Clinical trial NCT02237326: Visual Inspection With Acetic Acid Compared to Lugol's Iodine in HIV-infected Women
Official title: Safety and Validity Evaluation for Cervical Cancer Screening and Treatment Techniques Among HIV-infected Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Intraepithelial Neoplasia
Cervical Cancer
HIV
Keywords: Visual Inspection with Acetic Acid
Visual Inspection with Lugol's Iodine
Cervical Intraepithelial neoplasia
Cervical Cancer Screening
HIV infected women
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Kenya Medical Research Institute
First posted: 2014-09-11
Enrollment: 654
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* pregnant

Primary outcomes:
measure: Test Positivity Rate
timeFrame: eight months
Secondary outcomes:
measure: Sensitivity
timeFrame: 12 Months
Other outcomes:
measure: Specificity
timeFrame: 12 months
Locations:
city: Kisumu
country: Kenya
facility: Family AIDS Care and Education Services
state: Nyanza
Study officials:
References:
citation: Huchko MJ, Sneden J, Zakaras JM, Smith-McCune K, Sawaya G, Maloba M, Bukusi EA, Cohen CR. A randomized trial comparing the diagnostic accuracy of visual inspection with acetic acid to Visual Inspection with Lugol's Iodine for cervical cancer screening in HIV-infected women. PLoS One. 2015 Apr 7;10(4):e0118568. doi: 10.1371/journal.pone.0118568. eCollection 2015.