Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Gender:
Female
Minimum age:
21 Years
Maximum age:
40 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Colorado
Address:
City:
Denver
Zip:
13123
Country:
United States
Contact:
Last name:
Elizabeth McFarland, MD
Email:
BETSY.MCFARLAND@CUANSCHUTZ.EDU
Investigator:
Last name:
Elizabeth McFarland, MD
Email:
Principal Investigator
Facility:
Name:
Univeristy of Miami
Address:
City:
Miami
Zip:
33136
Country:
United States
Contact:
Last name:
Patricia Jeudin
Email:
pjeudin@med.miami.edu
Investigator:
Last name:
Patricia Jeudin, MD
Email:
Principal Investigator
Facility:
Name:
Ann & Robert H Lurie Children's Hospital of Chicago
Address:
City:
Chicago
Zip:
60611-2991
Country:
United States
Contact:
Last name:
Jennifer Jao, MD
Email:
JJao@luriechildrens.org
Investigator:
Last name:
Jennifer Jao, MD
Email:
Principal Investigator
Facility:
Name:
Children's Hospital New Orleans
Address:
City:
New Orleans
Zip:
70112
Country:
United States
Contact:
Last name:
Margarita Silio, MD
Email:
msilio@tulane.edu
Investigator:
Last name:
Margarita Silio, MD
Email:
Principal Investigator
Facility:
Name:
Boston Children's Hospital
Address:
City:
Boston
Zip:
02115
Country:
United States
Contact:
Last name:
Sandra Burchett, MD
Email:
sandra.burchett@childrens.harvard.edu
Investigator:
Last name:
Sandra Burchett, MD
Email:
Principal Investigator
Facility:
Name:
Bronx-Lebanon Hospital Center Health Care System
Address:
City:
Bronx
Zip:
10457
Country:
United States
Contact:
Last name:
Murli Purswani, MD
Email:
mpurswan@bronxleb.org
Investigator:
Last name:
Murli Purswani, MD
Email:
Principal Investigator
Facility:
Name:
Jacobi Medical Center
Address:
City:
Bronx
Zip:
10461
Country:
United States
Contact:
Last name:
Andrew Wiznia, MD
Email:
andrew.wiznia@einsteinmed.org
Investigator:
Last name:
Andrew Wiznia, MD
Email:
Principal Investigator
Facility:
Name:
St. Jude Children's research hospital
Address:
City:
Memphis
Zip:
38105
Country:
United States
Contact:
Last name:
Katherine Knapp, MD
Email:
katherine.knapp@stjude.org
Investigator:
Last name:
Katherine Knapp, MD
Email:
Principal Investigator
Facility:
Name:
Baylor college of Medicine
Address:
City:
Houston
Zip:
77030
Country:
United States
Contact:
Last name:
Mary Paul, MD
Email:
mepaul@texaschildrens.org
Investigator:
Last name:
Mary Paul, MD
Email:
Principal Investigator
Start date:
August 2024
Completion date:
August 2028
Lead sponsor:
Agency:
University of California, Los Angeles
Agency class:
Other
Collaborator:
Agency:
Harvard School of Public Health (HSPH)
Agency class:
Other
Collaborator:
Agency:
Frontier Science & Technology Research Foundation, Inc.
Agency class:
Industry
Collaborator:
Agency:
Albert Einstein College of Medicine
Agency class:
Other
Collaborator:
Agency:
Boston Children's Hospital
Agency class:
Other
Collaborator:
Agency:
St. Jude Children's Research Hospital
Agency class:
Other
Collaborator:
Agency:
University of Colorado, Denver
Agency class:
Other
Collaborator:
Agency:
Bronx-Lebanon Hospital Center Health Care System
Agency class:
Other
Collaborator:
Agency:
University of Miami
Agency class:
Other
Collaborator:
Agency:
Baylor College of Medicine
Agency class:
Other
Collaborator:
Agency:
Children's Hospital New Orleans, LA
Agency class:
Other
Collaborator:
Agency:
Jacobi Medical Center
Agency class:
Other
Collaborator:
Agency:
Ann & Robert H Lurie Children's Hospital of Chicago
Agency class:
Other
Collaborator:
Agency:
Westat
Agency class:
Other
Source:
University of California, Los Angeles
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06144229
