159 research outputs found

    Microbicide trials for preventing HIV/AIDS in South Africa: Phase II trial participants' experiences and psychological needs

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    The Microbicide Division of the Department of Medical Microbiology at MEDUNSA, South Africa, recently completed a phase II expanded safety trial of the candidate microbicide Carraguard. A microbicide is a vaginal product that women might use, if proven safe and effective, to protect themselves from HIV and possibly other sexually transmitted infections (STIs). The study participants were from Ga-Rankuwa and its neighbouring areas, an historically disadvantaged residential township near Pretoria. We conducted six focus group discussions with phase II trial participants to evaluate their experiences with trial participation and their psychological needs. Participants spontaneously talked about their experiences with the study gel and speculum examinations. They felt that they had received high quality medical care. They indicated that their personal hygiene and knowledge of the female reproductive system, HIV and other STIs had improved, which helped their families and empowered them as women. Participants valued being able to discuss their anxiety about HIV/AIDS with study staff. They felt that the study provided them with a supportive environment in which their personal problems (not necessarily restricted to HIV/AIDS) could be addressed. Some recommended that the study staff improve their professionalism and punctuality. They suggested the formation of participant support groups, and expressed a preference to remain involved in the trial. Some participants appeared to have become dependent on services provided during the trial. We have taken the results of these focus group discussions into account during planning for a phase III efficacy trial of Carraguard to be conducted in the same and other similar communities. SAHARA-J (2004) 1(2): 78-86 Keywords: HIV prevention, South Africa, microbicide, ethical challenges in microbicide trials. RÉSUMÉ La Division de Microbicide du DĂ©partement de Microbiologie MĂ©dicale de l'UniversitĂ© MĂ©dicale d'Afrique Australe, MEDUNSA, Afrique du Sud, a rĂ©cemment accompli la phase II de l' Ă©preuve de sĂ»retĂ© renforcĂ©e du candidat microbicide Carraguard. Un microbicide est un produit vaginal que les femmes pourraient employer, s'il est prouvĂ© sĂ»r et efficace, pour se protĂ©ger elles-mĂȘmes contre le VIH et probablement d'autres infections sexuellement transmises (STIs). Les participantes Ă  l'Ă©tude Ă©taient de Ga-Rankuwa et de ses environs, une banlieue noire rĂ©sidentielle historiquement dĂ©savantagĂ©e prĂšs de Pretoria.Nous avons conduit des discussions en six groupes d'Ă©tude avec les participants Ă  la phase II de l'Ă©preuve pour Ă©valuer leurs expĂ©riences concernant la participation Ă  l'Ă©preuve et leurs besoins psychologiques. Les participantes ont spontanĂ©ment parlĂ© de leurs expĂ©riences relatives aux Ă©tudes du gel et aux examens du speculum. Elles ont estimĂ© qu'elles avaient reçu le soin mĂ©dical de haute qualitĂ©. Elles ont indiquĂ© que leur hygiĂšne et connaissance personnelles du systĂšme reproducteur femelle, de VIH et de tout autre STIs s'Ă©taient amĂ©liorĂ©es, qui ont aidĂ© leurs familles et les ont Ă©mancipĂ©es comme femmes. Les participantes ont estimĂ© qu'elles Ă©taient en mesure de discuter leur inquiĂ©tude au sujet de VIH/SIDA avec le personnel de l'Ă©tude. Ils ont estimĂ© que l'Ă©tude leur a fourni un environnement de soutien dans lequel leurs problĂšmes personnels (pas nĂ©cessairement limitĂ©s au VIH/SIDA) pourraient ĂȘtre adressĂ©s. Certaines ont recommandĂ© que le personnel d'Ă©tude amĂ©liore son professionnalisme et ponctualitĂ©. Elles ont suggĂ©rĂ© la formation des groupes de soutien de participantes, et ont exprimĂ© leur prĂ©fĂ©rence de rester impliquĂ©es dans l'Ă©preuve. Quelques participantes ont semblĂ© ĂȘtre devenues dĂ©pendantes des services fournis pendant l'Ă©preuve. Nous avons tenu compte des rĂ©sultats de ces discussions de groupe d'Ă©tude pour la planification de la phase III de l'Ă©preuve d'efficacitĂ© du Carraguard qui devra ĂȘtre conduite dans la mĂȘme communautĂ© et d'autres communautĂ©s semblables. SAHARA-J (2004) 1(2): 78-86 Mots clĂ©s: PrĂ©vention de VIH, Afrique du Sud, microbicide, dĂ©fis Ă©thiques dans des Ă©preuves de microbicid

    Cost-Effectiveness of Pre-Exposure Prophylaxis (Prep) in Preventing HIV-1 Infections in Rural Zambia: A Modeling Study

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    Background: Pre-exposure prophylaxis (PrEP) with tenofovir and emtricitabine effectively prevents new HIV infections. The optimal scenario for implementing PrEP where most infections are averted at the lowest cost is unknown. We determined the impact of different PrEP strategies on averting new infections, prevalence, drug resistance and cost-effectiveness in Macha, a rural setting in Zambia. Methods: A deterministic mathematical model of HIV transmission was constructed using data from the Macha epidemic (antenatal prevalence 7.7%). Antiretroviral therapy is started at CD4/mm 3 . We compared the number of infections averted, cost-effectiveness, and potential emergence of drug resistance of two ends of the prioritization spectrum: prioritizing PrEP to half of the most sexually active individuals (5-15% of the total population), versus randomly putting 40-60% of the total population on PrEP. Results: Prioritizing PrEP to individuals with the highest sexual activity resulted in more infections averted than a non-prioritized strategy over ten years (31% and 23% reduction in new infections respectively), and also a lower HIV prevalence after ten years (5.7%, 6.4% respectively). The strategy was very cost-effective at $323 per quality adjusted life year gained and appeared to be both less costly and more effective than the non-prioritized strategy. The prevalence of drug resistance due to PrEP was as high as 11.6% when all assumed breakthrough infections resulted in resistance, and as low as 1.3% when 10% of breakthrough infections resulted in resistance in both our prioritized and non-prioritized scenarios. Conclusions: Even in settings with low test rates and treatment retention, the use of PrEP can still be a useful strategy in averting infections. Our model has shown that PrEP is a cost-effective strategy for reducing HIV incidence, even when adherence is suboptimal and prioritization is imperfect

    Health-related quality of life during the COVID-19 pandemic: The impact of restrictive measures using data from two Dutch population-based cohort studies

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    Objectives We describe health-related quality of life during the COVID-19 pandemic in the general Dutch population and correlations with restrictive measures. Methods Data were obtained from 18–85 year-old participants of two population-based cohort studies (February 2021-July 2022): PIENTER Corona (n = 8,019) and VASCO (n = 45,413). Per cohort, mean scores of mental and physical health and health utility from the SF-12 were calculated by age group, sex and presence of a medical risk condition. Spearman correlations with stringency of measures were calculated. Results Both cohorts showed comparable results. Participants <30 years had lowest health utility and mental health score, and highest physical health score. Health utility and mental health score increased with age (up to 79 years), while physical health score decreased with age. Women and participants with a medical risk condition scored lower than their counterparts. Fluctuations were small over time but most pronounced among participants <60 years, and correlated weakly, but mostly positively with measure stringency. Conclusions During the Dutch COVID-19 epidemic, health utility and mental health scores were lower and fluctuated strongest among young adults compared to older adults. In our study population, age, sex and presence of a medical risk condition seemed to have more impact on health scores than stringency of COVID-19 non-pharmaceutical interventions

    Vaccine effectiveness of primary and booster COVID-19 vaccinations against SARS-CoV-2 infection in the Netherlands from July 12, 2021 to June 6, 2022: A prospective cohort study

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    Objectives: We estimated vaccine effectiveness (VE) of primary and booster vaccinations against SARS-CoV-2 infection overall and in four risk groups defined by age and medical risk condition during the Delta and Omicron BA.1/BA.2 periods. Methods: VAccine Study COvid-19 is an ongoing prospective cohort study among Dutch adults. The primary end point was a self-reported positive SARS-CoV-2 test from July 12, 2021 to June 06, 2022. The analyses included only participants without a previous SARS-CoV-2 infection based on a positive test or serology. We used Cox proportional hazard models with vaccination status as the time-varying exposure and adjustment for age, sex, educational level, and medical risk condition. Results: A total of 37,170 participants (mean age 57 years) were included. In the Delta period, VE <6 weeks after the primary vaccination was 80% (95% confidence interval 69-87) and decreased to 71% (65-77) after 6 months. VE increased to 96% (86-99) shortly after the first booster vaccination. In the Omicron period, these estimates were 46% (22-63), 25% (8-39), and 57% (52-62), respectively. For the Omicron period, an interaction term between vaccination status and risk group significantly improved the model (P <0.001), with generally lower VEs for those with a medical risk condition. Conclusion: Our results show the benefit of booster vaccinations against infection, also in risk groups; although, the additional protection wanes quite rapidly

    The impact of Bacillus Calmette-Guérin vaccination on antibody response after COVID-19 vaccination

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    Earlier studies showed that BCG vaccination improves antibody responses of subsequent vaccinations. Similarly, in older volunteers we found an increased IgG receptor-binding domain (RBD) concentration after SARS-CoV-2 infection if they were recently vaccinated with BCG. This study aims to assess the effect of BCG on the serum antibody concentrations induced by COVID-19 vaccination in a population of adults older than 60 years. Serum was collected from 1,555 participants of the BCG-CORONA-ELDERLY trial a year after BCG or placebo, and we analyzed the anti-SARS-CoV-2 antibody concentrations using a fluorescent-microsphere-based multiplex immunoassay. Individuals who received the full primary COVID-19 vaccination series before serum collection and did not test positive for SARS-CoV-2 between inclusion and serum collection were included in analyses (n = 945). We found that BCG vaccination before first COVID-19 vaccine (median 347 days [IQR 329-359]) did not significantly impact the IgG RBD concentration after COVID-19 vaccination in an older European population

    Intravaginal and Menstrual Practices among Women Working in Food and Recreational Facilities in Mwanza, Tanzania: Implications for Microbicide Trials

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    Intravaginal and menstrual practices may potentially influence results of trials of microbicides for HIV prevention through effects on the vaginal environment and on adherence to microbicide and placebo products. As part of the feasibility study for the Microbicides Development Programme Phase 3 trial of a vaginal microbicide in Mwanza, a variety of quantitative and qualitative methods were used to describe these practices, associations with behaviour and underlying social norms among women working in food and recreational facilities. Intravaginal cleansing by inserting fingers and either water alone or soap and water was thought necessary to remove “uchafu” (dirt), referring to vaginal secretions, including menstrual blood and post-coital discharge. Vaginal cleansing was carried out within 2 hours after 45% of sex acts. Sexual enhancement practices were less common. Intravaginal and menstrual practices and associated behaviours and demographic factors should be measured and monitored throughout microbicide trials to enable analyses of their impacts on microbicide effectiveness

    Determinants of Systemic SARS-CoV-2-Specific Antibody Responses to Infection and to Vaccination: A Secondary Analysis of Randomised Controlled Trial Data

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    SARS-CoV-2 infections elicit antibodies against the viral spike (S) and nucleocapsid (N) proteins; COVID-19 vaccines against the S-protein only. The BCG-Corona trial, initiated in March 2020 in SARS-CoV-2-naĂŻve Dutch healthcare workers, captured several epidemic peaks and the introduction of COVID-19 vaccines during the one-year follow-up. We assessed determinants of systemic anti-S1 and anti-N immunoglobulin type G (IgG) responses using trial data. Participants were randomised to BCG or placebo vaccination, reported daily symptoms, SARS-CoV-2 test results, and COVID-19 vaccinations, and donated blood for SARS-CoV-2 serology at two time points. In the 970 participants, anti-S1 geometric mean antibody concentrations (GMCs) were much higher than anti-N GMCs. Anti-S1 GMCs significantly increased with increasing number of immune events (SARS-CoV-2 infection or COVID-19 vaccination): 104.7 international units (IU)/mL, 955.0 IU/mL, and 2290.9 IU/mL for one, two, and three immune events, respectively (p < 0.001). In adjusted multivariable linear regression models, anti-S1 and anti-N log10 concentrations were significantly associated with infection severity, and anti-S1 log10 concentration with COVID-19 vaccine type/dose. In univariable models, anti-N log10 concentration was also significantly associated with acute infection duration, and severity and duration of individual symptoms. Antibody concentrations were not associated with long COVID or long-term loss of smell/taste

    Prevalence of sexually transmitted infections and bacterial vaginosis among women in sub-Saharan Africa:An individual participant data meta-analysis of 18 HIV prevention studies

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    Background: Estimates of sexually transmitted infection (STI) prevalence are essential for efforts to prevent and control STIs. Few large STI prevalence studies exist, especially for low- and middle-income countries (LMICs). Our primary objective was to estimate prevalence of chlamydia, gonorrhea, trichomoniasis, syphilis, HSV-2, and bacterial vaginosis (BV) among women in sub-Saharan Africa by age, region, and population-type.Methods and Findings: We analyzed individual-level data from 18 HIV prevention studies (cohort studies, randomized controlled trials; conducted during 1993–2011), representing &gt;37,000 women, which tested participants for ≄1 selected STI/BV at baseline. We used a two-stage meta-analysis to combine data. After calculating the proportion with each STI/BV and standard error by study, we used a random-effects model to obtain a summary mean prevalence of each STI/BV and 95% confidence interval (CI) across age, region, and population-types. Despite substantial study heterogeneity for some STIs/populations, several patterns emerged. Across all regions/population groups, prevalence was higher among 15–24 year-old than 25–49 year-old women for all STIs except HSV-2. In general, higher-risk populations had greater prevalence of gonorrhea and syphilis than clinic/community-based populations. For chlamydia, prevalence among 15–24 year olds was 10.3% (95% CI: 7.4, 14.1; I2=75.7%) among women specifically recruited from higher-risk settings for HIV in Eastern Africa and was 15.1% (95% CI: 12.7, 17.8; I2=82.3%) in South African clinic/community-based populations. Among clinic/community-based populations, prevalence was generally greater in South Africa than in Southern/Eastern Africa for most STIs; for gonorrhea, prevalence among 15–24 year olds was 4.6% (95% CI: 4.4, 6.4; I2=82.8%) in South Africa and was 1.7% (95% CI: 1.2, 2.6; I2=55.2%) in Southern/Eastern Africa. Across all region/population groups, HSV-2 and BV prevalence was high among 25–49 year-olds (ranging from 70–83% and 33–44%, respectively). The main study limitation is that the data are not from random samples of the target populations. Conclusions: Combining data from 18 HIV prevention studies, our findings highlight important features of STI/BV epidemiology among sub-Saharan African women. This methodology can be used where routine STI surveillance is limited and offers a new approach to obtaining critical information on STI and BV prevalence in LMICs

    The interaction between vaginal microbiota, cervical length, and vaginal progesterone treatment for preterm birth risk

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    © The Author(s) 2017. Background: Preterm birth is the primary cause of infant death worldwide. A short cervix in the second trimester of pregnancy is a risk factor for preterm birth. In specific patient cohorts, vaginal progesterone reduces this risk. Using 16S rRNA gene sequencing, we undertook a prospective study in women at risk of preterm birth (n = 161) to assess (1) the relationship between vaginal microbiota and cervical length in the second trimester and preterm birth risk and (2) the impact of vaginal progesterone on vaginal bacterial communities in women with a short cervix. Results: Lactobacillus iners dominance at 16 weeks of gestation was significantly associated with both a short cervix < 25 mm (n = 15, P < 0.05) and preterm birth < 34+0 weeks (n = 18; P < 0.01; 69% PPV). In contrast, Lactobacillus crispatus dominance was highly predictive of term birth (n = 127, 98% PPV). Cervical shortening and preterm birth were not associated with vaginal dysbiosis. A longitudinal characterization of vaginal microbiota (< 18, 22, 28, and 34 weeks) was then undertaken in women receiving vaginal progesterone (400 mg/OD, n = 25) versus controls (n = 42). Progesterone did not alter vaginal bacterial community structure nor reduce L. iners-associated preterm birth (< 34 weeks). Conclusions: L. iners dominance of the vaginal microbiota at 16 weeks of gestation is a risk factor for preterm birth, whereas L. crispatus dominance is protective against preterm birth. Vaginal progesterone does not appear to impact the pregnancy vaginal microbiota. Patients and clinicians who may be concerned about "infection risk" associated with the use of a vaginal pessary during high-risk pregnancy can be reassured
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