Promoting Comprehensive Cervical Cancer Prevention and Better Women Health in Cameroon

NCT03757299CompletedNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Prof. Patrick Petignat

Enrollment

4473

Start Date

2018-10-01

Completion Date

2022-12-05

Study Type

INTERVENTIONAL

Official Title

Promoting Comprehensive Cervical Cancer Prevention and Better Women Health in Cameroon

Interventions

HPV Test

Conditions

Cervical Cancer

Eligibility

Age Range

30 Years – 49 Years

Sex

FEMALE

Inclusion Criteria:

* Women aged 30-49 years, able to comply with the study protocol

Exclusion Criteria:

* Pregnancy
* Previous total hysterectomy
* Conditions impairing examination of the cervix

Outcome Measures

Primary Outcomes

Sensitivity and specificity of HPV test followed by VIA/VILI to detect cervical precancerous lesions in sub-Saharan Africa using histology as gold standard

VIA/VILI is assessed by pelvic examination and Sensitivity and specificity are measured by using histology as gold stantard

Time frame: 3 - 5 years

Secondary Outcomes

Prevalence of HPV infection

HPV self-test analysed by GeneXpert machine

Time frame: 3 - 5 years

Prevalence of cervical pre-cancer and cancer among Cameroonian women

Histological analyses of cervical biopsies and endocervical brushing

Time frame: 3 - 5 years

HPV clearance

Measured by self HPV performed at 6 and 12 months follow up

Time frame: 3 - 5 years

Persistance of CIN2+ disease at the 12-month follow-up

Histological analyses of cervical biopsies and endocervical brushing

Time frame: 3 - 5 years

Provide teaching material for professional training on cervical cancer prevention through VIA/VILI (cervical images database)

images database

Time frame: 3 - 5 years

Acceptability rate of self-HPV test and cervical cancer screening procedures

To assess the acceptability of self-HPV, patients complete a questionnaire comprising different questions about the collection device (embarassment, comfort, anxiety and confidence about the test). Likert Scale 4 points : 1 (not at all) to 4 (very).

Time frame: 3 years

Proportion of side effects and complications after thermoablation or LEEP

questionnaire

Time frame: 3 - 5 years

VIA test-positive rate (HPV-positive women);

VIA/VILI is assessed by pelvic examination

Time frame: 3 - 5 years

VIA test-positive rate after 1- year follow-up of VIA-negative tests

VIA/VILI is assessed by pelvic examination

Time frame: 3 - 5 years

Thermal ablation efficacy rate

Thermal ablation efficacy rate will be assessed according to the biopsy proven CIN2+ rate after thermoablation treatment at the 6 and 12-month follow-up. The absence of CIN2+ will determine the success of the treatment in a patient who previously had a CIN2+ lesion. Adverses event : bleeding, complications, hospitalization

Time frame: 3 - 5 years

Acceptability rate of thermoablation

To assess the acceptability of thermoablation, patients completed a questionnaire comprising different questions about treatment tolerance, pain and following side effects. Respondent were invited to rate answers on a likert scale of 1 (no accpetability) to 4 (high acceptability)

Time frame: 3 years

Sexual dysfunction score, score of anxiety and method of contraception after screening procedures,

SF12, Asex, STAI 6 Y-form

Time frame: 2 years

Number of women screened with and without community health care workers.

community health workers registre

Time frame: 2 years

Increase awareness on gynecological pathologies, including cervical cancer, sexually transmitted diseases and HIV, vaginal fistula in the community of the study area,

questionnaire

Time frame: 3-5 years

Locations

University of Geneva, Geneva, Switzerland

Linked Papers

2025-12-19

Psychological and sexual impact of human papillomavirus screening in women in Cameroon: a prospective cohort study

Abstract Background Cervical cancer (CC) is a public health burden, particularly in low-and middle-income countries, but can be prevented by screening for Human Papillomavirus (HPV). Nevertheless, positive test results may have psychological and sexual impacts for women. This study aimed to assess the impact of HPV test results on anxiety and sexual dysfunction in Cameroonian women. Methods This prospective cohort study conducted from 2020 to 2022 in Cameroon, included women previously enrolled in the 3T-Approach trial. Participants underwent a same-day consultation, organized as follows: HPV screening, triage of HPV-positive women and treatment by thermal ablation or Large Loop Excision of the Transformation Zone (LLETZ), if necessary. They completed anxiety (STAI) and sexual function (ASEX) questionnaires at 1, 6, and 12 months post-screening. Results Among 273 women included in the study, 220 (80.6%) completed all time points. Upon inclusion, 24.5% were HPV-positive, of which 46.3% underwent treatment. Anxiety levels did not significantly differ by HPV status. Higher sexual dysfunction prevalence was observed in HPV-positive women at all intervals. Between 1 and 12 months HPV-positive women showed an increase in their mean sexual dysfunction score (+ 4.5, 95% CI: 0.5 to 8.4), which was not seen in HPV-negative women. This disparity persisted even after adjusting for socio-demographic factors. Conclusion HPV test results did not significantly impact anxiety levels in women in Cameroon. Nevertheless, HPV-positive women reported higher sexual dysfunction at one-year post-screening compared to HPV-negative women. Further research should focus on investigating the factors affecting sexual dysfunction, in order to propose strategies to maintain women’s well-being without compromising screening rates. Trial registration The protocol of the 3TApproach study was registered under ClinicalTrials.gov, (identifier NCT03757299) on 28, November, 2018.

2022-12-22

Utility of extended HPV genotyping for the triage of self-sampled HPV-positive women in a screen-and-treat strategy for cervical cancer prevention in Cameroon: a prospective study of diagnostic accuracy

Objective To explore the utility of extended Human Papillomavirus (HPV) genotyping to detect cervical intraepithelial neoplasia grade 2 or more (CIN2+) in a ‘screen-and-treat’ strategy for HPV-positive women in low-resource settings. Design Prospective study of diagnostic accuracy. Setting The study took place in West Cameroon between September 2018 and March 2020. Participants 2014 women were recruited. Asymptomatic, non-pregnant women aged 30–49 years without history of CIN treatment, anogenital cancer or hysterectomy were eligible. Interventions Participants performed self-sampling for HPV testing with GeneXpert followed by visual inspection with acetic acid and Lugol’s iodine (VIA) triage before treatment if required. Main outcome measures Liquid-based cytology, biopsies and endocervical brushing were performed in HPV-positive women as quality control. We assessed the detection rate of CIN2+ by HPV genotyping (two pools of genotypes obtained from the Xpert system, pool_1 (HPV 16, 18, 45) and pool_2 (HPV 16, 18, 45, 31, 33, 35, 52, 58)), VIA and cytology. Results 382 (18.2%) women were HPV-positive among which 11.5% (n=44) were CIN2+. Of those 44 participants, 41 were triaged positive by extended genotyping, versus 35 by VIA and 33 by cytology. Overall, triage positivity was of 68.4% for extended genotyping, 59.3% for VIA and 14.8% for cytology, with false positive rates of 83.4%, 84.1% and 37.7%, respectively. Extended genotyping had a higher sensitivity for CIN2+ detection (93.2%, CI: 81.3 to 98.6) than VIA (79.5%, CI: 64.7 to 90.2, p=0.034) and cytology (75.0%, CI: 59.7 to 86.8, p=0.005). No significant difference was observed in the overtreatment rate in triaged women by extended genotyping or VIA (9.9%, CI: 8.6 to 11.3, and 8.8%, CI: 7.7 to 10.1), with a ratio of 6.0 and 6.3 women treated per CIN2+ diagnosed. Conclusion Triage of HPV-positive women with extended HPV genotyping improves CIN2+ detection compared with VIA with a minor loss of specificity and could be used to optimize the management of HPV-positive women. Trial registration number NCT03757299 .

2022-04-04

ABCD criteria to improve visual inspection with acetic acid (VIA) triage in HPV-positive women: a prospective study of diagnostic accuracy

Objectives A simple system for visual inspection with acetic acid assessment, named ABCD criteria, has been developed to increase accuracy for triaging of high-risk human papillomavirus (HPV)-positive women. This study aimed to determine the accuracy of ABCD criteria for the detection of histologically confirmed cervical intraepithelial neoplasia grade two or worse (CIN2+) in HPV-positive women living in a low-resource setting. Design Prospective study of diagnostic accuracy. Setting Cervical cancer screening programme based on a 3T-Approach (test, triage and treat) in the Health District of Dschang, West Cameroon. Participants Asymptomatic non-pregnant women aged 30–49 years were eligible to participate. Exclusion criteria included history of CIN treatment, anogenital cancer or hysterectomy. A total of 1980 women were recruited (median age, 40 years; IQR 35–45 years), of whom 361 (18.4%) were HPV-positive and 340 (94.2%) completed the trial. Interventions HPV-positive women underwent a pelvic examination for visual assessment of the cervix according to ABCD criteria. The criteria comprised A for acetowhiteness, B for bleeding, C for colouring and D for diameter. The ABCD criteria results were codified as positive or negative and compared with histological analysis findings (reference standards). Primary outcome measure Diagnostic performance of ABCD criteria for CIN2+, defined as sensitivity, specificity, negative and positive predictive values. Results ABCD criteria had a sensitivity of 77.5% (95% CI 61.3% to 88.2%), specificity of 42.0% (95% CI 36.5% to 47.7%), positive predictive value of 15.1% (95% CI 10.8% to 20.8%), and negative predictive value of 93.3% (95% CI 87.6% to 96.5%) for detection of CIN2 +lesions. Most (86.7%) of the ABCD-positive women were treated on the same day. Conclusions ABCD criteria can be used in the context of a single-visit approach and may be the preferred triage method for management of HPV-positive women in a low-income context. Trial registration number NCT03757299 .

2022-02-02

Acceptability and safety of thermal ablation to prevent cervical cancer in sub-Saharan Africa

Abstract Background The World Health Organization recommends thermal ablation as an alternative to cryotherapy to treat women with precancerous lesions in low-resource settings. However, limited data are available on women’s experience and adverse events (AEs) of the procedure in the context of Sub-Saharan Africa. The objective of this study was to evaluate the acceptability and safety of thermal ablation in women screened positive for precancerous cervical lesions. Methods Asymptomatic women aged 30–49 years old living in the Dschang Health District were invited to participate in a cervical cancer screening campaign termed “3 T-Approach” (for Test-Triage and Treat). Recruited women were asked to perform HPV self-sampling followed by triage with visual assessment and treatment with thermal ablation if required. After treatment and 4–6 weeks later, interviews were conducted to assess women’s experience on anxiety, discomfort, and pain during thermal ablation. AEs were recorded on pre-defined electronic forms 4–6 weeks after treatment to assess the procedure’s safety. Results Between September 2018 and December 2020, 399 HPV-positive women (18.7% of women screened) were recruited, 236 (59.1%) had a positive visual assessment, 234 were treated by thermal ablation and 198 (84.6%) received therapy in the same visit. Treatment was not considered as painful (score ≤ 4/10) by 209 (90.9%) patients while 5 (2.5%) reported high pain (score 8–10/10). During post-treatment interviews 4–6 weeks later, most reported AEs were graded mild or moderate (grade I-II). The most frequent symptoms reported as mild AEs (grade 1–2) were vaginal watery discharge (75.5%), vaginal bloody-stained discharge (21.5%) and malodourous discharge (14.5%). None of the participants experienced serious AEs (grade 3–4) or AEs requiring admission to hospital or emergency consultation. The vast majority of women (99.6%) would agree to repeat the procedure if necessary and (99.6%) would recommend it to friends or family. Conclusion Thermal ablation is widely accepted by women and appears as a safe procedure. It may contribute to improving the link between screening and treatment in a single visit and to optimizing cervical cancer control in low-resource settings. Trial registration The study was registered on clinicaltrials.gov ( NCT03757299 ) in November 2018 (28/11/2018).

Promoting Comprehensive Cervical Cancer Prevention and Better Women Health in Cameroon