Antiretroviral Drugs Protect Against HIV-1 Infection in Heterosexuals

BackgroundAntiretroviral preexposure prophylaxis is a promising approach for preventing human immunodeficiency virus type 1 (HIV-1) infection in heterosexual populations.MethodsWe conducted a randomized trial of oral antiretroviral therapy for use as preexposure prophylaxis among HIV-1-serodiscordant heterosexual couples from Kenya and Uganda. The HIV-1-seronegative partner in each couple was randomly assigned to one of three study regimens--once-daily tenofovir (TDF), combination tenofovir-emtricitabine (TDF-FTC), or matching placebo--and followed monthly for up to 36 months. At enrollment, the HIV-1-seropositive partners were not eligible for antiretroviral therapy, according to national guidelines. All couples received standard HIV-1 treatment and prevention services.ResultsWe enrolled 4758 couples, of whom 4747 were followed: 1584 randomly assigned to TDF, 1579 to TDF-FTC, and 1584 to placebo. For 62% of the couples followed, the HIV-1-seronegative partner was male. Among HIV-1-seropositive participants, the median CD4 count was 495 cells per cubic millimeter (interquartile range, 375 to 662). A total of 82 HIV-1 infections occurred in seronegative participants during the study, 17 in the TDF group (incidence, 0.65 per 100 person-years), 13 in the TDF-FTC group (incidence, 0.50 per 100 person-years), and 52 in the placebo group (incidence, 1.99 per 100 person-years), indicating a relative reduction of 67% in the incidence of HIV-1 with TDF (95% confidence interval [CI], 44 to 81; P<0.001) and of 75% with TDF-FTC (95% CI, 55 to 87; P<0.001). Protective effects of TDF-FTC and TDF alone against HIV-1 were not significantly different (P=0.23), and both study medications significantly reduced the HIV-1 incidence among both men and women. The rate of serious adverse events was similar across the study groups. Eight participants receiving active treatment were found to have been infected with HIV-1 at baseline, and among these eight, antiretroviral resistance developed in two during the study.ConclusionsOral TDF and TDF-FTC both protect against HIV-1 infection in heterosexual men and women. (Funded by the Bill and Melinda Gates Foundation; Partners PrEP ClinicalTrials.gov number, NCT00557245.)

The perceptions of preceptors regarding assessment of clinical associate students at Walter Sisulu University

Thesis (MPhil)--Stellenbosch University, 2019.ENGLISH SUMMARY : Introduction: Preceptors are vital stakeholders in the training of clinical associate students at district hospital training sites in the Walter Sisulu University Bachelor of Medical Clinical practice (BMCP) programme. They conduct teaching and learning, and assessment activities. Whereas preceptors have facilitated learning and assessment for clinical associate students for ten years, their perceptions of the assessment process had not been explored and factored into clinical associate training. Aim: The aim of this study was to explore the perceptions of preceptors regarding assessing clinical associate students at district hospital training sites. Methods: This was a qualitative study using a phenomenological approach. Nine preceptors were purposively selected and interviewed from three district hospitals. The interviews were audio recorded, transcribed, and thematic analysis was conducted. Results: Four themes emerged from data analysis with several subthemes and categories. The themes were: assessment issues, student issues, preceptor issues and university issues. The subthemes under assessment issues were conduct of assessment, tools of assessment, validity of assessment and ease of assessment. The theme of student issues had the subthemes of poorly performing students, student demands, and conflicts with students. The theme of preceptor issues included the subthemes of preceptor skills for assessment, affect related to assessment, and preceptor motivation. The theme of university issues had one subtheme which was university support for assessment. Discussion: Preceptors were found to be actively engaged with students at the district hospitals, are highly motivated, and obtained satisfaction from the assessment that they do. There was no training of the preceptors in preparation for their role. They therefore employed various individual techniques to train and assess students which resulted in a heterogeneous picture across the sampled sites. The lack of training coupled with reluctance to fail poor performing students and the possibility of subjectivity bring the reliability of assessment by preceptors into question. Conclusion: The district hospital training sites are seen to be appropriate for training and assessing clinical associates. There is a need for training and continued support of preceptors so as to assure reliability and uniformity of the assessment process.AFRIKAANSE OPSOMMING : Inleiding: Preseptore is belangrike belanghebbendes in die opleiding van klinies geassosieerde studente by die distrik opleidingskampusse in die Baccalaureas Kliniese praktiese program by die Universiteit Walter Sisilu. Hulle doen leer en onderrig, sowel as assesseringsaktiwiteite. Die preseptore het die leer en assessering fasiliteer vir die klinies geassosieerde studente al vir die afgelope 10 jaar gefasiliteer, maar hulle ondervinding en persepsies van die assesseringsproses is nog nie ondersoek nie. Doel: Die doel van hierdie studie was om die persepsies en ondervinding van die preseptore rakende die assessering van die klinies geassosieerde studente by distrik hospitaal opleidingskampusse te ondersoek. Metodes: Dit was ‘n kwalitatiewe studie met ‘n fenomenologiese benadering. Nege preseptore van drie distrikhospitale is doelgerig gekies om mee onderhoude te voer Die onderhoude is gerekordeer en getranskribeer, waarna ‘n tematiese analise gedoen is. Resultate: Vier temas het ontstaan uit die data-analise met verskeie subtemas en kategorieë. Hierdie temas was: assesseringsprobleme, studenteprobleme, probleme met preseptore en universiteitsprobleme. Die subtemas onder assesseringsprobleme was die uitvoer van assessering, bronne van assessering, die geldigheid van assessering, sowel as die gemak van assessering. Studenteprobleme het die volgende subtemas gehad: studente wat swak vaar, eise van studente, en konflik met studente. Preseptorprobleme het subtemas ingesluit wat verband hou met die vaardighede vir assessering, die invloed rakende assessering, en motivering van preseptore. Universiteitsprobleme het slegs een subtema gehad, naamlik die ondersteuning van assessering van die universiteit. Bespreking: Dit is gevind dat preseptore aktief betrokke was by studente by distrik hospitale, dat hulle hoogs gemotiveerd is, en dat hulle tevrede is met die assessering wat hulle doen. Daar was geen opleiding van die preseptore gewees om hulle voor te berei vir die rol wat hulle moet vervul nie. Hulle het dus verskeie individuele tegnieke gebruik om studente op te lei en te assesseer; wat gevolglik gelei het tot ‘n heterogene beeld regoor die verkose kampusse. Die gebrek aan opleiding tesame met die onwilligheid om studente wat swak presteer te druip en die moontlikheid van subjektiwiteit trek die geldigheid van assessering deur preseptore in twyfel. Gevolgtrekking: Die distrik hospitaal opleiding areas word gesien as toepaslik vir die opleiding en assessering van klinies geassosieerde studente. Daar is egter ‘n behoefte vir opleiding en deurlopende ondersteuning van preseptore om sodoende die validiteit en uniformiteit van die assesseringsproses te verseker.Master

The efficacy and safety of complete pericardial drainage by means of intrapericardial fibrinolysis for the prevention of complications of pericardial effusion : a systematic review protocol

CITATION: Kakia, A., et al. 2016. The efficacy and safety of complete pericardial drainage by means of intrapericardial fibrinolysis for the prevention of complications of pericardial effusion : a systematic review protocol. BMJ Open, 6:e007842, doi:10.1136/bmjopen-2015-007842.The original publication is available at http://bmjopen.bmj.comENGLISH SUMMARY : Introduction: Intrapericardial fibrinolysis has been proposed as a means of preventing complications of pericardial effusion such as cardiac tamponade, persistent and recurrent pericardial effusion, and pericardial constriction. There is a need to understand the efficacy and safety of this procedure because it shows promise. Methods and analysis: We aim to assess the effects of intrapericardial fibrinolysis in the treatment of pericardial effusion. We will search PubMed, the Cochrane Library, African Journals online, Cumulative Index to Nursing and Allied Health Literature, Trip database, Clinical trials.gov and the WHO International Clinical Trials Registry Platform for studies that evaluate the efficacy and/or safety of complete pericardial fluid drainage by intrapericardial fibrinolysis irrespective of study design, geographical location, language, age of participants, aetiology of pericarditis or types of fibrinolytics. Two authors will do the search independently, screen the search outputs for potentially eligible studies and assess whether the studies meet the inclusion criteria. Discrepancies between the two authors will be resolved through discussion and arbitration by a third author. Data from the selected studies shall be extracted using a standardised data collection form which will be piloted before use. The methodological quality of studies will be assessed using the Cochrane Collaboration’s tools for assessing risk of bias for experimental studies and non-randomised studies, respectively. The primary meta- analysis will use random effects models due to expected interstudy heterogeneity. Dichotomous data will be analysed using relative risk and continuous with data mean differences, both with 95% CIs.http://bmjopen.bmj.com/content/6/1/e007842Publisher's versio

Antiretroviral Prophylaxis for HIV Prevention in Heterosexual Men and Women

BackgroundAntiretroviral preexposure prophylaxis is a promising approach for preventing human immunodeficiency virus type 1 (HIV-1) infection in heterosexual populations.MethodsWe conducted a randomized trial of oral antiretroviral therapy for use as preexposure prophylaxis among HIV-1-serodiscordant heterosexual couples from Kenya and Uganda. The HIV-1-seronegative partner in each couple was randomly assigned to one of three study regimens--once-daily tenofovir (TDF), combination tenofovir-emtricitabine (TDF-FTC), or matching placebo--and followed monthly for up to 36 months. At enrollment, the HIV-1-seropositive partners were not eligible for antiretroviral therapy, according to national guidelines. All couples received standard HIV-1 treatment and prevention services.ResultsWe enrolled 4758 couples, of whom 4747 were followed: 1584 randomly assigned to TDF, 1579 to TDF-FTC, and 1584 to placebo. For 62% of the couples followed, the HIV-1-seronegative partner was male. Among HIV-1-seropositive participants, the median CD4 count was 495 cells per cubic millimeter (interquartile range, 375 to 662). A total of 82 HIV-1 infections occurred in seronegative participants during the study, 17 in the TDF group (incidence, 0.65 per 100 person-years), 13 in the TDF-FTC group (incidence, 0.50 per 100 person-years), and 52 in the placebo group (incidence, 1.99 per 100 person-years), indicating a relative reduction of 67% in the incidence of HIV-1 with TDF (95% confidence interval [CI], 44 to 81; P<0.001) and of 75% with TDF-FTC (95% CI, 55 to 87; P<0.001). Protective effects of TDF-FTC and TDF alone against HIV-1 were not significantly different (P=0.23), and both study medications significantly reduced the HIV-1 incidence among both men and women. The rate of serious adverse events was similar across the study groups. Eight participants receiving active treatment were found to have been infected with HIV-1 at baseline, and among these eight, antiretroviral resistance developed in two during the study.ConclusionsOral TDF and TDF-FTC both protect against HIV-1 infection in heterosexual men and women. (Funded by the Bill and Melinda Gates Foundation; Partners PrEP ClinicalTrials.gov number, NCT00557245.)