HPV InfectionPhase 3H2VICTORYNCT05173324
Integration of HPV Vaccination and HPV-based Cervical Screening Into ARV Clinics: the H2VICTORY Trial
A Phase 3 study testing HPV vaccine, HPV testing and HAV vaccine in people with HPV Infection, run by International Agency for Research on Cancer.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- HPV Infection
- What is being tested?
- HPV vaccine, HPV testing and HAV vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 30 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women living with HIV (WLWH)
- Aged 25-35 years
- Attending ARV clinics
- Mentally competent to give informed consent
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Integration of HPV Vaccination and HPV-based Cervical Screening in Young Adult WLWH Into ARV Clinics to Speed the Pathway Towards Cervical Cancer Elimination: the H2VICTORY Trial
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.
Read the detailed description
An effectiveness-implementation hybrid study is proposed to evaluate the effectiveness of a dual intervention of HPV vaccination and HPV-triage-and-treat to reduce the risk of cervical cancer and to study its integration into ARV clinics. The overarching hypothesis will be that offering the dual intervention of HPV vaccination and HPV-triage-treat in young WLWH will catalyze the preventive effect of both evidence-based interventions as: (i) the HPV vaccination efficacy will be improved when applied after HPV infections are (progressively) removed by treatment of the TZ (enrolment, 12 months, both) as the vaccine will confer protection from new infections to new TZ growing cells; and (ii) the reduction of new HPV infections may allow extension of HPV-triage-treat intervals, contributing to feasible scale-up of comprehensive cervical cancer preventive care to WLWH attending ARV clinics. The H2VICTORY specific aims are:
- To assess the readiness ARV clinics in sub-Saharan African countries to inform contextually relevant strategies to de-implement current interventions (i.e. Pap, VIA) and implement and integrate the dual-intervention of HPV vaccination and HPV-based cervical screening and treatment.
- To study the implementation of the dual-intervention into ARV clinics in sub-Saharan African countries while evaluating its effectiveness (HPV vaccination \& cervical screening vs cervical screening alone) in reducing HPV infections (and therefore, the risk of cervical precancer and cancer) among WLWH aged 25-35 years.
- To assess the integration of the dual intervention in HIV clinical services and identify facilitators and barriers for the sustainability of proven effective interventions (dual-intervention, HPV cervical screening) in SSA.
H2VICTORY will include WLWH aged 25-35 years attending ARV clinics to complete HPV vaccination schemes (0-2-6-month) and to be screened with HPV testing. Participants will be evenly allocated (1:1:1) to receive HPV vaccine (3-doses or 1-dose) or placebo. WLWH in a single-dose HPV vaccination scheme will receive placebo at months 2 and 6. Follow-up visits would be scheduled at i) 2 and 6 months to complete vaccination schemes, ii) 12 months 12 (only HPV positives at screening) to complete HPV-based cervical screening according to WHO guidelines, and iii) at 24 months (all participants) to measure efficacy outcomes. Ablative treatment would be offered to those who test positive on HPV at entry and/or at 12 months according to WHO cervical cancer screening and treatment guidelines to progressively remove HPV infections present at baseline. Ablative treatment will be thermal ablation (TA) or cryotherapy (whichever is available) for eligible women (i.e., visualization of the transformation zone and no suspicion of cervical cancer). Women not eligible for TA/cryotherapy would be referred to colposcopy to assess the type of treatment (e.g., LLETZ).
Cervical samples for HPV testing and genotyping will be collected at entry, 12 months (for HPV positives at entry), and 24 months (for everyone), and blood samples for neutralizing HPV antibodies detection will be collected at entry and 24 months (for everyone). The study will initially start in four study centers in South Africa (Cape Town and Durban), Kenya (Nairobi), and Eswatini (Mbabane) where at least 500 participants will be included in each center. HPV vaccine available in school-based programs in each country will be used (i.e., bivalent in South Africa, quadrivalent in Kenya and Eswatini). Hepatitis A (HAV) vaccine will be administrated as a placebo. An experienced pharmacist will be in charge of preparing jabs according to randomization. Central computed randomization will be done. An experienced pharmacist will prepare identical appearance jabs with HPV vaccine or HAV vaccine according to assignation. Allocation will be blinded for participants, care providers, statisticians, and any other staff members. Permuted blocks size 3, and 6 will be used. Additional study centers and collaborators will be involved to extend the study to other countries and settings in order to reach the sample size.
- Conditions
- HPV Infection
- Being tested
- HPV vaccine, HPV testing, HAV vaccine
- Keywords
- HPV vaccination, HPV-based cervical screening, HIV infection, Cervical ablative treatment, Antiretroviral clinics, Implementation research, Hybrid effectiveness-implementation trials
- Medical subject headings
- Papillomavirus Infections, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV vaccineBiological
Licensed HPV vaccines (bivalent, quadrivalent, or nonvalent) available in the country of the study site
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
HAV vaccineBiological
Hepatitis A virus (HAV) vaccine to be offered as a placebo
| Study group | Role | What they receive |
|---|---|---|
| 3-doses HPV vaccination | Experimental | Participants will receive three doses of HPV vaccine at 0, 2, and 6 months Receives: Biological: HPV vaccine; Diagnostic Test: HPV testing |
| 1-dose HPV vaccination | Experimental | Participants will receive HPV vaccine at entry, and placebo (HAV vaccine) at 2 and 6 months Receives: Biological: HPV vaccine; Diagnostic Test: HPV testing; Biological: HAV vaccine |
| Placebo | Placebo comparator | Participants will receive Hepatitis A (HAV) vaccine at 0, 2, and 6 months Receives: Diagnostic Test: HPV testing; Biological: HAV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV infection
HPV prevalent infections at 24 months since initial screening
Measured: 24 months
Secondary outcomes (5)
HPV antibodies
Neutralizing antibodies of HPV at entry and at 24 months
Measured: 24 months
CD4
CD4 counts at entry and at 24 months
Measured: 24 months
HIV viral load
HIV viral load at entry and at 24 months
Measured: 24 months
Adverse events (AEs)
Adverse events
Measured: 24 months
Serious adverse events (SAEs)
SAEs
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start1 Feb 2023 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Agency for Research on Cancer
- Sponsor type
- University, hospital or other
- Collaborators
- University of New Mexico, University of Stellenbosch, University of KwaZulu, Coptic Hope Center, Emory University, Ministry of Health, Swaziland, Baylor College of Medicine Children's Foundation, Sefako Makgatho Health Sciences University, Aga Khan University, World Health Organization
- Responsible party
- Sponsor
- Investigators
- Maribel Almonte, MPH, MSc, PhD, Principal investigator, International Agency for Research on CancerArmando Baena, MSc, PhD, Principal investigator, International Agency for Research on CancerRolando Herrero, MD, PhD, Study chair, International Agency for Research on CancerMathilde Forestier, PhD, Study chair, International Agency for Research on CancerJoan Valls, MSc, PhD, Study chair, International Agency for Research on CancerLaura Downham, MSc, Study chair, International Agency for Research on CancerPrajakta Adsul, MBBS, MPH, PhD, Study chair, University of New MexicoHennie Botha, MD, PhD, Study chair, University of Stellenbosch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173324
- Sponsor's protocol ID
- PP202111-31
- Acronym
- H2VICTORY
- Status last verified
- Aug 2022
- First submitted
- 15 Dec 2021
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Plan to be defined
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of HPV Vaccination and HPV-based Cervical Screening in Young Adult WLWH Into ARV Clinics to Speed the Pathway Towards Cervical Cancer Elimination: the H2VICTORY Trial
- ClinicalTrials.gov ID
- NCT05173324
- Acronym / sponsor ID
- H2VICTORY / PP202111-31
- Conditions
- HPV Infection
- Keywords
- HPV vaccination, HPV-based cervical screening, HIV infection, Cervical ablative treatment, Antiretroviral clinics, Implementation research, Hybrid effectiveness-implementation trials
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- International Agency for Research on CancerUniversity, hospital or other
- Collaborators
- University of New Mexico, University of Stellenbosch, University of KwaZulu, Coptic Hope Center, Emory University, Ministry of Health, Swaziland, Baylor College of Medicine Children's Foundation, Sefako Makgatho Health Sciences University, Aga Khan University, World Health Organization
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 29 Dec 2021 (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.
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.
Detailed description
An effectiveness-implementation hybrid study is proposed to evaluate the effectiveness of a dual intervention of HPV vaccination and HPV-triage-and-treat to reduce the risk of cervical cancer and to study its integration into ARV clinics. The overarching hypothesis will be that offering the dual intervention of HPV vaccination and HPV-triage-treat in young WLWH will catalyze the preventive effect of both evidence-based interventions as: (i) the HPV vaccination efficacy will be improved when applied after HPV infections are (progressively) removed by treatment of the TZ (enrolment, 12 months, both) as the vaccine will confer protection from new infections to new TZ growing cells; and (ii) the reduction of new HPV infections may allow extension of HPV-triage-treat intervals, contributing to feasible scale-up of comprehensive cervical cancer preventive care to WLWH attending ARV clinics. The H2VICTORY specific aims are:
- To assess the readiness ARV clinics in sub-Saharan African countries to inform contextually relevant strategies to de-implement current interventions (i.e. Pap, VIA) and implement and integrate the dual-intervention of HPV vaccination and HPV-based cervical screening and treatment.
- To study the implementation of the dual-intervention into ARV clinics in sub-Saharan African countries while evaluating its effectiveness (HPV vaccination \& cervical screening vs cervical screening alone) in reducing HPV infections (and therefore, the risk of cervical precancer and cancer) among WLWH aged 25-35 years.
- To assess the integration of the dual intervention in HIV clinical services and identify facilitators and barriers for the sustainability of proven effective interventions (dual-intervention, HPV cervical screening) in SSA.
H2VICTORY will include WLWH aged 25-35 years attending ARV clinics to complete HPV vaccination schemes (0-2-6-month) and to be screened with HPV testing. Participants will be evenly allocated (1:1:1) to receive HPV vaccine (3-doses or 1-dose) or placebo. WLWH in a single-dose HPV vaccination scheme will receive placebo at months 2 and 6. Follow-up visits would be scheduled at i) 2 and 6 months to complete vaccination schemes, ii) 12 months 12 (only HPV positives at screening) to complete HPV-based cervical screening according to WHO guidelines, and iii) at 24 months (all participants) to measure efficacy outcomes. Ablative treatment would be offered to those who test positive on HPV at entry and/or at 12 months according to WHO cervical cancer screening and treatment guidelines to progressively remove HPV infections present at baseline. Ablative treatment will be thermal ablation (TA) or cryotherapy (whichever is available) for eligible women (i.e., visualization of the transformation zone and no suspicion of cervical cancer). Women not eligible for TA/cryotherapy would be referred to colposcopy to assess the type of treatment (e.g., LLETZ).
Cervical samples for HPV testing and genotyping will be collected at entry, 12 months (for HPV positives at entry), and 24 months (for everyone), and blood samples for neutralizing HPV antibodies detection will be collected at entry and 24 months (for everyone). The study will initially start in four study centers in South Africa (Cape Town and Durban), Kenya (Nairobi), and Eswatini (Mbabane) where at least 500 participants will be included in each center. HPV vaccine available in school-based programs in each country will be used (i.e., bivalent in South Africa, quadrivalent in Kenya and Eswatini). Hepatitis A (HAV) vaccine will be administrated as a placebo. An experienced pharmacist will be in charge of preparing jabs according to randomization. Central computed randomization will be done. An experienced pharmacist will prepare identical appearance jabs with HPV vaccine or HAV vaccine according to assignation. Allocation will be blinded for participants, care providers, statisticians, and any other staff members. Permuted blocks size 3, and 6 will be used. Additional study centers and collaborators will be involved to extend the study to other countries and settings in order to reach the sample size.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3-doses HPV vaccination | Experimental | Biological: HPV vaccine, Diagnostic Test: HPV testingParticipants will receive three doses of HPV vaccine at 0, 2, and 6 months |
| 1-dose HPV vaccination | Experimental | Biological: HPV vaccine, Diagnostic Test: HPV testing, Biological: HAV vaccineParticipants will receive HPV vaccine at entry, and placebo (HAV vaccine) at 2 and 6 months |
| Placebo | Placebo comparator | Diagnostic Test: HPV testing, Biological: HAV vaccineParticipants will receive Hepatitis A (HAV) vaccine at 0, 2, and 6 months |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women living with HIV (WLWH)
- Aged 25-35 years
- Attending ARV clinics
- Mentally competent to give informed consent
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| HPV vaccineLicensed HPV vaccines (bivalent, quadrivalent, or nonvalent) available in the country of the study site | Biological | 1-dose HPV vaccination, 3-doses HPV vaccination |
| HPV testingHPV 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 | Diagnostic test | 1-dose HPV vaccination, 3-doses HPV vaccination, Placebo |
| HAV vaccineHepatitis A virus (HAV) vaccine to be offered as a placebo | Biological | 1-dose HPV vaccination, Placebo |
Primary outcome
HPV infection
Time frame: 24 months
HPV prevalent infections at 24 months since initial screening
5 secondary outcomes
HPV antibodies
Time frame: 24 months
CD4
Time frame: 24 months
HIV viral load
Time frame: 24 months
Adverse events (AEs)
Time frame: 24 months
Serious adverse events (SAEs)
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Individual participant dataSharing planned: Undecided. Plan to be defined
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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.
Maribel Almonte, MPH, MSc, PhD principal investigator
International Agency for Research on Cancer
Armando Baena, MSc, PhD principal investigator
International Agency for Research on Cancer
Rolando Herrero, MD, PhD study chair
International Agency for Research on Cancer
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HPV vaccine, HPV testing and HAV vaccine in people with HPV Infection, run by International Agency for Research on Cancer.
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 4 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: opening soon, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Armando Baena, MSc, PhD (+33 4 72 73 88 55, baenaa@iarc.who.int), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV infection (time frame: 24 months). 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 3 Aug 2022.