HivLiVes-LLCNCT06144229
Real-world Effectiveness of HPV Vaccine in Women Living With HIV and Its Impact on Cervical Cancer Screening Accuracies
An observational study of Hiv and Hpv, run by University of California, Los Angeles at 9 sites in United States.
Trial summary
This study will examine both Human papillomavirus (HPV) vaccine effectiveness and Primary high-risk HPV PHS screening triage strategies in women living with HIV (WLHIV) by partnering with the Pediatric HIV/AIDs Cohort Study (PHACS) led, in part, by our investigative team. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women only
- What is being tested?
- Self-Collection HPV testing kit from Abbott
- How many people
- 650 participants
- Where
- 9 sitesUnited States
- Study dates
- 12 Nov 2024to Jan 2029
- Phase
- Observational
- 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 21 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Approximately 810 WLHIV greater than or equal to 21 years of age to less than or equal to 40 years of age who are current participants in PHACS (SMARTT, AMP Up, and AMP Up Lite) or HOPE will be tested for hrHPV using a Food and Drug Administration (FDA)-approved primary hrHPV screening test from self-collected specimens.
Who may be able to join
- At least 21 years of age and less than or equal to 40 years of age;
- WLHIV regardless of mode of transmission or HPV vaccination status;
- Current enrollment in the Pediatric HIV/AIDS Cohort Study (PHACS),Surveillance Monitoring for ART Toxicities (SMARTT), Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up), Adolescent Master Protocol for Participants 18 Years of Age and Older - Lite (AMP Up Lite), or Health Outcomes around Pregnancy and Exposure to HIV/ARVs (HOPE) studies;
- Willing to participate and able to provide informed consent;
- Willing to grant access to other PHACS/HOPE data; and
- Willing to provide access to medical records.
Who cannot join
- Currently known to be pregnant via self-report at hrHPV screening for initial consent;
- Special consideration: Women who test positive on urine pregnancy test at the baseline colposcopy visit will be asked to defer their colposcopy until after 6 weeks following the end of the pregnancy. However, pregnancy during follow-up will be allowed, and guidelines for endocervical curettage (ECC) and treatment will be followed.39
- Women known to have active CIN 2 or greater, undergoing active surveillance with colposcopy (per participant report);
- Women with known bleeding disorders;
- Women unable to consent for themselves; and
- Women with a hysterectomy with removal of the cervix will be excluded from the study and, if such a procedure is conducted during the participant's study enrollment, the individual will be censored from analysis at the last visit prior to the hysterectomy and taken off-study.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites
Boston Children's Hospital
Boston, Massachusetts, 02115
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611-2991
University of Colorado
Denver, Colorado, 13123
Baylor college of Medicine
Houston, Texas, 77030
St. Jude Children's research hospital
Memphis, Tennessee, 38105
Univeristy of Miami
Miami, Florida, 33136
Children's Hospital New Orleans
New Orleans, Louisiana, 70112
Bronx-Lebanon Hospital Center Health Care System
The Bronx, New York, 10457
Jacobi Medical Center
The Bronx, New York, 10461
About this study
Official title: Real-world Effectiveness of HPV Vaccine in Women Living With HIV and Its Impact on Cervical Cancer Screening Accuracies (LiVes LLC Study)
This study will examine both Human papillomavirus (HPV) vaccine effectiveness and Primary high-risk HPV PHS screening triage strategies in women living with HIV (WLHIV) by partnering with the Pediatric HIV/AIDs Cohort Study (PHACS) led, in part, by our investigative team. Among WWH, the study will examine the effectiveness of the HPV vaccine The study will screen approximately 810 WWH using a self-sampling kit and those who are PHS[+] will attend a clinical visit to have colposcopy/biopsy and 4 triage tests. WWH with <CIN 2+ are asked to return annually for colposcopy and HPV genotyping for up to 3 yrs. WWH PHS[-] will be asked to return in Year 2 for rescreening. Those PHS[+] will be followed as above and PHS[-] will be asked to obtain self-collected vaginal samples for HPV genotyping annually for 3 years.
- Being tested
- Self-Collection HPV testing kit from Abbott
- Keywords
- HPV vaccine effectiveness among those living with HIV, Biomarker evaluation for triage of primary HPV cervical cancer screening.
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Collection HPV testing kit from AbbottDiagnostic test
Self-swab collection kits, participates will self-collected vaginal swab for hrHPV test (at home or in the clinic)
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of HPV vaccine in WLHIV
-3-year cumulative risk of (i) vaccine-hrHPV types that persist 12 months or longer, and (ii) histologic (h) CIN 2+ (CIN 2+ throughout the protocol means "CIN 2 and worse").
Measured: 3-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start12 Nov 2024
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Frontier Science & Technology Research Foundation, Inc., Albert Einstein College of Medicine, St. Jude Children's Research Hospital, University of Colorado, Denver, Bronx-Lebanon Hospital Center Health Care System, University of Miami, Baylor College of Medicine, Children's Hospital New Orleans, LA, Jacobi Medical Center, Ann & Robert H Lurie Children's Hospital of Chicago
- Responsible party
- Principal investigator, Anna-Barbara Moscicki, MD, University of California, Los Angeles
- Investigators
- Anna-Barbara Moscicki, MD, Principal investigator, University of California, Los AngelesDenise L Jacobson, PhD,MPH, Study chair, Harvard School of Public Health (HSPH)Howard D Strickler, MD, MPH, Study chair, Albert Einstein College of MedicineTzy-Jyun Yao, PhD, Study chair, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144229
- Sponsor's protocol ID
- PH700
- Acronym
- LiVes-LLC
- Status last verified
- Apr 2026
- First submitted
- 16 Nov 2023
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Effectiveness of HPV Vaccine in Women Living With HIV and Its Impact on Cervical Cancer Screening Accuracies (LiVes LLC Study)
- ClinicalTrials.gov ID
- NCT06144229
- Acronym / sponsor ID
- LiVes-LLC / PH700
- Keywords
- HPV vaccine effectiveness among those living with HIV, Biomarker evaluation for triage of primary HPV cervical cancer screening.
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Frontier Science & Technology Research Foundation, Inc., Albert Einstein College of Medicine, St. Jude Children's Research Hospital, University of Colorado, Denver, Bronx-Lebanon Hospital Center Health Care System, University of Miami, Baylor College of Medicine, Children's Hospital New Orleans, LA, Jacobi Medical Center, Ann & Robert H Lurie Children's Hospital of Chicago
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 22 Nov 2023 (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.
This study will examine both Human papillomavirus (HPV) vaccine effectiveness and Primary high-risk HPV PHS screening triage strategies in women living with HIV (WLHIV) by partnering with the Pediatric HIV/AIDs Cohort Study (PHACS) led, in part, by our investigative team. Among WWH, the study will examine the effectiveness of the HPV vaccine The study will screen approximately 810 WWH using a self-sampling kit and those who are PHS[+] will attend a clinical visit to have colposcopy/biopsy and 4 triage tests. WWH with <CIN 2+ are asked to return annually for colposcopy and HPV genotyping for up to 3 yrs. WWH PHS[-] will be asked to return in Year 2 for rescreening. Those PHS[+] will be followed as above and PHS[-] will be asked to obtain self-collected vaginal samples for HPV genotyping annually for 3 years.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Approximately 810 WLHIV greater than or equal to 21 years of age to less than or equal to 40 years of age who are current participants in PHACS (SMARTT, AMP Up, and AMP Up Lite) or HOPE will be tested for hrHPV using a Food and Drug Administration (FDA)-approved primary hrHPV screening test from self-collected specimens.
Key inclusion criteria (6 listed)
- At least 21 years of age and less than or equal to 40 years of age;
- WLHIV regardless of mode of transmission or HPV vaccination status;
- Current enrollment in the Pediatric HIV/AIDS Cohort Study (PHACS),Surveillance Monitoring for ART Toxicities (SMARTT), Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up), Adolescent Master Protocol for Participants 18 Years of Age and Older - Lite (AMP Up Lite), or Health Outcomes around Pregnancy and Exposure to HIV/ARVs (HOPE) studies;
- Willing to participate and able to provide informed consent;
- Willing to grant access to other PHACS/HOPE data; and
Key exclusion criteria (6 listed)
- Currently known to be pregnant via self-report at hrHPV screening for initial consent;
- Special consideration: Women who test positive on urine pregnancy test at the baseline colposcopy visit will be asked to defer their colposcopy until after 6 weeks following the end of the pregnancy. However, pregnancy during follow-up will be allowed, and guidelines for endocervical curettage (ECC) and treatment will be followed.39
- Women known to have active CIN 2 or greater, undergoing active surveillance with colposcopy (per participant report);
- Women with known bleeding disorders;
- Women unable to consent for themselves; and
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 |
|---|---|---|
| Self-Collection HPV testing kit from AbbottSelf-swab collection kits, participates will self-collected vaginal swab for hrHPV test (at home or in the clinic) | Diagnostic test | – |
Primary outcome
Effectiveness of HPV vaccine in WLHIV
Time frame: 3-year
-3-year cumulative risk of (i) vaccine-hrHPV types that persist 12 months or longer, and (ii) histologic (h) CIN 2+ (CIN 2+ throughout the protocol means "CIN 2 and worse").
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 18 May 2026.
- Individual participant dataSharing planned: No
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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.
Anna-Barbara Moscicki, MD principal investigator
University of California, Los Angeles
Denise L Jacobson, PhD,MPH study chair
Harvard School of Public Health (HSPH)
Howard D Strickler, MD, MPH study chair
Albert Einstein College of Medicine
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hiv and Hpv, run by University of California, Los Angeles at 9 sites in United States.
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 6 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of HPV vaccine in WLHIV (time frame: 3-year). 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 18 May 2026.