Cryotherapy vs. LEEP to Treat Cervical Intraepithelial Neoplasia (CIN) 2/3 Among HIV-positive Women
PHE-LEEP
Impact of Cryotherapy Versus Loop Electrosurgical Excision Procedure (LEEP) on Recurrence of Cervical Intraepithelial Neoplasia and HIV-1 Cervical Shedding Among HIV-positive Women
2 other identifiers
interventional
400
1 country
1
Brief Summary
The purpose of this study is to compare the rate of recurrence of cervical intraepithelial neoplasia among HIV-positive women receiving cryotherapy versus LEEP over 2 years of follow-up and to compare the shedding of HIV-1 from the cervix between HIV-positive women receiving cryotherapy versus LEEP over 3 weeks of follow-up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2011
CompletedFirst Posted
Study publicly available on registry
February 17, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedResults Posted
Study results publicly available
October 18, 2019
CompletedNovember 12, 2019
October 1, 2019
5.3 years
February 16, 2011
September 23, 2019
October 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Recurrence of Cervical Intraepithelial Neoplasia Among HIV-positive Women
Rate of recurrence of cervical intraepithelial neoplasia among HIV-positive women receiving cryotherapy versus LEEP over 2 years of follow-up
2 years
Secondary Outcomes (1)
Shedding of HIV-1 From the Cervix Between HIV-positive Women
3 weeks
Study Arms (2)
Cryotherapy
EXPERIMENTALCryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix
Loop Electrosurgical Excision Procedure
EXPERIMENTALLoop Electrosurgical Excision Procedure (LEEP) uses a low-voltage electrified wire loop to cut out diseased part of cervix
Interventions
LEEP procedure uses a low-voltage electrified wire loop to cut out diseased part of cervix
Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix
Eligibility Criteria
You may qualify if:
- HIV positive receiving care at the Coptic Hope Center
- Not pregnant by clinical examination or history
- Have an intact cervix
- Have not received prior cervical treatment
- Do not have a history of a bleeding disorder
- Are above 18 years of age
You may not qualify if:
- HIV-negative
- Male
- Below 18 years of age
- Pregnant by clinical examination or history
- Post-hysterectomy
- Post-cervical cancer treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- University of Nairobicollaborator
- International Agency for Research on Cancercollaborator
Study Sites (1)
Coptic Hospital
Nairobi, 21570-00505, Kenya
Related Publications (3)
Chung MH, De Vuyst H, Greene SA, Mugo NR, Querec TD, Nyongesa-Malava E, Cagle A, Sakr SR, Luchters S, Temmerman M, Unger ER, McGrath CJ. Human Papillomavirus Persistence and Association With Recurrent Cervical Intraepithelial Neoplasia After Cryotherapy vs Loop Electrosurgical Excision Procedure Among HIV-Positive Women: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2021 Oct 1;7(10):1514-1520. doi: 10.1001/jamaoncol.2021.2683.
PMID: 34351377DERIVEDGreene SA, De Vuyst H, John-Stewart GC, Richardson BA, McGrath CJ, Marson KG, Trinh TT, Yatich N, Kiptinness C, Cagle A, Nyongesa-Malava E, Sakr SR, Mugo NR, Chung MH. Effect of Cryotherapy vs Loop Electrosurgical Excision Procedure on Cervical Disease Recurrence Among Women With HIV and High-Grade Cervical Lesions in Kenya: A Randomized Clinical Trial. JAMA. 2019 Oct 22;322(16):1570-1579. doi: 10.1001/jama.2019.14969.
PMID: 31638680DERIVEDGreene SA, McGrath CJ, Lehman DA, Marson KG, Trinh TT, Yatich N, Nyongesa-Malava E, Kiptinness C, Richardson BA, John-Stewart GC, De Vuyst H, Sakr SR, Mugo NR, Chung MH. Increased Cervical Human Immunodeficiency Virus (HIV) RNA Shedding Among HIV-Infected Women Randomized to Loop Electrosurgical Excision Procedure Compared to Cryotherapy for Cervical Intraepithelial Neoplasia 2/3. Clin Infect Dis. 2018 May 17;66(11):1778-1784. doi: 10.1093/cid/cix1096.
PMID: 29272368DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
1\) Conducted in a single center with one clinician administering all procedures 2) Human papillomavirus-type specific results not available 3) HIV factors vary with time 4) Longer follow-up is necessary 5) Imbalance in cervical HIV RNA at baseline
Results Point of Contact
- Title
- Dr. Michael H. Chung
- Organization
- University of Washington
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Chung, MD
University of Washington
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 16, 2011
First Posted
February 17, 2011
Study Start
June 1, 2011
Primary Completion
October 1, 2016
Study Completion
January 1, 2017
Last Updated
November 12, 2019
Results First Posted
October 18, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share