NCT05173324

Brief Summary

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,000

participants targeted

Target at P75+ for phase_3

Timeline
14mo left

Started Feb 2023

Typical duration for phase_3

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress74%
Feb 2023Jun 2027

First Submitted

Initial submission to the registry

December 15, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 29, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

4.4 years

First QC Date

December 15, 2021

Last Update Submit

August 2, 2022

Conditions

HPV Infection

Keywords

HPV vaccinationHPV-based cervical screeningHIV infectionCervical ablative treatmentAntiretroviral clinicsImplementation researchHybrid effectiveness-implementation trials

Outcome Measures

Primary Outcomes (1)

  • HPV infection

    HPV prevalent infections at 24 months since initial screening

    24 months

Secondary Outcomes (5)

  • HPV antibodies

    24 months

  • CD4

    24 months

  • HIV viral load

    24 months

  • Adverse events (AEs)

    24 months

  • Serious adverse events (SAEs)

    24 months

Study Arms (3)

3-doses HPV vaccination

EXPERIMENTAL

Participants will receive three doses of HPV vaccine at 0, 2, and 6 months

Biological: HPV vaccineDiagnostic Test: HPV testing

1-dose HPV vaccination

EXPERIMENTAL

Participants will receive HPV vaccine at entry, and placebo (HAV vaccine) at 2 and 6 months

Biological: HPV vaccineDiagnostic Test: HPV testingBiological: HAV vaccine

Placebo

PLACEBO COMPARATOR

Participants will receive Hepatitis A (HAV) vaccine at 0, 2, and 6 months

Diagnostic Test: HPV testingBiological: HAV vaccine

Interventions

HPV vaccineBIOLOGICAL

Licensed HPV vaccines (bivalent, quadrivalent, or nonvalent) available in the country of the study site

1-dose HPV vaccination3-doses HPV vaccination
HPV testingDIAGNOSTIC_TEST

HPV testing with partial genotyping of HPV16/18 (and/or 45) to be used as a primary cervical screening test for all participants regardless of the study arm

1-dose HPV vaccination3-doses HPV vaccinationPlacebo
HAV vaccineBIOLOGICAL

Hepatitis A virus (HAV) vaccine to be offered as a placebo

1-dose HPV vaccinationPlacebo

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen with cervix
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women living with HIV (WLWH)
  • Aged 25-35 years
  • Attending ARV clinics
  • Mentally competent to give informed consent

You may not qualify if:

  • Pregnancy
  • Less than 3 months postpartum
  • Women without a cervix (e.g., hysterectomy)
  • Plans to move to another city in the next 2 years or any other reason to prevent finalizing the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Papillomavirus InfectionsHIV Infections

Interventions

Papillomavirus Vaccines

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBlood-Borne InfectionsLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Maribel Almonte, MPH, MSc, PhD

    International Agency for Research on Cancer

    PRINCIPAL INVESTIGATOR

  • Armando Baena, MSc, PhD

    International Agency for Research on Cancer

    PRINCIPAL INVESTIGATOR

  • Rolando Herrero, MD, PhD

    International Agency for Research on Cancer

    STUDY CHAIR

  • Mathilde Forestier, PhD

    International Agency for Research on Cancer

    STUDY CHAIR

  • Joan Valls, MSc, PhD

    International Agency for Research on Cancer

    STUDY CHAIR

  • Laura Downham, MSc

    International Agency for Research on Cancer

    STUDY CHAIR

  • Prajakta Adsul, MBBS, MPH, PhD

    University of New Mexico

    STUDY CHAIR

  • Hennie Botha, MD, PhD

    University of Stellenbosch

    STUDY CHAIR

  • Haynes van der Merwe, MD, PhD

    University of Stellenbosch

    STUDY CHAIR

  • Motshedisi Sebitloane, MBChB, PhD

    University of KwaZulu

    STUDY CHAIR

  • Themba Ginindza, MSc, MPH, PhD

    University of KwaZulu

    STUDY CHAIR

  • Samah R Sakr, MBChB

    Coptic Hope Center

    STUDY CHAIR

  • Michael H Chung, MD, MPH, PhD

    Emory University

    STUDY CHAIR

  • Xolisile Dlamini, MPH

    National Cancer Control Unit - Eswatini Ministry of Health

    STUDY CHAIR

  • Florence A Anabwani-Richter, MBChB, MPH

    Baylor College of Medicine Children's Foundation

    STUDY CHAIR

  • Lisbeth Lebelo, PhD

    Sefako Makgatho Health Sciences University

    STUDY CHAIR

  • Marleen Temmerman, MD, PhD

    Aga Khan University

    STUDY CHAIR

  • Jean-Marie Dangou, PhD

    World Health Organization (AFRO/WHO)

    STUDY CHAIR

  • Nathalie Broutet, MD, PhD

    World Health Organization

    STUDY CHAIR

  • Sami L Gottlieb, PhD

    World Health Organization

    STUDY CHAIR

  • Paul Bloem, MSc

    World Health Organization

    STUDY CHAIR

  • Soe Soe Thwin, MSc, PhD

    World Health Organization

    STUDY CHAIR

  • Ajay Rangaraj, MD, MSc

    World Health Organization

    STUDY CHAIR

Central Study Contacts

Armando Baena, MSc, PhD

CONTACT

+33 4 72 73 88 55baenaa@iarc.who.int

Maribel Almonte, MPH, MSc, PhD

CONTACT

+33 4 72 73 84 92almontem@iarc.who.int

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2021

First Posted

December 29, 2021

Study Start

February 1, 2023

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

August 3, 2022

Record last verified: 2022-08