RESUMEN
Every clinical trial must be registered in a publicly accessible trial registry before enrollment of the first participant. Prospectively registering clinical trials before enrolling participants helps to prevent unethical research misconduct from occurring, duplication of research and increases transparency in research. The aim of this study was to provide cross-sectional survey analysis of planned, ongoing and completed human papillomavirus (HPV) clinical trials conducted worldwide. We searched the International Clinical Trials Registry Platform (ICTR) for registered HPV trials on 5 March 2023. Two authors independently extracted data including name of the clinical trial registry, location of the trial, recruitment status of the trial, gender of participants, phase of the trial, and type of trial sponsor. We used Microsoft Excel to perform descriptive analysis. The search yielded 1632 trials registered between 1999 and 2023. Most of the trials were registered in ClinicalTrials.gov and were registered retrospectively. We also found that most trials were conducted in North America, in recruiting stage, and indicated "not applicable" under the phase of the trial field. Finally, most trials were sponsored by hospitals. Our study found that there are many HPV clinical trials registered in different clinical trial primary registries around the world. However, many of the trials were registered retrospectively instead of the required prospectively and some had missing fields. Therefore, there is a need for registries to promote prospective trial registration and completion of all fields during the registration process.
Asunto(s)
Ensayos Clínicos como Asunto , Infecciones por Papillomavirus , Sistema de Registros , Humanos , Estudios Transversales , Infecciones por Papillomavirus/prevención & control , Ensayos Clínicos como Asunto/ética , Femenino , Masculino , Vacunas contra Papillomavirus/administración & dosificación , Papillomaviridae , Virus del Papiloma HumanoRESUMEN
INTRODUCTION: Research has shown an association between increased disclosure of HIV status by pregnant and breastfeeding women and improved clinical health and that of their infant. Increasing awareness about their male partner's HIV status will no doubt lead to even better outcomes at the population level. Male partner involvement is important for improving outcomes of prevention of mother-to-child transmission of HIV (MTCT) as it improves social support and commitment from both parents of the baby to ensure sustained good health. Although lack of knowledge of the HIV status of a male partner is of great concern, limited research has been done to determine whether it remains one of the barriers to reaching the proposed goals of eliminating MTCT in pregnant or postpartum women. Our aim is to determine if lack of knowledge of a male partner's HIV status is a significant risk factor for HIV incidence and poor HIV clinical outcomes among pregnant women and postpartum women and their infants. METHODS AND ANALYSIS: A systematic review and meta-analysis of experimental and observational studies will be conducted. The review will focus on knowledge of male partner's HIV status in the 21 priority countries most affected by HIV in Africa. We will search electronic databases such as PubMed/Medline, Scopus, Web of Science and Cochrane library, Science Direct, CINAHL, LILACS and SciELO databases from January 2011 to December 2021. We will also search the Pan African and WHO clinical trial registries and conference archives. We will conduct a quality assessment of eligible studies and evaluate the heterogeneity of the pooled studies using the I 2 statistic. The statistical analysis will be performed using STATA statistical software V.16. ETHICS AND DISSEMINATION: The study will use publicly available data and ethics exemption has been obtained from Human Research Ethics Committees, Faculty of Medicine & Health Sciences, Stellenbosch University. The protocol was registered on Prospective Register of Systematic Reviews, registration number CRD42021247686, in May 2021. Findings of this systematic review will be disseminated in peer-review journals including various media platforms, that is, webinars, symposia, conferences or congresses. PROSPERO REGISTRATION NUMBER: Registration number CRD42021247686.