office of Sustainable Development, chaired this session. It included a worldwide view of country introduction strategies, a focused look at a single country that has made a commitment to introducing the female condom primarily through family planning clinics, and a description of social marketing activities focused primarily on pharmacy distribution. Country Introduction Strategies. Mitchell Warren of the Female Health Company (FHC) provided a brief history and overview of introducing the female condom, which has taken place in more than 70 countries. Mostly these have been small pilot projects. In the last two years, United Nations agencies have made a commitment to providing women with female-initiated protection methods to prevent STI/HIV infection. Distribution of the female condom has increased from 900,000 female condoms in 1997 to nearly seven million in 2001. The largest country programs (with cumulative distribution in millions) are Brazil (6.1), South Africa (4.9), Zimbabwe (1.9), Ghana (1.5), and Uganda (1.2). The participant packet included a summary by country and year of the number of female condoms distributed since 1996, when UNAIDS and FHC established a global sector price, now US $0.58. Warren emphasized that the most important aspect of a successful introduction was the program elements, not the product itself. Important elements for success have emerged: political commitment, adequate planning, community advocacy, partnerships, successful pilot projects, provider training, adequate supplies, specific target audiences, and an outreach mechanism that allows users a place to go with questions. Training needs to emphasize that "practice makes perfect" and incorporate anatomy, sexuality, communication, and negotiation. Men need to be involved. The overall process is introducing an entirely new method, not just a new kind of condom. This is complex and takes time. For introductions to expand and stabilize, more donor commitment to prevention is needed, along with documenting of lessons learned, especially as they might apply to future technologies such as microbicides. Adolescents need to be addressed, and advocacy at all levels is needed. A strategic planning guide developed by UNAIDS, WHO, and FHC needs financial, technical, and commodity support to be implemented. Finally, Warren emphasized, "It is the program, not the product" that is most important. The challenges of introducing the female condom are part of the larger challenge of providing more ways for women and men to protect themselves from HIV/AIDS and strengthen their self-esteem in the process. South Africa Case Study. Tara Nutley of FHI discussed one of the few female condom introduction programs that have been implemented through the national public health family planning system. The introduction is part of a project that includes dual protection messages and emergency contraception. In 1994 the RHRU and the WHO conducted a survey on the reproductive health status of South African women. The survey showed that contraceptive choice was limited and that there were very high HIV and STI rates among the general population of women. In response, the Department of Health gave priority to dual protection by implementing a national intervention that promoted male and female condoms via social marketing and the family planning clinic infrastructure. Nutley's presentation focused on the family planning component of the program, responsible for distributing the bulk of the female condoms in South Africa. The national program includes provider training in promoting dual protection, male and female condom promotion, risk assessment, and emergency contraception promotion. Data were collected to monitor and evaluate services. A research component examined factors influencing program success. One hundred and ninety-eight interviews were held with women who had accepted the female condom at least one time from a family planning service delivery point. Results found that women use the female condom; dual method use (hormonal and barrier use) is common; dual method users alternate between female and male condoms; more women use female condoms as a dual purpose device than the male condom; and more sex acts are protected with the availability of the female condom. Additionally, 25 client-provider observations were held to assess the quality of services provided and 18 interviews were conducted with providers actively promoting the female condom. Findings showed that many providers were not promoting the female condom because they were overworked; providers who actively promoted female condoms found "cascade training" to be successful in transferring information from formally trained providers to their colleagues. The program produced some macro-level programmatic lessons: support from every level of the health system is critical to ensure the implementation of intervention components; integration of female condom activities into existing programs and monitoring systems is necessary for program sustainability; and programs can potentially cover some costs by charging for services. More generally, a public sector program that includes both the male and female condom looks promising to increase the number of sex acts protected by increasing dual protection. Cascade training can be effective in transferring skills and knowledge to providers, but actual female condom service delivery depends on this responsibility being established as a performance expectation. South Africa is embarking on expanding services to an additional 82 sites. An effort is being made to expand beyond the family planning clinic to reach men and adolescents. The expansion plans underscore the government's commitment to female condom provision despite concern about the public health impact and the costs of the program. In response to this concern additional research is planned to measure the public health impact of the program. Social Marketing. Elizabeth Warnick of Population Services International (PSI) discussed PSI and the lessons it has learned in introducing the female condom through social marketing. PSI has been the primary organization working with female condom social marketing projects, beginning in 1996 in five countries. Social marketing campaigns for the female condom currently exist in 16 countries with support from multiple donors. PSI has used different strategies, including targeting to high-risk groups or to more general audiences, mass media campaigns and interpersonal activities, and marketing the female condom for specific needs such as HIV prevention and/or contraception. Major social marketing efforts now exist in Brazil (where 1,800,000 female condoms were sold between January 1998 and October 2001), Zimbabwe (900,000 sold between June 1997 and October 2001), Zambia (200,000 sold between December 1995 and October 2001), Tanzania (200,000 sold between November 1997 and October 2001), South Africa (200,000 sold between March 1996 and October 2001), and Haiti (100,000 sold between December 1996 and October 2001), with smaller efforts in seven other countries. In total, since 1995, some 4 million female condoms have been sold through social marketing projects in 13 countries. PSI has found that direct, targeted sales, such as workplace programs and commercial sex worker interventions, are more successful than general public campaigns. Interpersonal communication contributes to improved product understanding and more consistent use, but provider understanding and interest are still limited. Generally, cost per unit sold decreases as volume increases and programs mature. Hence, the cost to market the female condom in 2000 was US $2.90, down seven percent from 1999. The male condom is US $0.11, same as 1999. Program costs include salaries, administrative expenses, program operations, and product cost. Donors have heavily subsidized both female and male condom social marketing projects. PSI found in Zambia and Zimbabwe that the female condom users were most often female, aged 25 to 35, of slightly higher socioeconomic status and education, monogamous, with low HIV risk perception. More than four of every five also used male condoms at times. Challenges to female condom social marketing include lack of awareness of the female condom before its introduction; inadequate investment to build demand through information and promotion efforts; and restricted awareness and commercial sustainability stemming from targeted marketing through interpersonal means. On the other hand, social marketing offers an ability to target at-need sectors and utilize more flexible marketing approaches than the public sector, as well as an ability to recover some costs through sales. Warnick recommended that social marketing programs focus on high-risk groups, make a commitment to sustained communication and education, and focus on high HIV-prevalence countries. Audience Discussion. Questions about different analytical criteria for the male and female condom continued from the first discussion, this time in terms of field impact of programs. For example, one participant questioned whether studies of the female condom should attempt to measure social benefits that the female condom may have, such as reduced domestic violence and women's empowerment in other areas of her life. Presenters responded to questions about targeting adolescents and community-based distribution, audiences that few programs have yet targeted. The degree of targeting from both public sector and social marketing programs, several pointed out, depends on the setting. A participant noted that assessments of the effectiveness of cascade training, such as that found in South Africa, might include the client perspective of how well providers gain communication skills. Provider motivation seems a critical variable, so incorporating clients' views into evaluation of the training could be important. A central question in program development is the balance between supply and demand, several pointed out. How can programs launch major introductory campaigns if they are not sure what the supplies will be from donors? At this point, subsidized supplies are essential. Having an adequate supply seems to be a critical step to ensure that the product remains viable in the market. Assessing the Role of the Female Condom Gaps in Knowledge. Dr. Theresa Hatzell, FHI, discussed how gaps in knowledge continue to obstruct decision making about the appropriate role of the female condom in reproductive health programs. The presentation was framed around research priorities set in 1998 by USAID's Female Condom Working Group, as outlined below.
Major Unanswered Questions. After the presentations and discussions of the content issues, Bill Finger of FHI guided the group through a values clarification exercise and discussion. He explained that the purpose was to allow participants to explore difficult choices they have to make regarding the female condom, given their professional positions and personal beliefs and feelings. First, all of the participants, about 40 in total, assembled in a large open space in the room. The facilitator then read a statement and asked participants to walk to one of three areas of the room labeled, "Agree," "Disagree" and "Not Sure." After participants "voted with their feet" on the first statement, the facilitator asked for a few comments from each group on why they voted as they did and guided a short discussion based on these comments. The facilitator emphasized that there is no right or wrong answer to the statements. Below are the five statements read with a summary of the most important comments from participants.
Meeting Conclusions and Recommendations Jeff Spieler, USAID/G, concluded the meeting by facilitating a brainstorming session to elicit critical issues for making decisions. These ideas, listed below in no order of priority, suggest some next steps and recommendations for future research and dialogue on the female condom.
Appendix : Agenda
Agenda (times include questions/discussion):
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