Goals for girls: a cluster-randomized trial to investigate a school-based sexual health programme amongst female learners in South Africa.

The delivery of comprehensive sexuality education to adolescents at school is recognized as a long-term strategy to support adolescent health. Suboptimal sexual and reproductive health (SRH) outcomes among South African adolescents necessitate the ongoing development and optimization of SRH education and promotion models. We conducted a cluster-randomized controlled trial amongst secondary schools (n = 38) in Cape Town, South Africa, to evaluate a sport-based, near-peer-led SRH curriculum, SKILLZ, amongst female learners (n = 2791). Biomedical (sexually transmitted infections [STIs], human immunodeficiency virus [HIV] and pregnancy) and socio-behavioural (social support, gender norms and self-concept) outcomes were assessed pre and post intervention. Attendance at SKILLZ was low and intervention participants did not show an improvement in SRH outcomes, with HIV and pregnancy incidence remaining stable and STI prevalence remaining high and increasing in both control and intervention arms. Although evidence of positive socio-behavioural measures was present at baseline, participants with high attendance showed further improvement in positive gender norms. SKILLZ did not demonstrate the capacity to significantly impact clinical SRH outcomes. Modest improvements in outcomes amongst high attenders suggest that the impact may be possible with improved attendance; however, in the absence of optimal attendance, alternative intervention strategies may be required to improve SRH outcomes amongst adolescents.

Costs and economies of scale in the accelerated program for prevention of mother-to-child transmission of HIV in Zimbabwe.

BACKGROUND: Despite a growing body of literature on HIV service costs in sub-Saharan Africa, only a few studies have estimated the facility-level cost of prevention of Mother-to-Child Transmission (PMTCT) services, and even fewer provide insights into the variation of PMTCT costs across facilities. In this study, we present the first empirical costs estimation of the accelerated program for the prevention of mother-to-child transmission of HIV in Zimbabwe and investigate the determinants of heterogeneity of the facility-level average cost per service. To understand such variation, we explored the association between average costs per service and supply-and demand-side characteristics, and quality of services. One aspect of the supply-side we explore carefully is the scale of production-which we define as the annual number of women tested or the yearly number of HIV-positive women on prophylaxis. METHODS: We collected rich data on the costs and PMTCT services provided by 157 health facilities out of 699 catchment areas in five provinces in Zimbabwe for 2013. In each health facility, we measured total costs and the number of women covered with PMTCT services and estimated the average cost per woman tested and the average cost per woman on either ARV prophylaxis or ART. We refer to these facility-level average costs per service as unitary costs. We also collected information on potential determinants of the variation of unitary costs. On the supply-side, we gathered data on the scale of production, staff composition and on the types of antenatal and family planning services provided. On the demand side, we measured the total population at the catchment area and surveyed eligible pairs of mothers and infants about previous use of HIV testing and prenatal care, and on the HIV status of both mothers and infants. We explored the determinants of unitary cost variation using a two-stage linear regression strategy. RESULTS: The average annual total cost of the PMTCT program per facility was US$16,821 (median US$8,920). The average cost per pregnant woman tested was US$80 (median US$47), and the average cost per HIV-positive pregnant woman initiated on ARV prophylaxis or treatment was US$786 annually (median US$420). We found substantial heterogeneity of unitary costs across facilities regardless of facility type. The scale of production was a strong predictor of unitary costs variation across facilities, with a negative and statistically significant correlation between the two variables (p<0.01). CONCLUSIONS: These findings are the first empirical estimations of PMTCT costs in Zimbabwe. Unitary costs were found to be heterogeneous across health facilities, with evidence consistent with economies of scale.

Discrepancies in diagnosis of incident HIV infection between antibody- and DNA-based tests in a phase III prevention trial in southern Africa.

Dried blood spots (DBS) are widely used to test for HIV in a variety of research and service delivery settings; however, uniform guidelines regarding collection, storage and DNA extraction processes have neither been developed nor evaluated. Previously published reports suggested DBS may be stored at room temperature for up to 60 days, and intensive stability tests have shown that DBS can withstand high temperatures, humidity and freeze-thawing. During the implementation of a large randomized controlled trial (RCT) in southern Africa, with HIV acquisition as the primary endpoint, we observed 65 instances when DBS samples collected from the same day as a positive HIV antibody test yielded negative DNA polymerase chain reaction (PCR) results. The source of this discrepancy may have been due to inadequate specimen volume, filter paper or DNA extraction procedures, but were most likely due to storage conditions that have been reported as acceptable in other settings.

The relative contribution of viral and bacterial sexually transmitted infections on HIV acquisition in southern African women in the Methods for Improving Reproductive Health in Africa study.

We assess the relative contribution of viral and bacterial sexually transmitted infections (STIs) on HIV acquisition among southern African women in a nested case-control study within the Methods for Improving Reproductive Health in Africa (MIRA) trial. Cases were women with incident HIV infection; controls were HIV-uninfected at the time of case seroconversion selected in a 1 to 3 case to control ratio (risk-set sampling), matched on study site and time of follow-up. Conditional logistic regression models were used to calculate adjusted odds ratios (AORs) and population-attributable fractions (PAF). Among 4948 enrolled women, we analysed 309 cases and 927 controls. The overall HIV incidence rate was 4.0 per 100 women-years. The incidence of HIV infection was markedly higher in women who had prevalent Herpes simplex virus type 2 (HSV-2) (AOR: 2.14; 95% confidence interval [CI]: 1.55-2.96), incident HSV-2 (AOR: 4.43; 95% CI: 1.77-11.05) and incident Neisseria gonorrhoeae (AOR: 6.92; 95% CI: 3.01-15.90). The adjusted PAF of HIV incidence for prevalent HSV-2 was 29.0% (95% CI: 16.8-39.3), for incident HSV-2 2.1% (95% CI: 0.6-3.6) and for incident N. gonorrhoeae 4.1% (95% CI: 2.5-5.8). Women's greatest risk factors for HIV acquisition were incident bacterial and viral STIs. Women-centred interventions aimed at decreasing HIV incidence in young African women need to address these common co-morbid conditions.

Immigration and sexual partner risk among Latino adolescents in San Francisco.

Sexual partner characteristics increase risk for adverse reproductive health outcomes. Evidence is limited regarding whether choice of sexual partners among Latino adolescents changes with U.S. acculturation/adaptation. We used generalized estimating equations to assess the associations between immigrant generation (recent immigrant, 1.5 [immigrated prior to adolescence], 2nd and 3rd) and sexual partner risk in a prospective cohort study of 411 Latino adolescents aged 14-19. We examined three measures of partner risk and mediating effects of family influence (familism and parental monitoring). The odds of reporting a partner with frequent substance use increased with increasing immigrant generation (odds ratios (OR) [reference = recent immigrants]: 2.3, 3.4, and 5.6) as did having a partner who was in a gang/incarcerated (OR [reference = recent immigrants]: 2.4, 3.6, and 5.7). Though the odds of having high-risk partners decreased with higher parental monitoring, neither family influence measure mediated these relationships. Findings underscore the need for a prevention focus on partner choice with attention to increased risk with increasing U.S. generation.

Sexual network position and risk of sexually transmitted infections.

OBJECTIVES: A population-based sexual network study was used to identify sexual network structures associated with sexually transmitted infection (STI) risk, and to evaluate the degree to which the use of network-level data furthers the understanding of STI risk. METHODS: Participants (n = 655) were from the baseline and 12-month follow-up waves of a 2001-2 population-based longitudinal study of sexual networks among urban African-American adolescents. Sexual network position was characterised as the interaction between degree (number of partners) and two-reach centrality (number of partners' partners), resulting in the following five positions: confirmed dyad, unconfirmed dyad, periphery of non-dyadic component, centre of star-like component and interior of non-star component. STI risk was measured as laboratory-confirmed infection with gonorrhoea and/or chlamydia. RESULTS: Results of logistic regression models with generalised estimating equations showed that being in the centre of a sexual network component increased the odds of infection at least sixfold compared with being in a confirmed dyad. Individuals on the periphery of non-dyadic components were nearly five times more likely to be infected than individuals in confirmed dyads, despite having only one partner. Measuring network position using only individual-based information led to twofold underestimates of the associations between STI risk and network position. CONCLUSIONS: These results demonstrate the importance of measuring sexual network structure using network data to fully capture the probability of exposure to an infected partner.

Gang exposure and pregnancy incidence among female adolescents in San Francisco: evidence for the need to integrate reproductive health with violence prevention efforts.

Among a cohort of 237 sexually active females aged 14-19 years recruited from community venues in a predominantly Latino neighborhood in San Francisco, California, the authors examined the relation between gang exposure and pregnancy incidence over 2 years of follow-up between 2001 and 2004. Using discrete-time survival analysis, they investigated whether gang membership by individuals and partners was associated with pregnancy incidence and determined whether partnership characteristics, contraceptive behaviors, and pregnancy intentions mediated the relation between gang membership and pregnancy. Pregnancy incidence was determined by urine-based testing and self-report. Latinas represented 77% of participants, with one in five born outside the United States. One quarter (27.4%) became pregnant over follow-up. Participants' gang membership had no significant effect on pregnancy incidence (hazard ratio = 1.25, 95% confidence interval: 0.54, 3.45); however, having partners who were in gangs was associated with pregnancy (hazard ratio = 1.90, 95% confidence interval: 1.09, 3.32). The male partner's perceived pregnancy intentions and having a partner in detention each mediated the effect of partner's gang membership on pregnancy risk. Increased pregnancy incidence among young women with gang-involved partners highlights the importance of integrating reproductive health prevention into programs for gang-involved youth. In addition, high pregnancy rates indicate a heightened risk for sexually transmitted infections.

Maternal versus paternal orphans and HIV/STI risk among adolescent girls in Zimbabwe.

The AIDS epidemic has contributed to a drastic increase in the number of orphans in Zimbabwe. Orphans (whether orphaned by AIDS or other causes) have been shown to have economic and educational disadvantages as well as poor reproductive health outcomes. We recruited a convenience sample of 200 girls in a peri-urban area of Zimbabwe to examine the impact of orphan status (compared to non-orphans) on household composition, education, risk behaviour, pregnancy and prevalent HIV and HSV-2 infection. In our population, maternal orphans were more likely to be in households headed by themselves or a sibling, to be sexually active, to have had an STI, to have been pregnant and to be infected with HIV. Paternal orphans were more likely to have ever been homeless and to be out of school. Our findings suggest that maternal care and support is important for HIV prevention. This finding corroborates previous research in Zimbabwe and has implications for intervention strategies among orphan girls.

A common pathway toward women's health.

This paper calls for an alternate approach to studying the aetiology of women's health conditions. Instead of the long-established disease-specific, compartmentalized approach, it recommends focusing on risk exposures that allows for the identification of multiple disease conditions that stem from the same risk factors. Identifying common risk factors and the related pathways to adverse health outcomes can lead to the development of interventions that would favourably affect more than one disease condition. The utility of such an approach is illustrated by a review of literature from across the globe on the association between gender inequity-related exposures and women's health (namely, three health conditions: sexually transmitted infections [STIs], including Human Immunodeficiency Virus [HIV], blindness, and depression; as well as two risk behaviours: eating disorders and tobacco use). The review demonstrates how women's health cannot be viewed independently from the larger social, economic, and political context in which women are situated. Promoting women's health necessitates more comprehensive approaches, such as gender-sensitization of other family members, and the development of more creative and flexible mechanisms of healthcare delivery, that acknowledge the gender inequity-related constraints that women face in their daily lives.

Effectiveness of female controlled barrier methods in preventing sexually transmitted infections and HIV: current evidence and future research directions.

OBJECTIVES: To evaluate evidence for the effectiveness of female controlled physical and chemical barrier methods in preventing STI/HIV transmission, to examine recent reviews on microbicide development, and to highlight promising research directions. To discuss challenges in conducting effectiveness research and in translating results to public health intervention. METHODS: Systematic review of articles that examined the disease prevention effectiveness of at least one female controlled barrier method. Review of conference abstracts that presented clinical and preclinical microbicide data. RESULTS: Randomised controlled trials provide evidence that female condoms confer as much protection from STIs as male condoms. Observational studies suggest that the diaphragm protects against STI pathogens. Several microbicide effectiveness studies are under way and new directions, such as adaptation of therapeutic agents as preventive products, are being examined. Substantial attention is now given to product formulation and novel delivery strategies. Combining microbicide products with different mechanisms of action as well as combining chemical and physical barriers will be necessary to maximise prevention effectiveness. CONCLUSIONS: Increased investment in the development and identification of female controlled barrier methods offers promise that additional products will be available in the years ahead. Generalizing trial results to a community setting, promoting products that may be less effective than male condoms, and bringing an effective product to scale introduce public health challenges that warrant attention. The need for female controlled barrier methods that provide women with the opportunity to take an active role in reducing their STI/HIV risk are urgently needed and constitute an essential tool to prevent continued spread of these infections.

Association of cervical SIL and HIV-1 infection among Zimbabwean women in an HIV/STI prevention study.

A cross-sectional study was conducted on women attending family planning clinics in Harare, Zimbabwe to determine the prevalence of cervical neoplasia among HIV-1 positive women relative to an HIV-1 negative control group. Five hundred and fifty four women were recruited and the prevalence of HIV-1 was 36.8%. Cervical cytology was abnormal in 25.6% of HIV-infected women compared to only 6.7% HIV-1 seronegative women. Cervical neoplasia was significantly associated with HIV infection (chi(2)=42.4, P<0.001). Cellular changes typical of HPV infection (koilocytocis) were recorded in 6.4% of HIV infected women compared with 1.7% of HIV-1-uninfected women (chi(2)=8.43, P=0.004). HIV-1-positive women had twice the risk of having abnormal cervical cells than HIV-negative women (relative risk 2.47, odds ratio 10.14, P<0.001). Therefore the introduction of national cervical screening programme in HIV-1 endemic countries like Zimbabwe where the highest burden of pre-malignant lesions is among HIV-1-infected women needs careful planning because these women have other competing health needs including high rates of opportunistic infections.

The profile and context of the epidemics of sexually transmitted infections including HIV in Zimbabwe.

Zimbabwe has widespread and widely disseminated epidemics of most major sexually transmitted infections (STI) including HIV. This epidemiological situation is examined from a broad historical perspective, exploring the interactions between the population incidence of STI and the social profile of the country. The results suggest opportunities for upstream prevention efforts. Examples of these include: integration of prevention with care and social support; increasing general communication and openness about sexuality; economic support initiatives including income generating and micro-credit programmes, offering living accommodations for families in cities, mines, and military camps; and programmes focusing on adolescents before they become sexually active.

Sociodemographic, behavioral, and clinical correlates of inconsistent condom use in HIV-serodiscordant heterosexual couples.

We examined sociodemographic, behavioral, and clinical characteristics associated with inconsistent condom use in a cross-sectional analysis of 145 sexually active HIV-serodiscordant heterosexual couples who participated in the California Partners Study II. All couples were aware of their HIV-serodiscordant status. Forty-five percent of couples reported having had unprotected vaginal or anal sex in the previous 6 months. In the multivariate couple-level analyses, factors independently associated with inconsistent (i.e., <100%) condom use in the previous 6 months included lower educational level, unemployment, African-American ethnicity, and practice of anal sex by the couple. Injection drug use was associated with inconsistent condom use among couples with younger HIV-infected partners. In addition, couples with HIV-infected partners who had higher CD4 cell counts and couples in which the HIV-infected male partner ever had sex with a man were more likely to use condoms inconsistently. Consistency of condom use did not depend on the gender of the HIV-infected partner or duration of sexual relationship. The findings suggest that many HIV-serodiscordant heterosexual couples remain at high risk of HIV transmission and may benefit not only from behavioral interventions but also from structural interventions aimed at improving their social and economic conditions.

Reliability of adolescents' self-reported sexual behavior: a comparison of two diary methodologies.

PURPOSE: To evaluate techniques for measuring high-risk sexual behaviors by comparing the reliability and acceptability of two daily sexual behavior diary modes: a written calendar and an automated telephone interview. METHODS: This randomized controlled study included 105 sexually active female adolescents aged 15-19 years recruited from among teens seeking reproductive health care services at a family planning clinic in the San Francisco Bay Area. Participants completed a standardized sexual behavior questionnaire each day for 4 weeks. Contraceptive use by method type was recorded. Reporting differences between the two diary modes were assessed using generalized estimating equations, concordance of diary and retrospective interview responses was evaluated using kappa statistics, and contingency table analysis and Poisson regression models were constructed to examine mode acceptability. RESULTS: Respondents randomized to the telephone diary cohort reported less frequent use of barrier contraceptive methods, specifically less spermicide use (odds ratio 0.27, 95% confidence interval 0.08, 0.95), and decreasing male condom use over time, whereas reports of male condom use increased for written diary respondents (p = .007). Participant characteristics associated with diary acceptability, defined as the frequency of diary completion, were assessed and teens classified as higher risk provided fewer diary reports (p < .01). Regardless of mode completed, 65% of respondents believed the telephone diary would be preferable to the written diary for most teens. CONCLUSIONS: The automated telephone diary offered an acceptable, even preferred, methodologic alternative to the written diary calendar and elicited more accurate reporting of selected contraceptive behavior.

Choice of female-controlled barrier methods among young women and their male sexual partners.

CONTEXT: Little is known about the factors associated with the choice of female-controlled, over-the-counter barrier contraceptive methods among women and their male sexual partners. METHODS: Predictors of method choice were assessed following an educational presentation on contraceptive use and risk reduction among 510 sexually active females aged 15-30 who were recruited in the San Francisco Bay Area. In addition, the primary partners of 160 of these women participated in the survey RESULTS: Twenty-two percent of women who enrolled in the study alone, 25% of those who enrolled with their main partner and 18% of these male partners chose female-controlled, over-the-counter barrier methods alone. The strongest predictor of this choice was current use of a hormonal contraceptive both for women who participated in the study on their own (odds ratio, 2.1) and for those who enrolled their partner in the study (odds ratio, 6.3). Female-controlled methods were also chosen significantly more often by teenagers than by older women; for example, among those who enrolled with a male partner, the odds ratio for selection of a female-controlled barrier method by women younger than 18 was 6.0. Among women who enrolled without a partner, those who had had multiple partners in the previous six months and those who were current users of male condoms were less likely to choose female-controlled methods (odds ratios, 0.7 and 0.5, respectively). CONCLUSIONS: Although the majority of participants did not choose female-controlled, over-the-counter barrier methods without also choosing male condoms, such female-controlled methods appear to offer an acceptable alternative for prevention of sexually transmitted infections. They may be a particularly attractive option for individuals using hormonal contraceptives and for teenage women.

Phase 1 trial of the topical microbicide BufferGel: safety results from four international sites.

AIM: To evaluate the safety of BufferGel (ReProtect LLC, Baltimore, MD), a spermicidal microbicide that acidifies semen and maintains the protective acidity of the vagina, in a high-dose tolerance trial. METHODS: HIV/STD negative, sexually abstinent, and sexually active women in India, Thailand, Malawi, and Zimbabwe were asked to insert one applicator ( approximately 5 ml) of BufferGel vaginally twice per day for 14 days. Sexually active women agreed to have sex (while using BufferGel and nonlubricated condoms) at least twice per week. RESULTS: In total, 98 women (30 sexually abstinent and 68 sexually active) were enrolled. Overall compliance with product use was 93%. Epithelial abnormalities detected by pelvic examination or colposcopy were uncommon (8 cases in 271 examinations). Irritation was reported by approximately one quarter of the women (0.58 events per woman-week) but was generally mild and of short duration. The prevalence of bacterial vaginosis (BV) fell significantly, from 30% at enrollment to 6% at one week, and 7% at two weeks of BufferGel use. Thirty-two women acquired microscopically detectable yeast during BufferGel exposure, but only 3 developed symptomatic vaginitis. CONCLUSION: BufferGel appears to be safe and well tolerated by the cervicovaginal epithelium. Its effect on BV and yeasts merits further study.

HIV-specific IgG in cervicovaginal secretions of exposed HIV-uninfected female sexual partners of HIV-infected men.

The presence of human immunodeficiency virus (HIV)-specific antibodies was examined in plasma and cervicovaginal (mucosal) samples of 24 HIV-exposed uninfected (EU) female sexual partners of HIV-infected men, and compared with findings in 18 HIV-infected and 15 low-risk HIV-uninfected women. Only HIV-infected women had detectable HIV-specific immunoglobulin G (IgG) (18 of 18) or HIV-IgA (6 of 18) in cervicovaginal samples by enzyme immunoassay (EIA). However, 3 of 24 EU women had positive Western blot (WB) for HIV-IgG in cervicovaginal secretions, while 2 of 24 EU women and 1 of 15 low-risk controls had indeterminate IgG-WB. EU women with positive or indeterminate IgG-WB in the cervicovaginal samples were similar in risk to the remaining EU women. None of the HIV-uninfected women had mucosal HIV-IgA. The findings suggest that some sexually or parenterally exposed HIV-uninfected women might develop low-level mucosal IgG responses. However, it appears unlikely that HIV-specific cervicovaginal antibodies play a major role in protection from HIV infection in this EU population.