HPV Testing on Vaginal/Cervical Nurse Assisted Self-Samples
Versus Clinician-Taken Specimens and EHE HPV Prevalence, in Adama Town, Ethiopia

Eshetu LH; Cindy S; Ina B; Gurja B; Jean-Pierre VG; Sharon
AR; Ramokone LL and Johannes PB

doi:10.23880/eoij-16000208

Ergonomics International Journal Research Article 21 min read

HPV Testing on Vaginal/Cervical Nurse Assisted Self-Samples Versus Clinician-Taken Specimens and EHE HPV Prevalence, in Adama Town, Ethiopia

Eshetu LH^*, Cindy S, Ina B, Gurja B, Jean-Pierre VG, Sharon AR, Ramokone LL and Johannes PB

^* Corresponding author

ISSN: 2577-2953 10.23880/eoij-16000208 Received: May 08, 2019 Published: May 28, 2019

— views

34 references

8 tables

PDF

Keywords

Cervical Cancer Nurse Self-Sampling HPV Thinprep Preservcyt Solution Liquid Cytology Clinician-Taken Ethiopia

Abstract

This study aimed to determine the feasibility of vaginal/cervical Nurse Assisted Self-Sampling (NASS) and the agreement between Human papillomavirus (HPV) test on self-samples versus clinician-taken (CT) specimens. Women participated voluntary for the cervical cancer screening at St. Aklesia Memorial Hospital. Eighty three (83) women provided a total of 166 coupled self and clinician taken specimens collected. Specimens were stored at room temperature for maximum 10 months and analyzed using validated the RIATOL qPCR HPV genotyping test, a quantitative Polymerase Chain Reaction (qPCR) high-throughput HPV E6, E7 assay. The average age of the participating women was 32 years. Seventy three of the 83 women (87.9%) felt that NASS was easy to use. An overall HPV, HR (High Risk) HPV and LR (Low Risk) HPV prevalence was 22.7% (15/66), 18.2% (12/66) and 6.1% (4/66), respectively. The overall HR HPV prevalence was 17.2% (NASS) and 15.5% (CT). The most prevalent HPV type was HPV51; HPV 16 was only detected in 1 woman (CT+NASS) and HPV18 only in 1 woman (CT). The overall measurement agreement between self- and clinician-collected samples was moderate with a kappa value of 0.576 (p

Introduction

Invasive cervical cancer (ICC) is the fourth most frequent malignancy and cause of death in women suffering from cancer worldwide [1]. In Ethiopia, ICC is even at the second place among women between 15 and 44 years of age. Ethiopia has 31.5 million women aged 15 years and older and 7.095 women were diagnosed yearly with ICC of whom 4.732 died from the disease, Currently, there is only sparse data on the Human papillomavirus (HPV) burden in the general population of Ethiopia [2].

A study in Nigeria for example, found 93% participation in the self-sampling arm, compared to only 56% in the hospital-collection arm [3]. Another study in Sub-Saharan Africa, indicated a comparable HPV prevalence for self- (14,6%) and physician (12,7%) samples, so similar accuracy of the test on both sampling methods [4]. A study in Madagascar showed absolute acceptance (100%) of self-sampling (with a flocked swab) followed by HPV testing as cervical cancer screening method [5].

Available data indicate that the HPV prevalence in Ethiopia among women with normal cervical cytology varies between 15.9 % and 17.5%, and 96.6% of the invasive cervical cancers are attributed to HPV16 (78.4%) and 18 (18.2%) [2].

Cervical cancer develops over a long period of time through precursor lesions. These lesions can be detected by (cytological or visual) screening, and progression towards cancer can then be stopped by treatment (ablation or excision) in an early phase [6]. Currently in Ethiopia, 200 health facilities are providing VIA (Visual Inspection with Acetic acid) screening followed by cryotherapy (ablative treatment technique), and more than 52,000 women were screened in 2016/17. Of the 20 million women eligible for screening only 0.3% of them screened. In addition, Loop electrosurgical excision procedure (LEEP) service was scaled up from five to fifteen hospitals and the Federal Ministry of Health (FMoH) is working to expand VIA screening and cryotherapy into 823 districts [7]. However, more efforts or other screening techniques are urgently necessary to scale up the cervical cancer screening coverage in Ethiopia.

In this study, the feasibility and acceptability of self- sampling followed by an HPV test was verified in the Ethiopian population.

Methodology

The study aimed to determine the feasibility of vaginal/cervical Nurse Assisted Self-Sampling (NASS) and the agreement between Human papillomavirus (HPV) testing on self-samples versus clinician-taken (CT) specimens.

The study was conducted in Adama Town, Oromia region, having a total population of 1,356,342 people of whom 659,992 are females. The St. Aklesia Memorial Hospital (SAMH), located in Adama Town, is a private hospital with a long time historyand expertise in cervical cancer screening.

To reach in an efficient way a lot of woman for recruitment in the study, radio calls and face to face interactions were organized. Through these channels, women were encouraged to schedule an appointment for cervical cancer screening approximately two weeks (10- 18 days) after the first day of their last menstrual period. Also women visiting the hospital for reproductive health related issues were called for participation in the study.

Women were eligible if they were 20 years or older, had an intact uterus, had no history of cervical cancer, were mentally competent and able and willing to provide informed consent. Based on the upset of this study, a cross-sectional and probability sampling technique was used. The sample size was calculated by considering 5% margin error; 95% confidence level, 659,992 female populations of East Shewa, and according to pilot study 95% of a time women were responded self-sampling was acceptable means of screening and by adding 10% of non- respondent rate the minimum sample size was 73.

Women who were interested in participating in the study were given following instructions: no douche 48 hours prior to the test; no use of tampons, birth control foams, jellies or other vaginal creams or vaginal medications for 48 hours prior to the test and also advised to refrain from intercourse 48 hours prior to the test.

After signing an informed consent document, women were subjected to two ways of sample collection, both performed within the clinic: 1) nurse assisted self- sampling with supervision; 2) clinician-taken specimens i.e. a physician collected the samples according to the standard procedure of the clinic. Women were also asked to fill in a questionnaire.

Nurse Assisted Self-Sampling (NASS) at the Clinic

Women were invited to the private area of the clinic and were given verbal and printed diagrammatic instructions by the trained nurse for collecting the vaginal specimen. When the women confirmed that al instruction were clear, the nurse opened the collection kit and handed over the collection devices (in sequence order of spatula followed by cytobrush) to the woman.

The vaginal fornix and ectocervix was sampled before the endocervix. To start the NASS, women were instructed to take a sample of the ectocervix using a plastic spatula, without speculum. The women were asked to insert the spatula, laying on the bed, into their vagina and to rotate three times 360°, to remove and to handover the collection device to the nurse. The nurse then rinsed the spatula into a labeled vial with ThinPrep PreservCyt solution.

In the next step, the nurse provided the cytobrush to the woman to sample the endocervix. It was inserted by the woman herself until it met with resistance, rotated 45-90°, removed and handed over to the nurse. The nurse inserted the cytobrush sample into the same ThinPrep PreservCyt labeled vial. This procedure was not involving any invasive steps rather non-invasive simple and easy collection techniques. Collected samples were kept at 22°C (room temperature) for about 10 months, until shipment and processing.

Clinician-Taken (CT) Sample at the Clinic

The clinicians collected cervical samples according to standard protocols i.e. both ectocervix and endocervix samples were collected with a cytobrush and rinsed in a labeled vial with ThinPrep PreservCyt solution. Collected samples were kept at 22°C (room temperature) for about 10 months, untilshipment and processing.

Visual Inspection with Acetic Acid (VIA)

After the NASS and the CT sample, all women underwent VIA. A women was classified as VIA positive when acetowhite lesions were visualized by the clinician.

All VIA positive women were eligible for cryotherapy and were treated.

Ethical Clearance

The ethical committee of the College of Natural Sciences, Addis Ababa University, has examined the project and approved. The SAMH Hospital also approved the project. All women signed an informed consent before enrolment in the study.

Laboratory

Both CT and NASS specimens were tested for presence of HPV with the RIOTOL qPCR HPV genotyping test (Algemeen Medisch Laboratorium (AML), Belgium).This clinically validated and ISO certified lab developed (LDT) high-throughput HPV test, detects 14 high risk HPV (HR HPV) types i.e. 16,18,31,33,35,39,45,51,52,56,57,58,59,66 and 68, 4 intermediate/low risk HPV (LR HPV) types i.e. 6, 11, 53 and 67,68 and a cell control [8, 9]. Samples with less than 10 cell/µl are considered as invalid and reported as samples of poor quality.

Data Source and Analysis

Quantitative data was collected and for some of demographic variables were decode accordingly. Any missed variables identified during collection of data, the supervisor was responsible to follow up the patients and correct it accordingly. Statistical analysis was performed using the Statistical Package for the Social Sciences (SPSS) version 20 software. The overall measurement agreement between self- and clinician-collected samples was calculated with a kappa value. The dependent variable was HPV outcome and independent variables are socio- demographic. Pearson’s chi-squared test and 95% confidence interval (CI) were used and statistically significant if the p-value was less than or equal to 0.05.

Results

A total of 83 eligible women were enrolled between October 2015 and July 2016 at SAMH hospital, Adama, Oromia region, Ethiopia. The study had no missed data or variables.

Patient Demographics

The average age of the participating and eligible women was 32 years, with the youngest being 20 and the oldest 65 years. Fourty-seven women (56.6%) had an education level below grade 10 (high school); 33.7% (28/83) and 27.7% (23/83) of the study population were laborers and housewives, respectively. Seventy one women (85.5%) were married at the time of the study and 69.9% had one life time partner. A total of 80.7% (67/83) had gravidity equal to or above one and 7.5% (5/67) of these women had a spontaneous abortion

	Categories		Variables		Count		%
Age Group		20-30		39		46.9
		31-40		34		40.9
		41-50		8		9.6
		51-60		1		1.2
		>=61		1		1.2
Education		Under grade 8		23		27.7
		Under grade 10		24		28.9
		Preparatory (University)		3		3.6
		Diploma		19		22.9
		Degree		13		15.7
		PhD		1		1.2
Occupation		Student		3		3.6
		House wife		23		27.7
		Laborer		28		33.7
		Government Employee		7		8.4
		Private employee		15		18.1
		Self-employee		7		8.4
Marital Status		Married		71		85.5
		Single		7		8.4
		Separated		4		4.8
		Living with partners		1		1.2
Life time partners		1		58		69.9
		2		21		25.3
		3		4		4.8
Gravidity		0		16		19.3
		1		21		25.3
		2		32		38.6
		3		6		7.2
		4		6		7.2
		5		1		1.2
		6		1		1.2
Abortion		Induced		5		7.5
		Spontaneous		5		7.5
		No abortion		57		85.1
Current use of any birth control		Yes		33		39.8
Current use of any birth control		No		50		60.2
Current Smoking		Yes		15		18.1
Current Smoking		No		68		81.9
HIV Status		Reactive		4		4.8
		Non-Reactive		70		84.3
		Unknown		9		10.8
Chief presenting symptoms		Dyspareunia		4		4.8
		Intermestral		6		7.2
		Urinary Symptom		34		41
		Backache		14		16.9

Table 1: Characteristics of women enrolled in our cervical cancer screening study (N=83), between October 2015 and July 2016, at

	Vaginal discharge	25	30.1
VIA results	No acetowhite lesion	57	68.7
VIA results	Acetowhite lesion	9	10.8

Table 2: Characteristics of women enrolled in our cervical cancer screening study (N=83), between October 2015 and July 2016, at

Acceptance and Feasibility of Self-Samples

In the feasibility questionnaire (Table 2), a high number of the women indicated that self-sampling was easy to use (87.9%); easy to insert and collect (79.5%) and user-friendly (91.6%). Especially the privacy of a self- sample compared to a clinician-taken specimen scored very high (92.8%). More than 80.0% of the women had confidence in the results of their self-taken sample. Furthermore, over 85.0% of the women were willing to perform self-sampling at the clinic or home, would go to a clinic that would provide the self-sampling and were even willing to pay for a NASS followed by an HPV test if it would be available over the counter.

	Categories		Variables		Count		%
Practicability		Easy		73		87.9
		Moderate		7		8.4
		Difficult		3		3.6
Is easy to insert and collect the device?		Yes		66		79.5
Is easy to insert and collect the device?		No		17		20.5
Is collection device user friendly?		Yes		76		91.6
Is collection device user friendly?		No		7		8.4
Is self-sampling more private compared to sampling by clinician?		Yes		77		92.8
		No		6		7.2
Do you believe on the results that were taken by yourself?		Yes		69		83.1
Do you believe on the results that were taken by yourself?		No		14		16.9
Do you have plans to visit the clinic that provides self-sampling thereafter?		Yes		71		85.5
		No		12		14.5
Preference of self-sampling over clinician?		Yes		79		95.1
Preference of self-sampling over clinician?		No		4		4.9
Willing to pay for HPV self-test if available over the counter?		Yes		71		85.5
		No		12		14.5
Willing to perform self-sampling at clinic or home		Yes		73		88
Willing to perform self-sampling at clinic or home		No		10		12

Table 3: Acceptability and feasibility of vaginal self-sampling by women enrolled in our cervical cancer screening study (N=83).

Sample Quality

between the two sample groups (NASS: 19/83 and CT: 25/83) (p=0.3794). (Table 3).For 17 women (20.5%), both the CT and the NASS sample were of poor sample quality (Table 4). These 17 women were excluded from further analysis.

	Sample types		Human DNA detected		No Human DNA detected		Total
SS		64		19		83
CT		58		25		83
Total		122		44		166

Table 4: Sample quality comparison between self-samples (SS) and clinician-taken samples (CT) (N=166).


	Clinician taken (CT) sample
		HPV (+)	HPV ( -)	No DNA	Total
		HPV (+)	HPV ( -)	No DNA	Total
HPV (+)		5	3	1	9
HPV (-)		6	42	1	49
No DNA		0	8	17	25
Total		11	53	19	83

Table 5: HPV test results of the self-samples (SS) and clinician-taken (CT) samples (N=83).Type specific qPCR (Riatol HPV test).

HPV Test Results from the NASS and CT Specimens

On all collected NASS and CT specimens the RIATOL qPCR HPV genotyping test was performed. The HPV results of the remaining 66 women are presented in detail in table 5. The overall prevalence of HPV was 22.7% (15/66). The prevalence of HR HPV was 18.2% (12/66) and LR HPV types 6.1% (4/66). The CT samples had an HPV prevalence of 15.5% (9/58) (all types), with a prevalence of 12.1% (7/58) for the high risk types and 3.4% (2/58) for the low risk types. The results from the NASS samples showed a somewhat higher prevalence of 17.2% (11/64), and 14.1% (9/64) and 4.7% (3/64) for all HPV types, HR and LR types respectively (Tables 4 and 5).

																Low risk HPV
#	of HPV positiv	e		Type of		High risk HPV typing										Low risk HPV				Total
	of HPV positiv			Type of												typing
	women			samples
					16		18	31	45	51	56	58	59	68	6		53	67	Overall		SS	CT
					16		18	31	45	51	56	58	59	68	6		53	67	Overall			CT
1			CT		-		1	-	-	-	-	-	-	-	-		-	-	1			1
2			CT		-		-	1	-	-	-	-	-	-	-		-	-	1			1
3			SS		-		-	-	1	-	-	-	-	-	-		-	-	1		1	1
3			CT		-		-	-	1	-	-	-	-	-	-		-	-	1		1
4			SS		-		-	-	-	-	-	-	1	-	-		-	-	1		1
5			CT		-		-	1	-	-	-	-	-	-	-		-	-	1		1	1
5			SS		-		-	1	-	-	-	-	-	-	-		-	-	1		1	1
6			CT		-		-	-	-	-	-	-	-	-	-		1		1		1	1
6			SS		-		-	-	-	-	-	-	-	-	-		1		1		1
7			SS		-		-	-	-	-	1	-	-	-	-		-	-	1		1
8			CT		-		-	-	-	-	-	-	-	-	-		-	1	1			1
9			CT		-		-	-	-	-	-	-	-	1	-		-	-	1			1
10			SS		-		-	-	-	-	-	1	-	-	-		-	-	1		1
11			SS		-		-	-	-	-	-	-	-	-	1		-	-	1		1
12			SS		-		-	-	-	1	-	-	-	-	-		-	-	1		1
13			CT		-		-	-	-	1	-	1	-	-	-		-	-	1		1	1
13			SS		-		-	-	-	1	-	-	-	-	-		-	-	1		1
14			SS		-		-	-	-	1	-	-	-	-	-		-	-	1		1
15			CT		1		-	-	-	1	-	-	-	1	-		-	-	1		1	1
15			SS		1		-	-	-	1	-	-	-	1	1		-	1	1		1	1
Total			SS		1		-	-	-	1	-	-	-	1	1		-	1	15		11	9

Table 6: HPV distribution by type, of the self-samples (SS) and clinician-taken (CT) samples. Type specific qPCR (Riatol HPV test

The most prevalent HPV type was HR HPV51 (4/66, 6.1%), followed by HR HPV31, 58 and 68 and LR HPV6 and 67 which were all found twice (2/66, 3.0%). HPV16

was detected in 1 woman, in both the CT and the NASS sample (overall prevalence: 1/66=1.5%) and HPV18 also in 1 woman, but only in the CT sample (overall/CT: 1/66=1.5%, NASS: 0%). Two women were co-infected with at least two HPV types (multiple infections: 2/66=3.0%).One woman out of these two was co-infected with 5 HPV subtypes: HPV6, 16, 51, 67, and 68 (according to the NASS HPV DNA result). A total of 12 different HPV types were identified in this study, out of the 18 HPV types that were tested for (Table 5).

Results from NASS and CT HPV Test Versus (VIA)

			CT VIA test
	HPV result
		Acetowhite lesion		No acetowhite lesion	Total
		Acetowhite lesion		No acetowhite lesion	Total
HPV (+)		5		4	9
HPV (-)		4		45	49
Total		9		49	58
			SS VIA test
	HPV result
		Acetowhite lesion		No acetowhite lesion	Total
		Acetowhite lesion		No acetowhite lesion	Total
HPV (+)		7		4	11
HPV (-)		1		52	53
Total		8		56	64

Table 7: HPV test results versus VIA CT & SS HPV test results (N=58, N=64).

Pearson’s Chi-Squared Test

Table 7 shows the result of the Pearson’s Chi-square test using the HR HPV test result (combined NASS and CT results) and all collected variables, with HR HPV-negative status as the reference group. Having more than two life time sexual partners (p=0.000447) and being VIA positive Variables HRHPV Result Pearson Chi-Square Age Group Education Under grade 8 3 11 1.115 0.953 Under grade 10 4 15

20-30 3 24 9.132 0.058 31-40 8 21 41-50 0 8 51-60 1 0 >=61 0 1

	Preparatory (University)	0	3
	Diploma	3	14
	Degree	2	10
	PhD	0	1
Occupation	Student	1	1	13.88	0.016
	House wife	8	11
	Laborer	2	15
	Government Employee	0	6
	Private employee	0	15
	Self-employee	1	6
Marital Status	Married	11	46	0.724	0.868
	Single	1	5
	Separated	0	2
	Living with partners	0	1
Life time partners	1	2	41	15.424	0.000447
	2	9	11
	3	1	2
Gravidity	0	6	9	7.643	0.265
	1	2	17
	2	3	21
	3	0	3
	4	1	2
	5	0	1
	6	0	1
Abortion	Induced	1	1	7..694	0.021
	Spontaneous	2	3
	No abortion	3	41
Current use of any birth control	Yes	7	22	1.234	0.267
Current use of any birth control	No	5	32	1.234	0.267
Current smoking	Yes	3	7	1.107	0.293
Current smoking	No	9	47	1.107	0.293
HIV Status	Reactive	0	3	2.933	0.231
	Non-Reactive	12	43
	Unknown	0	8
Chief presenting symptoms	Dyspareunia	0	3	0.816	0.936
	Intermestral	1	3
	Urinary Symptom	5	22
	Backache	2	8
	Vaginal discharge	4	18
VIA results	No acetowhite lesion	4	53	35.236	0 2.23E-8
VIA results	Acetowhite lesion	8	1	35.236	0 2.23E-8

Table 8: Pearson’s chi-squared test of HRHPV test result (SS+CT results) with all studied variables (N=66).

Discussion

Feasibility/Acceptability of Self Sampling

Self-sampling devices are not commercially available in Ethiopia and not used for routine basis for cervical cancer screening. Moreover this study can be considered as first in kind where no other similar studies currently found in Ethiopia. The acceptability of a self-sampling (SS) device was very high in this study and women felt self- sampling device was easy to use, to insert and to collect and user-friendly. Women were willing to perform the self-sampling because of its privacy nature. Ghanaian women reported that 76.3% self-collected (SC) were very easy/easy to obtain, 57.7% preferred SS over clinician sample (CS) and felt SC would increase their likelihood to access cervical cancer screening which were comparable percentage of women felt same in our study too [10, 11].

Our study was further supported by data from Bolivia where SS was generally preferred over CS for a screening program based on HPV detection [12]. Furthermore, a number of studies report that HPV self-sampling was found to be highly acceptable and feasible among hard-to- reach women.

A study in El Salvador that reported Self-sampling revealed an acceptability of 68%, although lower than reported in our study [13]. Others studies from American Indian and Hopi women were also supported our findings where self-sampling HPV testing was feasible and acceptable that may contribute to an increase of uptake [14].

Most women showed a willingness to pay for self- sampling services and believed their results which could be seen as a driving force for screening among hard-to- reach women [15].

Almost the same percentage of women between our study and Japanese were reported they would use self- sampling again and found instructions easy to follow and reported no issues with the usability of the self-sampling device. However, women in our study reported that they had confidence in the results of self-taken sampling unlike of women who lacked confidence on the test [16].

Similar studies supported our findings from Latinas and Haitian populations where women agreed HPV self- sampling was faster, more private, easy to use, and would prefer to use it again [17]. Furthermore, in German, self- sampling is considered to be easy by 89.0 % as well as user-friendly by 96.0% of the women [18]. Therefore, Ethiopian women might use nurse assisted self-sampling service as alternative options for fighting cervical cancer prevention.

HPV Prevalence in General Population

We reported an overall HPV prevalence in this study of22.7% and a prevalence of HR HPV 18.2% and LR HPV of6.1%. HPV prevalence in Africa varied within a range of 12% to 46% [19]. Studies elsewhere in Ethiopia reported an HPV prevalence of 17.3% and 15.8% for HR HPV [20, 21]. Thus, our study revealed an HR HPV prevalence that is consistent with sub-Saharan Africa report with slightly higher. The overall HPV prevalence from SS and CT sample was 10.8% and 13.2% respectively. The author concluded that no report found on HR HPV prevalence among self-sampling and doctor sampling was 14.1% and 12.1% respectively in general population in Ethiopia.

In Rwanda HR HPV prevalence was 19.0% that was slightly higher than our result [22]. The prevalence of HR HPV in Dakar was 17.4% as comparable to our 18.2% where geographical and population difference could be a reason [23]. HPV prevalence in Cameroon was 18.5% that was comparable to our findings [24].

A study from Northern Africa, a Muslim community, HPV infection was 6.3% (4.0% of high-risk types), with no significant variation by age [25]. However, a study done by Traore IMA, et al. [26] in Burkina Faso showed that HR HPV prevalence was 38.3% which was twice of our result. Therefore, HPV prevalence in different countries and segment of population is varies as indicated in all previous studies.

Accordingly to study done by Laia Bruni, et al. [19] the estimated prevalence of HPV in Sub-Saharan Africa is 24.4% and global prevalence was 11.7% where almost comparable in our study [19]. Further studies from 11 countries (Nigeria, India, Vietnam, Thailand, Korea, Colombia, Argentina, Chile, the Netherlands, Italy, and Spain) without cytological abnormalities were included and age-standardized HPV prevalence varied from nearly 20 times between populations, from 1.4% in Spain to 25.6% in Nigeria where 22.5% HPV prevalence were presented in our study [27].

HPV Type Distribution

From our study the most prevalent HPV type was HPV51 and followed by HPV31, 58 and 68 (HR types) and HPV6 and 67 (LR types). Women were co-infected with at least two HPV types and the higher were co-infected with five HPV subtypes: HPV6, 16, 51, 67, and 68. A total of 12 HPV types were identified in this study, out of the 19 HPV types that were tested. HPV 16 was the most frequent genotype identified in samples from previous Ethiopia studies and HPV 52, 58, and 18 were the second, third and fourth common genotypes identified respectively, whereas in our study HPV 51 and 31 were the common genotypes identified [28]. Thus, even within the same country, it observed that there are genotypes differences among population segments.

Study from South Africa, HPV 16, 35, and 58 were the most common high-risk HPV types with no major differences in the type distribution by HIV status [29]. In Mozambique, most frequently were HPV51, HPV35, HPV18, HPV31 and HPV52. Likewise multiple infections were detected in HPV51 of HPVs 16/18 normal cytology. While HPVs 51 and 35 were the two most common types [30].

HPV positive women in Europe were significantly more likely to be infected with HPV16 than those in sub- Saharan Africa. Heterogeneity between areas of Asia was significant where that supported by previous Ethiopian studies [27, 31]. Study from Burkna Faso HPV 52, HPV 33, and HPV 59 were most identified genotypes where HPV 51, 31, and58 were most prevalent in our study.

HPV 52 (3.2%) was the most prevalent HPV type, followed by HPV 31 (3.0%) and HPV 16, 45, and 53 (all 2.8% [23]. In a study from Nigeria, the prevalence of HPV35 and HPV16 were equally frequent [32]. HPV16 was the most common type among the general population of Guinea (7.3%) [33].

HPV Tests Versus VIA

In this study, the overall agreement between SS HPV and VIA result was higher than CT results. Sensitivity between HPV and VIA test results was relatively higher on self- sampling over clinician- taken samples. There was an almost equal specificity value found between SS and CT samples. Study from Cameroon, indicated that the sensitivity and specificity of VIA/VILI among HPV positive women 80.0% and 44.0%, respectively that was less compared with this study [24].

A combination of HPV‐based and VIA screen‐and‐treat approach may be feasible in a low‐resource context and may contribute to improving the effectiveness of CC prevention programs. The combination of HPV‐testing and VIA/VILI for CC screening might reduce overtreatment [24].

Agreement between NASS and CT HPV Test

The overall agreement of HPV test results between NASS and CT samples was moderate, with a kappa value of 0.58.A study from Bolivia showed good agreement between self- and physician collected samples for HR HPV detection (κ = 0.71) was higher as compared to this study [12]. A study from Sub-Saharan Africa revealed that the overall HPV positivity agreement between Self- and doctor was κ value of 0.52, respectively which had similar agreement with our study [34].

Conclusion

There was a moderate agreement between a NASS and a CT sample for HPV detection. NASS could replace CT samples for HPV testing as an alternative ways in Ethiopia;

however, the sample quality may need improvement. NASS-HPV is a valuable tool for the follow-up of HPV- positive women in low-resource settings. NASS HPV testing using Thin Prep Preserv Cyt solution could be considered an alternative for cervical cancer screening modality in low-resource setting countries where the coverage is low. This strategy may increase cervical cancer screening coverage in Ethiopia and other countries. Individuals living in different geographical localities should receive vaccines based on the specific genotypes circulating in the area and according to our findings a vaccine targeting HPV 51, 31, 16, 45, 52, and 58 may be optimal for the prevention of cervical cancer in Ethiopia. Genotyping information could be important to guide vaccine policy. Our study was the first report on self- sampling using Thin Prep Preserv Cyt solution or liquid based cytology in Ethiopia and may be used as a platform for similar studies in the future.

Limitation

Although this research was carefully prepared, we concluded that the sample size was small and not able to generalize.

Acknowledgments

The authors want to acknowledge the staff of SAMH for helping with the sample collection and Hologic Inc Company, USA for donating ThinPrep Preserv Cyt solution, cytobrush, spatula through IPRH. The laboratory analysis was done at, AML. E.L., G.B., S.R, JP.B conceived and designed the study. E.L., S.R. took part in data collection. E.L., I.B, C.S and JP.B performed laboratory data analysis. E.L, C.S., JP.B analyzed the data. E.L., C.S., G.B, JP.B. JP.V. performed data interpretation. E.L., C.S., G.B., JP.V, S.R, R.L, JP.B contributed to the writing of the manuscript. The source of fund was university of Antwerp, Hologic Inc company and International partnership for reproductive health.

References

Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, et al. (2012) Cancer Incidence and Mortality Worldwide: IARC Cancer Base No. 11.
Bruni L, Albero G, Serrano B, Mena M, Gómez D, et al. (2017) ICO Information Centre on HPV and Cancer (hpv Information Centre). Human Papillomavirus and Related Diseases in Ethiopia. Summary Report.
Fatima M, Iregbu KC, James O, Annemiek L, Annemieke K, et al. (2017) Randomized trial evaluating self-sampling for HPV DNA based tests for cervical cancer screening in Nigeria. Infectious Agents and Cancer 12: 11.
Untiet S, Vassilakos P, McCarey C, Tebeu PM, Kengne- Fosso G, et al. (2017) HPV self-sampling as primary screening test in sub-Saharan Africa: implication for a triaging strategy. Int J Cancer 135 (8): 1911-1917.
Céline B, Deborah T, Sarah U, Sonja S, Patrick P, et al. (2015) Acceptability of self-collected vaginal samples for HPV testing in an urban and rural population of Madagascar. Afr Health Sci 15(3): 755-761.
Arbyn M, Verdoodt F, Snijders PJ, Verhoef VM, Suonio E, et al. (2014) Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis. Lancet Oncol 15(2): 172- 183.
Federal Democratic Republic of Ethiopia Ministry of Health (FMOH) (2017) Improving the performance of the health system: A foundation for universal health coverage.
Micalessi IM, Boulet GA, Bogers JJ, Benoy IH, Depuydt CE (2011) High-throughput detection, genotyping and quantification of the human papillomavirus using real-time PCR. Clin Chem Lab Med 50(4): 655-661.
Obiri-Yeboah D, Adu-Sarkodie Y, Djigma F, Hayfron- Benjamin A, Abdul L, et al. (2017) Self-collected vaginal sampling for the detection of genital human papillomavirus (HPV) using careHPV among Ghanaian women. BMC Womens Health 17(1): 86.
Racey CS, Withrow DR, Gesink D (2013) Self-collected HPV testing improves participation in cervical cancer screening: a systematic review and meta-analysis. Can J Public Health 104(2): e159-e166.
Surriabre P, Allende G, Prado M, Cáceres L, Bellot D, et al. (2017) Self-sampling for human papillomavirus DNA detection: a preliminary study of compliance and feasibility in BOLIVIA. BMC Womens Health 17(1): 135.
Laskow B, Figueroa R, Alfaro KM, Scarinci IC, Conlisk E, et al. (2017) A pilot study of community-based self- sampling for HPV testing among non-attenders of cervical cancer screening programs in El Salvador. Int J Gynaecol Obstet 138(2): 194-200.
Winer RL, Gonzales AA, Noonan CJ, Cherne SL, Buchwald DS (2016) Assessing Acceptability of Self- Sampling Kits, Prevalence, and Risk Factors for Human Papillomavirus Infection in American Indian Women. Collaborative to Improve Native Cancer Outcomes (CINCO). J Community Health 41(5): 1049- 1061.
Madzima TR, Vahabi M, Lofters A (2017) Emerging role of HPVself-sampling in cervical cancer screening for hard-to-reach women: Focused literature review. Can Fam Physician 63(8): 597-601.
Hanley SJ, Fujita H, Yokoyama S, Kunisawa S, Tamakoshi A, et al. (2016) HPV self-sampling in Japanese women: A feasibility study in a population with limited experience of tampon use. NJ Med Screen 23(3): 164-170.
Ilangovan K, Kobetz E, Koru-Sengul T, Marcus EN, Rodriguez B, et al. (2016) Acceptability and Feasibility of Human Papilloma Virus Self-Sampling for Cervical Cancer Screening. J Womens Health (Larchmt) 25(9): 944-951.
Castell S, Krause G, Schmitt M, Pawlita M, Deleré Y, et al. (2014) Feasibility and acceptance of cervicovaginal self-sampling within the German National Cohort (Pretest 2). Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 57(11): 1270-1276.
Bruni L, Diaz M, Castellsagué X, Ferrer E, Bosch FX, et al. (2010) Cervical Human Papillomavirus Prevalence in 5 Continents: Meta-Analysis of 1 Million Women with Normal Cytological Findings. J Infect Dis 202(12): 1789-1799.
Ruland R, Prugger C, Schiffer R, Regidor M, Lellé RJ (2006) Prevalence of human papilloma virus infection in women in rural Ethiopia. European Journal of Epidemiology 21: 727-729.
Sönke JW, Ulrike W, Monika J, Herbert P (2010) Quantification of beta-human papillomavirus DNA by real-time PCR. Nature protocols 5(1): 1-13.
Ngabo F, Franceschi S, Baussano I, Umulisa MC, Snijders PJ, et al. (2016) Human papillomavirus infection in Rwanda at the moment of implementation of a national HPV vaccination programme. BMC Infect Dis 16: 225.
Mbaye el HS, Gheit T, Dem A, McKay-Chopin S, Toure- Kane NC, et al. (2014) Human papillomavirus infection in women in four regions of Senegal. J Med Virol 86(2): 248-256.
Margot K, Fanny S, Bruno K, Rosa C, Manuela V, et al. (2017) Cervical cancer screening in a low‐resource setting: a pilot study on an HPV‐based screen‐and‐treat approach. Cancer Med 6(7): 1752- 1761.
Hammouda D, Clifford GM, Pallardy S, Ayyach G, Chékiri A, et al. (2011) Human papillomavirus infection in a population-based sample of women in Algiers, Algeria. Int J Cancer 128(9): 2224-2229.
Traore IMA, Zohoncon TM, Ndo O, Djigma FW, Obiri- Yeboah D, et al. (2016) Oncogenic Human Papillomavirus Infection and Genotype Characterization among Women in Orodara, Western Burkina Faso. Pak J Biol Sci 19(7): 306-311.
Clifford GM, Gallus S, Herrero R, Muñoz N, Snijders PJ, et al. (2005) Worldwide distribution of human papillomavirus types in cytologically normal women in the International Agency for Research on Cancer HPV prevalence surveys: a pooled analysis. IARC HPV Prevalence Surveys Study Group. SLancet 366(9490): 991-998.
Abate E, Aseffa A, El-Tayeb M, El-Hassan I, Yamuah L, et al. (2013) Genotyping of human papillomavirus in paraffin embedded cervical tissue samples from women in Ethiopia and the Sudan. J Med Virol 85(2): 282-287.
McDonald AC, Tergas AI, Kuhn L, Denny L, Wright TC Jr (2014) Distribution of Human Papillomavirus Genotypes among HIV-Positive and HIV-Negative Women in Cape Town, South Africa. Front Oncol 4: 48.
Castellsagué X, Klaustermeier J, Carrilho C, Albero G, Sacarlal J, et al. (2008) Vaccine-related HPV genotypes in women with and without cervical cancer in Mozambique: burden and potential for prevention. Int J Cancer 122(8): 1901-1904.
Leyh-Bannurah SR, Prugger C, de Koning MN, Goette H, Lellé RJ (2014) Cervical Human Papillomavirus Prevalence and genotype distribution among hybrid capture 2 positive women 15 to 64 years of age in the Gurage zone, rural Ethiopia. Infectious Agents and Cancer 9(1): 33.
Okolo C, Franceschi S, Adewole I, Thomas JO, Follen M, et al. (2010) Human papillomavirus infection in women with and without cervical cancer in Ibadan, Nigeria. Infect Agent Cancer 5(1): 24.
Keita N, Clifford GM, Koulibaly M, Douno K, Kabba I, et al. (2009) HPV infection in women with and without cervical cancer in Conakry, Guinea. Br J Cancer 101(1): 202-208.
Viviano M, Tran PL, Kenfack B, Catarino R, Akaaboune M, et al. (2018) Self- versus physician-collected samples for the follow-up of human papillomavirus- positive women in sub-Saharan Africa. Int J Womens Health 10: 187-194.
Depuydt CE, Benoy IH, Beert JF, Criel AM, Bogers JJ, et al. (2012) Clinical validation of a type-specific real- time quantitative human papillomavirus PCR against the performance of hybrid capture 2 for the purpose of cervical cancer screening. J Clin Microbiol 50(12): 4073-4077.

← Previous Article Stress and Burnout among Nurses Working in Menoufia University Hospitals Next Article → Can Emergency Medicine become Redundant?