Prevention and Screening for Early Detection of HPV-related Cancers in Gay and Bisexual Men in Tanzania

December 13, 2023 updated by: University of Minnesota
The long-term objective of the parent study is "to reduce the effects of OPCa through secondary prevention (i.e., early detection, diagnosis and treatment referral)." Consistent with this, this supplement will test HPV-related interventions tailored for Sexual Minority Men (SMM). Acceptability, feasibility and preliminary effectiveness of a smart-phone delivered Oropharyngeal Cancer (OPCA) self-assessment tool will be assessed. Given that homosexuality is stigmatized and criminalized in Tanzania, and that cell phone use is the key way SMM communicate in Tanzania, a self-assessment screening cell phone intervention holds particular promise for SMM in Tanzania but warrants separate evaluation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Not Applicable

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

  • Tanzania
      • Dar es Salaam, Tanzania
        • Dar es Salaam

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

Description

Inclusion Criteria:

  • Age over 18
  • gay or bisexual men
  • speak Kiswahili or English
  • resident in Dar es Salam

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

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Training on self-screening and HPV vaccination administration
teaching SMM in Tanzania to conduct self-exams for oropharyngeal hrHPV-associated cancers using cellphone-mediated oral selfies, and administering the HPV vaccination series (with 2 and 6-8 month follow-up) to those who request it
Other: Training on self-screening and HPV vaccination administration
Participants will be taught how to do self-screening for HPV-associated cancers using Training on self-screening and HPV vaccination administration. They will also be given HPV vaccination series.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assess screening practices of hrHPV-related OPCa
Time Frame: Baseline
Questionaire
Baseline
To assess the acceptability and feasibility of teaching SMM in Tanzania to conduct self-exams
Time Frame: baseline to 6 months
Questionaire to assess post-test selfie evaluations, Scores: 0= was not trained; 1= was trained; 2=took a selfie; 3= clear selfie
baseline to 6 months
To assess the acceptability and feasibility of hrHPV vaccination
Time Frame: baseline
percentage of individuals recruited for aim 1 who request HPV vaccination, Scores are 0=no vaccination; 1=first vaccination; 2= second vaccination; 3=third vaccination
baseline
To assess the acceptability and feasibility of hrHPV vaccination
Time Frame: 1 month
percentage of individuals recruited for aim 1 who request HPV vaccination, Scores are 0=no vaccination; 1=first vaccination; 2= second vaccination; 3=third vaccination
1 month
To assess the acceptability and feasibility of hrHPV vaccination
Time Frame: 6 months
percentage of individuals recruited for aim 1 who request HPV vaccination, Scores are 0=no vaccination; 1=first vaccination; 2= second vaccination; 3=third vaccination
6 months

Collaborators and Investigators

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

Sponsor

University of Minnesota

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 (Actual)

November 30, 2022

Primary Completion (Actual)

April 25, 2023

Study Completion (Actual)

April 25, 2023

Study Registration Dates

First Submitted

October 28, 2022

First Submitted That Met QC Criteria

November 8, 2022

First Posted (Actual)

November 15, 2022

Study Record Updates

Last Update Posted (Estimated)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 000017185

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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