scholarly journals Participating in HIV Prevention Clinical Trial: Reasons and Experiences among Female Participants in Antibody Mediated Prevention Study at UNC Project, Lilongwe, Malawi

2020 ◽  
Author(s):  
Ruth Holla ◽  
Adamson Muula
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Hiv Prevention ◽  
Cross Sectional Study ◽  
Prevention Study ◽  
Cross Sectional ◽  
Prevention Clinical Trial ◽  
Hiv Research ◽  
Project Data ◽  
Study Participants

Aim: The overall aim of the study was to assess the reasons and experiences of participants involved in Antibody Mediated Prevention (AMP) HIV prevention clinical trial at University of North Carolina (UNC) Project, Lilongwe, Malawi. We determined the participants’ reasons for participating in HIV Prevention clinical trials; and the experiences of participants in HIV Prevention clinical trials. Methods: We adopted the qualitative cross-sectional study method. Data were collected using in-depth interviews (IDIs). Purposive sampling was used to select 12 study participants who consented to take part in the study. All participants were the ones taking part in the AMP HIV prevention study at the UNC Project. Data analysis was done concurrently with data collection using content analysis. Results: Individuals were motivated to participate in HIV research due to a range of perceived benefits. These included personal, health, and financial benefits. Participants' research experiences and their continued participation in HIV research were influenced by the research clinic context and the nature of their interactions with research staff. Conclusion: When the clinical trial study participants’ expectations are met through what they experience in the study, the chances of them adhering to the study visits and procedures are high. Even for those who did not have any expectations prior to the study, feeling welcomed and being able to open up to the study staff encouraged their continued participation. In the end, this outweighed the negative comments made by the people in their communities or their friends

scholarly journals Emerging trends in contraceptive use, transitions and preferences among female sex workers screened for an HIV prevention clinical trial in Kisumu, Kenya: a cross-sectional study

2019 ◽  
Vol 3 ◽  
pp. 1505 ◽  
Author(s):  
Dismas Oketch ◽  
Eunice C. Kaguiri ◽  
Joseph O. Orinda ◽  
Grace Mboya ◽  
Phoebe Ogutu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Hiv Prevention ◽  
Reproductive Health ◽  
Sex Workers ◽  
Female Sex Workers ◽  
Contraceptive Use ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Cross Sectional ◽  
Prevention Clinical Trial

Background: Globally about 210 million women conceive annually and 38% of these pregnancies are unintended. Female sex workers (FSWs) are at increased risk of both unintended pregnancy and acquiring HIV, which could lead to adverse sexual and reproductive health (SRH) outcomes. We sought to assess contraceptive use or non-use, preferences and determinants among a cohort of FSWs screened for an HIV prevention clinical trial in Kisumu, Kenya. Methods: A cross sectional study of healthy FSWs referred for possible recruitment into the Antibody Mediated HIV Prevention (AMP) Study was conducted between December 2016 and September 2018. Potentially eligible participants were screened for HIV and data on social-demographic, contraceptive use and other SRH characteristics were collected. Those not on a method recorded their contraceptive preferences.   Results: Data on 210 FSWs with a median age of 24.5 years (interquartile range, IQR 22-26) are presented. Of these, 187 (89.1%) had two children or fewer; only 56 (26.7%) had completed secondary or higher education. At the time of the interview, 18 (8.6%) were HIV-infected and 181 (86.2%) were using a modern contraceptive. Implants (48.6%) and depot injections (37.6%) were the most commonly used methods. Most (41.4%) of those not on family planning preferred oral pills. Respondents who had two or more children were three times more likely than their primiparous and nulliparous counterparts to report use of a contraceptive. Use of modern contraception methods did not differ by respondent’s ownership of a medical insurance cover or other occupation. Conclusion: There is high use of modern contraception among FSWs in Kisumu with the majority using subdermal implants. Reproductive health programs should implement targeted SRH interventions for specific populations and risk groups. Effective contraceptive counselling and interventions among FSWs should consider the client’s parity and level of education.

scholarly journals Results availability and timeliness of registered COVID-19 clinical trials: interim cross-sectional results from the DIRECCT study

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e053096
Author(s):  
Maia Salholz-Hillel ◽  
Peter Grabitz ◽  
Molly Pugh-Jones ◽  
Daniel Strech ◽  
Nicholas J DeVito
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Journal Article ◽  
Cross Sectional Study ◽  
Sensitivity Analyses ◽  
Cross Sectional ◽  
Registration Data ◽  
Clinical Trial Registries ◽  
Treatment And Prevention

ObjectiveTo examine how and when the results of COVID-19 clinical trials are disseminated.DesignCross-sectional study.SettingThe COVID-19 clinical trial landscape.Participants285 registered interventional clinical trials for the treatment and prevention of COVID-19 completed by 30 June 2020.Main outcome measuresOverall reporting and reporting by dissemination route (ie, by journal article, preprint or results on a registry); time to reporting by dissemination route.ResultsFollowing automated and manual searches of the COVID-19 literature, we located 41 trials (14%) with results spread across 47 individual results publications published by 15 August 2020. The most common dissemination route was preprints (n=25) followed by journal articles (n=18), and results on a registry (n=2). Of these, four trials were available as both a preprint and journal publication. The cumulative incidence of any reporting surpassed 20% at 119 days from completion. Sensitivity analyses using alternate dates and definitions of results did not appreciably change the reporting percentage. Expanding minimum follow-up time to 3 months increased the overall reporting percentage to 19%.ConclusionCOVID-19 trials completed during the first 6 months of the pandemic did not consistently yield rapid results in the literature or on clinical trial registries. Our findings suggest that the COVID-19 response may be seeing quicker results disclosure compared with non-emergency conditions. Issues with the reliability and timeliness of trial registration data may impact our estimates. Ensuring registry data are accurate should be a priority for the research community during a pandemic. Data collection is underway for the next phase of the DIssemination of REgistered COVID-19 Clinical Trials study expanding both our trial population and follow-up time.

scholarly journals Knowledge of medical students on clinical trials

2019 ◽  
Vol 8 (7) ◽  
pp. 1484
Author(s):  
Ravi Shankar Kanna ◽  
Jagadeesh Alla ◽  
Krishnakanth K.
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Students ◽  
Basic Research ◽  
Thinking Skills ◽  
Cross Sectional Study ◽  
Critical Thinking Skills ◽  
School Students ◽  
Cross Sectional ◽  
Institutional Ethics

Background: Basic research can help medical school students improve critical thinking skills required by medical practice. In this era of evidence-based medicine, the combination of medical education with clinical research is the key to ensure scientific discoveries are translated into clinical practice. This study’s objective was to know the awareness about clinical trials among undergraduate medical students.Methods: After obtaining approval from the Institutional Ethics Committee of NRI Academy of Medical Sciences, Guntur, India, this cross sectional study was conducted in second year medical students after taking their consent. A sample of 90was considered for statistical analysis. A structured questionnaire was used to measure the objective of this study, which had general, regulatory and ethical questions related to clinical trials. Qualitative data variables were expressed by using frequency and Percentage (%).Results: Out of 90 students, it was observed that in the general questions category, 70% of students were aware of the purpose of conducting clinical trials, 50% were aware of the pre-requisites for a participant before participating in a clinical trial and 50% were aware of the parameters evaluated in a clinical trial. 95% of students did not know the response for regulatory questions. The students’ awareness regarding ethics related to clinical trials was better than the other two categories.Conclusions: The overall awareness of clinical trials was low among students though they demonstrated good awareness regarding few aspects of clinical trials.

Willingness of patients with pancreatic cancer to participate in clinical trials.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4055-4055
Author(s):  
Pelin Cinar ◽  
Anitra W. Talley ◽  
Jimmy Hwang ◽  
Daniel Paul Dohan ◽  
Margaret A. Tempero
Keyword(s):  
Pancreatic Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Cross Sectional Study ◽  
Trial Participation ◽  
Trial Recruitment ◽  
Chi Square ◽  
Cross Sectional ◽  
Recruitment Methods ◽  
Clinical Trial Recruitment

4055 Background: Recruitment of oncology patients into clinical trials continues to be a challenge as <5% of patients are accrued. Low accrual rates may be due to reduced awareness of trial availability and eligibility by physicians/patients. Our objective was to study the attitudes of patients with pancreatic cancer (PC) regarding clinical trial participation and to identify possible barriers to recruitment. Methods: In this cross-sectional study, we collaborated with Pancreatic Cancer Action Network (PanCAN) and invited patients with PC or their caregivers to complete a survey. The survey that was developed consisted of 22 questions and inquired about patients’ previous clinical trial enrollment experiences and their views on participation. The surveys were collected over a 6-month period via the PanCAN website and regional meetings. Comparison analyses between groups were done by Chi-square and Fisher’s test using STATA software. Results: Of the390 surveys received, 149 were included in the final analyses. 30% of the patients were offered to participate in a trial by their physicians. When asked to participate, 62% of the patients agreed. Of the patients who were not enrolled in a clinical trial, 61% were offered to participate in a trial but did not agree. This suggests that these patients were eligible to participate but declined. Conclusions: Majority of the patients with pancreatic cancer were not offered to participate in clinical trials by their physicians but would have agreed if asked. While low clinical trial recruitment rates for PC may be multifactorial, further research may focus on the important role of physicians in clinical trial recruitment efforts. [Table: see text]

scholarly journals Fishermen as a Suitable Population for HIV Intervention Trials

2010 ◽  
Vol 2010 ◽  
pp. 1-6 ◽  
Author(s):  
Zachary A. Kwena ◽  
Craig R. Cohen ◽  
Norton M. Sang ◽  
Musa O. Ng'ayo ◽  
Jeremiah H. Ochieng ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Hiv Prevention ◽  
High Risk Group ◽  
Transmitted Infection ◽  
Cross Sectional ◽  
Sti Prevention ◽  
Hiv Intervention ◽  
Concurrent Sexual Partnerships ◽  
Prevention Clinical Trial ◽  
Intervention Trials

Background. Suitable populations to sustain continued evaluation of HIV and sexually transmitted infection (STI) prevention interventions are required. We sought to determine whether fishermen are a suitable population for HIV intervention trials.Methods. In a cross-sectional descriptive survey, we selected 250 fishermen from proportional to size sampled boats. We collected socioeconomic and behavioral information, and specimens for HIV, herpes simplex virus (HSV-2), syphilis, gonorrhea, chlamydia and human papillomavirus (HPV) tests from consenting participants.Results. One third of the fishermen had concurrent sexual partnerships and two thirds were involved in transactional sex. About 70% were involved in extramarital sex with only one quarter using condoms in their three most recent sexual encounters. HIV prevalence was 26% and HSV-2 and HPV was 57%. Over 98% were willing to participate in a future HIV prevention clinical trial.Conclusion. Fishermen are a high-risk group for HIV/STI infections that may be suitable for HIV prevention trials. A cohort study would be useful to measure the incidence of HIV/STIs to ultimately determine the feasibility of enrolling this population in an HIV/STI prevention clinical trial.

Assessment of the Quality of Randomized Clinical Trials Published by Iranian Researchers in Persian Internal Journals in 2014

2020 ◽  
Vol 7 (1) ◽  
pp. 65-70
Author(s):  
Mohammad Rafiei ◽  
Awat Feizi ◽  
Seyyed P. Shariatpanahi ◽  
Iman Hamraz ◽  
Danial Habibi
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Cross Sectional Study ◽  
Random Allocation ◽  
Time Duration ◽  
Cross Sectional ◽  
Persian Language ◽  
Presentation Time ◽  
Study Participants

Introduction: A randomized clinical trial is known as the best and most effective way to assess the effects of interventions if it is properly planned and implemented. The purpose of this study was to evaluate the quality of clinical trials published in Persian internal journals by Iranian researchers. Method: In this cross-sectional study, all the clinical trials published by Iranian researchers in the Iranian Journals in 2014, were evaluated according to entry criteria and finally 587 included articles were reviewed and their quality was evaluated by using Consolidated Standards of Reporting Trials (CONSORT) checklist. Results: The results revealed that the mean±SD adherence to the CONSORT checklist’s item in our included articles was 59.61±24.99. The lowest adherence to the items was seen for random allocation (76.1%), description of the sampling method (70.1%) and presenting RCT code registration (60.4%), respectively. The highest adherence was observed for title suitability (96%), appropriate presentation time and place of study (84.2%), a suitable expression of study participants (82.8%) and time duration of the study (82.3%). Conclusion: The adherence to the various items of CONSORT checklist in Iranian Persian language journals was not in satisfactory status. In this regard, the CONSORT checklist needs to be carefully followed for conducting and reporting RCTs by Iranian researchers.

scholarly journals Translation and Validation of the Greek Version of a Questionnaire Measuring Patient Views on Participation in Clinical Trials

2021 ◽  
Author(s):  
Dimitrios Karampatakis ◽  
Angeliki Kakavouti-Doudos ◽  
Panagiotis Oikonomidis ◽  
Polychronis Voultsos
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cross Sectional Study ◽  
Willingness To Participate ◽  
Validity And Reliability ◽  
Greek Version ◽  
Factor Solution ◽  
Cross Sectional ◽  
Risks And Benefits ◽  
Patient Views

Abstract BackgroundThe increasing number of clinical research opportunities requires increasing numbers of participants in clinical trials. However, it may become increasingly problematic, as protocols have become increasingly complex. Better understanding of patients’ attitudes towards their potential participation in clinical trials is essential for developing effective clinical trial recruitment strategies. In Greece, limited research has been conducted on this topic so far. This study aims to contribute to filling this gap. MethodsA cross-sectional study was conducted. Purposive sampling was used to select participants. The Greek version of a recently developed questionnaire measuring patient views on participation in clinical trials, a 27‐item scale distributed into four factors, was tested. In addition, participants were asked to provide information regarding their socio-demographics. A demographic comparison was conducted.ResultsThe four-factor solution derived in our study consisted of the same 27 items and it was different from the six-factor solution that Arnetz et al. proposed. The factors risks and benefits, that consisted of 5 and 3 items respectively in the six-factor solution, were merged into one factor that consisted of 10 items in the four-factor solution. The four factors produced were Risks and benefits (ten items, α= 0,867), Patient’s expectations (six items, α= 0.864), Patient’s participation (five items, α= 0.827), and Cost and convenience (five items, α= 0,770). We found that demographic factors did not impact patients' opinions about clinical trials participation, except for gender. The participants reported as important for participating in clinical trial: receiving clear and adequate information (95,5%) and being given the opportunity to ask questions (97,8%), take part in discussions regarding their own treatment (94,6%), and voice their concerns and opinions (91,1%). As factors strongly associated with participants’ willingness to participate in a clinical trial were reported: concerns about the risks of being in a clinical trial (87,5%), the possible side effects of clinical trials (86,3%), the type of treatment given in a clinical trial (83,7%), and whether participation would improve their quality of life (QoL) (81,5%).ConclusionThe preliminary validation of the Greek version of the questionnaire measuring patient perceptions and expectations of participating in clinical trials demonstrated acceptable validity and reliability and could be further tested in larger samples. The findings that emerged from this study are in line with previous literature.

scholarly journals Results Availability and Timeliness of Registered COVID-19 Clinical Trials: A Cross-Sectional Study

2021 ◽  
Author(s):  
Maia Salholz-Hillel ◽  
Peter Grabitz ◽  
Molly Pugh-Jones ◽  
Daniel Strech ◽  
Nicholas J DeVito
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Journal Article ◽  
Cross Sectional Study ◽  
Sensitivity Analyses ◽  
Cross Sectional ◽  
Registration Data ◽  
Clinical Trial Registries ◽  
Treatment And Prevention

Objective: To examine how and when the results of COVID-19 clinical trials are disseminated Design: Cross-sectional bibliographic study Setting: The COVID-19 clinical trial landscape Participants: 285 registered interventional clinical trials for the treatment and prevention of COVID-19 completed by 30 June 2020 Main outcome measures: Overall reporting and reporting by dissemination route (i.e., by journal article, preprint, or results on a registry); time to reporting by dissemination route. Results: Following automated and manual searches of the COVID-19 literature, we located 41 trials (14%) with results spread across 47 individual results publications published by 15 August 2020. The most common dissemination route was preprints (n = 25) followed by journal articles (n = 18), and results on a registry (n = 2). Of these, four trials were available as both a preprint and journal publication. The cumulative incidence of any reporting surpassed 20% at 119 days from completion. Sensitivity analyses using alternate dates available and definitions of results did not appreciably change the reporting percentage. Expanding minimum follow-up time to 3 months increased the overall reporting percentage to 19%. Conclusion: COVID-19 trials completed during the first six months of the pandemic did not consistently yield rapid results in the literature or on clinical trial registries. Our findings suggest that the COVID-19 response may be seeing quicker results disclosure compared to non-emergency conditions. Issues with the reliability and timeliness of trial registration data may impact our estimates. Ensuring registry data is accurate should be a priority for the research community during a pandemic. Data collection is underway for Phase 2 of the DIRECCT study expanding our trial population to those completed anytime in 2020.

scholarly journals Knowledge and Attitudes Towards Clinical Trial Participation in Oman: A cross-sectional study

2018 ◽  
Vol 18 (1) ◽  
pp. 54 ◽  
Author(s):  
Hussain Al-Lawati ◽  
Khalid Al-Baimani ◽  
Mahra Al-Zadjali ◽  
Nasra Al-Obaidani ◽  
Ziyana Al-Kiyumi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Human Subjects ◽  
Cross Sectional Study ◽  
University Hospital ◽  
Trial Participation ◽  
Sectional Study ◽  
Cross Sectional ◽  
Female Ratio ◽  
Knowledge And Attitudes

Objectives: Clinical trials are prospective studies on human subjects designed to answer various clinical questions. However, only a limited number of clinical trials have been conducted in Oman. This study aimed to assess the knowledge and attitudes of Omani patients and their relatives towards participating in clinical trials. Methods: This cross-sectional study was conducted between October 2015 and March 2016 among 174 patients and relatives attending the Haematology and Oncology Outpatient Clinics and Day Care Unit of the Sultan Qaboos University Hospital, Muscat, Oman. A self-administered questionnaire was designed to elicit participants’ knowledge of and attitudes towards participation in clinical trials. Results: A total of 100 patients and relatives agreed to take part in the study (response rate: 57.5%). The male-to-female ratio was 1:1.2. Only 31.3% of the studied population knew what clinical trials were and only 6.5% had themselves previously participated in a clinical trial. The majority agreed or strongly agreed that they would participate in clinical trials related to their own condition (59.2%). Overall, 89.7% expected to be informed about potential clinical trials by their treating physicians. Conclusion: Omanis had a low level of knowledge of clinical trials and a very low rate of previous participation in such trials, despite a moderate level of interest. Patients should therefore be educated and informed of ongoing clinical trials in order to improve participation rates for clinical trials conducted in Oman.

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