Supporting the National Expansion of HPV-based Cervical Cancer Screening in Tanzania Among Women Living With HIV - Trial NCT06402383

Timeline & Enrollment

Primary Outcome

Evidence Generation for use of a 4-step HPV testing, triage and vaccinate strategy

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 Tanzania's 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.

ICD-10 Classifications