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| Name | Class |
|---|---|
| Frontier Science & Technology Research Foundation, Inc. | INDUSTRY |
| Albert Einstein College of Medicine | OTHER |
| St. Jude Children's Research Hospital | OTHER |
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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 \
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-Collection HPV testing kit from Abbott | Diagnostic Test | Self-swab collection kits, participates will self-collected vaginal swab for hrHPV test (at home or in the clinic) |
| Measure | Description | Time Frame |
|---|---|---|
| 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"). | 3-year |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Anna-Barbara Moscicki, MD | University of California, Los Angeles | Principal Investigator |
| Denise L Jacobson, PhD,MPH | Harvard School of Public Health (HSPH) | Study Chair |
| Howard D Strickler, MD, MPH | Albert Einstein College of Medicine | Study Chair |
| Tzy-Jyun Yao, PhD | Harvard School of Public Health (HSPH) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Denver | Colorado | 13123 | United States | ||
| Univeristy of Miami |
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| University of Colorado, Denver |
| OTHER |
| Bronx-Lebanon Hospital Center Health Care System | OTHER |
| University of Miami | OTHER |
| Baylor College of Medicine | OTHER |
| Children's Hospital New Orleans, LA | OTHER |
| Jacobi Medical Center | OTHER |
| Ann & Robert H Lurie Children's Hospital of Chicago | OTHER |
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Cervical vaginal normal saline washes Exfoliated cervical cells
| Miami |
| Florida |
| 33136 |
| United States |
| Ann & Robert H Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611-2991 | United States |
| Children's Hospital New Orleans | New Orleans | Louisiana | 70112 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| Bronx-Lebanon Hospital Center Health Care System | The Bronx | New York | 10457 | United States |
| Jacobi Medical Center | The Bronx | New York | 10461 | United States |
| St. Jude Children's research hospital | Memphis | Tennessee | 38105 | United States |
| Baylor college of Medicine | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D004266 | DNA Virus Infections |
| D014412 | Tumor Virus Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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