Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402383
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-04-05
Brief Title:
Supporting the National Expansion of HPV-based Cervical Cancer Screening in Tanzania Among Women Living With HIV
Sponsor:
Queens University
Organization:
Queens University
Study Overview
Official Title:
Supporting the National Expansion of HPV-based Cervical Cancer Screening in Tanzania Among Women Living With HIV NECST-HIV
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cervical cancer is caused by persistent infections with one of 13 carcinogenic human papillomavirus HPV types and causes substantial morbidity and mortality worldwide
Highly effective strategies exist including HPV vaccination and HPV-based screening for early detection and treatment of precancerous lesions
The investigators are proposing an innovative implementation research program and randomized trial evaluating HPV DNA testing as a primary screening tool for cervical cancer screening in HIV Care and Treatment clinics within Tanzanias National Cervical Cancer Prevention CECAP program
The investigators will combine HPV DNA testing with high quality visual assessment of the cervix for treatment and management of cervical precancerous lesions among HPV Women Living with HIV WLWH
At 12-month follow up women will be recalled for repeat screening for HPV and visual assessment of the cervix for treatment combined with a second therapeutic dose of HPV vaccine
The investigators propose to recruit 2000 WLWH from 4 HIV Clinics in Kilimanjaro Region Two clinics will be randomized to the test treat and vaccinate strategy and two clinics will be randomized to test treat and re-screen and then vaccinate strategy
Currently there is no Standard of Care SOC for vaccination of women who are at risk for HPV in the country These two arms of the study will allow for treatment and observation to occur that would not be available otherwise
Highly effective strategies exist including HPV vaccination and HPV-based screening for early detection and treatment of precancerous lesions
The investigators are proposing an innovative implementation research program and randomized trial evaluating HPV DNA testing as a primary screening tool for cervical cancer screening in HIV Care and Treatment clinics within Tanzanias National Cervical Cancer Prevention CECAP program
The investigators will combine HPV DNA testing with high quality visual assessment of the cervix for treatment and management of cervical precancerous lesions among HPV Women Living with HIV WLWH
At 12-month follow up women will be recalled for repeat screening for HPV and visual assessment of the cervix for treatment combined with a second therapeutic dose of HPV vaccine
The investigators propose to recruit 2000 WLWH from 4 HIV Clinics in Kilimanjaro Region Two clinics will be randomized to the test treat and vaccinate strategy and two clinics will be randomized to test treat and re-screen and then vaccinate strategy
Currently there is no Standard of Care SOC for vaccination of women who are at risk for HPV in the country These two arms of the study will allow for treatment and observation to occur that would not be available otherwise
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None