Clinical Research Directory

Integration to Improve Adolescent Health and HPV Vaccination in Laos

The goal of this study is to find out if adding HPV vaccination to adolescent health services works to increase HPV vaccine uptake in 10-13-year-old girls in Laos. The study will also look at the effects of adding HPV vaccination on the use of other health services in 10-13-year-old boys and girls. The main questions the study aims to answer are: 1. Does adding HPV vaccination to adolescent health services increase HPV vaccine uptake in girls aged 10-13 years compared to girls who only receive standard HPV vaccination services? 2. Does adding HPV vaccination to adolescent health services increase the use of other health services in 10-13-year-old adolescent boys and girls compared to adolescents who only receive standard HPV vaccination services? 3. What are the barriers and facilitators to using the combined intervention in Laos? 4. What are the opinions of adolescents, caregivers, healthcare providers, and other stakeholders on the combined intervention? 5. How much does it cost and how well it works to combine HPV vaccination with adolescent health services, as opposed to providing HPV vaccination alone? Researchers will compare a combined intervention to standard HPV vaccination services to see if the combined intervention works to increase HPV vaccination uptake and the use of other health services. The combined intervention includes HPV vaccination given at schools, health facilities, and through community outreach. It also includes education on sexual and reproductive health, counseling, and other health services. Participants in the combined intervention group will: 1. Receive the HPV vaccine at school or at a health facility. 2. Take part in group discussions about sexual and reproductive health. 3. Take part in individual counseling sessions. 4. Use other health services as needed. Participants in the comparison group will receive standard HPV vaccination services, including: • HPV vaccination given at schools, health facilities, and through community outreach.

Multiple Human Papillomavirus Infections in the Development of CIN

Multiple infections of high-risk genotypes of Human Papillomavirus (HR-HPV) in patients with abnormal cervical cytological or histological findings are detectable in a percentage ranging from 20% to 50% of cases. Some studies have detected a certain tendency to specific clustering in multiple infections, both inter-species and inter-genotypic, such as HPV 31-35-56, HPV 16-51-52, HPV 16-18, HPV 51-52. Furthermore, a greater tendency of the HPV16 genotype to cluster with genotypes of different species is reported in the literature. However, other studies claim a random character of such genotypic associations in multiple infections. This heterogeneity of results of the studies present in the literature underlies multiple factors, both epidemiological and methodological, implicated in the high variability of prevalence and diagnostic findings of multiple infections. In particular, with regard to epidemiological characteristics, factors influencing the distribution of multiple infections appear to be the origin and type of population, economic-social status, young age, HIV seropositivity and recent sexual activity. A further hypothesized element is represented by a possible individual susceptibility dictated by the immune profile of the host towards specific genotypes, potentially facilitating the occurrence of co-infections by these, possibly resulting in a synergistic effect on the oncogenic potential. From a clinical point of view, to date multiple cross-sectional studies suggest an association between multiple infections of HR-HPVs and an increased risk of high-grade cervical dysplasia. In particular, a proportional relationship is observed between the number of genotypes present and the severity of the lesion. Furthermore, it has been reported that the correlation between multiple HR-HPV infections and severe cervical dysplasia CIN2+ is significant both in the presence and absence of the known oncogenic genotype HPV16, assuming a possible synergistic interaction between specific high-risk genotypes. However, other studies seem to refute the clinical relevance of multiple infections in the risk of neoplastic progression of cervical lesions, mostly claiming the precept of "one virus, one lesion", such that each dysplastic lesion is associated with the action of a distinct HR-HPV genotype. In this assumption, therefore, it is argued that moderate-severe cervical dysplasias are due to the action of a single oncogenic genotype, predominantly HPV16, while the presence of other HR-HPVs is attributable to transient infections, mostly represented by mild dysplasias (CIN1). As far as biological knowledge is concerned, in vitro studies currently demonstrate how it is possible for a single cell to be co-infected by at least two HR-HPV genotypes and how this can result in peculiar inter-genotypic molecular interactions that influence the replication cycle and the respective capacity for cellular persistence and transformation of the individual genotypes involved. The inter-genotypic competition mechanisms detected, therefore, occur mostly during the initial phases of acute infection by the HR-HPVs involved. However, it has been demonstrated that when a persistent infection of a genotype has already been established, this is no longer able to negatively interact with a subsequent incident infection by a different HR-HPV genotype. This finding in the biological field is consistent with the clinical correlate according to which the association between multiple HR-HPV infections and the risk of high-grade cervical dysplasia is greater when these are established on a pre-existing persistent infection. Therefore, it is conceivable that there is a higher rate of genotype-specific association in multiple HR-HPV infections found in cervical dysplastic lesions, defined by the peculiar capacities of the individual genotypes to give rise to persistent cellular infections. Despite the proven efficacy of vaccination programs in preventing cervical dysplastic lesions and infection by the main viral genotypes with high oncogenic risk, numerous studies demonstrate the clinical efficacy of HPV vaccination also in reducing the rate of disease recurrence in patients undergoing excisional treatment. A first explanatory hypothesis of this phenomenon is represented by the protection that the vaccination procedure would provide to those patients not previously infected by the target HR-HPV genotypes, potentially causative of de novo infections with high oncogenic risk. A further hypothesis under study is represented by the fact that the administration of the HPV vaccine following excisional treatment would prevent the reduction of the immune response against HPV.

HPV Vaccine Integrated Service Implementation Research in Cameroon

The goal of this implementation research study is to understand whether a package of community-based interventions can increase access to and uptake of the human papillomavirus (HPV) vaccine among very young adolescent girls and boys in the North and Far North Regions of Cameroon. The main questions this study aims to answer are: * Can a package of community-based interventions increase delivery of routine HPV vaccination to boys and girls aged 9-13 in Cameroon's North and Far North Regions? * What is the acceptability, feasibility, cost, and potential for maintenance and scale of an integrated health intervention to deliver routine HPV vaccination in Cameroon? To evaluate the effectiveness of the intervention, researchers will compare HPV vaccination within regions where the new intervention model is being implemented (intervention areas) to regions where the new routine HPV vaccination delivery model is not being implemented (comparison areas) for approximately 1 year before the new intervention model is implemented and for approximately 9 months after the start of implementation to compare changes over time and between intervention and comparison areas. The study will evaluate the effect of the intervention on HPV vaccination delivery using routine health facility data. To understand acceptability, feasibility, implementation, and potential for scale, the study will enroll participants including health officials and providers, adolescents girls receiving HPV vaccination and other services in intervention areas, and their parents/caregivers. The study will be conducted in two phases, with the first phase focused on gathering formative data through interviews with key informants. This data will be used to inform the design of the intervention, which will be implemented and evaluated in phase 2. Only phase 1 of this study protocol has been currently approved. In phase 1, key informant interview participants will be asked to participate in a an interview to discuss HPV vaccination services and their perspectives on how to integrate HPV vaccination within existing community-based and health facility structures and programs. Key informants will include government officials, health program implementers, representatives from non-government organizations working on HPV vaccine delivery, and healthcare providers, as well as community leaders including school and religious leaders.

HPV Vaccine Integrated Service Implementation Research in Ethiopia

The goal of this implementation research study is to understand whether a package of community-based interventions can increase access to and uptake of the human papillomavirus (HPV) vaccine among very young adolescent girls in rural Ethiopia. The main questions this study aims to answer are: * Can a package of community-based interventions increase delivery of routine HPV vaccination to girls aged 9-14 in rural Ethiopia? * Is an intervention model that incorporates strategies that address gender norms and gender-specific barriers more effective at increasing delivery of routine HPV vaccination than a model that does not explicitly address gender? * What is the acceptability, feasibility, cost, and potential for maintenance and scale of an integrated health intervention to delivery routine HPV vaccination in rural Ethiopia? To evaluate the effectiveness of the intervention, researchers will compare HPV vaccination within regions where the new intervention model is being implemented (intervention areas) to regions where the new routine HPV vaccination delivery model is not being implemented (comparison areas) for approximately 1 year before the new intervention model is implemented and for approximately 1 year after the start of implementation to compare changes over time and between intervention and comparison areas. The study will evaluate the effect of the intervention on HPV vaccination delivery using routine health facility data. To understand acceptability, feasibility, implementation, and potential for scale, the study will enroll participants including health officials and providers, adolescents girls receiving HPV vaccination and other services in intervention areas, and their parents/caregivers. These participants may be asked to participate in one or more of the following: * Completing a short questionnaire after receiving health services, including HPV vaccination, and their knowledge and attitudes towards HPV vaccination and experiences of care * Participating in an interview or a focus group discussion to discuss HPV vaccination services and the role of the intervention in delivering care