ISRCTN90623294 - Utility of visual inspection of the cervix in diagnosing early forms of cervical CANcer in HIV positive women

Welcome

21 March 2013

	Trial registration
	Unique identification scheme
	International databases

[ Print-friendly version ]

Utility of visual inspection of the cervix in diagnosing early forms of cervical CANcer in HIV positive women

ISRCTN	ISRCTN90623294
DOI	10.1186/ISRCTN90623294
ClinicalTrials.gov identifier
EudraCT number
Public title	Utility of visual inspection of the cervix in diagnosing early forms of cervical CANcer in HIV positive women
Scientific title	Effect of HIV infection on Human Papilloma Virus (HPV) distribution pattern, cervical cancer burden and diagnostic accuracy of direct visual inspection in Nigeria
Acronym	CANHIV
Serial number at source	NM/MRCH/12/001
Study hypothesis	The sensitivity and specificity of Direct Visual Inspection will significantly be altered by Human Immunodeficiency Virus (HIV) infection and immunosuppression.
Lay summary	Background and study aims Cervical cancer is one of the leading causes of cancer-related deaths for middle-aged women in low income countries. It is estimated that annually, 80,000 new cases and 60,000 deaths occur as a result of cervical cancer in sub Saharan Africa. However, it is a preventable and curable disease; preventable by vaccination and screening and curable if identified at an early stage. The mainstay of cervical cancer screening, cervical cytology, is not feasible in many low income countries at high risk for cervical cancer in view of the considerable financial, technical and manpower resources required for organizing such a program. Hence the adoption of Direct Visual Inspection (DVI) with Acetic acid (DVIA) and/or Lugol’s Iodine (DVILI) methods for cervical screening in low income countries with high cervical cancer burden because of its comparable ability to detect early precancerous lesions of the cervix, its low technology requirement and cost-effectiveness. In these same settings of high cervical cancer burden, the HIV/AIDS pandemic has overwhelmed the health care systems and had an enormous impact on women, particularly those of reproductive age. Several studies have shown that HIV-infected women have an increased risk for the precursors to cervical cancer, known as human papillomavirus (HPV)-associated cervical intraepithelial lesions. With the introduction of more effective antiretroviral (ARV) therapy to treat HIV, the spectrum of disease in the AIDS epidemic has been shifting. It is projected that 20 - 40% of HIV infected individuals will be diagnosed with cancer, including cervical cancer. As a result of the ARV drug scale up, increasing numbers of women are linked to antiretroviral therapy treatment programs that have the potential to improve their lifespan. At present, DVIA is being used to diagnose early forms of cervical cancer in HIV positive women. However considering the poor detection rate of other diseases like tuberculosis using proven tools in HIV positive people, perhaps DVIA will be less effective in women infected with HIV. Until now, no randomised controlled studies (a type of study design) have evaluated how sensitive DVIA will be in diagnosing early forms of cervical cancer in women living with HIV. The objective of this study is to determine how accurate DVIA is in diagnosing early forms of cervical cancer using cytology as the gold standard. Who can participate? HIV positive women aged 18 years and above. Women who refuse to give consent or are allergic to Lugol’s iodine cannot participate. What does the study involve? 500 participants will be randomly divided into two groups of those that will be screened with acetic acid and those that will be screened with Lugol's iodine. All the participants will also be screened with a Pap smear. What are the possible benefits and risks of participating? Participants will know their HIV status as well as be screened for early forms of cancer of the cervix. HIV positive women will also be offered free comprehensive HIV services at our treatment centre. Women who test positive for early forms of cervical cancer will be sent to a service at a nearby teaching hospital where we have an arrangement with the consultant in charge. There is no known side effect of the diagnosis. However we are aware that some women may react to Lugol's iodine and we will exclude women with history of this. Where is the study run from? Clinical Research Centre, Nigerian Institute of Medical Research Lagos. When is the study starting and how long is it expected to run for? Recruitment for the study started in December 2012 and will last for 6 months. The study is expected to end in June 2013. Who is funding the study? Nigerian Institute of Medical Research Lagos Who is the main contact? Dr. Oliver Ezechi oezechi@nimr.gov.ng
Ethics approval	Institutional Review Board, Nigerian Institute of Medical Research Lagos, February 2011, ref: IRB-10-126A
Study design	Randomised controlled open label trial
Countries of recruitment	Nigeria
Disease/condition/study domain	HIV, premalignant lesion of the cervix
Participants - inclusion criteria	1. Nigerian 2. Female 3. Aged 18 years or over 4. Known HIV status
Participants - exclusion criteria	1. Known reaction to Lugol's iodine 2. Refusal to do HIV test 3. Overt cancer of the cervix
Anticipated start date	01/12/2012
Anticipated end date	30/06/2013
Status of trial	Ongoing
Patient information material	Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants	500
Interventions	Screening of premalignant conditions of the cervix using visual inspection with Direct Visual Inspection (DVI) with Acetic acid (DVIA) and/or Lugol’s Iodine (DVILI).
Primary outcome measure(s)	Premalignant lesion of the cervix
Secondary outcome measure(s)	High risk HPV types
Sources of funding	Nigerian Institute of Medical Research, Lagos (Nigeria)
Trial website
Publications
Contact name	Dr Oliver Ezechi
Address	Clinical Sciences Division Nigerian Institute of Medical Research
City/town	Lagos
Zip/Postcode	101212
Country	Nigeria
Tel	+234 (0)803 3065683
Email	oezechi@nimr.gov.ng
Sponsor	Nigerian Institute of Medical Research (Nigeria)
Address	6 Edmund Crescent Yaba
City/town	Lagos
Zip/Postcode	101212
Country	Nigeria
Email	admin@nimr.gov.ng
Sponsor website:	http://www.nimr.gov.ng/
Date applied	08/12/2012
Last edited	17/01/2013
Date ISRCTN assigned	17/01/2013


© 2013 ISRCTN unless otherwise stated.