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

HIV Clinical Trial

— SAVE  

Official title:

Safety and Validity Evaluation for Cervical Cancer Screening and Treatment Techniques Among HIV-infected Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02237326
• Other study ID #: SSC 1825
• Secondary ID: 10-00197
• Status: Completed
• Phase: N/A
• First received: September 3, 2014
• Last updated: September 9, 2014
• Start date: October 2011
• Est. completion date: October 2012

Study information

• Verified date: September 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kenya: Ethical Review CommitteeUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 654
• Est. completion date: October 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 23 Years to 59 Years

Eligibility

Inclusion Criteria:

• 23-59

• Intact cervix/uterus

• no evidence of infection

• ability to provide informed consent

Exclusion Criteria:

• pregnant

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Cancer
• Cervical Intraepithelial Neoplasia
• HIV
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Visual Inspection with Acetic Acid
Visual Inspection with Acetic Acid is the application of acetic acid to a cervix, followed by examination with a light source. It is not a new drug or device, and has been used in resource-limited settings for several decades. The purpose of this trial is to compare the two screening techniques, which had not been done previously.
• Visual Inspection with Lugol's Iodine
Visual Inspection with Lugol's Iodine is the application of lugol's iodine to a woman's cervix, followed by examination with a light source with the goal of detecting precancerous lesions. Like Visual Inspection with Acetic Acid, it is not a new drug or device.

Locations

Country	Name	City	State
Kenya	Family AIDS Care and Education Services	Kisumu	Nyanza

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Kenya Medical Research Institute

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Specificity	Investigators compared the specificity of VIA and VILI for the outcome of cervical intraepithelial neoplasia 2 or greater	12 months	No
Primary	Test Positivity Rate	Investigators compared the test positivity between VIA and VILI.	eight months	No
Secondary	Sensitivity	Investigators compared the sensitivity of VIA and VILI for the outcome of cervical intraepithelial neoplasia 2 or greater.	12 Months	No