NCT00932009

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,933

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

August 11, 2015

Status Verified

August 1, 2015

Enrollment Period

5 months

First QC Date

June 30, 2009

Last Update Submit

August 7, 2015

Conditions

Keywords

Human papillomavirus infectionTanzanian menPrevalence

Outcome Measures

Primary Outcomes (1)

  • HPV infection

    At enrollment

Secondary Outcomes (1)

  • HIV infection

    At enrollment

Study Arms (1)

Human papillomavirus

Tanzanian men with HPV and Tanzanian men without

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inst. of Cancer Epidemiology, Danish Cancer Society

Copenhagen, DK-2100, Denmark

Location

Related Publications (4)

  • Olesen TB, Munk C, Mwaiselage J, Kahesa C, Rasch V, Frederiksen K, Iftner T, Kjaer SK. Male circumcision and the risk of gonorrhoea, syphilis, HIV and human papillomavirus among men in Tanzania. Int J STD AIDS. 2019 Dec;30(14):1408-1416. doi: 10.1177/0956462419874593. No abstract available.

  • Olesen TB, Mwaiselage J, Iftner T, Kahesa C, Rasch V, Frederiksen K, Munk C, Kjaer SK. Risk factors for genital human papillomavirus among men in Tanzania. J Med Virol. 2017 Feb;89(2):345-351. doi: 10.1002/jmv.24627. Epub 2016 Jul 20.

  • Olesen TB, Munk C, Christensen J, Andersen KK, Kjaer SK. Human papillomavirus prevalence among men in sub-Saharan Africa: a systematic review and meta-analysis. Sex Transm Infect. 2014 Sep;90(6):455-62. doi: 10.1136/sextrans-2013-051456. Epub 2014 May 7.

  • Olesen TB, Iftner T, Mwaiselage J, Kahesa C, Rasch V, Ngoma T, Munk C, Kjaer SK. Prevalence and type distribution of human papillomavirus among 1813 men in Tanzania and the relationship to HIV status. Sex Transm Dis. 2013 Jul;40(7):592-8. doi: 10.1097/OLQ.0b013e31828fcf57.

Biospecimen

Retention: SAMPLES WITH DNA

cell scrapes from penis

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Susanne K. Kjaer, Professor MD

    Inst. of Cancer Epidemiology,Danish Cancer Society

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 30, 2009

First Posted

July 2, 2009

Study Start

March 1, 2009

Primary Completion

August 1, 2009

Study Completion

December 1, 2009

Last Updated

August 11, 2015

Record last verified: 2015-08

Locations