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

HPV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05616767
• Other study ID #: 000017185
• Status: Completed
• Phase: N/A
• Start date: November 30, 2022
• Est. completion date: April 25, 2023

Study information

• Verified date: December 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: April 25, 2023
• Est. primary completion date: April 25, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age over 18

• gay or bisexual men

• speak Kiswahili or English

• resident in Dar es Salam

Related Conditions & MeSH terms

• HPV

Intervention

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.

Locations

Country	Name	City	State
Tanzania	Dar es Salaam	Dar es Salaam

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assess screening practices of hrHPV-related OPCa	Questionaire	Baseline
Primary	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
Primary	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
Primary	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
Primary	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