Preview Chapter 5

Introduction

This chapter addresses the following issues:

• Efficacy and effectiveness of the male latex condom
• Improving condom promotion and access
• Condom logistics management
• Other barrier contraceptives including spermicides, female condoms, male plastic condoms, vaginal sponges and diaphragms

Efficacy and Effectiveness of the Male Latex Condom

• Laboratory studies indicate that sperm and disease-causing organisms do not pass through latex condoms.
• Epidemiolgic studies in human populations indicate that STDs enhance HIV transmission, but that the correct use of latex condoms reduces the risk of contracting STD/HIV.
• Other factors influencing effectiveness include failure to use a condom correctly, condom slippage, use of an oil-based lubricant and insufficient vaginal lubrication.

Improving Condom Promotion and Access

For STD case management, condom promotion is a three-pronged effort that includes the following:

• Condom education and counseling
• Condom skill building
• Condom distribution

Constraints and Opportunities

Ignorance and myths contribute to constraints on consistent and correct condom use. Clinic staff members who foster a positive attitude about using condoms correctly can help to diminish client anxiety.

Condom promotion:

Public sector

• Clinic-based services can be expanded by ensuring that all health center staff are involved as much as possible in condom promotion and distribution.
• Clinic linkages to family planning and maternal/child health (MCH) programs can provide additional opportunities for condom promotion.

Private sector

• Nongovernmental organizations (NGOs) are another resource in community condom promotion efforts.
• Condom social marketing (CSM) programs combine greater condom accessibility with affordable prices.
• Despite competition between the public and private sectors, it is essential that they work together if condom promotion efforts are to be expanded.
• Due to their influence, traditional healers should be relied upon for spreading positive messages about condom use.

Condom Distribution and Logistics Management

Estimating condom requirements is essential to ensure that the supply of condoms keep up with an expanding demand. Clinicians should be vigilant in guarding against the use of condoms that have expired.

Adequate condom storage means protection from excessive heat or cold, ultraviolet light, moisture, rodents and pesticides. Failure to provide proper storage can make condoms unreliable.

Evaluation of Condom Programs at Health Facilities

All the components of a condom distribution and promotion program should be assessed periodically to maintain the program's effectiveness. Evaluation indicators are used for this purpose.

Conclusion

Although the development of microbicides and other barrier methods holds promise, the male latex condom remains the barrier method of choice in preventing STDs and HIV. Therefore, it is critical that STD program managers promote the condom as one of the most important tools for reducing STD and HIV infection.

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Introduction

Prevention is the most important and effective strategy for reducing or controlling the spread of sexually acquired infections, including HIV. There are two main approaches to reducing the spread of STD/HIV: (1) avoidance of exposure, and (2) prompt and effective treatment for bacterial STDs.

Other chapters address STD diagnosis and treatment. Exposure to STDs and HIV may be avoided or minimized by:

• Eliminating the risk of exposure through abstinence, nonpenetrative sexual intercourse, or sex with one mutually faithful, uninfected partner
• Reducing the risk of exposure through avoidance of high-risk sexual partners, reduction in the number of sexual partners, and consistent and correct use of barrier contraception, particularly the male latex condom

Proper and consistent use of the male latex condom reduces the risk of STD.¹ For a man, a male latex condom reduces the risk of infection through penile exposure to cervical, vaginal, vulvar or rectal secretions, or lesions; for a woman, condoms prevent exposure of the female genital and rectal mucosa to urethral discharge, semen and penile lesions.

Individuals who have STDs are prime candidates for HIV, yet the opportunity to reach those who seek treatment for STDs is often missed. Although the male latex condom is an important method for preventing STD/HIV, it has been poorly promoted by STD program managers and is not readily available through STD services in many developing countries. A comprehensive STD service should include both biomedical and behavioral components that ensure both appropriate diagnosis and treatment, as well as appropriate patient education.

Critical messages for STD case management are often referred to as the "four Cs": counseling/education, condom promotion, compliance with antibiotic treatment and contact referral/partner notification for the treatment of sex partners.² Given the resource constraints common to public health services around the world, building strong services requires STD program managers to adopt a "fifth C"–connections to community resources. There is an urgent need to integrate critical messages–including condom promotion and distribution–across the spectrum of possible STD service delivery systems. These systems span public sector services (such as specialized STD clinics, primary health care centers, and secondary and tertiary health services) to private sector services (including pharmacies and chemist shops, private medical clinics, NGO community-based condom distribution and condom social marketing projects, and other community influencers such as traditional healers). To be most effective, STD program managers must be able to connect to all of these community resources to create a partnership for STD prevention promotion.

This chapter will focus primarily on the role of male latex condoms in STD/HIV prevention and how STD program managers can improve their promotion and distribution. It will cover the following issues:

• Efficacy and effectiveness of the male latex condom.
• Improving condom promotion, access, and connection to community resources.
• Condom logistics management.
• Evaluation and monitoring of condom programs at health facilities.
• Efficacy and role of other barrier contraceptives in STD/HIV prevention, including spermicides, female condoms, male plastic condoms, vaginal sponges, and diaphragms.

Efficacy and Effectiveness of the Male Latex Condom

Laboratory Data

Several laboratory, or in vitro, studies of condoms indicate that sperm and disease-causing organisms do not pass through latex condoms.^3,4 Male latex condoms have been shown in laboratory tests to be efficacious against herpes simplex virus, Chlamydia trachomatis, cytomegalovirus and HIV.^5—11 Although comparatively small numbers of latex condoms have been tested and studies are not definitive–for example, leakage in laboratory tests does not necessarily mean leakage during use–study results consistently show that high-quality latex condoms prevent the passage of disease organisms, including HIV.⁴

Human Data

Epidemiologic studies in human populations, or in vivo studies, indicate that STDs enhance HIV transmission.^12—16 When male latex condoms are used correctly and consistently, they are effective in substantially reducing the risk of contracting STD/HIV.^4,17—21

Studies of serodiscordant couples–one infected partner, one not–offer the most compelling data, because regular exposure to an infected partner can be followed. In one multi-country European study, researchers followed 304 HIV serodiscordant couples for an average of 20 months.¹⁷ Of these, 245 couples who continued to have vaginal or anal intercourse for more than three months after beginning the study and who answered questions about condom use were included in the analysis. The results revealed that none of the 124 seronegative partners who used condoms with each act of intercourse over two years became infected with HIV. Among the 121 seronegative partners using condoms inconsistently, 12 became infected.

In a second multi-center study, 343 HIV-positive Italian men and their HIV-negative female partners were followed for a median of 24 months.¹⁸ Among the 305 women continuing to have vaginal intercourse with their HIV-infected partner, two percent of women who always used condoms became infected with HIV, compared to 15 percent of women who used them inconsistently or never. These two studies clearly show that consistent use of condoms decreases the risk of HIV infection. Moreover, inconsistent use carries significant risks of HIV infection.⁴

Studies such as those described above, which are designed to measure incidence of specific STDs and HIV, are expensive, time-consuming and impractical. A more practical measure of the impact of condom use in a health care facility may be the proportion of recurring cases of urethritis among men seen at the facility (Indicator V; see "Evaluation of Condom Programs at Health Facilities" section). For example, as shown in Figure 1, promotion of condom use among military recruits in Rwanda led to a reduction in the incidence of urethritis from 12 percent to less than five percent over 16 months.²²

Other Factors Influencing Effectiveness

While condoms are the most reliable technology currently available for preventing STD/HIV, their effectiveness can be compromised by improper use or product failure. Some product failures, such as condom breaks, may be caused by deterioration as a result of poor storage conditions (such as excessive exposure to heat or humidity) or poor manufacturing quality.^3,23 Other evidence indicates that individual behavior, not the condoms, is usually responsible for condom breaks and semen seepage. User-related failures are caused by incorrect and inconsistent use, including the following:³

• Failure to use a condom for each act of sexual intercourse
• Failure to put a condom on before any genital contact occurs
• Unrolling the condom before putting it on
• Slippage of condom resulting in spillage of semen
• Use of oil-based lubricant (e.g., cooking oils or lotion)
• Insufficient vaginal lubrication
• Re-use of the same condom for multiple acts of intercourse

In addition, to ensure that condoms are effective in preventing STD/HIV, high-quality condoms must be used consistently and correctly. In summary, condom users' attitudes and behaviors are as important to condom effectiveness as the quality of the condom itself.

Improving Condom Promotion and Access

Condom and STD Case Management

Condom promotion as part of STD patient counseling has been demonstrated to be an effective means of reducing high-risk behaviors and incidence of STD in both individuals and couples.^24,25 Therefore, condom promotion is becoming recognized as a critical component of effective STD case management.^26—29 For example, "advice on condom use" is one of the two variables (the other is partner notification) that WHO and AIDSCAP use to define "appropriate STD case management" for the core evaluation indicators for HIV prevention programs.

Condom promotion to STD patients should include (1) advice about using condoms, (2) a demonstration of correct use, and (3) provision of condoms to the patient. This chapter defines condom promotion broadly as a three-pronged effort consisting of the following:

Condom education and counseling: providing basic information about condoms (their effectiveness in preventing HIV or other STDs, the benefits of their use and where they can be obtained) as well as conducting a dialogue with each client to identify and address potential barriers to condom use.

Condom skill building: using condoms and penis models to demonstrate correct use, and teaching partner negotiation skills for condom use.

Condom distribution: immediate dispensing of condoms and referring clients to sources for additional supplies.

These three components work together to support necessary preconditions to condom use, including increased personal knowledge, appropriate personal risk assessment, and self-efficacy with and accessibility to the required technology or tools. All three are necessary if behavior change is to be sustained over time.

Unfortunately, comprehensive condom promotion–counseling and education, skill building, and distribution–is seldom incorporated into STD case management. Field trials by WHO and AIDSCAP testing the evaluation indicators for STD management showed that when this rigorous definition of condom promotion was used, comprehensive case management rarely occurred.²⁹ In Ethiopia, for example, the field trial observations of STD case management practices showed that 25 percent of practitioners mentioned condom use as an STD prevention tool, but only 15 percent provided advice on condoms and demonstrated correct use to their clients.³⁰ Only 10 percent of all practitioners in the survey mentioned condoms as a preventive measure, demonstrated correct condom use and provided their client with one or more condoms.

A 1993 survey of clinicians at STD clinics in Nairobi and Nakuru, Kenya, found that less than half the clinicians thought "adequate counseling" included providing condom advice, and less than 5 percent thought that demonstrating correct condom use was important.³¹ But demonstrating condom use is important not only because it builds skills, but also because it breaks down inhibitions of individuals who may not have handled condoms in the past.

Arguments for intensifying clinic efforts to strengthen condom education, condom use demonstrations and condom distribution as part of STD clinical management include the following points:

1. A number of accepted behavior change theories suggest that accurate perception of one's need to change and self-efficacy in the skills necessary for change are essential to the adoption of new behaviors. Seeking treatment for an STD provides an important opportunity for an STD patient to accurately assess his or her personal risk of HIV or other STDs and to learn needed skills.^32—36
2. Case management implies not only treatment but prevention. Information that will empower clients with the means of avoiding reinfection is as important as information to ensure treatment compliance.
3. Correctly used, condoms are a cost-effective intervention for reducing the spread of STDs because they are generally more available and are far less expensive than antibiotics.
4. Including condom promotion (and other risk-reduction advice) as part of case management increases the cost-effectiveness of STD services.
5. For many males in developing countries, STD clinic services may be the only contact they have with the formal health care system. Thus, a visit to a health clinic for STD services may represent one of the few opportunities for face-to-face condom education and skill building, both of which are critical for reducing the likelihood of reinfection.

Constraints and Opportunities

The constraints to consistent and correct condom use are well-known. They include the poor image of condoms, their perceived unreliability, unfamiliarity with the product that leads to embarrassment, implied lack of trust in a partner if condom use is suggested, reduced sexual pleasure, inaccessibility and inconvenience.^9,37—43

Health services also face constraints in attempting to provide comprehensive STD case management to clients. Some of these constraints include inadequate staff training, lack of time to spend with each patient, inadequate resources, staff shortages, lack of privacy and space, poor attitudes of staff and an overemphasis on the treatment aspects of STD management at the expense of prevention and behavior change.

Fortunately, these constraints–whether personal or institutional–can be addressed and minimized through careful examination and effective program planning (see Chapter 2). The constraints are often synergistic, which means that the resolution can often be synergistic as well. For example, creating positive attitudes in clinic staff about condom promotion can help anxious and fearful clients open up about their lack of condom knowledge and use.

Condom Promotion

STD program managers are often reminded of the original "four Cs" regarding critical messages for effective case management: counseling and education, compliance with antibiotic treatment, contact referral/partner notification for the treatment of sex partners and condom promotion^.2

A number of communication strategies and tools can be used to promote condom use (see Chapters 4 and 10). Strategies range from one-on-one interpersonal counseling to small group discussions to large group "condom events"–dramas, rallies and community events. Facilitators of these strategies can also vary, from clinical officers or nurses to auxiliary health professionals to trained peer educators and community mobilizers and influencers.

A variety of tools also are available to support communication strategies. These include posters, brochures and booklets (so-called "small media") and community-developed AIDS dramas, radio shows, films and videos ("mass media"). Special tools include risk-assessment score cards, which help individuals assess their level of risk to HIV or other STDs; penis models, which help in condom demonstrations; and condom promotional items such as key chains, T-shirts, and bags, which help spread the message.

The broader the mix of communication strategies and tools, the more opportunities there will be to encourage condom use for STD prevention. Fortunately, STD program managers do not have to create all the components of this broad mix of strategies and tools for their service. By remembering the proposed "fifth C"–connection with community resources–STD program managers can ensure a lively, comprehensive condom promotion strategy.

Thus, it is important for STD program managers not to think of themselves as the sole or major providers of condom promotion for STD patients but instead to act as "condom promotion managers." In this role, STD program managers will be responsible for providing basic condom promotion messages and condoms directly to their clients while drawing upon the participation of the entire clinic health team as well as numerous external resources to ensure comprehensive case management. (Table 1 summarizes strategies that can be used to improve condom promotion in clinic-based services.)

As STD program managers adopt the role of "condom promotion managers," they will need to explore diverse communication strategies (such as those noted above and elsewhere in this handbook) and local condom distribution access points, develop extensive community linkages and broaden the definition of what it means to be a service provider. STD service options are available through both the public and private sectors.

In the public sector, condom promotion for STD prevention must be available not only in specialized STD clinics but also widely through the primary health care system, including maternal and child health and family planning clinics. In the private sector, STD program managers need to connect with condom social marketing (CSM) projects, private STD clinics, pharmacies and chemist shops, and other community-based condom distribution programs, including those in the informal sector such as traditional healers. Each of these services can provide health education and condom promotion to extend the reach of effective STD case management. The STD program manager should see himself/herself as the center of this system, connecting the various services available in the community (see Figure 2).

The following section explores the role of the public sector in STD case management.

Public Sector

Clinic-based STD services

Services within a clinic can be expanded by ensuring that all available health center staff are involved as much as possible in condom promotion and distribution. Nursing staff should be trained in providing one-on-one or small-group condom counseling and interpersonal communication. Other medical staff (medical assistants, nursing aides) as well as auxiliary and para-health staff (community volunteers, drivers, cleaners) can be trained to serve as condom demonstrators and promoters to individuals in small-group settings or in clinic waiting rooms. Videos shown in waiting rooms also have been used effectively to promote condom use both in developing and developed countries around the world.⁴⁴

On the Caribbean island of St. Lucia, for example, nurses were trained to conduct risk assessments with patients waiting to see STD clinical officers and to counsel patients following treatment. Groundskeepers at a rural hospital in Chilema, Malawi, have been trained to demonstrate condom use in waiting rooms and to serve as peer educators to men who come to the clinic for STD services.

Health clinics already facing staff shortages may not have enough excess staff time to meet condom promotion needs. In that case, recruiting volunteer staff from local nongovernmental or community-based organizations, such as family planning associations, is an alternative strategy, particularly for clinics experiencing high demand for STD services. On-site assistance from such community groups, even once or twice a week, could also create a strong basis for community support for specific services.

Support from condom social marketing (CSM) projects through part-time detailing of CSM sales staff as condom promoters at busy clinics could be beneficial to both the STD service and the CSM program. Providing free samples of the CSM product as part of the condom promotion presentation could benefit both the clinic and the CSM program.

Often clinic or volunteer staff are unfamiliar with condoms. Some may allow personal or religious biases to interfere with their ability to provide informative, nonjudgmental services to special client populations, such as youth or sex workers. Effective use of para-health and NGO volunteer "counselors" may require an initial commitment of time and resources to help these individuals confront their personal beliefs and attitudes about their potential clients, as well as provide training in technical information and counseling skills.

As a condom promotion "manager," a clinician should also examine his or her health facility's practices to ensure that they are "condom-friendly" for STD clients. The checklist below will help clinic managers assess how "condom-friendly" their site is.

Condom Accessibility to Clients

Are condoms easily accessible for clients? Condoms should be located where clients have access to condoms with minimal constraints. Unfortunately, this is not always the case. In Papua, New Guinea, for example, condoms are provided only to married STD patients. In other countries, youth seeking condoms may receive morality lectures instead–or two to three condoms at most. Many primary health clinics require men to register as clinic patients before they can obtain condoms, adding a significant time constraint and a disincentive to men. This practice runs counter to evidence that suggests that condom use increases when accessibility is enhanced.⁴⁵

Educational Materials

Are condom educational materials and information provided to each STD patient? Are they available in the waiting room? Condom education can and should use multiple, reinforcing media, including small media (posters, brochures, video), interpersonal/small-group communication and innovative approaches (drama, local popular music, even games and rallies). Educational approaches should be adapted to the local situation, the resources available and the needs of the target audience.

Linking Prevention to Treatment

Does the clinic use every opportunity to link prevention and treatment? Educational materials, counseling messages and patient drug use instructions should always ensure that prevention messages are linked with treatment. In Zimbabwe, where STD case management has been integrated into the comprehensive primary health care system, clinicians promote this linkage by including a supply of condoms along with the antibiotics on the prescriptions they write.⁴⁵ The use of prepackaged STD therapy that includes antibiotics, condoms, education materials and referral cards provides a strong linkage between treatment and prevention.

Counseling

Does the clinic have private space where STD patients–particularly repeat clients–can be counseled by health educators, nurses or medical assistants and taught correct condom use skills? Are counselors trained in procedures for risk assessment, identifying/resolving condom use barriers and demonstrating correct condom use?

Clinic Supply

Does the clinic "send the right message" to STD patients about the importance of condoms by keeping an adequate supply on hand at all times? Are condoms properly stored to maintain quality? (See storage issues later in this chapter.)

Sources of Condoms in the Community

Are all clinic staff made aware of other sources of free and subsidized condoms in the community? Are they prepared to advise clients of these sources?

STD service providers need to be knowledgeable about and supportive of non-clinic-based condom distribution efforts for the following reasons:

• Some STD patients may prefer to obtain condoms from non-clinic settings.
• Condoms may need to be sought by potential users outside of clinic hours.
• Increasing reliance on private sector (including subsidized private sector) condoms will reduce the demand and the cost to the public sector for condom supplies.
• Community-based distribution and social marketing programs are more effective in providing condoms when and where they are needed.

Clinicians who have created a condom-friendly environment can use their position of authority to reinforce critical condom promotion messages delivered by other clinic staff. This may be especially important in countries where age and personal status significantly affect the credibility of the messenger.^30,46 Such messages can be delivered during the standard five minutes to which clinicians are often limited for each patient^.46,47

Critical condom promotion messages should:

• Reinforce the efficacy of correct use of condoms to prevent STD/HIV infection
• Direct the patient to follow up on communication counseling services available at the clinic or in the community
• Inform patients of two or three local sources for free or price-subsidized condoms
• Ensure that patients leave the clinic with an initial supply of condoms

Family Planning and Maternal/Child Health Services

Once clinicians have done all they can to improve condom promotion within their clinic setting, they should build linkages to related health programs and services, such as maternal/child health (MCH) programs and governmental and nongovernmental family planning (FP) programs. Such linkages can also extend the reach of a clinic-based STD program and serve as reinforcing communication channels and referral points.

MCH and FP programs are often the most developed health services available at primary health clinics. They are excellent venues for reaching women who are sexually active and who may have asymptomatic STDs, particularly where routine syphilis screening of antenatal women is conducted.⁴⁸ These programs can also educate women about (1) the importance of encouraging their partners with STDs to seek treatment, (2) the dangers of untreated STDs (particularly the risk of HIV and infertility), and (3) STD prevention, including correct condom use. STD program managers should seek to ensure that family-planning providers make condoms available to women at risk for HIV or other STDs even if they use another contraceptive family planning.

Connecting to Private Sector Services

Community-based NGO programs

Developing linkages to NGO-managed community-based distribution of condoms, condom social marketing, and HIV peer health education programs can expand the condom promotion efforts as well as clinical reach of STD services. In Zimbabwe, for example, community-based distributors of family-planning products have not only been trained to promote correct condom use, but also to teach clients to recognize STD symptoms and seek treatment. In Botswana, family welfare educators are providing similar support to clients of their community-based services.⁴⁶

NGO-managed peer education programs for target audiences, including high-risk individuals, in communities, workplaces and bars have proven effective in increasing condom use and other appropriate health-seeking behavior.^48—50 Closer and more formal linkages between STD service providers and peer educators can provide mutual support and synergistic strengthening of both programs. In the Dominican Republic, collaboration between the public sector health services and a peer education program for sex workers resulted in a decrease in syphilis prevalence among sex workers from 11.6 to 8.2 percent.⁵¹ Such collaboration can include sharing behavior change communication materials, upgrading staff skills in condom counseling and health education, providing referral for condoms, and improving patient and partner follow-up.

Condom social marketing

Condom social marketing (CSM) programs combine vastly expanded condom accessibility with consumer-friendly promotion. Condom social marketing was first launched over 20 years ago; the first countries to test the concept were India, Colombia, Jamaica and Sri Lanka. These early programs proved the hypothesis that individuals would be willing to pay an affordable price for contraceptives in exchange for greater accessibility to the product. Interest in social marketing has grown rapidly over the last 20 years. Figure 3 shows the regional dispersion of the world's major CSM projects (defined as providing contraceptive protection to the equivalent of 10,000 people or more per year). The number of new CSM projects has doubled in the last five years. Most of the new projects started in the last ten years have been in Africa, which now has more projects than either the Asia or Latin America/Caribbean regions. Programs around the world have demonstrated that making condoms available at an affordable price in places convenient to users can result in staggering condom sales. As Figure 4 shows, rates of increase of sales of condoms are often impressive; condom sales in Ethiopia have grown from approximately 300,000 in 1990 to 11.8 million in 1993 and over 19.8 million in 1995.⁵² Over a period of four years (1991—1995), AIDSCAP has provided 177 million condoms for HIV prevention, with CSM representing nearly 90% of the condoms provided. More than 5.6 billion condoms were sold through CSM programs worldwide in 1994.⁵²

Condom social marketing programs sell brand-name condoms through a wide variety of sales points, including traditional chemist and small retail shops and a myriad of nontraditional outlets, such as bars, hotels, restaurants, market stalls, sidewalk vendors, brothels, kiosks, taxis and boat launches. Figure 5 shows the sales of condoms by outlet type in the Ethiopia Social Marketing Program. Over 90 percent of the condoms were sold through non-traditional outlets. In Cameroon, commercial sex workers have been trained to be condom salespersons in bars and brothels.⁵³ In Haiti, project managers have learned that NGOs can be effective distributors of CSM condoms and that the revenues help to sustain the often fragile NGO sector.⁵⁴ The use of NGOs as condom distributors in Haiti during the mid-1990s economic embargo resulted in sustaining condom availability when distribution through commercial outlets was severely compromised. In the Philippines, socially marketed condoms are being sold in bakeries, bookstores, barber/beauty shops and fast food outlets.⁵⁵ Social marketing projects in countries around the world have found little difficulty in generating a high demand for condoms once barriers to accessibility have been reduced.

In addition to greatly expanding access to condoms through traditional and nontraditional sales outlets, CSM programs have demonstrated a unique ability to diminish social taboos surrounding condom use through their innovative use of both conventional and nonconventional advertising, comedy, street theater, promotional items and other techniques for changing attitudes. These strategies have served to reposition condoms in the minds of members of target audiences. As a result, the condom is no longer viewed as foreign, sterile medical technology, but rather as a simple consumer product that is easy to use, effective and increasingly popular.

Condom social marketing programs begin from the premise, confirmed in Knowledge, Attitude, Behavior and Practice surveys (KABP surveys) in countries around the world, that most people know that using a condom correctly prevents HIV transmission. From there, CSM seeks to break down the major barriers to its use: embarrassment about discussing condoms, a lack of information about where to obtain them, and a lack of information about how to use them.

Many of the CSM-sponsored activities are fun and appeal to young people especially. For example, Prudence condoms are promoted across Africa through "condom soir‚es," rallies featuring music, games and dancing interspersed with both light-hearted and serious HIV education and condom promotion. In Burkina Faso, a youthful sales team holds dances and drama productions for its young target audience. In Benin, CSM sponsors a 10-day bicycle race and hosts a rally with music, games and condom demonstrations.⁵⁶ These activities, part of CSM's community-based education outreach, provide information about HIV, AIDS, other STDs and pregnancy prevention in a format that is understandable, entertaining and targeted to the attending audience.

Condom social marketing programs also use more traditional promotional strategies, including a liberal sampling of condoms; the distribution of promotional items, such as posters, T-shirts, pocket calendars, key chains and pens; and mass-media advertising where possible. The radio script in Box 1 was developed for Maximum condoms sold in Zambia. The script is part of a successful campaign that has resulted in increased sales. December 1992 product sales for Maximum were 435,000, but sales averaged 600,000 per month in the last six months of 1995.⁵⁸

One of the important benefits of CSM programs is their ability to impact condom sales and distribution generally. As Figure 6 shows, innovative advertising, and marketing in Brazil caused the sales of the CSM brand, Prudence, to increase from just over 100,000 condoms in 1991 to approximately 1.2 million condoms three years later. During that same time, however, commercial sales of condoms, which had been stagnant in Brazil for years, doubled from 50 to 100 million.⁵⁷

STD clinicians who are effective condom promotion managers can establish linkages with CSM programs by:

• Encouraging STD prevention as one of the standard CSM condom promotion messages in addition to prevention of unwanted pregnancy or HIV infection
• Providing basic training to socially marketed condom promoters to make them more effective communicators about treatment and prevention of STDs, and to offer individuals a place where they can obtain quality services
• Seeking the part-time assistance of CSM promoters in giving condom presentations and demonstrations at the clinic and in providing sample condoms for distribution by clinic staff

Condom social marketing programs are also beginning to explore more direct linkages to STD treatment and prevention. Chapter 13 describes in detail an innovative strategy to sell prepackaged therapy and prevention (antibiotics, condoms, and partner referral cards) kits for treatment of urethritis.

Private sector health services

Coordination with private sector STD services may be difficult for public sector clinic managers, because the former is independent and there is some competition between the two sectors; however, coordination is important for the following reasons:

• Private sector services are often the first (and sometimes the only) places where men seek treatment for STDs.^58,59
• The private sector often reaches a greater proportion of high risk groups than the public sector has the resources to do.
• Private practice may be more heavily focused on treatment than prevention.
• Physicians and pharmacists may be unaware of research results on changing etiologies or the reduced efficacy of drugs due to resistance.
• Pharmacists/chemists faced with clients who cannot afford a full course of therapy may dispense an incomplete regimen, thereby contributing to drug resistance.
• Private sector physicians and pharmacists may not promote condom use.

Research studies of STD knowledge, beliefs and treatment-seeking behavior in Ethiopia and Senegal report that individuals with STDs frequently seek treatment from pharmacists, traditional healers, and/or street vendors before going to a public clinic. ^60,61 These sources can be and often are outlets of condoms.

Public health clinicians can help improve and link private and public STD services by:

• Conducting continuing education courses for physicians and pharmacists that focus on client communication and correct condom use skills for prevention
• Disseminating research results from etiologic and antibiotic sensitivity studies conducted through the public sector
• Sharing condom promotion and STD prevention materials with them
• Encouraging dialogue on patient referrals

Encouraging private sector pharmacists and physicians to promote condom use will create reinforcing communication channels for this important message. Pharmacist and medical practitioner associations in countries around the world, including Tanzania, Nigeria, Thailand, Nepal, Philippines, Brazil and Jamaica, have demonstrated an interest in specialized continuing education and training in condom promotion. Efforts to date to encourage participation of pharmacists and private physicians in HIV/STD prevention, including condom promotion, have been very promising. In Nigeria, the training of pharmacists and pharmacy operators in HIV prevention and the introduction of socially marketed condoms at the pharmacy resulted in increased sensitization of these community health providers to HIV/AIDS issues, improved client counseling and education, and a higher level of condom distribution.⁶¹ In India and Nepal, physicians along truck routes were trained in STD treatment and prevention as well as communication skills for working with truck drivers. Program managers preliminarily report improved, anonymous services and greater condom use.⁶²

Traditional healers

Other potential condom educators and promoters include traditional healers. In South Africa and Uganda, healers have accepted and passed on HIV prevention counseling and correct condom use skills for prevention of HIV and other STDs.^63,64 Given the important role of traditional healers in providing health care in many developing countries, STD clinicians cannot afford to ignore their potential for reinforcing condom promotion messages and referring patients to health clinics.

Condom Distribution and Logistics Management

In ideal situations, condom distribution is an integral component of STD case management–as is the distribution of appropriate antibiotics. As clinicians who favor single-dose antibiotics over long, multiple-dose regimens know, distributing drugs and condoms at the point of service delivery increases the likelihood that the commodity will be obtained and used.⁴⁵

Most clinics will store some condoms for distribution to clients. Depending on the particular clinic and national condom distribution system in place, the source for a supply of condoms will be a district hospital, a regional medical store facility or central medical stores.

Estimating Condom Requirements

Clinics known to distribute condoms must maintain stock levels and quality assurance procedures to ensure that adequate supplies of high-quality condoms are available at all times. To do so requires careful condom supply forecasting and stock management.Most countries have adopted sound condom supply management, storage and distribution systems at the central warehouse level. Many have also established reasonable condom management procedures and systems at the secondary, regional or middle levels. But clinics and other health facilities often lack appropriate ordering and management procedures and systems, resulting in stock outages or even distribution of condoms that have long passed their expiration date.

Since most condoms do not specifically state an expiration date, STD program managers need to know how to correlate the date of manufacture (which is often stamped on the condom or at least noted on the condom shipping carton) with an expiration date. A general rule of thumb states that condoms are safe to use within three years of manufacture assuming they are appropriately stored to prevent accelerated damage beyond their normal "life span."

Condom supplies are generally provided at fixed intervals, either monthly or quarterly. The length of this interval is often a function of ministry delivery schedules but will also depend on the storage capacity of the health facility. To make a condom supply system work, clinic supply managers must know:

• The average number of condoms used during the relevant interval
• The lead time required between placement and receipt of condom supply orders
• The number of condoms–so-called "safety" stock–required to meet unanticipated delays in delivery

Clinic supply managers also must know whether changes in any of the factors listed above can be anticipated during a specific period. Such changes might include the following:

• A newly instituted condom promotion program (such as those described earlier)
• Plans to aggressively promote STD health-seeking behavior among youth
• Establishment of a new, regional commodity warehouse system
• A planned reduction in delivery schedules due to fuel shortages

Once a clinic supply manager knows the average distribution figures, lead time and safety stock requirements, he or she can calculate the appropriate "maximum stock level" for a facility. Condom ordering is then simply a function of subtracting stock-on-hand from the maximum stock level.⁶⁵

Condom Storage

The second element of effective supply management is ensuring that stocks are properly stored and issued. Proper storage is important because the quality of latex condoms deteriorates over time. Distributing condoms that have been improperly stored or are too old will increase the likelihood of product failure. Condom breakage exposes people to risks of pregnancy, STDs and HIV and can result in a decrease in confidence in the product.

Fortunately, correct condom storage procedures are simple to follow. They include protecting condoms from excessive heat or cold, ultraviolet light, moisture, rodents and pesticides.⁶⁶ (See Table 2, "Six Steps to Proper Condom Storage.")

Condoms arriving in cartons that have been crushed, punctured or that demonstrate evidence of water soaking or contact with chemicals should not be distributed. Condoms that are brittle or gummy or have broken wrapper seals should never be used. Condoms that are discolored may also be unreliable, but if the discoloration is limited to the packaging material, the condoms themselves are usable.

Even when condoms appear to be in acceptable condition, wise managers will be alert to feedback from users. Increased reports of breakage, particularly when users can demonstrate correct condom use or have not had breakage problems in the past, can signal poor quality, which may not be visible. In such instances, reports should be forwarded to the immediate distribution source, and efforts should be made to replace any remaining supplies with new stock. Since latex breaks down over time, it is important that the condoms with the earliest manufacturing date always be dispensed first.

Condoms should be given out as soon as possible. In no instance should programs dispense condoms that are five or more years old.^67,68 Such condoms should be returned to the central medical stores for appropriate and certain destruction to ensure that they do not get into the formal (or informal) distribution system.

Evaluation of Condom Programs At Health Facilities

Periodic assessments of the reach and impact of condom promotion and distribution efforts are essential if such efforts are to be fully integrated into the STD case management system. The following issues must be addressed as part of an assessment of the condom promotion and distribution program in a health care facility:

1. How good is the logistics system for condoms at the facility? The logistics system should consist of explicitly defined methods for adequate storage and effective distribution that ensure reliable and constant availability of high-quality condoms.

2. How consistently are condoms promoted in the STD case management efforts of clinic staff? Included in this assessment should be an examination of the extent to which community linkages have been established and the vibrancy of those linkages.

3. How effective are the promotional and marketing services? How successful is the program in improving acceptability, accessibility and use of condoms and distribution and/or sale of condoms to individuals seeking care at the health facility?

4. How effective is the health care facility's condom program in preventing further spread of STD/HIV? A measure of STD incidence or prevalence is the ideal indicator for assessing the impact on STD/HIV prevention. But are STD/HIV indicators sensitive enough to measure the full impact of condom use?

Mathematical modeling of the AIDS epidemic suggests that condom use can lead to a measurable reduction in the prevalence of HIV. Figure 7 shows the projected impact of condom use on the prevalence of HIV in an urban African population.⁶⁹ This model suggests that if condom use rates increased from two to five percent among the general population and from 20 to 60 percent in casual sex encounters, then the prevalence of HIV could be reduced by as much as two-thirds over 15 years. As pointed out earlier in this chapter, increased condom distribution among Rwandan military recruits did correlate with significant reductions in the incidence of urethritis.²²

Evaluation of STD case management is addressed in Chapter 14 of this handbook. Evaluating the condom promotion/distribution component should be an integral part of this assessment and should be planned in conjunction with assessing the broader service. The way to specifically evaluate the four major issues noted earlier is by examining the quality of services as well as the result of those services as measured in increased condom use and, ultimately, reduction in STD episodes.

Evaluation Indicators

Table 3 describes five indicators for evaluating condom programming. Indicator I measures the availability of condoms as a ratio of the total number of condoms available at the health facility for distribution as a function of the total number of individuals seeking STD care. Indicator II measures the results of condom promotion and marketing activities by showing the ratio of the number of condoms sold or dispensed per individual seeking STD care in the health facility during the preceding 12 months. This ratio, when compared to Indicator I, should provide a sense of the level of distribution given the availability of stocks.

Indicator III is a standard measure adopted by AIDSCAP, WHO and others to measure the quality and consistency of appropriate case management services as provided by clinic staff. It measures the percent of persons who present with an STD or are treated for an STD who are provided with information on condom use and partner notification. Indicator IV, also a ratio, assesses the effect of the promotional and marketing activities on reported condom use rates of individuals seeking STD care at the health facility. Finally, Indicator V provides a measure of the effectiveness of the program by assessing whether increased promotion and reported use of condoms is, in fact, resulting in fewer repeat episodes of urethritis in men.

Data needed for Indicators I, II and V will be available from clinic records, particularly from the logistics management system and the clinic record book. Data for Indicator III can be collected through a standard KABP questionnaire of men in the community served by the clinic. The questionnaire can also ask men to report the number of urethritis episodes during the past six months as a way of measuring frequency of STD syndrome incidence. Indicator IV information can be collected in direct observation of the behaviors of clinic staff as they interact with clients. These data should be collected prior to efforts to strengthen the condom promotion component of STD case management and again 12 months later to measure change from the baseline.

Assessing how well staff are connected to other community activities also should be included in the evaluation of the program. This assessment can be accomplished through several means, including listening for community services referrals during the direct observations of case management (Indicator IV), conducting "exit" interviews with clients on a periodic basis to see whether the clinician or any other staff member provided information about other community sources of condoms, and keeping a clinic log of community linkage activities involving clinic staff. These activities might include staff participation in "condom soir‚es" sponsored by the CSM project and tracking the following items: the distribution of print materials that list condom sources in the community, the number of visits to the clinic by community-based HIV/AIDS programs to provide education and promotional activities at the clinic, and other outreach efforts.

Future Prospects: Other Barrier Contraceptives in STD/HIV Prevention

At present, latex condoms are the most widely used barrier method for the prevention of HIV. Yet even in the face of effective condom promotion, some clients who need to use condoms will find it difficult to do so. Since condoms are a male-controlled technology and since women often have less power in sexual relationships, women are often put at risk for HIV or other STDs when their male partners refuse to use condoms. Teaching women condom negotiation strategies can help, but these skills can be insufficient when partners are intoxicated or otherwise unreasonable. Women require methods they can control themselves to protect themselves. How effective are other barrier contraceptives in preventing the spread of STD/HIV? Correct and consistent use of barrier contraceptives (including spermicides alone or in combination with other barrier methods such as the vaginal sponge and the diaphragm, the female condom and the male plastic condom) may provide some protection against STD/HIV.

Spermicides, including the Sponge, Diaphragm and Cervical Cap

Spermicides are chemical barriers that inactivate sperm and other organisms. They are sold and used in the form of a cream, gel, foam, suppository or film. A spermicide may also be used in combination with a physical barrier (such as a male or female condom, vaginal sponge, diaphragm or cervical cap). The spermicide agent in most products sold in the United States, Europe and Japan is nonoxynol-9 (N-9), benzalkonium chloride (BZK) and menfegol, respectively.

In vitro efficacy

Results from laboratory studies of N-9 spermicides show that N-9 effectively inactivates treponomes, gonococci, chlamydiae, herpes virus and organisms causing bacterial vaginosis.^70—72 Other laboratory studies confirm that BZK and menfegol exhibit similar efficacy against sperm and these STDs.^73—75 N-9 spermicides, as well as BZK and menfegol have also been shown in laboratory tests to inactivate HIV-4.^76—78

In vivo effectiveness

Results from several epidemiologic studies support those laboratory studies mentioned above and consistently demonstrate that spermicides, used either alone or in combination with other barrier methods, reduce the incidence of gonorrhea, chlamydial infection, tri-chomoniasis and bacterial vaginosis.^4,21,79—82 However, the relationship between N-9 use and HIV incidence remains unclear and currently inconclusive.^21,83,84 Only two human studies have been published and their findings conflict. In one study, a group of Nairobi commercial sex workers regularly used a contraceptive sponge with N-9 and were compared to a control group.⁸⁵ HIV seroconversion rates after two years were 56 percent and 41 percent in the sponge and control groups, respectively. In assessing the results of this study, it is important to consider several limitations of the study, including the sponge's high dose of N-9 (one gram) and its tendency to dry in the vagina (which may lead to increased trauma and ulceration as a result of sexual intercourse).^21,86,87

In the second study, which compared the use of a much lower dose of N-9 (100 mg) and incidence of HIV infection, 272 seronegative women in Cameroon were supplied male latex condoms and 100 mg N-9 suppositories and were asked to use both during each act of intercourse.⁸⁸ Although 19 HIV infections occurred, HIV incidence decreased as N-9 consistency increased.⁸⁹ In an unpublished study carried out in Zambia, those who used N-9 suppositories had a reduced risk of HIV infection.⁸³

Use of N-9 with the vaginal sponge, diaphragm or cervical cap

Vaginal sponges are impregnated with a spermicide and inserted into the vagina before intercourse. Laboratory studies show that spermicides in the vaginal sponge have inactivated HIV, chlamydial and trichomonal infections.¹ In addition to the Nairobi study detailed above, two other observational trials of the contraceptive sponge showed 25 to 40 percent reductions in chlamydial infection, and 10 to 69 percent reductions in gonorrhea. ^81,82

Diaphragms and cervical caps should be used with spermicides and are inserted into the vagina to block the cervix during intercourse. Observational studies of these barriers used together with spermicides show a reduction in STDs of between 50 and 100 percent.²⁰

It should be noted, however, that because diaphragms and cervical caps shield only the cervix and leave a portion of the vagina exposed, these barriers may offer better protection against organisms that infect the cervix (such as C. trachomatis and N. gonorrhoeae) than against other organisms that can be transmitted through the vagina or external genital contact (including HIV, herpes simplex virus, T. pallidum and H. ducreyi).

Genital irritation

Although N-9 spermicides used alone or in combination with other barrier methods may offer some protection against STDs/HIV, other studies have reported genital irritation following N-9 use.^{83,87,90—92} Reported adverse reactions include discomfort with use, an increase in genital ulcers, genital itching and burning, and inflammation. Results from these studies indicate that the more frequent the use of spermicides and the higher the dosage, the more elevated the rates of genital irritation. When lower doses of spermicide are used, increased risk is minimal or not present.⁴

The Female Condom

The female condom is a soft, loose-fitting plastic pouch that lines the vagina and protects the cervix, vagina and external genitalia. The pouch has a soft, flexible ring at each end. The closed end of the female condom is inserted and anchored inside the vagina. The open ring remains outside the vagina after insertion, protecting the labia and the base of the penis during intercourse. It is prelubricated and is intended for one-time use. The female condom, sold as Femidom™ in Europe and Reality™ in the United States, is commercially available in Switzerland, Britain, Austria, Netherlands and the U.S.

The efficacy of the female condom in preventing STDs is inconclusive, although results from laboratory studies and a few epidemiological studies indicate that the female condom may offer some protection against pregnancy, some STDs and HIV.^93—98

In vitro efficacy

Drew and co-authors used an artificial intercourse model to test the permeability of the female condom to cytomegalovirus and HIV.⁹⁷ Results from the three trials showed no viral leakage.

In vivo effectiveness

Limited epidemiologic research has been done on the effectiveness of the female condom. Results from a randomized trial of the female condom and diaphragm showed no significant trauma to the vagina, cervix or vulva of women using either devices.⁹⁹ In another study of 104 sexually active women, consistent use of the female condom protected against recurrent vaginal trichomoniasis.⁹⁷ Reinfection with Trichomonas vaginalis occurred in seven out of 50 (14 percent) of controls, in five of 34 (14.7 percent) non-compliant users, but in none of 20 compliant users.

Acceptability

Results of acceptability studies of the female condom in African, Asian, European and American women are mixed.^1,98—101 In a comparative study of the male and female condom in Cameroonian sex workers, more than 90 percent of women reported that they liked the female condom and almost two thirds preferred the female condom to the male condom. Half of their clients reported that they liked the female condom; in fact, 40 percent preferred the female condom over the male condom. Breakage rates were 13 percent for the male condom and 9 percent for the female condom. Results of studies of married or cohabitating women in Kenya reveal that over three-fourths of the women liked the female condom better or about the same as the male condom.⁹⁸ However, in two acceptability studies among sex workers in Thailand results were less favorable.^101,102 Continuation rates in the two trials were zero and 43 percent, respectively.

Advantages and disadvantages

Some of the reported advantages and disadvantages of the female condom are outlined in Table 4. The female condom has the advantage of offering women more control over their bodies than the male condom. However, the female condom's role in STD/HIV prevention will continue to be limited until its acceptability improves and issues involving reuse and its high price (U.S.$1.00—$4.50) are resolved.

The Plastic Male Condom

The escalation of the STD/HIV epidemics throughout the world and drawbacks to the male latex condom have encouraged the development of male plastic condoms.¹ These condoms are made to be thinner, stronger and more sensitive than male latex condoms. They are not as susceptible to poor storage conditions and can be used with any type of lubricant. No clinical efficacy data exist yet on the effectiveness of the male plastic condom for prevention of pregnancy and STDs.

Other Barrier Methods in Development

No data are available on the efficacy either a diaphragm or a cervical cap used without spermicide in the prevention of STD/HIV. Moreover, despite promising data from several studies, consensus among health care professionals has nor been reached on the roles of spermicides (used alone or in combination with barriers), the vaginal sponge and the female condom in preventing STD/HIV. Table 5 provides an overview of currently available barrier contraception, along with the benefits and constraints of each.

Although it will take years of development before new barrier methods become available, some new HIV microbicides are being studied, including sulfated polysaccharides (compounds that block infection of vaginal or cervical cells); temperature-sensitive gels that may disperse infection-fighting drugs in the female genital tract; and new formulations of spermicides.¹⁰²

Conclusion

Promising new microbicides and other more recent barrier methods such as the female and plastic male condoms need to be adequately studied in order to expand options for STD/HIV prevention. Until then, the male latex condom remains the barrier method of choice in preventing STDs and HIV. Therefore, it is critical that STD program managers accept the condom as one of the most important tools for helping to reduce STD and HIV infection. It is also important that STD program managers establish linkages to all of the sources of condom promotion and distribution available in the community to ensure that maximum accessibility and use are achieved.

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