Emtonjeni-A Structural Intervention to Integrate Sexual and Reproductive Health into Public Sector HIV Care in Cape Town, South Africa: Results of a Phase II Study.

Integration of sexual and reproductive health within HIV care services is a promising strategy for increasing access to family planning and STI services and reducing unwanted pregnancies, perinatal HIV transmission and maternal and infant mortality among people living with HIV and their partners. We conducted a Phase II randomized futility trial of a multi-level intervention to increase adherence to safer sex guidelines among those wishing to avoid pregnancy and adherence to safer conception guidelines among those seeking conception in newly-diagnosed HIV-positive persons in four public-sector HIV clinics in Cape Town. Clinics were pair-matched and the two clinics within each pair were randomized to either a three-session provider-delivered enhanced intervention (EI) (onsite contraceptive services and brief milieu intervention for staff) or standard-of-care (SOC) provider-delivered intervention. The futility analysis showed that we cannot rule out the possibility that the EI intervention has a 10 % point or greater success rate in improving adherence to safer sex/safer conception guidelines than does SOC (p = 0.573), indicating that the intervention holds merit, and a larger-scale confirmatory study showing whether the EI is superior to SOC has merit.

Use-effectiveness of the female versus male condom in preventing sexually transmitted disease in women.

BACKGROUND: Data are limited on the female condom's effectiveness against STDs. GOAL: The goal was to compare STD rates between women given small-group education on, and free supplies of, either female or male condoms. STUDY DESIGN: Female patients at an STD clinic (n = 1442) were randomly assigned to condom type and followed via medical records for STDs (gonorrhea, chlamydia, early syphilis, or trichomoniasis). RESULTS: In an intention-to-treat analysis, the odds ratio for a comparison of STD occurrence between the female and male condom groups was 0.75 (95% confidence interval [CI], 0.56-1.01), and it did not change with adjustment. In a second analysis among women returning for subsequent screening, incidence rates for the first new postintervention STD per 100 woman-months of observation were 6.8 in the female condom group and 8.5 in the male condom group (rate ratio = 0.79 [CI, 0.59-1.06]). CONCLUSION: Compared with those provided with male condoms alone, women counseled on, and provided with, female condoms fared no worse and experienced a nonsignificant reduction in STDs.

The acceptability of the female condom: perspectives of family planning providers in New York City, South Africa, and Nigeria.

This article seeks to fill the gap in female condom acceptability research by examining family planning (FP) providers' attitudes and experiences regarding the female condom in three countries (South Africa, the US, and Nigeria) to highlight providers' potential integral role in the introduction of the female condom. The case studies used data drawn from three independent projects, each of which was designed to study or to change FP providers' attitudes and practices in relation to the female condom. The case study for New York City used data from semistructured interviews with providers in one FP consortium in which no special female condom training had been undertaken. The data from South Africa were drawn from transcripts and observations of a female condom training program and from interviews conducted in preparation for the training. The Nigerian study used observations of client visits before and after providers were trained concerning the female condom. In New York City, providers were skeptical about the contraceptive efficacy of the female condom, with only 8 of 22 providers (36%) reporting they would recommend it as a primary contraceptive. In South Africa, providers who had practiced insertion of the female condom as part of their training expressed concern about its physical appearance and effects on sexual pleasure. However, they also saw the female condom as a tool to empower clients to increase their capacity for self-protection. Structured observations of providers' counseling interactions with clients following training indicated that Nigerian providers discussed the female condom with clients in 80% of the visits observed. Despite the lack of a uniform methodology, the three case studies illuminate various dimensions of FP providers' perceptions of the acceptability of the female condom. FP providers must be viewed as a critical factor in female condom acceptability, uptake, and continued use. Designing training programs and other interventions that address sources of provider resistance and enhance providers' skills in teaching female condom negotiation strategies may help to increase clients' use of the female condom.

Silicone breast implants: epidemiological evidence of sequelae.

Skeptics may certainly find fault with the third study (the only one to report a significant finding) or with all or any of the statistics described. But few could argue, after examining these studies, that the relative risk for a known and well-defined connective tissue disease is likely greater than 2. Another possibility has been raised, one that calls to mind other difficult-to-study syndromes linked to exposures. In a study addressing Gulf War syndrome, signs and symptoms were often mentioned that proved difficult to describe systematically and therefore difficult to study. What if a suspected silicone exposure syndrome were so mild and transient that it did not warrant a physician visit (as in the Mayo Clinic study). receive a diagnosis (as in the Nurses' Health Study), or require admission to a hospital (as in the Danish and Swedish studies)? And if such a disorder were, in fact, mild and transient, should it merit the concern that has been shown and the compensation that has been awarded in the silicone implant litigation cases to date? We suggest that neither a well-described disorder with a relative risk of less than 2 nor a transient and mild disorder seems compatible with the number of litigants over silicone implants and the apparent seriousness of their complaints. Some 400,000 women joined in one class action suit for damages, and 170,000 joined in another. Even if there had been 2 million implants undertaken in the United States over the 3 decades in which implant surgery has been practiced (and some estimates put the number closer to 1 million), there is no conceivable way in which a relative risk of 2 or 3 (or even 4) for each of the rare syndromes reported could explain so many exposed women being affected. At most, 2200 out of 2 million unexposed women would be expected to have had any one of the listed forms of connective tissue disorders, most of which are very rare. Doubling the risk among the exposed population yields 4400, and increasing the risk 20-fold produces 44,000. At this rate, there is no way in which 400,000 litigants could all be affected. Extensions of the already-completed studies are ongoing, at least 1 of which is government funded; apparently it is thought in the United States (though not in the United Kingdom or elsewhere) that there is still room for reasonable doubt as to the supposed causal relationships. But if epidemiology is invoked in the interest of public health to prevent the many uses of silicone, the weight of the evidence abstracted here supports the inference that silicone breast implants have not been proved guilty of causing connective tissue disorders.

Cesarean deliveries and maternal-infant HIV transmission: results from a prospective study in South Africa.

Data from a prospective study undertaken at an urban hospital in Durban, South Africa, were used to investigate associations between maternal-infant HIV transmission, mode of delivery, and specific circumstances of cesarean deliveries. A total of 141 children of HIV-infected women were followed until the children were 15 months of age to determine their HIV status. supplementary data were collected from obstetric records, masked to the HIV status of the children. In this African and predominantly breast-fed population, infants delivered vaginally were more likely to be infected (39.8% infected) than were infants delivered by cesarean section [22.9% infected; odds ratio (OR), 0.45; 95% confidence interval (CI), 0.20-0.99]. There were no significant differences between cesarean deliveries undertaken following prior rupture of membranes and those undertaken with membranes intact, but numbers for this comparison were small. Singleton cesarean deliveries without concurrent obstetric complications had lower rates of transmission than did vaginal deliveries (OR, 0.20; 95% CI, 0.04-0.94). These results suggest that certain intrapartum events may modify the risk of HIV transmission and highlight the importance of collecting more detailed intrapartum information in order to clarify the route by which mode of delivery may be associated with maternal-infant HIV transmission.

PIP: In South Africa, researchers tried to follow 229 mother-child pairs attending the prenatal care clinic of and delivering at King Edward VIII Hospital in Durban until the index child was at least 15 months old. They examined the associations between mode of delivery and maternal-infant HIV transmission. Outcomes were known for 136 women and their 141 children. There were no significant differences between these mother-child pairs and those lost to follow-up in terms of maternal age, parity, weight at first prenatal visit, number of prenatal visits, or the detection of other sexually transmitted diseases, nor in the child's gender, birth weight, gestation, circumstances of delivery, or feeding practices. Children delivered by cesarean section were less likely to develop HIV infection than those delivered vaginally (22.9% vs. 39.8%; odds ratio [OR] = 0.45 for univariate analysis and 0.41 for multivariate analysis). Singleton cesarean deliveries without concurrent obstetric complications were significantly less likely to develop HIV infection than vaginal deliveries (11.7% vs. 39.8%; OR = 0.20; p 0.5). The HIV transmission rates in the other cesarean section subgroups were not significantly different than those in the vaginal delivery group. They were still lower, however. Survival to 18 months was not significantly different between the nine HIV infected infants delivered by cesarean section and their vaginally delivered counterparts (67% vs. 74%; p = 0.7). These findings indicate that some intrapartum events may influence the risk of HIV transmission. They highlight the need to collect more detailed intrapartum information to identify the route by which mode of delivery may be associated with maternal-infant HIV transmission. The intrapartum events that may have influenced HIV transmission in this study include ruptured membranes, twin delivery, and intrapartum hemorrhage.

The effects of vitamin A supplementation on the morbidity of children born to HIV-infected women.

OBJECTIVE: The effects of vitamin A supplementation on morbidity of children born to human immunodeficiency virus (HIV)-infected women were evaluated in a population where vitamin A deficiency is not endemic. METHODS: A randomized, placebo-controlled trial of vitamin A supplementation was carried out in 118 offspring of HIV-infected women in Durban, South Africa. Those assigned to receive a supplement were given 50,000 IU of vitamin A at 1 and 3 months of age; 100,000 IU at 6 and 9 months; and 200,000 IU at 12 and 15 months. Morbidity in the past month was then recalled at each follow-up visit. Analysis was based on 806 child-months. RESULTS: Among all children, the supplemented group had lower overall morbidity than the placebo group (OR = 0.69; 95% confidence interval [CI] = 0.48, 0.99). Among the 85 children of known HIV status (28 infected, 57 uninfected), morbidity associated with diarrhea was significantly reduced in the supplemented infected children (OR = 0.51; 95% CI = 0.27, 0.99), whereas no effect of supplementation on diarrheal morbidity was noted among the uninfected children. CONCLUSION: In a population not generally vitamin A deficient, vitamin A supplementation for children of HIV-infected women appeared to be beneficial, reducing morbidity. The benefit was observed particularly for diarrhea among HIV-infected children.

Changes over time in survival of children after AIDS diagnosis in New York City.

We determined whether survival of children following AIDS diagnosis is improving over time through 1991. AIDS surveillance data from New York City Department of Health on 914 pediatric AIDS patients, diagnosed between 1979 and 1991 and presumed due to maternal-infant HIV transmission, were analyzed. Survival following AIDS diagnosis, established from hospital records and death certificates, was compared by calendar year of initial diagnosis using Kaplan-Meier lifetable analysis. Cox Proportional Hazards regression models were used to compare survival for patients diagnosed earlier or later in the decade, controlling for age at diagnosis, presenting opportunistic illness, and gender of the child. Patients diagnosed with AIDS from October 1987 to September 1989 survived longer, median survival 17 months after diagnosis, than patients diagnosed before September 1987, median survival 10 months (relative risk [RR] = 0.76; 95% confidence intervals [CI] = 0.62, 0.93). Patients diagnosed from October 1989 to December 1991 also survived a median of 17 months. Secular improvements in survival after AIDS diagnosis remained after controlling for age at diagnosis, presenting diagnosis, and gender, even if deaths within three months of diagnosis were excluded. These data suggest that for recent years, survival following AIDS diagnosis in those contracting the infection through maternal-infant transmission has been prolonged. Possible explanations for these findings include both methodological issues (changes in diagnostic criteria, incomplete ascertainment of deaths) and substantive issues (developments in therapeutic interventions and management of pediatric AIDS).

Mother-to-infant HIV transmission: timing, risk factors and prevention.

Identifying when--during pregnancy, delivery or the postnatal period--transmission of human immunodeficiency virus (HIV) from mother to infant usually takes place is critical to the development of methods to prevent maternal-infant transmission. Evidence is reviewed in this paper as to whether transmission occurs prepartum (early or late in gestation), intrapartum, or postpartum with breast feeding. Evidence in support of the notion of prepartum transmission has come from isolation of HIV from aborted fetal organs, comparison of maternal-child viral genotypes and study of neonatal cell-mediated immune responses. Evidence against prepartum transmission is that fewer than half of the children later known to be HIV-infected can be identified by virological tests carried out close to birth. A reduced rate of transmission in infants delivered by Caesarean section, and a reduced risk of transmission to second-born twins delivered vaginally, offers support to the view that intrapartum factors influence the risk of HIV transmission. Transmission through breast feeding can occur if a mother is infected postpartum and seems to pose some additional risk if she is already infected at parturition. The risk of infection increases with the stage of maternal HIV disease, but specific immunological, clinical and viral characteristics need to be investigated further. A clinical trial of zidovudine, used during late pregnancy and delivery and given to the infant at birth, has reported a significant reduction in transmission. Primary prevention of HIV infection in women remains a principal priority.

Maternal-infant HIV transmission and circumstances of delivery.

OBJECTIVES: Circumstances of delivery among children with acquired immunodeficiency syndrome (AIDS) were investigated to assess whether they were consistent with predictions that intrapartum factors affect the risk of maternal-infant human immunodeficiency virus (HIV) transmission. METHODS: Pediatric AIDS patients (maternal-infant transmission; n = 632) reported to the New York City Health Department through 1991 were compared with a series of infants born to predominantly uninfected women. For each case patient, five control subjects were selected and matched from birth certificate files. Hypothesized case-control comparisons for mode of delivery and preselected complications were tested. RESULTS: Compared with control subjects, case patients were less likely to have been delivered by cesarean section without complications (odds ratio [OR] = 0.77; 95% confidence interval [CI] = 0.59, 1.01) and more likely to have been delivered with complications, whether delivery was by cesarean section (OR = 1.54; 95% CI = 0.98, 2.43) or vaginal (OR = 1.66; 95% CI = 1.15, 2.39). CONCLUSIONS: Assuming that HIV-infected and uninfected women have comparable circumstances of delivery, conditional on sociomedical characteristics, these results suggest that intrapartum events may be associated with maternal-infant HIV transmission.

The effects of a natural disaster on child behavior: evidence for posttraumatic stress.

OBJECTIVES: A prospective study of children examined both before and after a flood disaster in Bangladesh is used to test the hypothesis that stressful events play a causal role in the development of behavioral disorders in children. METHODS: Six months before the disaster, structured measures of selected behavioral problems were made during an epidemiological study of disability among 2- to 9-year-old children. Five months after the disaster, a representative sample of 162 surviving children was reevaluated. RESULTS: Between the pre- and postflood assessments, the prevalence of aggressive behavior increased from zero to nearly 10%, and 45 of the 134 children who had bladder control before the flood (34%) developed enuresis. CONCLUSIONS: These results help define what may be considered symptoms of posttraumatic distress in childhood; they also contribute to mounting evidence of the need to develop and evaluate interventions aimed at ameliorating the behavioral and psychological consequences of children's exposure to extreme and traumatic situations.

The Dutch famine birth cohort study: design, validation of exposure, and selected characteristics of subjects after 43 years follow-up.

A historical birth cohort study of 1116 women born between August 1 1944 and April 15 1946 in the Wilhelmina Gasthuis hospital in Amsterdam, the Netherlands, was set up to study the short- and long-term effects of a limited period of extreme nutritional deprivation in the winter of 1944-1945 in the Western Netherlands. The degree of food deprivation is evidenced by a dramatic decline in third trimester pregnancy weight gain and infant birthweight. All women were traced and 84% (683/813) of survivors presently resident in the Netherlands agreed to be interviewed in their homes. There were no differences in characteristics at birth between interviewed and uninterviewed survivors. The women who were interviewed had 1299 offspring and were able to recall birthweight of all of them. Additional birthweight information from hospital and well-baby clinic (WBC) records is available for about half of the offspring. Since the famine was imposed on the entire population of a well-defined area, whose opportunities to obtain food elsewhere were severely restricted, and the women from this hospital cohort were predominantly lower middle class, the relationship between fetal nutrition and subsequent health outcomes in this cohort is not likely to be confounded by unmeasured attributes related to social class. In addition, selective losses to follow-up could be excluded, which makes the Dutch famine birth cohort a valuable resource for future studies in perinatal epidemiology.

Commentary: the new female condom--item 1 on a women's AIDS prevention agenda.

A US Food and Drug Administration (FDA) advisory panel has recommended that the female condom Reality be approved for contraception and acquired immunodeficiency syndrome (AIDS) prevention. Final FDA approval will mark the first official recognition of a woman-controlled method for protection against sexually transmitted disease. A female condom allows women to use just one method to respond to the twin anxieties of AIDS and unwanted pregnancy. In those couples in which the man refuses to wear a male condom, the availability of a female condom makes protection possible for the first time. Although the female condom has some advantages over the male condom--greater comfort for some women and men and nonreliance on male arousal--general population experience with the device is needed to achieve regular widespread use and hence effectiveness at population levels. The FDA still lags behind in responding to women's needs for information on AIDS and sexually transmitted disease.

HIV prevention: the need for methods women can use.

Efforts to prevent heterosexual transmission of HIV (human immunodeficiency virus) infection have thus far focused on modifying sexual behaviors and the use of condoms. While the experience of family planners, particularly in those countries most threatened by heterosexual HIV transmission, has shown that the most effective measures of pregnancy prevention have relied on women, little attention has been given to barriers to HIV transmission that depend on the woman and are under her control. Tactics which interrupt transmission of the virus should be considered in their own right and separated from those that interrupt pregnancy, for insurance, the diaphragm. Greater emphasis is urged for research on preventive methods women could use, including the possibility of a topical virucide that might block transmission through the vaginal route.

Working during pregnancy: physical and psychosocial strain.

The article concerns more general aspects of stress during pregnancy in connection with employment. Various existing studies are reviewed, mainly related to pre-term delivery and birth weight.