Visual Inspection With Acetic Acid Compared to Lugol's Iodine in HIV-infected Women

Not Applicable

Completed

• Conditions: Cervical Intraepithelial Neoplasia; Cervical Cancer; HIV
• Interventions: Procedure: Visual Inspection with Lugol's Iodine; Procedure: Visual Inspection with Acetic Acid

• Registration Number: NCT02237326
• Lead Sponsor: University of California, San Francisco

Brief Summary

The clinical trial is part of a larger study to evaluate the safety and efficacy of screening techniques for cervical cancer among HIV-infected women. The investigators randomized women to undergo screening with Visual Inspection with Acetic Acid (VIA) or Visual Inspection with Lugol's Iodine (VILI), along with a colposcopy. All outcome and treatment decisions were based on the colposcopy exam done at the study visit. The investigators then compared outcomes between the two groups to assess the test characteristics of both VIA and VILI.

Detailed Description

Cervical cancer and HIV are intersecting epidemics that both disproportionately affect low-income women; the impact of the socioeconomic disparity and biologic synergy of these two diseases is seen dramatically in Kenya, where cervical cancer is the most common cancer killer. HIV-infected women are at increased risk for the development of cervical precancer and cancer, develop more aggressive lesions and are affected at younger ages. Although screening for and treatment of precancer has reduced the incidence of cervical cancer to close to zero in resource-rich countries, strategies are costly and not available in most resource-limited countries. Novel testing and treatment methods that can be carried out in low-resource settings are urgently needed to prevent cervical cancer in these settings, especially among HIV-infected women. Using a cross-sectional study design, the investigators tested two potentially low-cost and effective cervical cancer screening methods: visual inspection with acetic acid (VIA) and protein biomarkers expressed in the presence of cervical dysplasia, neither of which have been well-studied in HIV-infected women. Investigators also randomized a small subset of women to undergo VIA compared to Visual Inspection with Lugol's Iodine (VILI) to compare the test characteristics of these two screening exams. In addition, remarkably little is known about the potential impact of the presence, diagnosis and treatment of human papillomavirus-related dysplasia on HIV genital shedding, a major risk factor for HIV transmission. To explore the impact of the presence, diagnosis and treatment of human papillomavirus-related cervical dysplasia on HIV-1 in genital secretions, investigators compared the levels of HIV-1 RNA found in the cervicovaginal secretions of women with no evidence of cervical dysplasia to levels in women with high-grade cervical dysplasia. They also compared the levels of HIV-1 RNA prior to and after cervical biopsy as well as up to 14 weeks after standard treatment for cervical dysplasia using loop electrosurgical excision procedure (LEEP). Results from this study will inform the prioritization and design of safe, effective and low-cost cervical cancer screening and prevention programs for HIV-infected

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2012-06
• Study Completion: 2012-10
• Status Verified: 2014-09
• Study First Submitted: 2014-09-03
• Study First Submitted QC: 2014-09-09
• Last Update Submitted: 2014-09-09
• Study First Posted: 2014-09-11
• Last Update Posted: 2014-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 654

Inclusion Criteria

• 23-59
• Intact cervix/uterus
• no evidence of infection
• ability to provide informed consent

Exclusion Criteria

• pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Visual Inspection with Lugol's Iodine	Visual Inspection with Lugol's Iodine	Participants underwent colposcopic exam, followed by Visual Inspection with Lugol's Iodine (VILI) by a second, blinded clinician (the order of exams was reversed to eliminate potential interference with exam results due to iodine staining). Biopsy was done after the VILI.
Visual Inspection with Acetic Acid	Visual Inspection with Acetic Acid	Participants underwent Visual Inspection with Acetic Acid followed by colposcopy by a second clinician who was blinded to the screening test result.

Primary Outcome Measures

Name	Time	Method
Test Positivity Rate	eight months	Investigators compared the test positivity between VIA and VILI.

Secondary Outcome Measures

Name	Time	Method
Sensitivity	12 Months	Investigators compared the sensitivity of VIA and VILI for the outcome of cervical intraepithelial neoplasia 2 or greater.

Trial Locations

Locations (1)

Family AIDS Care and Education Services; 🇰🇪 Kisumu, Nyanza, Kenya