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1.
Van Damme L Chandeying V Ramjee G Rees H Sirivongrangson P Laga M Perriëns J 《AIDS (London, England)》2000,14(1):85-88
RATIONALE: COL-1492 is a nonoxynol-9 (N-9)-containing vaginal gel and may be a potential microbicide. As part of an effectiveness trial, an initial toxicity study was conducted. OBJECTIVES: The main objective of the reported study was the assessment of the toxicity of a 52.5 mg N-9 gel, COL-1492, when used a number of times each day by female sex workers. METHODS: This was a randomized, placebo-controlled triple-blinded trial among female sex workers. The participants were asked to use the product for each vaginal sexual act. At each monthly visit a gynaecological examination with sexually transmitted disease sampling and colposcopy was performed. Venous blood was drawn for syphilis and HIV serology. All women received intensive counselling on condom use. Male condoms and sexually transmitted disease treatment were given free of charge. RESULTS: Only blinded results on the colposcopic examinations are reported. The incidence of lesions with or without an epithelial disruption was low: 0.06 and 0.29, respectively, per 100 woman-days in group A; 0.09 and 0.26 respectively per 100 woman-days in group B. There was no significant difference between the two arms. CONCLUSION: The multiple daily use of COL-1492 by female sex workers did not show an increase of local toxicity over that of a placebo. Colposcopy was discontinued in the autumn of 1997 in accordance with a Data Safety Monitoring Board decision. In the currently ongoing effectiveness trial the assessment of the product's toxicity continues to be monitored by simple visual examination. 相似文献
2.
There is a need to better understand the effectiveness of HIV-prevention programs. Cluster randomized designs have major limitations to evaluate such complex large-scale combination programs. To close the prevention evaluation gap, alternative evaluation designs are needed, but also better articulation of the program impact pathways and proper documentation of program implementation. Building a plausible case using mixed methods and modeling can provide a valid alternative to probability evidence. HIV prevention policies should not be limited to evidences from randomized designs only. 相似文献
3.
Alvaro C. Laga Jessica W. Crothers Connie F. Caete-Gibas Nathan P. Wiederhold Isaac H. Solomon 《Emerging infectious diseases》2022,28(4):856
We report 2 cases of Rigidoporus corticola (Oxyporus corticola) infection in humans in the United States. Clinical manifestations consisted of angioinvasive fungal sinusitis in 1 patient and pulmonary intracavitary fungus ball in the other patient. These cases illustrate previously undescribed clinicopathologic manifestations of infection by this filamentous basidiomycete in humans. 相似文献
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Effect of interventions to control sexually transmitted disease on the incidence of HIV infection in female sex workers 总被引:6,自引:0,他引:6
Ghys PD Diallo MO Ettiègne-Traoré V Satten GA Anoma CK Maurice C Kadjo JC Coulibaly IM Wiktor SZ Greenberg AE Laga M 《AIDS (London, England)》2001,15(11):1421-1431
OBJECTIVE: To compare the seroincidence of HIV infection among female sex workers in Abidjan, C?te d'Ivoire before and during an intervention study to control sexually transmitted diseases (STD) and to study the effect of two STD diagnosis and treatment strategies on the prevalence of STD and on the seroincidence of HIV infection. METHOD: A screening facility for STD and HIV had been available since October 1992 for female sex workers. From June 1994, women who were HIV seronegative or HIV-2 positive during the screening could enroll in the intervention study in which participants reported once a month to a confidential clinic where they received health education, condoms and STD treatment if indicated. Women in the study were randomized either to a basic STD diagnosis and treatment strategy, which included a gynecologic examination when symptomatic, or to an intensive strategy that included a gynecologic examination regardless of symptoms. An outcome assessment every 6 months included a gynecologic examination, HIV serology and laboratory tests for STD. RESULTS: Of 542 women enrolled in the study, 225 (42%) had at least one outcome assessment. The HIV-1 seroincidence rate during the intervention study was significantly lower than before the study (6.5 versus 16.3 per 100 person-years; P = 0.02). During the study, the HIV-1 seroincidence rate was slightly lower in the intensive than in the basic strategy (5.3 versus 7.6 per 100 person-years; P = 0.5). CONCLUSION: National AIDS control programs should consider adopting as policy the type of integrated approach used in this intervention study for HIV prevention in female sex workers. 相似文献
6.
R Rustomjee Q Abdool Karim S S Abdool Karim M Laga Z Stein 《AIDS (London, England)》1999,13(12):1511-1515
OBJECTIVES: To assess the acceptability and safety of a vaginal nonoxynol-9 film in a group of sex workers at a truck stop in South Africa. DESIGN: A randomized double-blinded crossover trial was conducted between April 1995 and July 1995. INTERVENTION: Seventy-two mg nonoxynol-9 film and an identical glycerine placebo film. METHODS: Following informed consent, each study participant was randomly assigned the designated pre-coded film for 1 month. The second month was a film-free washout period and the participants used the alternate film in the third month. Besides measuring behavioural and clinical outcomes, colposcopy examination for genital lesions, serology and microbiology investigations for sexually transmitted diseases and semi-quantitative PCR for vaginal HIV load estimates were performed. RESULTS: Twenty women participated in the study. The women reported, on average, 19 sexual encounters per week. Vaginal intercourse was protected 25% of the time by condoms. On average, 11 vaginal films, either nonoxynol-9 or placebos were inserted per week. There were no statistically significant differences between the two treatment groups for genital lesions (P = 0.29), reported side effects (P = 0.73), and viral load (P = 0.9). However, the proportions of clinically detected genital lesions (six out of eight versus two out of eight) and self-reported side-effects (five out of eight versus three out of eight) were higher in the nonoxynol-9 group when compared with the placebo group. Incident sexually transmitted diseases occurred more frequently in the placebo group. An increased viral load was associated with the development of a genital lesion (relative risk, 6.0; 95% confidence interval, 0.81-44.4). CONCLUSIONS: The 72 mg film formulation of nonoxynol-9 was an acceptable product for use in this population of sex workers. Although no statistically significant differences in adverse outcomes were detected, clinically there appeared to be an increase in minor lesions and self-reported side-effects with nonoxynol-9 and less protection against sexually transmitted diseases with the placebo. Furthermore, HIV shedding was correlated with the presence of incident vaginal or cervical lesions. This brings into question the potential narrow margin of safety for this product; additional Phase 2 studies are therefore required. 相似文献
7.
Vita W Jongen Thijs Reyniers Zorah MH Ypma Maarten F Schim van der Loeff Udi Davidovich Hanne ML Zimmermann Liza Coyer Mark AM van den Elshout Henry JC de Vries Kristien Wouters Tom Smekens Bea Vuylsteke Maria Prins Marie Laga Elske Hoornenborg 《Journal of the International AIDS Society》2021,24(8)
IntroductionDaily and event‐driven PrEP are both efficacious in reducing the risk for HIV infection. However, the practice of event‐driven PrEP (edPrEP) is less well studied, in particular when provided as an alternative to daily PrEP. We studied regimen preferences and switches, and sexually transmitted infection (STI) incidence.MethodsWe analysed pooled data from two prospective cohort studies among MSM: Be‐PrEP‐ared, Belgium and AMPrEP, the Netherlands. In both projects, participants could choose between daily and edPrEP at three‐monthly study visits, when they were also screened for sexually transmitted infections including hepatitis C (HCV). We assessed the proportion choosing each regimen, and the determinants of choosing edPrEP at baseline. Additionally, we compared the incidence rates (IRs) of HCV, syphilis and chlamydia or gonorrhoea between regimens using Poisson regression. The study period was from 3 August 2015 until 24 September 2018.Results and discussionWe included 571 MSM, of whom 148 (25.9%) chose edPrEP at baseline. 31.7% of participants switched regimen at least once. After 28 months, 23.5% used edPrEP. Older participants (adjusted odds ratio (aOR) = 1.38 per 10 years, 95% confidence interval (CI) = 1.15 to 1.64) and those unemployed (aOR = 1.68, 95% CI = 1.03 to 1.75) were more likely to initially choose edPrEP. IR of HCV and syphilis did not differ between regimens, but the IR of chlamydia/gonorrhoea was higher among daily users (adjusted incidence rate ratio = 1.61, 95% CI = 1.35 to 1.94).ConclusionsA quarter of participants chose edPrEP at baseline and at 28 months this proportion was similar. Although the IR of HCV and syphilis were similar in the two regimens, the lower incidence of chlamydia and gonorrhoea among edPrEP users may suggest that less frequent STI testing of this group could be considered. 相似文献
8.
9.
Chlamydia trachomatis prevalence and sexual behaviour among female adolescents in Belgium 总被引:6,自引:2,他引:4
B. Vuylsteke M. Vandenbruaene P. Vandenbalcke E. Van Dyck M. Laga 《Sexually transmitted infections》1999,75(3):152-155
OBJECTIVES: To determine prevalence and risk factors of Chlamydia trachomatis among female secondary school students and to develop potential selective screening strategies. METHODS: A cross sectional survey was conducted in the 17 school medical centres in Antwerp municipality, Belgium. All female students of forms 5 or 6, who were due for their medical check up during the school year 1996-7, were invited to participate. A self administered questionnaire on general and sexual behaviour, and a first void urine sample were collected. The urine specimen was tested for C trachomatis with ligase chain reaction assay, and positive tests were confirmed with polymerase chain reaction assays. RESULTS: 2784 female students participated in the study. Their median age was 17, and 52% of them reported having sexual intercourse at least once. The prevalence of C trachomatis among sexually active women was 1.4%. Factors significantly associated with infection in multivariate analysis were number of lifetime partners, genital complaints of partner, type of secondary school, and a history of pregnancy. Selective screening of those women who are at highest risk for infection would have detected 90% of all infections, and require testing of 14% to 18% of the population. CONCLUSIONS: The prevalence of C trachomatis was relatively low among female secondary school students in Antwerp, but unsafe sex practices were evident because of the high number of unplanned pregnancies. Selective screening strategies with a high sensitivity can be proposed, but should be assessed for acceptability, feasibility, and cost. 相似文献
10.
J. Bogaerts B. Vuylsteke W. Martinez Tello V. Mukantabana J. Akingeneye M. Laga P. Piot 《Bulletin of the World Health Organization》1995,73(6):761-767
A cross-sectional study was conducted among 395 patients presenting with genital ulcers at a primary health care centre in Kigali, Rwanda. Using clinical data and the results of a rapid plasma reagin (RPR) test, we simulated the diagnostic outcome of two simple WHO flowcharts for the management of genital ulcers. These outcomes and a clinical diagnosis were then compared with the laboratory diagnosis based on culture for genital herpes and Haemophilus ducreyi and serology for syphilis. The prevalence of HIV infection was high (73%) but there was no difference between HIV-positive and HIV-negative patients in the clinical presentation and etiology of genital ulcer disease. The proportion of correctly managed chancroid and/or syphilis cases was 99% using a syndromic approach, 82.1% using a hierarchical algorithm including an RPR test, and 38.3% with a clinical diagnosis. In situations where no laboratory support is available, a simple syndromic approach is preferable to the clinical approach for the management of genital ulcer. If an RPR test can be included in the diagnostic strategy, patients with a reactive RPR test should be treated for both syphilis and chancroid infection. 相似文献