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| ID | Type | Description | Link |
|---|---|---|---|
| KE.09.0238 | Other Identifier | Kenya Ethical Review Committee |
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| Name | Class |
|---|---|
| University of Nairobi | OTHER |
| International Agency for Research on Cancer | OTHER |
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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.
The recent scale-up of antiretroviral treatment programs in resource-limited settings provides an unprecedented opportunity to implement a comprehensive cervical cancer screening and treatment program for women who, by virtue of having HIV, are at significant risk for cervical disease. Unfortunately, even if screening is offered free of charge to millions of women living with HIV, it is unclear which treatment modality for pre-cancerous cervical lesions will be most effective since HIV appears to affect outcomes of treatment by increasing the recurrence and severity of cervical disease. Cervical treatment may also increase shedding of HIV from the cervix which may put discordant couples at risk and possibly spread HIV more widely. This study proposes to randomize HIV-positive women with cervical intraepithelial neoplasia grade 2 and 3 (CIN 2 and 3) to cryotherapy vs. loop electrosurgical excision procedure (LEEP) and measure the recurrence of cervical disease in each group over 2-years of follow-up as well as HIV shedding from the cervix for 6 weeks after treatment.
Our hypothesis is that compared to cryotherapy, LEEP is significantly more likely to prevent recurrence of cervical lesions over 2 years of follow-up and less likely to cause shedding of HIV-1 from the cervix over 3 weeks of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryotherapy | Experimental | Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix |
|
| Loop Electrosurgical Excision Procedure | Experimental | Loop Electrosurgical Excision Procedure (LEEP) uses a low-voltage electrified wire loop to cut out diseased part of cervix |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loop Electrosurgical Excision Procedure (LEEP) | Procedure | LEEP procedure uses a low-voltage electrified wire loop to cut out diseased part of cervix |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Shedding of HIV-1 From the Cervix Between HIV-positive Women | Shedding of HIV-1 from the cervix between HIV-positive women receiving cryotherapy versus LEEP between baseline and weeks 1, 2, and 3 of follow-up | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Chung, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coptic Hospital | Nairobi | 21570-00505 | Kenya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34351377 | Derived | 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. | |
| 31638680 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cryotherapy | Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix Cryotherapy: Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix |
| FG001 | Loop Electrosurgical Excision Procedure | Loop Electrosurgical Excision Procedure (LEEP) uses a low-voltage electrified wire loop to cut out diseased part of cervix Loop Electrosurgical Excision Procedure (LEEP): LEEP procedure uses a low-voltage electrified wire loop to cut out diseased part of cervix |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cryotherapy | Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix Cryotherapy: Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Not all women provided age or a date of birth at baseline |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | 2 years |
|
24 months
We used Division of AIDS Table for Grading the Severity of Adult Adverse Events version 1.0.
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cryotherapy | Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix Cryotherapy: Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HIV complications | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Related to procedure | Surgical and medical procedures | Non-systematic Assessment | post-operative bleeding |
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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael H. Chung | University of Washington | â€(206) 302-8361‬ | mhchung@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Nov 20, 2015 | Oct 18, 2019 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
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| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| Cryotherapy | Procedure | Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix |
|
| Derived |
| Greene 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. |
| 29272368 | Derived | Greene 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. |
| Lost to Follow-up |
|
| Referred for further management |
|
| Loop Electrosurgical Excision Procedure |
Loop Electrosurgical Excision Procedure (LEEP) uses a low-voltage electrified wire loop to cut out diseased part of cervix Loop Electrosurgical Excision Procedure (LEEP): LEEP procedure uses a low-voltage electrified wire loop to cut out diseased part of cervix |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Not all women provided age or a date of birth at baseline | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Previously screened for cervical cancer | Some women were uncertain of prior screening status | Count of Participants | Participants |
|
|
|
| Secondary | Shedding of HIV-1 From the Cervix Between HIV-positive Women | Shedding of HIV-1 from the cervix between HIV-positive women receiving cryotherapy versus LEEP between baseline and weeks 1, 2, and 3 of follow-up | Posted | Mean | 95% Confidence Interval | change in log10 cps HIV RNA per swab | 3 weeks |
|
|
|
| 5 |
| 200 |
| 2 |
| 200 |
| EG001 | Loop Electrosurgical Excision Procedure | Loop Electrosurgical Excision Procedure (LEEP) uses a low-voltage electrified wire loop to cut out diseased part of cervix Loop Electrosurgical Excision Procedure (LEEP): LEEP procedure uses a low-voltage electrified wire loop to cut out diseased part of cervix | 2 | 200 | 0 | 200 |
|
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| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| Baseline and Week 3 |
|