Dataset Information

Protocol for the study of cervical cancer screening technologies in HIV-infected women living in Rwanda.

ABSTRACT:

Introduction

The optimal method(s) for screening HIV-infected women, especially for those living in sub-Saharan Africa, for cervical precancer and early cancer has yet to be established.

Methods and analysis

A convenience sample of >5000?Rwandan women, ages 30-54 years and living with HIV infection, is being consented and enroled into a cross-sectional study of cervical cancer screening strategies. Participants are completing an administered short risk factor questionnaire and being screened for high-risk human papillomavirus (hrHPV) using the Xpert HPV assay (Cepheid, Sunnyvale, California, USA), unaided visual inspection after acetic acid (VIA) and aided VIA using the Enhanced Visual Assessment (EVA) system (Mobile ODT, Tel Aviv, Israel). Women positive for hrHPV and/or by unaided VIA undergo colposcopy, which includes the collection of two cervical specimens prior to undergoing a four-quadrant microbiopsy protocol. The colposcopy-collected specimens are being tested by dual immunocytochemical staining for p16^INK4a and Ki-67 (CINtec PLUS Cytology, Ventana, Tucson, Arizona, USA) and for E6 or E7 oncoprotein for 8 hrHPV genotypes (HPV16, 18, 31, 33, 35, 45, 52 and 58) using the next-generation AV Avantage hrHPV E6/E7 test (Arbor Vita Corporation, Freemont, California, USA). Women with a local pathology diagnosis of cervical intraepithelial neoplasia grade 2 (CIN2) or more severe (CIN2+) or pathology review diagnosis of CIN grade three or more severe (CIN3+) will receive treatment. Clinical performance and cost-effectiveness (eg, sensitivity, specificity and predictive values) of different screening strategies and algorithms will be evaluated.

Ethics and dissemination

The protocol was approved by local and institutional review boards for human subjects research. At the completion of the study, results will be disseminated to the scientific community through peer-reviewed publication and to the Rwandan stakeholders through an external advisory panel.

SUBMITTER: Murenzi G

PROVIDER: S-EPMC6078254 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Protocol for the study of cervical cancer screening technologies in HIV-infected women living in Rwanda.

Murenzi Gad G Dusingize Jean-Claude JC Rurangwa Theogene T Sinayobye Jean d'Amour JD Munyaneza Athanase A Murangwa Anthere A Zawadi Thierry T Hebert Tiffany T Mugenzi Pacifique P Adedimeji Adebola A Mutesa Leon L Anastos Kathryn K Castle Philip E PE

BMJ open 20180805 8

<h4>Introduction</h4>The optimal method(s) for screening HIV-infected women, especially for those living in sub-Saharan Africa, for cervical precancer and early cancer has yet to be established.<h4>Methods and analysis</h4>A convenience sample of >5000 Rwandan women, ages 30-54 years and living with HIV infection, is being consented and enroled into a cross-sectional study of cervical cancer screening strategies. Participants are completing an administered short risk factor questionnaire and bei ...[more]

PMID: 30082342

Similar Datasets

Project description:OBJECTIVE:We suggested cervical cancer screening strategies for women living with HIV (WLHIV) by comparing their precancer risks to general population women, and then compared our suggestions with current Centers for Disease Control and Prevention (CDC) guidelines. DESIGN:We compared risks of biopsy-confirmed cervical high-grade squamous intraepithelial neoplasia or worse (bHSIL+), calculated among WLHIV in the Women's Interagency HIV Study, to 'risk benchmarks' for specific management strategies in the general population. METHODS:We applied parametric survival models among 2423 WLHIV with negative or atypical squamous cell of undetermined significance (ASC-US) cytology during 2000-2015. Separately, we synthesized published general population bHSIL+ risks to generate 3-year risk benchmarks for a 3-year return (after negative cytology, i.e. 'rescreening threshold'), a 6-12-month return (after ASC-US), and immediate colposcopy [after low-grade squamous intraepithelial lesion (LSIL)]. RESULTS:Average 3-year bHSIL+ risks among general population women ('risk benchmarks') were 0.69% for a 3-year return (after negative cytology), 8.8% for a 6-12-month return (after ASC-US), and 14.4% for colposcopy (after LSIL). Most CDC guidelines for WLHIV were supported by comparing risks in WLHIV to these benchmarks, including a 3-year return with CD4 greater than 500 cells/?l and after either three negative cytology tests or a negative cytology/oncogenic human papillomavirus cotest (all 3-year risks?1.3%); a 1-year return after negative cytology with either positive oncogenic human papillomavirus cotest (1-year risk?=?1.0%) or CD4 cell count less than 500 cells/?l (1-year risk?=?1.1%); and a 6-12-month return after ASC-US (3-year risk?=?8.2% if CD4 cell count at least 500 cells/?l; 10.4% if CD4 cell count?=?350-499 cells/?l). Other suggestions differed modestly from current guidelines, including colposcopy (vs. 6-12 month return) for WLHIV with ASC-US and CD4 cell count less than 350 cells/?l (3-year risk?=?16.4%) and a lengthened 2-year (vs. 1-year) interval after negative cytology with CD4 cell count at least 500 cells/?l (2-year risk?=?0.98%). CONCLUSIONS:Current cervical cancer screening guidelines for WLHIV are largely appropriate. CD4 cell count may inform risk-tailored strategies.

Project description:ObjectivesDespite the increasing number of interventions aiming to integrate cervical cancer screening into HIV clinics in sub-Saharan Africa, Women living with HIV (WLHIV) still have a high risk of developing cervical cancer. The aim of this study was to estimate the coverage of cervical cancer screening and associated factors among WLHIV in Abidjan, Côte d'Ivoire.DesignCross-sectional survey conducted from May to August 2017.SettingsOutpatient setting in the four highest volume urban HIV clinics of government's or non-governmental organisation's sector in Côte d'Ivoire.ParticipantsAll WLHIV, aged 25-55 years, followed since at least 1?year, selected through a systematic sampling procedure.InterventionA standardised questionnaire administered to each participant by trained healthcare workers.OutcomeCervical cancer screening uptake.ResultsA total of 1991 WLHIV were included in the study, aged in median 42 years (IQR 37-47), and a median CD4 count (last known) of 563 (378-773) cells/mm3. Among the participants, 1913 (96.1%) had ever heard about cervical cancer, 1444 (72.5%) had been offered cervical cancer screening, mainly in the HIV clinic for 1284 (88.9%), and 1188 reported a personal history of cervical cancer screening for an overall coverage of 59.7% (95% CI 57.6 to 62.0). In multivariable analysis, university level (adjusted OR (aOR) 2.1; 95% CI 1.4 to 3.1, p<0.001), being informed on cervical cancer at the HIV clinic (aOR 1.5; 95% CI 1.1 to 2.0, p=0.017), receiving information self-perceived as 'clear and understood' on cervical cancer (aOR 1.7; 95% CI 1.4 to 2.2, p<0.001), identifying HIV as a risk factor for cervical cancer (aOR 1.4; 95% CI 1.1 to 1.8, p=0.002) and being proposed cervical cancer screening in the HIV clinic (aOR 10.1; 95% CI 7.6 to 13.5, p<0.001), were associated with cervical cancer screening uptake.ConclusionInitiatives to support cervical cancer screening in HIV care programmes resulted in effective access to more than half of the WLHIV in Abidjan. Efforts are still needed to provide universal access to cervical cancer screening, especially among socioeconomically disadvantaged WLHIV.

Dataset Information

Protocol for the study of cervical cancer screening technologies in HIV-infected women living in Rwanda.

Introduction

Methods and analysis

Ethics and dissemination

Publications

Protocol for the study of cervical cancer screening technologies in HIV-infected women living in Rwanda.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets