Clinical trial · Interventional
Cryotherapy vs. LEEP to Treat Cervical Intraepithelial Neoplasia (CIN) 2/3 Among HIV-positive Women
Impact of Cryotherapy Versus Loop Electrosurgical Excision Procedure (LEEP) on Recurrence of Cervical Intraepithelial Neoplasia and HIV-1 Cervical Shedding Among HIV-positive Women
NCT01298596CI-TRIAL-00041584PHE-LEEPcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryotherapy | Procedure | — | UNRESOLVED |
| Loop Electrosurgical Excision Procedure (LEEP) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cryotherapy
- description
- Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix
- interventionNames
- Procedure: Cryotherapy
- type
- EXPERIMENTAL
- label
- Loop Electrosurgical Excision Procedure
- description
- Loop Electrosurgical Excision Procedure (LEEP) uses a low-voltage electrified wire loop to cut out diseased part of cervix
- interventionNames
- Procedure: Loop Electrosurgical Excision Procedure (LEEP)
Primary outcomes (1)
- measure
- Recurrence of Cervical Intraepithelial Neoplasia Among HIV-positive Women
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * HIV-negative * Male * Below 18 years of age * Pregnant by clinical examination or history * Post-hysterectomy * Post-cervical cancer treatment.
References
Publications (3)
- DERIVEDChung 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 34351377
- DERIVEDGreene 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 31638680
- DERIVEDGreene 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 29272368