A new vaginal antimicrobial contraceptive formulation: phase I clinical pilot studies.

Pilot clinical trials were performed with a new vaginal suppository called "Long Acting, Sustained Release of Spermicide" ("LASRS"). No visual or colposcopic lesions or patient complaints occurred as a result of using LASRS with increasing doses of nonoxynol-9 (up to 20%) for 5 days or of applying the highest dose of nonoxynol-9 (20%; total 400 mg) for 8 h. Colposcopic or visual lesions were also not induced when LASRS with 20% nonoxynol-9 was used for 7 consecutive days by the study participants except for those who developed symptomatic monilia vaginitis. Symptoms were reported although these were mostly minor. A long-lasting, bioadhesive, translucent layer (film) of formulation formed over the vaginal and cervical surfaces. Postcoital spermicidal studies showed LASRS to be highly effective for prolonged periods of time. Although intercourse was delayed for 5 to 8.5 h after insertion of the formulation, an average of only 0. 2 motile sperm/HPF could be found in cervical mucus. These studies suggest LASRS to possess advantages over presently marketed formulations by having long-term efficacy and by forming a bioadhesive, presumably protective layer over the genital tract epithelium. The results also suggest the formulation to decrease the vaginal irritation caused by nonoxynol-9 as noted by colposcopy. These pilot data support a more extensive study with the LASRS suppository.

[Physicians denounce precariousness of reproductive health in the country and propose an addendum to the Brazilian document for the Cairo conference]. / Medicos denunciam precariedade da saude reprodutiva no Pais e propoem adendo ao documento brasileiro para Conferencia do Cairo.

PIP: On June 21, 1994, in Sao Paulo, a meeting took place of reproductive health professionals: service providers, university professors, representatives of nongovernmental organizations, secretaries of health of states and municipalities. They issued a manifesto on reproductive health in Brazil. In view of the preparations for the 3rd International Conference on Population and Development to take place in Cairo in September, 1994, it is hoped that these points will be incorporated into the official platform and in government action plans. Reproductive health is a basic human right. The growth of population decreased in Brazil in the 1980s, yet assistance in the area of reproductive health is still insufficient and unsatisfactory. The population decrease did not result in the improvement of health care and family planning. Maternal morbidity and mortality rates are still high in Brazil, especially in the north-northeastern regions, where it is 10 times higher than the national rate. There are 5 maternal deaths per 100,000 live births in Canada, 8 in the US, and 140 in Brazil. 90% of these deaths could be avoided by routine reproductive health measures. Important causes of infant mortality in Brazil are malnutrition and infectious diseases, which could be prevented by lifting the low socioeconomic level and through vaccination and birth spacing. Although fertility has been on the decline, the fertility of 10-19 year old adolescents has increased significantly, leading to high mortality rates for their infants. An estimated 1.4 million abortions occur per year in Brazil with frequent complications because of its illegal, clandestine nature. It is also estimated that 6-8 million women have been sterilized, which is the primary means of family planning because of the lack of other contraceptive options. The combination of cesarean-tubal ligation operations has been institutionalized in health services, which creates major distortions in the delivery of health care. Sexually transmitted diseases are on the rise, and HIV infections are contracted mainly from sexual intercourse and IV drug abuse. Furthermore, it is absolutely necessary for men to participate in family planning education in order to raise the status of women.^ieng

Physicians' attitudes, recommendations and practice of male and female sterilization in São Paulo.

While prevalence of vasectomy is low in Brazil, female sterilization is very high. The potential for growth of vasectomy services may be related to attitudes and practices of physicians. In 1984, 660 physicians at seven major hospitals in São Paulo were randomly selected from a total population of 2207 physicians in these hospitals. They were interviewed about their attitudes towards family planning in general, and specifically towards voluntary sterilization. A high degree of vasectomy among this medical community is indicated by its relatively high prevalence among married physicians and their spouses; about one in ten reported that either they or their spouse had had a vasectomy. Half of the physicians who perform sterilizations perform vasectomies: 22% of obstetricians and gynecologists, 85% of surgeons, and all urologists. In general, physicians would recommend vasectomy and tubal ligation equally often to their clients. Depending on the circumstances, up to 85% of all physicians recommend some sterilization procedure. Recommendation was modified by the type of procedure a physician performed, and by the patient's characteristics. Physician's recommendations of sterilization increased with age and parity of patient and was related to the health conditions and socioeconomic circumstances of the couple.

The impact of mass media advertising on a voluntary sterilization program in Brazil.

The effect of magazine advertising on vasectomy acceptance was tested in São Paulo, Brazil. Four advertisements ran for ten weeks in eight magazines. Clinic performance doubled during the campaign and stabilized at 54 percent higher than baseline. The advertisements selectively attracted the target audience without bringing in large numbers of ineligible candidates, completely avoided negative reactions, and recruited men previously unexposed to vasectomy. The cost of the advertising campaign was offset by additional revenue generated by the increase in vasectomies performed. The results suggest that while interpersonal communications can maintain performance in voluntary sterilization programs, mass media promotion may be necessary for program growth.

PIP: A simple before-and-after time-series analysis was employed to study the effect of magazine advertising on vasectomy acceptance in Sao Paulo, Brazil. The study design used the single Pro-Pater Sao Paulo clinic and a single intervention, i.e., the mass media promotional campaign. Service statistics for the years 1984-85 provided the baseline; clinic performance was continuously monitored during the intervention and for a 12-month postintervention period. The formal campaign was initiated during September 1985. 4 advertisements ran for 10 weeks in 8 magazines. By the end of the study, the patient file included 3403 records for the baseline period, 1475 records for the campaign, and 5388 records for the post-campaign period. The telephone calls file contained 4393 records and the letters file 386 records. A clear impact of the advertising campaign was demonstrated, both in terms of total number of telephone calls received and in terms of referral source. The advertisements generated 32% of all telephone calls received, 47% of calls received during the campaign itself, and 9-10% of the calls received in the 2nd half of the post-campaign year. As referrals by advertisements dropped off, they were replaced in part by increased referrals from traditional sources, providing the 1st evidence of a "multiplier effect." Magazine referrals were significantly less likely to schedule an intake interview than were callers referred by traditional sources -- 51% versus 78%. Clinic performance was positively and significantly affected by the advertising campaign. The mean daily number of new clients doubled during the campaign as compared to the baseline period and remained 60% higher in the post-campaign period. The mean daily number of vasectomies performed increased 76% from the baseline to the campaign period and stabilized at a level 54% higher than baseline during the post-campaign period. 18% of the new clients arriving during the campaign reporting having seen a magazine advertisement; this figure was 4 of the new clients in the post-campaign period. New clients referred by the campaign were, on the average, 1 year older than those referred by traditional sources. Number of living children did not vary by period. The mean educational level rose slightly during the campaign, after which it returned to baseline levels. The cost of the advertising campaign was offset by the additional revenue gained from the increase in vasectomies performed. In sum, the study findings support the conclusion that mass media that mass media advertising as an effective and cost-effective means to increase the demand for vasectomy services in Sao Paulo, Brazil.

Creating a male contraceptive service.

PIP: Pro-Pater offers family planning services exclusively to men. Since its founding in 1980, through June 1987, Pro-Pater performed 16,062 vasectomies and trained 127 Brazilian and foreign physicians in vasectomy. Total vasectomies represent procedures performed on almost 80% of the prospective candidates who presented themselves to the clinic. Most family planning programs are biased toward women and have little or no experience with male contraception. In 1980, program administrators, international donors, physicians, and specialists in family planning expected the proposed exclusively male program to fail in Brazil due to the country's cultural underdevelopment and widespread machismo. Pro-Pater was nonetheless founded in Sao Paulo with funds from the Association for Voluntary Surgical Contraception (AVSC) and staff set out to personally advertise its existence among their friends. A pamphlet was also published explaining vasectomy for distribution to nurses, laboratory technicians, taxi drivers, publicists, and pharmaceutical company salesmen. This initial approach garnered the group's first clients who subsequently became strong promoters of vasectomy. A series of talks was held with social workers and other personnel professionals of large companies in Sao Paulo in the attempt to expand Pro-Pater's client base. The social workers welcomed the message about vasectomy and soon helped in its promotion. Pro-Pater televised a report on vasectomy in 1983 and ran an advertising campaign in magazines in 1985.^ieng