Prevalence and Type Distribution of Human Papillomavirus (HPV) in Tanzanian Men

August 7, 2015 updated by: Susanne Kruger Kjaer, Danish Cancer Society

Prevalence and Type Distribution of Genital Human Papillomavirus (HPV) in Tanzanian Men

The purpose of this study is to determine the prevalence and type distribution of genital human papillomavirus (HPV) infection in Tanzanian men.

Study Overview

Status

Completed

Conditions

Detailed Description

STUDY POPULATION The study will be performed in an urban and a rural setting in Tanzania. In the urban setting we aim to include men from different employment categories at larger industries, which potentially have already been identified (Twinga cement, ALAF-Aluminum Company, Bakhresa Food Industry, Simba plastics Industry, and Mohamed Enterprise Food Industry), and in addition we will include men from the College/University environment in Dar es Salaam (Vocational Education Training Dar-es-salaam branch, and Dar-es-salaam Institute of Transport). From the 2002 Census it has been estimated that the population of Dar es Salaam was 2,497,940

The recruitment of men for the study in the rural setting will take place in villages in the Kihaba district and the Bagamoyo district.

Kibaha is one of the 6 districts of the Pwani Region located in Eastern Tanzania. It is the capital of Pwani region. The district is bordered to the North by the Bagamoyo District, to the East by Dar-es-Salaam, to the South by the Kisarawe District and to the West by the Morogoro Region. One of the villages potentially selected for this study is Mlandizi village located in Kibaha district. According to the 2002 Tanzania National Census, the population of the Kibaha District was 132,045 Bagamoyo is also one of the 6 districts of the Pwani Region of Tanzania. It is bordered to the North by the Tanga Region, to the West by the Morogoro Region, to the East by the Indian Ocean and to the South by the Kibaha District. The district capitol is at Bagamoyo. According to the 2002 Tanzania National Census, the population of e.g. the Bagamoyo District was 230,164.

The overall study population in the present investigation will include 2000 men aged 18-60 years. Based on our experience from the recent male study conducted in Denmark and also on the experience obtained in the female study in Tanzania, we will establish a study team that will travel to the different study sites and obtain the penile samples, do interviews, and be responsible for the HIV counseling at the respective study site. The study team will consist of a male doctor to take the penile swabs, two male study assistants to do the interviews, and one HIV counselor. We will also employ a Danish researcher who will work together with the Tanzanian doctor and the rest of the study team in the data collection and entry of the data. Dr. Crispen Kahesa, who was also involved in our study of HPV infection in Tanzanian women, and the Danish researcher will collaborate in the day-to-day conduct of the study with the supervision/assistance of Dr Julius Mwaiselage on a weekly basis and with Professor Susanne Krüger Kjær. Before initiation of the study, the Danish part of the team from the Danish Cancer Society will teach the investigating team to take the penile swabs so that it will be done the same way as it was done in the recent Danish male study.

DATA COLLECTION We have chosen an HPV strategy which matches the strategy we are using in the female Tanzanian study and previously have used in our Danish male study, namely initial testing with HC2 followed by genotyping of the samples positive for HC2 high-risk (HR) types and/ or low-risk (LR) types.

HPV DNA prevalence: HPV samples will be obtained by rubbing a moist cotton swab on glans penis (including sulcus coronarius and underneath preputium), the penile shaft, scrotum and perineum following a loosening of the cells with a nail file. This procedure is adapted from the Merck male clinical studies. We have previously documented that this technique is useful for obtaining HPV samples among men (Morré et al., 2000; Morré et al., 2002; Kjær et al. 2005), and most recently, we have included more than 2,500 men from Danish military barracks in a study assessing the presence of HPV DNA and HPV type distribution in Danish men. The HPV samples from the Tanzanian men will be sent with currier to Prof. Iftners laboratory in Germany where they will be tested for HPV by means of the Hybrid Capture 2 (HC2) method (Digene), low-risk and high-risk probes.

HPV type distribution: HPV genotyping will be performed using Papillocheck - a DNA-Chip analysis for the type-specific identification of 18 high-risk and 6 low-risk types of HPV. Alternatively if funding allows it, we will use a reverse hybridization line probe assay test (LiPa test) from Innogenetics (which is more expensive, but is slightly more sensitive than the Papillocheck test, and another advantage is that we have used this test in our Danish HPV study of 2,500 men). The testing strategy will be to genotype all HC2 positive (HR positive and/or LR positive) samples.

Assessment of HIV status: An HIV test will be offered to all men enrolled in the study and performed taking into account the individual person's wish to be tested and informed about their HIV status. HIV antibody presence in whole blood samples will be assessed following the WHO approved HIV serial testing algorithm. Initially, the Bioline HIV-1/2 immunodetection is used, and is subsequently followed by Determine HIV-1/2 test in order to confirm Bioline potentially positive results.

Assessment of risk factors associated with HPV infection: A structured interview focusing on socio-economic characteristics, circumcision status, sexual activity, STI history and knowledge about HPV and the HPV/ cancer relationship, will be conducted.

Study Type

Observational

Enrollment (Actual)

1933

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, DK-2100
        • Inst. of Cancer Epidemiology, Danish Cancer Society

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Tanzanian men from an urban setting (Dar es Sallam)(factories, University, college)and men from an rural setting (Muhesa, Mwanga, Bagamoyo)

Description

Inclusion Criteria:

  • men who are able to understand the information about the study (in writing or oral)

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Human papillomavirus
Tanzanian men with HPV and Tanzanian men without

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HPV infection
Time Frame: At enrollment
At enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
HIV infection
Time Frame: At enrollment
At enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Cancer Society

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Susanne K. Kjaer, Professor MD, Inst. of Cancer Epidemiology,Danish Cancer Society

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

June 30, 2009

First Submitted That Met QC Criteria

June 30, 2009

First Posted (Estimate)

July 2, 2009

Study Record Updates

Last Update Posted (Estimate)

August 11, 2015

Last Update Submitted That Met QC Criteria

August 7, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPV IISP #36113

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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