Real-world Effectiveness of HPV Vaccine in Women Living With HIV and Its Impact on Cervical Cancer Screening Accuracies (LiVes LLC Study)
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Hiv
- 发起方
- University of California, Los Angeles
- 入组人数
- 810
- 试验地点
- 18
- 主要终点
- Effectiveness of HPV vaccine in WLHIV
- 状态
- Enrolling By Invitation
- 最后更新
- 昨天
概览
简要总结
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.
研究者
Anna-Barbara Moscicki, MD
Principal Investigator
University of California, Los Angeles
入排标准
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Effectiveness of HPV vaccine in WLHIV
时间窗: 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").