Ninety-day oral toxicity studies on two genetically modified maize MON810 varieties in Wistar Han RCC rats (EU 7th Framework Programme project GRACE)

The GMO Risk Assessment and Communication of Evidence (GRACE; www.grace-fp7.eu) project is funded by the European Commission within the 7th Framework Programme. A key objective of GRACE is to conduct 90-day animal feeding trials, animal studies with an extended time frame as well as analytical, in vitro and in silico studies on genetically modified (GM) maize in order to comparatively evaluate their use in GM plant risk assessment. In the present study, the results of two 90-day feeding trials with two different GM maize MON810 varieties, their near-isogenic non-GM varieties and four additional conventional maize varieties are presented. The feeding trials were performed by taking into account the guidance for such studies published by the EFSA Scientific Committee in 2011 and the OECD Test Guideline 408. The results obtained show that the MON810 maize at a level of up to 33 % in the diet did not induce adverse effects in male and female Wistar Han RCC rats after subchronic exposure, independently of the two different genetic backgrounds of the event

Implementation and Operational Research: Cohort Analysis of Program Data to Estimate HIV Incidence and Uptake of HIV-Related Services Among Female Sex Workers in Zimbabwe, 2009-2014.

BACKGROUND: HIV epidemiology and intervention uptake among female sex workers (FSW) in sub-Saharan Africa remain poorly understood. Data from outreach programs are a neglected resource. METHODS: Analysis of data from FSW consultations with Zimbabwe's National Sex Work program, 2009-2014. At each visit, data were collected on sociodemographic characteristics, HIV testing history, HIV tests conducted by the program and antiretroviral (ARV) history. Characteristics at first visit and longitudinal data on program engagement, repeat HIV testing, and HIV seroconversion were analyzed using a cohort approach. RESULTS: Data were available for 13,360 women, 31,389 visits, 14,579 reported HIV tests, 2750 tests undertaken by the program, and 2387 reported ARV treatment initiations. At first visit, 72% of FSW had tested for HIV; 50% of these reported being HIV positive. Among HIV-positive women, 41% reported being on ARV. 56% of FSW attended the program only once. FSW who had not previously had an HIV-positive test had been tested within the last 6 months 27% of the time during follow-up. After testing HIV positive, women started on ARV at a rate of 23/100 person years of follow-up. Among those with 2 or more HIV tests, the HIV seroconversion rate was 9.8/100 person years of follow-up (95% confidence interval: 7.1 to 15.9). CONCLUSIONS: Individual-level outreach program data can be used to estimate HIV incidence and intervention uptake among FSW in Zimbabwe. Current data suggest very high HIV prevalence and incidence among this group and help identify areas for program improvement. Further methodological validation is required

Changes Over Time in HIV Prevalence and Sexual Behaviour Among Young Female Sex-Workers in 14 Sites in Zimbabwe, 2013-2016.

Young female sex-workers (FSW) aged 18-24 are at high risk of HIV due to high numbers of sexual partners, difficulty negotiating condom use, increased risk of gender-based violence, and limited access to services. Here we describe changes in sexual behaviours among young FSW across Zimbabwe between 2013 and 2016, and risk factors for prevalent HIV in 2013 and 2016. FSW ≥ 18 years were recruited using respondent-driven sampling in 14 sites across Zimbabwe in 2013 and 2016 as part of the SAPPH-IRe trial. We collected data on socio-demographics and sexual behaviour and offered HIV testing. Statistical analyses were RDS-II weighted. Characteristics of young FSW aged 18-24 were described, stratified by age. Logistic regression was used to assess difference in sexual behaviours by reported HIV status between 2013 and 2016, and to explore associations with prevalent HIV in 2013 and 2016. 656 young FSW were recruited in 2013 and 503 in 2016. Characteristics of young FSW were similar across both surveys. HIV prevalence was similar at both time points (35% vs 36%) and rose steeply with age. Compared to young FSW in 2013, reported condom-less sex with a steady partner and condom-less sex with clients was higher in 2016 among women self-reporting HIV negative status (OR = 6.41; 95%CI: 3.40-12.09; P<0.001) and (OR = 1.69; 95%CI: 1.14-2.51, P = 0.008), respectively, but not among young FSW self-reporting HIV positive status (OR = 2.35; 95%CI: 0.57-9.76; P = 0.236) and (OR = 1.87; 95%CI: 0.74-4.74; P = 0.186). After adjusting for age in 2016, young FSW who had ever been married had increased odds of testing HIV positive (OR = 1.88; 95% CI 1.04-3.39; P = 0.036) compared with those who had never married. Young FSW who completed secondary education or higher were less likely to test HIV positive (OR = 0.41; 95% CI 0.20-0.83; P = 0.012) compared with those with primary education or less. Young FSW remain at very high risk of HIV. Strategies to identify young FSW when they first start selling and refer them into services that address their economic, social and sexual vulnerabilities are critical

Engagement in HIV Care Among Young Female Sex Workers in Zimbabwe.

INTRODUCTION: Young female sex workers (FSWs) are at greater HIV risk than their older counterparts. Yet, the extent of their engagement with HIV services is largely unknown. We compared engagement among FSWs aged 18-24 years with those 25 years and older. METHODS: We used respondent-driven sampling to recruit FSWs from 14 communities in Zimbabwe from November to December 2013. We collected data on demographics, behavior, service uptake, and HIV and viral load testing. Data were pooled and weighted using respondent-driven sampling-2 estimation. We analyzed HIV care cascade variables by age group. To identify potential drivers of younger FSW service use, we explored factors associated with knowing one's HIV status. RESULTS: Among 2617 participants, mean age was 31 years and 26% were 18-24 years. Over half of FSWs initiated sex work before the age of 25 years. Overall HIV prevalence was 59% but was lower among younger FSWs (35% vs 67%, P < 0.01). Younger HIV-infected FSWs were significantly less engaged at each step of the care cascade. Among younger FSWs reporting antiretroviral therapy use, 62% had an undetectable viral load compared with 79% in older FSWs. In multivariable regression, young FSWs encouraged to have an HIV test by another FSW (adjusted odds ratio = 2.54; 95% confidence interval: 1.44 to 4.50), and those with no recent clients (adjusted odds ratio = 4.31; 95% confidence interval: 1.30 to 14.33) were more likely to report knowing their status. CONCLUSIONS: The high proportion of FSWs initiating sex work before the age of 25 years and their lower engagement in HIV services highlights the importance of considering this vulnerable population in HIV programming. Implementing targeted services tailored to the unique needs of young FSWs is a public health imperative

Estimating the Population Size of Female Sex Workers in Zimbabwe: Comparison of Estimates Obtained Using Different Methods in Twenty Sites and Development of a National-Level Estimate.

BACKGROUND: National-level population size estimates (PSEs) for hidden populations are required for HIV programming and modelling. Various estimation methods are available at the site-level, but it remains unclear which are optimal and how best to obtain national-level estimates. SETTING: Zimbabwe. METHODS: Using 2015-2017 data from respondent-driven sampling (RDS) surveys among female sex workers (FSW) aged 18+ years, mappings, and program records, we calculated PSEs for each of the 20 sites across Zimbabwe, using up to 3 methods per site (service and unique object multipliers, census, and capture-recapture). We compared estimates from different methods, and calculated site medians. We estimated prevalence of sex work at each site using census data available on the number of 15-49-year-old women, generated a list of all "hotspot" sites for sex work nationally, and matched sites into strata in which the prevalence of sex work from sites with PSEs was applied to those without. Directly and indirectly estimated PSEs for all hotspot sites were summed to provide a national-level PSE, incorporating an adjustment accounting for sex work outside hotspots. RESULTS: Median site PSEs ranged from 12,863 in Harare to 247 in a rural growth-point. Multiplier methods produced the highest PSEs. We identified 55 hotspots estimated to include 95% of all FSW. FSW nationally were estimated to number 40,491, 1.23% of women aged 15-49 years, (plausibility bounds 28,177-58,797, 0.86-1.79%, those under 18 considered sexually exploited minors). CONCLUSION: There are large numbers of FSW estimated in Zimbabwe. Uncertainty in population size estimation should be reflected in policy-making

Targeted combination prevention to support female sex workers in Zimbabwe accessing and adhering to antiretrovirals for treatment and prevention of HIV (SAPPH-IRe): a cluster-randomised trial.

BACKGROUND: Strengthening engagement of female sex workers with health services is needed to eliminate HIV. We assessed the efficacy of a targeted combination intervention for female sex workers in Zimbabwe. METHODS: We did a cluster-randomised trial from 2014 to 2016. Clusters were areas surrounding female sex worker clinics and were enrolled in matched pairs. Sites were randomly assigned (1:1) to receive usual care (free sexual-health services supported by peer educators, including HIV testing on demand, referral for antiretroviral therapy [ART], and health education) or an intervention that supported additional regular HIV testing, on-site initiation of ART, pre-exposure prophylaxis, adherence, and intensified community mobilisation. The primary outcome was the proportion of all female sex workers with HIV viral load 1000 copies per mL or greater, assessed through respondent-driven sampling surveys. We used an adapted cluster-summary approach to estimate risk differences. This trial is registered with Pan African Clinical Trials Registry, number PACTR201312000722390. RESULTS: We randomly assigned 14 clusters to usual care or the intervention (seven in each group). 3612 female sex workers attended clinics in the usual-care clusters and 4619 in the intervention clusters during the study. Half as many were tested (1151 vs 2606) and diagnosed as being HIV positive (546 vs 1052) in the usual-care clusters. The proportion of all female sex workers with viral loads of 1000 copies per mL or greater fell in both study groups (from 421 [30%] of 1363 to 279 [19%] of 1443 in the usual-care group and from 399 [30%] of 1303 to 240 [16%] of 1439 in the intervention group), but with a risk difference at the end of the assessment period of only -2·8% (95% CI -8·1 to 2·5, p=0·23). Among HIV-positive women, the proportions with viral loads less than 1000 copies per mL were 590 (68%) of 869 in the usual-care group and 588 (72%) of 828 in the intervention group at the end of the assessment period, adjusted risk difference of 5·3% (95% CI -4·0 to 14·6, p=0·20). There were no adverse events. INTERPRETATION: Our intervention of a dedicated programme for female sex workers led to high levels of HIV diagnosis and treatment. Further research is needed to optimise programme content and intensity for the broader population. FUNDING: UN Population Fund (through Zimbabwe's Integrated Support Fund funded by UK Department for International Development, Irish Aid, and Swedish International Development Cooperation Agency)

Underage and underserved: reaching young women who sell sex in Zimbabwe.

Young women who sell sex (YWSS) in Southern Africa are highly vulnerable to HIV, as the risks of being young and female in a high prevalence setting coalesce with those of commercial sex. YWSS are less able to negotiate safe sex, more likely to have higher risk partners, and less likely to use available health services compared to older sex workers. In Zimbabwe's national HIV programme for sex workers, fewer than 1% of clients were 15-29. We developed monthly interactive workshops for YWSS based on an Activity Pack consisting of 21 sessions organised into six modules. The aim was to encourage YWSS' interaction with each other, build their trust, confidence and skills, and encourage uptake of clinical services. We conducted a process evaluation to assess programme strengths, identify challenges, and recommend changes. This paper presents findings synthesising programme records with qualitative data and discusses feasibility, acceptability, and outputs during the pilot phase. In total, 143 YWSS attended meetings and most were from the target 15-19-year-old age group. Participants enjoyed the sessions and reported improved cooperation, willingness to negotiate with clients, and self-reflection about their futures. Staff found facilitating sessions easy and activities clear and appropriate. Challenges included identifying appropriate referrals, initial recruitment of women in some sites, and managing participants' requests for financial compensation. The number of clients aged 15-19 increased at sex worker clinics in all sites. This programme is the first to target YWSS in Zimbabwe to address their disproportionately low service use. It proved feasible to staff and acceptable to participants over a one-year period. Given enhanced vulnerability of YWSS, this programme provides one workable model for reaching this underserved group

Effectiveness of the Sista2Sista programme in improving HIV and other sexual and reproductive health outcomes among vulnerable adolescent girls and young women in Zimbabwe

Background: In Zimbabwe, adolescent girls and young women (AGYW) experience high rates of HIV and other sexual and reproductive health challenges. In 2013, the Zimbabwe Ministry of Health and Child Care partnered with the United Nations Population Fund to implement the Sista2Sista programme, a structured peer group intervention aimed at improving health outcomes among vulnerable in- and out-of-school AGYW.Methods: Programme data was analysed for 91 612 AGYW aged 10–24 years old who participated in Sista2Sista from 2013 to 2019. Logistic regression was used to determine odds ratios (OR) and evaluate programme exposure as a factor in a set of defined variables.Results: 58 471 AGYW (63.82%) graduated from the Sista2Sista programme by completing at least 30 of 40 exercises. Graduates were more likely to take an HIV test (2.78 OR 95% CI 2.52–3.10), less likely to get married (0.63 OR 95% CI 0.55–0.73) and less likely to drop out of&nbsp; school (0.60 OR 95% CI 0.53–0.69). At higher thresholds of programme completion, additional positive outcomes were observed. Participants who completed all 40 exercises were more likely to return to school (1.41 OR 95% CI 1.18–1.69), more likely to use&nbsp; contraception (1.38 OR 95% CI 1.21–1.56), more likely to report sexual abuse (1.76 OR 95% CI 1.17–2.66), and less likely to become pregnant as adolescents (0.41 OR 95% CI 0.24–0.72). Individual counselling improved the likelihood of programme graduation.Conclusions: The Sista2Sista programme had a positive effect on HIV and other sexual health outcomes among vulnerable AGYW in Zimbabwe. Strategies to improve graduation rates should be explored

Brief Report: Adolescent Girls Who Sell Sex in Zimbabwe: HIV Risk, Behaviours, and Service Engagement.

BACKGROUND: To reduce HIV incidence among adolescent girls who sell sex (AGSS) in Zimbabwe, we need to better understand how vulnerabilities intersect with HIV infection and how those living with HIV engage in care. METHODS: In 2017, we conducted social mapping in 4 locations in Zimbabwe and recruited girls aged 16-19 years who sell sex, using respondent-driven sampling or census sampling methods. Participants completed a questionnaire and provided finger prick blood samples for HIV antibody testing. RESULTS: Of 605 AGSS recruited, 74.4% considered themselves sex workers, 24.4% reported experiencing violence in the past year, 91.7% were not in school, and 83.8% had less than a complete secondary education. Prevalence of HIV increased steeply from 2.1% among those aged 16 years to 26.9% among those aged 19 years; overall, 20.2% of AGSS were HIV-positive. In the multivariate analysis, age, education, marital status, and violence from a client were associated with HIV. Among the 605 AGSS, 86.3% had ever tested for HIV, with 64.1% having tested in the past 6 months. Among AGSS living with HIV, half (50.8%) were aware of their status, among whom 83.9% reported taking antiretroviral therapy. CONCLUSION: The steep rise in HIV prevalence among those aged between 16 and 19 years suggests the window to engage with AGSS before HIV acquisition is short. To accelerate reductions in incidence among AGSS, intensified combination prevention strategies that address structural factors and tailor services to the needs of AGSS are required, particularly ensuring girls enroll and remain in school