Integration of HPV Vaccination and HPV-based Cervical Screening Into ARV Clinics: the H2VICTORY Trial

Brief summary (registry, in English)

A 3-dose HPV vaccination scheme has shown to be safe and immunogenic in people living with HIV (PLWH), although evidence on 1-dose, which is important to improve coverage, is scarce. Available HPV vaccines only prevent new infections. Since a large fraction of WLWH is already infected with HPV (\>50%), vaccines' efficacy to prevent HPV infections (and therefore cervical disease) in this population is limited. Current WHO cervical cancer screening guidelines recommend treatment of the transformation zone (TZ) of WLWH who harbor HPV infections either at initial screening or one year later. Therefore, HPV vaccination at the time of the screening may improve vaccines efficacy conferring protection to newly growing cells of the treated TZ against HPV infections/re-infections. Consequently, a dual-intervention of HPV vaccination and HPV-based cervical screening in WLWH may alleviate the burden of HPV-related disease by improving HPV vaccination efficacy while extending cervical screening intervals. Nevertheless, implementing the dual-intervention may be challenging particularly in some contexts without well-established cervical cancer screening such as sub-Saharan African (SSA) countries. However, in these countries, at least 60% of PLWH regularly attend ARV clinics to be monitored and receive ARV treatment (cART). Therefore, integrating the dual-intervention into ARV clinics seems to be an efficient approach to reduce loss to follow-up while improving overall coverages of HPV vaccination and cervical screening. Such integration may also facilitate the implementation of a platform for the delivery of other HPV-related preventive measures such as HPV therapeutic vaccines. Nevertheless, little is known about the efficacy of HPV vaccination in WLWH to prevent HPV infections and HPV-related diseases, especially in young adults. Moreover, evidence on how best to conduct cervical cancer prevention, particularly recently released WHO guidelines, through ARV clinics is limited. Therefore, IARC/WHO in collaboration with HRP/WHO and colleagues in SSA proposes to conduct a hybrid effectiveness-implementation trial (H2VICTORY) to evaluate the effectiveness of the dual-intervention of HPV vaccination and HPV-based cervical screening to reduce HPV infections (and therefore, the risk of cervical cancer) in WLWH aged 25-35 years while conducting implementation research to identify facilitators and barriers for adoption and sustainability of proven evidence-based cervical cancer prevention approaches integrated into ARV clinics across sub-Saharan Africa.

What you commit to

• Study type: Interventional · Phase 3
• Planned participants: 8000
• From 1 Feb 2023 to the primary completion date, 30 Jun 2027
• No sites listed in no country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 25 years to 35 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov