Investigator(s)
| WHO Technical Officer |
Preshila Chandimali Samaraweera WHO Country Office Sri Lanka Preshila Chandimali Samaraweera 
|
| Principal Investigator |
Jinadari Kaushalya Amarasena University Of Sri Jayawardenapura Jinadari Kaushalya Amarasena
|
Title(s) and abstract
| Scientific title | Human papillomavirus-driven male carcinogenic disease burden among men of 20-70 years in Gampaha District and cost effectiveness of different preventive strategies |
| Public title | Human papillomavirus-driven male carcinogenic disease burden among men of 20-70 years in Gampaha District and cost effectiveness of different preventive strategies |
| Background | Human papillomavirus (HPV) infection is the most prevalent sexually transmitted infection in the world. It accounts variable range of carcinomas in males and females including cervical cancer. However, 73rd World Health Assembly accepts a global approach to eliminate cervical cancer between 2059 and 2102. It can reach all countries, predominantly with HPV prophylactic vaccination with additional hope of HPV therapeutic vaccination. Universal HPV vaccination will offer an added advantage to males in HPV-driven carcinogenic disease prevention while improving the population-level impact to achieve the cervical cancer elimination targets earlier than expected.However, the HPV vaccination programmes in most the countries are limited to females as prophylactic vaccination, while some countries are now being extended to include prophylactic male HPV vaccination considering the added benefits HPV vaccination. in Sri Lanka, HPV vaccination started in late 2017 only for the 10-year-old girls’ cohort. However male HPV prevalence in different socio-demographic categories and HPV attributable male cancer burden was not previously studied in Sri Lanka. |
| Objectives | The General objective of the project is to determine HPV prevalence, associated factors, risk attribution for HPV-driven male cancers among 20-70 years old males in different risk categories, and the economic impact of HPV vaccination among males for cancer prevention in the Gampaha District, Sri Lanka. There are four Specific objectives in the study as follows, 1. To estimate the prevalence of HPV infection among 20–70 year old healthy men and men attending Sexually Transmitted Disease (STD) clinics in the Gampaha District 2. To describe the sexual behaviour and associated factors for the prevalence of HPV infection among 20–70 year old healthy men and men attending STD clinics in the Gampaha District 3. To determine the etiologic fraction attributed to HPV in anal and penile cancers among males. 4. To determine the cost effectiveness of scaling up HPV vaccination to males in preventing HPV driven male cancers compared to other methods of managing HPV driven male cancers (further to the contribution to cervical cancer prevention) The research study comprises three components, and Component one Includes two descriptive cross-sectional studies as parts I and II. These two s |
| Study Methods | This research project comprises three components and study period will be from 2022-2024 in Gampaha District Sri Lanka. Component one includes two descriptive cross-sectional studies to identify the HPV prevalence and associated factors of HPV among healthy men in a community setting and men attending STD clinics in a hospital setting. The community-based study participant will be selected from multistage, stratified, probability proportionate to size cluster sampling technique. There will be 32 clusters including 20 numbers of 20–70-year-old sexually active men in each cluster to get a total of 640 men. Total of 194 participants will be selected from the four STD clinics in Gampaha District by consecutive sampling for STD attendees’ prevalence study. Component two is a hospital-based, case-control study to determine the etiologic fraction and risk attribution of HPV driven anal and penile cancer among men diagnosed with anogenital cancer. Consecutive sampling will be performed to select 21 anogenital cancer patients which include 13 penile cancer and 8 anal cancer patients with the agreement of national penile to anal cancer proportions who reside in the Gampaha District. After recruiting 21 cases, for each case, four controls will be selected. A validated pre tested interviewer administered questionnaire will be used to collect data and a penile swab specimen will be collected for PCR by a male doctor for the studies in components 1 and 2. Prevalence rates of HPV infection will be estimated and associated factors will be described as frequencies and percentages. Multivariate (logistic regression) analysis will be carried out to explore possible determinants of HPV infection accounting for confounding. Component 3 a costing study to estimate the economic burden of HPV |
| Expected outcomes and use of results | The two prevalence studies in the first component will estimate prevalence rates of HPV infection among healthy males and STD attendees in the Gampaha District. The associated factors and possible determinants of the HPV infection will identify to be consider during future HPV preventive programmes. Components two and three will estimate the economic burden of HPV-driven male carcinogenic diseases and finally, the cost-effectiveness of different preventive strategies for HPV-driven male cancer will be established. The concluding results will be shared with the Epidemiology unit, Ministry of Health Sri Lanka to be utilized for policy-making on HPV vaccination and National Immunization Technical Advisory Groups for evidence reviewing process, where relevant such as scaling up vaccination to males, selected high risk categories etc. Also, this information will be beneficial for policy decisions in therapeutic vaccine deployment which is on track in identifying product characterization at the global level.The expected final outcome of this project will be to strengthen the country’s capacity in scientific data on males HPV infection driven carcinogenic disease burden and the cost effectiveness of different strategies, of male HPV driven cancer prevention. The incidence of male HPV driven cancer is increasing over the years in Sri Lanka and the direct health system cost for cancer management also increasing parallelly. It is economical to assess the cost effectiveness of different strategies, of male HPV driven cancer prevention scientifically, before decision making on both preventive and therapeutic HPV vaccines. Also, National Immunization Technical Advisory Groups (NITAGs) in the country and the region have the necessity of this independent, transparent evidence. |
| Keywords | HPV, Male prevalence |
Research Details
| Student research | Yes |
| Institution: University of Sri Jayawardenapura | |
| Academic degree: Other | |
| Supervisor of the student(s) | |
| Full Name and title: Dr.Deepa Gamage | |
| Email: deepagamage@gmail.com | |
| Start Date | 01-Sep-2022 |
| End Date | 01-Mar-2024 |
| Key Implementing Institution | Epidemiology Unit |
| Multi-country research | No |
| Nationwide research | Yes, with randomly selected geographical areas |
| Sri Lanka | |
| Research Domain(s) | Communicable Disease Research |
| Research field(s) | Immunization/Vaccine Preventable Disease |
| Involves human subjects | Yes |
| Data Collection | Primary data |
| Proposal reviewed by other Committee | Final decision available |