Hormonal contraception and area of cervical ectopy: a longitudinal assessment.

BACKGROUND: The effect of combined oral contraceptives (COCs) and depot-medroxyprogesterone acetate (DMPA) on the area of cervical ectopy is not well understood. STUDY DESIGN: From 1996 to 1999, we recruited women not using hormonal contraception from two family planning centers in Baltimore, MD. Upon study entry and 3, 6 and 12 months after the initial visit, participants were interviewed and received visual cervical examinations with photography. Ectopy was measured from digitized photographs and was analyzed both continuously and categorically (small [≤0.48 cm(2)] vs. large [>0.48 cm(2)]). RESULTS: Of 1003 enrolled women, 802 returned for at least one follow-up visit. At 12 months, the numbers of women using COCs, DMPA or no hormonal method at least 50% of the time since the prior visit were 230, 76 and 229, respectively. After multivariable adjustment, COC use (vs. no hormonal use) was associated with large area of ectopy (odds ratio [OR]: 1.8, 95% confidence interval [CI]: 1.0-3.3). No significant relationship was observed between DMPA and large area of ectopy (OR: 0.5, 95% CI: 0.2-1.3). The incidence of large area of ectopy by contraceptive exposure (COC, DMPA or no hormonal method) was 17.4 (CI: 11.8-24.6), 10.9 (CI: 4.4-22.4) and 4.6 (CI: 2.2-8.4) per 100 woman-years, respectively. CONCLUSIONS: Use of COCs, but not DMPA, was associated with large area of cervical ectopy. Area of ectopy at baseline was the strongest predictor of area of ectopy at follow-up.

Treatment of patients with new onset Type 1 diabetes with a single course of anti-CD3 mAb Teplizumab preserves insulin production for up to 5 years.

Anti-CD3 mAbs may prolong beta cell function up to 2 years in patients with new onset Type 1 diabetes (T1DM). A randomized open label trial of anti-CD3 mAb, Teplizumab, in T1DM was stopped after 10 subjects because of increased adverse events than in a previous trial related with higher dosing of drug. Teplizumab caused transient reduction in circulating T cells, but the recovered cells were not new thymic emigrants because T cell receptor excision circles were not increased. There was a trend for reduced loss of C-peptide over 2 years with drug treatment (p=0.1), and insulin use was lower (p<0.001). In 4 drug-treated subjects followed up to 60 months, C-peptide responses were maintained. We conclude that increased doses of Teplizumab are associated with greater adverse events without improved efficacy. The drug may marginate rather than deplete T cells. C-peptide levels may remain detectable up to 5 years after treatment.

Pregnancy among sex workers participating in a condom intervention trial highlights the need for dual protection.

BACKGROUND: Little is known about pregnancy rates among sex workers (SWs) or the factors that predispose SWs to this risk. We aimed to estimate the pregnancy incidence rate among Madagascar SWs participating in an intervention trial promoting use of male and female condoms and assess the influence of various predictive factors on pregnancy risk. METHODS: SWs from two study clinics in Madagascar participated in a randomized trial to assess the effect of peer education and clinic-based counseling on use of male and female condoms and prevalence of sexually transmitted infections (STIs). Women were seen every 2 months for up to 18 months; they received structured interviews at every visit, and physical exams at baseline and every 6 months thereafter. Site staff recorded information on pregnancies during interviews; pregnancy data were then merged with trial data for this analysis. RESULTS: Of 935 SWs in the analysis population, 250 became pregnant during follow-up. The cumulative probability of pregnancy was 0.149 at 6 months and 0.227 at 12 months. Comparable proportions of nonpregnant and pregnant SWs reported using highly effective contraception at baseline (approximately 16%); these users were younger and were more consistent condom users. Method switching and discontinuation were frequent. In multivariate analysis, nonuse of effective contraceptives and any self-reported unprotected sex were associated with higher incidence of pregnancy. Approximately 51% of women delivered, 13% reported a spontaneous abortion, 13% reported an induced abortion and 23% had missing pregnancy outcomes. CONCLUSIONS: Women traditionally targeted for STI/HIV preventive interventions need more comprehensive reproductive health services. In particular, SWs could benefit from targeted family planning counseling and services.

Randomised controlled trial of alternative male and female condom promotion strategies targeting sex workers in Madagascar.

OBJECTIVES: To assess whether individual clinic-based counselling as a supplement to peer education for male and female condom promotion leads to greater use of protection and lower STI prevalence among sex workers in Madagascar already exposed to intensive male condom promotion. METHODS: In two public dispensaries in Madagascar, a total of 901 sex workers were randomly allocated between two alternative male and female condom promotion INTERVENTIONS: peer education only, or peer education supplemented with individual clinic-based counselling. Participants were followed for 12 months. Every 2 months they made clinic visits, where they were interviewed on condom use. Peer educators counselled all participants on condom use as they accompanied their assigned participants to study visits. Participants assigned to receive the supplemental intervention were counselled by a trained clinician following study interviews. Participants were tested and treated for chlamydia, gonorrhoea and trichomoniasis every 6 months. We used logistic regression to assess whether the more intensive intervention was associated with reduced STI prevalence. Use of protection with clients and non-paying partners was assessed by study arm, site, and visit. RESULTS: There was no statistically significant association between study arm and aggregated STI prevalence. No substantial differences in levels of reported protection were noted between study groups. CONCLUSIONS: This study found little evidence for gains from more thorough clinical counselling on male and female condom use. These findings suggest that less clinically intensive interventions such as peer education could be suitable for male and female condom promotion in populations already exposed to barrier method promotion.

Randomised controlled trial on whether advance knowledge of prostate-specific antigen testing improves participant reporting of unprotected sex.

OBJECTIVES: To determine whether the process of informing research participants that they would be tested for the presence of a biological marker of semen exposure would reduce bias in their reports of unprotected sex. METHODS: A randomised trial of 210 female sex workers from Mombasa, Kenya, was conducted, where half the group had advance knowledge (via the request for informed consent) that they would be tested for prostate-specific antigen (PSA) in their vaginal fluid before they reported on sex and condom use for the past 48 h. The other half were invited to participate (via additional informed consent) in the test for PSA after they had already consented to be questioned and reported on these sexual behaviours. A trained nurse instructed participants to self-swab to collect vaginal fluid specimens, which were tested for PSA using ELISA. RESULTS: Reporting of unprotected sex did not differ between those with advance knowledge of the test for PSA and those without this knowledge (14.3% v 11.4%, respectively; p = 0.27). Surprisingly, more women with advance knowledge (15.8%) had discrepant self reports and PSA results than women without advance knowledge (9.1%); however, the difference was not statistically significant (OR 1.9; 95% CI 0.8 to 4.5). CONCLUSIONS: Knowing that one's answers to a questionnaire could be verified with a biological marker of semen exposure did not make respondents more likely to report unprotected sex.

Informed consent: an international researchers' perspective.

We reported 164 researchers' recommendations for information that should be included in the informed consent process. These recommendations were obtained during training workshops conducted in Africa, Europe, and the United States. The 8 elements of informed consent of the US Code of Federal Regulations were used to identify 95 items of information ("points"), most related to benefits and research description. Limited consensus was found among the 3 workshops: of the 95 points, only 27 (28%) were identified as useful by all groups. These points serve as a springboard for identifying information applicable in different geographic areas and indicate the need for involving a variety of individuals and stakeholders, with different research and cultural perspectives, in the development of informed consent, particularly for research undertaken in international settings.

Adolescents' use of maternal and child health services in developing countries.

CONTEXT: Because of high levels of early childbearing in developing countries, pregnancy and childbirth are the leading causes of death among women aged 15-19. Use of skilled antenatal and delivery care improves maternal outcomes through the prevention, management and treatment of obstetric complications, and infant immunizations prevent many childhood diseases. METHODS: Logistic regression analysis of Demographic and Health Survey data for 15 developing countries examined adolescents' use of antenatal care, delivery care and infant immunization services compared with use by older women. RESULTS: In general, the use of maternal and child health care did not vary by mother's age. In five of the 15 countries, women aged 18 or younger were less likely than women aged 19-23 to use either antenatal care or delivery care, or both (odds ratios, 0.5-0.9). Younger mothers in six countries were less likely than older mothers to have their infants immunized, particularly for diphtheria, pertussis and tetanus and for measles (0.5-0.8). The association of age and health care use was largely limited to Bangladesh, India, Indonesia, Nicaragua, Peru and Uganda. In Latin America, controlling for parity allowed differences between adolescents and older women to emerge. Except in Uganda, there were no differences in health care use by mother's age in the African countries. CONCLUSION: Country-specific investigations are needed in Asia to better understand the reasons for differences in service use by age. In general, further systematic evidence would help identify long-term interventions that will be most effective in increasing adolescents' use of maternal and child health services.

Use of male condoms during and after randomized, controlled trial participation in Cameroon.

BACKGROUND AND OBJECTIVE: This study evaluated patterns of long-term use of male condoms among partners of 966 Cameroonian women who received eight intensive, monthly counseling sessions about condoms and sexually transmitted infection testing and treatment. METHOD: An interrupted time-series design was used with study participants reporting condom use and other covariates at enrollment, monthly for 6 months during the randomized, controlled trial, and at approximately 14 months after the trial. RESULTS: Consistent condom use began decreasing while women were still receiving monthly condom use counseling, with every month in the trial associated with an odds ratio of 0.96 (95% confidence interval [CI], 0.94-0.99) of consistent condom use and dropped substantively after the trial with a 0.39 (95% CI, 0.26-0.59) odds ratio in a logistic regression analysis. The incidence of unprotected coital acts as each month passed increased by 3% (95% CI, 1-4%) with no statistically significant change during the condom use follow-up survey as indicated in a zero-inflated Poisson regression model for unprotected coital acts. Condom use in a coital act was 0.84 (95% CI, 0.78-0.92) less likely during the follow-up survey than during the trial. CONCLUSION: Only a few women sustained consistent condom use throughout the study period and for more than 1 year after. It is important to continue documenting the impact of condom promotion in a rigorous manner and to identify content and delivery of counseling that will lead to sustained condom use beyond the intervention period.

Hormonal contraceptive use, cervical ectopy, and the acquisition of cervical infections.

BACKGROUND AND OBJECTIVES: Several previous studies have suggested that hormonal contraception could be associated with increased risk of cervical infections. However, few high-quality prospective studies have examined this relationship. GOAL: The goal of this study was to measure the effect of oral contraceptives (OC) and depot-medroxyprogesterone acetate (DMPA) on the acquisition of cervical chlamydial and gonococcal infections. STUDY: Women attending 2 reproductive health centers in Baltimore, MD, were enrolled into a prospective cohort study. Participants were 15 to 45 years and were initiating OCs or DMPA or not using hormonal contraception. Interviews, physical examinations, and testing for incident cervical infections were conducted at 3, 6, and 12 months. RESULTS: The analysis included 819 women. Most were single (77%) and nulliparous (75%); 43% were black. Median age was 22 years. During the study, 45 women acquired a chlamydial or gonococcal infection (6.2 per 100 women-years). DMPA use (hazard ratio [HR], 3.6; 95% confidence interval [CI], 1.6-8.5), but not OC use (HR, 1.5; 95% CI, 0.6-3.5), was significantly associated with increased acquisition of cervical infections after adjusting for other risk factors. Cervical ectopy was not an important mediator of cervical infection risk. CONCLUSIONS: DMPA use, but not OC use, appeared to be significantly associated with increased acquisition of cervical chlamydial and gonococcal infections.

Unintended pregnancy and women's psychological well-being in Indonesia.

Few studies have examined the impact of unintended pregnancy on women in developing countries. This paper examines the impact of unintended pregnancy on Indonesian women's psychological well-being. It is hypothesized that experiencing unintended pregnancy is associated with lower psychological well-being and that use of family planning and small family size are associated with higher levels of psychological well-being. Data are drawn from a 1996 survey of 796 women aged 15-49 from two Indonesian provinces, Lampung and South Sumatra. This article focuses on the 71% of women (n=562) who answered all 41 survey items related to psychological well-being. In cluster analysis, women grouped into three clusters, differentiated by their scores on four scales of well-being established through factor analysis (general negative feelings, satisfaction with relationships, satisfaction with economic/family/personal conditions, and negative feelings regarding domestic issues). Women in cluster 3 were characterized mainly by their high level of psychological well-being. Women in cluster 1 had the lowest level of well-being, and women in cluster 2 were in the middle. Multinomial logistic regression was used to assess jointly the effect of unintended pregnancy, contraceptive use, number of children and other factors on a woman's level of psychological well-being. Unintended pregnancy was associated with lower levels of psychological well-being and contraceptive use was associated with higher levels of psychological well-being, while number of children was not associated with level of well-being. Women who had experienced an unintended pregnancy were less likely to be in the high psychosocial well-being cluster versus both the medium and low clusters. In addition, women using contraception were more likely to be classified in the high than in the low or medium well-being clusters.