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

NCT05616767 | Completed

• 1 other identifier: 000017185
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

HPV

Outcome Measures

Primary Outcomes (5)

• assess screening practices of hrHPV-related OPCa

  Questionaire

  Baseline

• To assess the acceptability and feasibility of teaching SMM in Tanzania to conduct self-exams

  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

  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

  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

  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

Study Arms (1)

Training on self-screening and HPV vaccination administration

EXPERIMENTAL

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

Interventions

Training on self-screening and HPV vaccination administration OTHER

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.

Training on self-screening and HPV vaccination administration

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: gay or bisexual men
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Dar es Salaam

Dar es Salaam, Tanzania

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 15, 2022
• Study Start: November 30, 2022
• Primary Completion: April 25, 2023
• Study Completion: April 25, 2023
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1)