HPVNCT05616767
Prevention and Screening for Early Detection of HPV-related Cancers in Gay and Bisexual Men in Tanzania
A study testing Training on self-screening and HPV vaccination administration in people with HPV, run by University of Minnesota at 1 site in Tanzania.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HPV
- What is being tested?
- Training on self-screening and HPV vaccination administration
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteTanzania
- Study dates
- 30 Nov 2022to 25 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18
- gay or bisexual men
- speak Kiswahili or English
- resident in Dar es Salam
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Training on self-screening and HPV vaccination administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training on self-screening and HPV vaccination administrationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Training on self-screening and HPV vaccination administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess screening practices of hrHPV-related OPCa
Questionaire
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start30 Nov 2022
- Primary completion25 Apr 2023
- Study completion25 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPVStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616767
- Sponsor's protocol ID
- 000017185
- Status last verified
- Dec 2023
- First submitted
- 28 Oct 2022
- Last updated
- 14 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Screening for Early Detection of HPV-related Cancers in Gay and Bisexual Men in Tanzania
- ClinicalTrials.gov ID
- NCT05616767
- Acronym / sponsor ID
- 000017185
- Conditions
- HPV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 25 Apr 2023 (actual)
- First posted
- 15 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training on self-screening and HPV vaccination administration | Experimental | Other: Training on self-screening and HPV vaccination administrationteaching 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18
- gay or bisexual men
- speak Kiswahili or English
- resident in Dar es Salam
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training on self-screening and HPV vaccination administrationParticipants 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. | Other | Training on self-screening and HPV vaccination administration |
Primary outcome
assess screening practices of hrHPV-related OPCa
Time frame: Baseline
Questionaire
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for HPV
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training on self-screening and HPV vaccination administration in people with HPV, run by University of Minnesota at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess screening practices of hrHPV-related OPCa (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.