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

Sponsor

University of Minnesota (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05616767

Collaborator

(none)

100

Enrollment

Location

Arm

Anticipated Duration (Months)

11.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
HPV	Other: Training on self-screening and HPV vaccination administration	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Anticipated Study Start Date :

Nov 30, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

assess screening practices of hrHPV-related OPCa [Baseline]
Questionaire
To assess the acceptability and feasibility of teaching SMM in Tanzania to conduct self-exams [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
To assess the acceptability and feasibility of hrHPV vaccination [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
To assess the acceptability and feasibility of hrHPV vaccination [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
To assess the acceptability and feasibility of hrHPV vaccination [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dar es Salaam	Dar es Salaam		Tanzania

Sponsors and Collaborators

University of Minnesota

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Minnesota

ClinicalTrials.gov Identifier:

NCT05616767

Other Study ID Numbers:

000017185

First Posted:

Nov 15, 2022

Last Update Posted:

Nov 15, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Nov 15, 2022