Training, Supervision, and Competence Assessment of Cameroonian Health Care Providers Using HPV Self-Sampling, Triage by Visual Inspection, and Treatment by Thermal Ablation in a Single Visit.

Background: Developing human resource capacity and efficient deployment of skilled personnel are essential for cervical cancer screening program implementation in resource-limited countries. Our aim was to provide a context-specific training framework, supervision, and effectiveness evaluation of health care providers in a cervical cancer screening program. Methods: A 5-year cervical cancer screening program was implemented in Dschang, West Cameroon. Women were invited to perform human papillomavirus self-sampling (Self-HPV), followed by triage using visual inspection with acetic acid (VIA) and thermal ablation if needed. Health care providers were trained in four key learning phases to perform counseling, screening, and treatment process in a single visit. Training included (i) a 3-day basic course, (ii) 3-day advanced practical training, (iii) 2 weeks of supervision, and (iv) bi-monthly supervision by a mentor. The diagnostic performance of health care providers was compared between two time periods, period I (September 2018 to April 2019) and period II (May 2019 to January 2020), for an overall 17-month study period. Results: Fourteen health care providers were recruited for the training course and 12 of them completed the training objectives. Follow-up and evaluations were conducted for three health care providers working in the screening unit at Dschang District Hospital. During the study period, 1,609 women performed Self-HPV, among which 759 were screened during period I and 850 during period II. HPV positivity was 18.2 and 17.1%, and VIA positivity was 45.7 and 71.0% in period I and II, respectively. VIA sensitivity was 60.0% (95% confidence interval [CI] 26.2-87.8) and 80.8% (95% CI 60.6-93.4) in period I and II, respectively (p = 0.390). VIA specificity decreased between period I (57.4, 95% CI 48.1-66.3) and II (30.8, 95% CI 22.6-40.0) (p < 0.001). Health care providers demonstrated substantial agreement with their mentor in their diagnoses during both periods (period I: Cohen's kappa coefficient [k] = 0.73, 95% CI 0.62-0.85, and period II: k = 0.62 0.47-0.76; p = 0.0549). Discussion: Training, supervision, and a focus on effectiveness in cervical cancer screening are interventions that contribute to improving frontline provider competencies and maintaining a high quality of health care service delivery.

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.

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

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).

Implementing the 3T-approach for cervical cancer screening in Cameroon: Preliminary results on program performance.

Option recommended by World Health Organization (WHO) includes human papillomavirus (HPV) primary screening followed by visual inspection with acetic acid (VIA) triage. We implemented a program based on a 3T-approach (Test-Triage and Treat). Our objective was to verify the effectiveness of the program by defining a set of performance indices. A sensitization campaign was performed in Dschang (Cameroon) and women aged 30-49 years were invited to participate for screening based on the 3T-approach. Participants performed HPV self-sampling (Self-HPV), analyzed with the point-of-care Xpert HPV assay followed by VIA/VILI triage and treatment if required. Key performance indicators (KPIs) for screening, diagnosis, treatment and follow-up were defined, and achievable targets were described for which the approach is likely to be running optimally. A total of 840 women with a mean age of 39.4±5.9 years participated. The KPIs included (i) the screening rate (8.4% at 7 months, target =20% at 12 months), (ii) HPV positivity rate (19.8%, expected range 18-25%), (iii) compliance to referral to VIA/VILI and complete test (100%, target >90%), (iv) compliance to referral to thermal ablation (100%, target >90%), (v) VIA/VILI positivity rate (50.6%, expected range 45-55%), (vi) a single visit from diagnostic to treatment (79.8%, target >80%), (vii) compliance to follow-up at 1 month (96.4%, target >80%) and (viii) at 6 months (70.6%, target >80%). Program performance based on the single-visit 3T-approach corresponded to defined targets and preliminary results support adequateness of KPIs for periodic monitoring.

Benefit of Watching a Live Visual Inspection of the Cervix With Acetic Acid and Lugol Iodine on Women's Anxiety: Randomized Controlled Trial of an Educational Intervention Conducted in a Low-Resource Setting.

BACKGROUND: Women undergoing pelvic examination for cervical cancer screening can experience periprocedural anxiety. OBJECTIVE: The aim of this study was to assess the anxiety level experienced by women undergoing a visual inspection with acetic acid and Lugol iodine (VIA and VILI) examination, with or without watching the procedure on a digital screen. METHODS: This prospective randomized study took place in the district of Dschang, Cameroon. A previous cervical cancer screening campaign tested women aged between 30 and 49 years for human papillomavirus (HPV). HPV-positive women were invited for the 12-month follow-up control visit, including a VIA/VILI examination. During that visit, we recruited women to participate in this study. Before the examination, participants were randomized in a 1:1 ratio to a control group (CG) and an intervention group (IG). Women in both groups underwent a pelvic examination and were verbally informed about the steps undertaken during the gynecological examination. The IG could also watch it live on a tablet screen. Women's anxiety was assessed before and immediately after the examination, using the Spielberger State-Trait Anxiety Inventory (STAI). A paired t test was used to compare the mean STAI score for each question before and after VIA/VILI while a nonpaired, 2-sided t test was used to compare the mean differences of the STAI score between the 2 study groups. RESULTS: A total of 122 women were randomized in the study; 4 of them were excluded as they did not undergo the pelvic examination, did not answer to the second STAI questionnaire because of personal reasons, or the cervix could not be properly visualized. Thus, the final sample size consisted of 118 patients of whom 58 women were assigned to the CG and 60 to the IG. The mean age was 39.1 (SD 5.2) years. Before the examination, the mean (SD) STAI score was 33.6 (SD 10.9) in the CG and 36.4 (SD 11.8) in the IG (P=.17). The STAI score after pelvic examination was significantly reduced for both groups (CG: 29.3 [SD 11.2]; IG: 28.5 [SD 12.0]). Overall, the difference of the STAI scores before and after the pelvic examination was lower in the CG (4.2 [SD 9.0]) than in the IG (7.9 [SD 14.3]), although the difference was not significant (P=.10). However, the women's emotional state, such as I feel secure and I feel strained, was improved in the IG as compared with the CG (CG: P=.01; IG: P=.007). CONCLUSIONS: Watching the VIA/VILI procedure in real time improved the women's emotional state but did not reduce the periprocedural anxiety measured by the STAI score. Furthermore, larger studies should assess women's satisfaction with watching their pelvic examination in real time to determine whether this tool could be included in VIA/VILI routine practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT02945111; http://clinicaltrials.gov/ct2/show/NCT02945111.

Clearance and persistence of the human papillomavirus infection among Cameroonian women.

OBJECTIVE: Persistent infection with human papillomavirus is the prerequisite for the development of cervical precancerous and cancerous lesions. The aim of this study was to determine the time-to-viral clearance in a population of human papillomavirus-infected Cameroonian women and to examine the possible predictors of viral persistence. METHODS: We conducted a prospective cohort study based on a population of human papillomavirus-positive women having previously been recruited in a self-human papillomavirus-based cervical cancer screening campaign, who were invited for a control visit at 6 and 12 months. We determined human papillomavirus clearance using self-sampling (Self-HPV) and physician-sampling (Dr-HPV), which were analyzed with a point-of-care assay (GeneXpert® IV; Cepheid, Sunnyvale, CA, USA). Logistic regression was performed to assess the relationship between sociodemographic and clinical characteristics with HPV clearance according to the two sampling techniques. RESULTS: A total of 187 participants were included in the study. At the 12 months follow-up, 79.5% (n = 104) and 65.3% (n = 86) had cleared their human papillomavirus infection according to Dr-HPV and self-HPV, respectively (p = 0.001). Only parity (>5 children) was statistically associated with viral persistence (p = 0.033). According to Dr-HPV, clearance of women treated with thermoablation at 12 months was of 84.1% versus 70.2% for non-treated women (p = 0.075). CONCLUSION: The human papillomavirus clearing rates found in our study are close to those found in other studies worldwide. Parity was significantly associated with human papillomavirus persistence. Larger, prospective studies are needed to confirm our results.

Cervical cancer screening in a low-resource setting: a pilot study on an HPV-based screen-and-treat approach.

Cervical cancer (CC) is the leading cause of cancer-related death among women in sub-Saharan Africa, primarily because of limited access to effective screening and preventive treatment. Our aim was to assess the feasibility of a human papillomavirus (HPV)-based CC screen-and-treat approach in a low-resource context. We recruited 1012 women aged 30-49 years through a CC screening campaign conducted in the District Hospital of Dschang, Cameroon. Participants performed HPV self-sampling, which was tested for high-risk HPV (HR-HPV) DNA using the point-of-care Xpert HPV assay. All HPV-positive women were invited for visual inspection with acetic acid and Lugol's iodine (VIA/VILI) to exclude CC or enable triage. A cervical sample for histological analysis was also collected. Women positive for HPV 16/18/45 and for other HR-HPV with pathological VIA/VILI were selected to undergo treatment with thermocoagulation. The HPV prevalence in the study population was 18.5% (n = 187); of these cases, 20 (10.6%), 42 (22.3%) and 140 (74.9%) were positive for HPV16, HPV18/45 and other HR-HPV types, respectively. Overall, 107/185 (57.8%) VIA/VILI examinations were classified as pathological and 78 (42.2%) as normal. Women positive for HPV16/18/45 were 4.2 times more likely to harbor cervical intraepithelial neoplasia grade 2 or worse (CIN2+) than those with other HPV types. The specificity of HPV 16/18/45 genotypes for detection of high-grade lesions among HR-HPV positive women was higher than that of VIA/VILI in all age groups. The sensitivity and specificity of VIA/VILI in detecting CIN2+ among HPV positive women were 80% and 44%, respectively. Overall, 110/121 screen-positive women (90.9%) were eligible for, and were treated with, thermocoagulation. An HPV-based screen-and-treat approach is feasible in a low-resource context and may contribute to improving the effectiveness of CC prevention programs. Immediate thermocoagulation treatment for women who are HPV16- and/or HPV18/45-positive is a practical approach for the treatment of CIN2+. The combination of HPV-testing and VIA/VILI for CC screening might reduce overtreatment.

Feasibility of thermocoagulation in a screen-and-treat approach for the treatment of cervical precancerous lesions in sub-Saharan Africa.

BACKGROUND: The use of thermocoagulation for the treatment of cervical precancerous lesions has recently generated a great deal of interest. Our aim was to determine the feasibility of this outpatient procedure in the context of a cervical cancer (CC) screen-and-treat campaign in sub-Saharan Africa. METHODS: Between July and December 2015, women living in the area of Dschang (Cameroon) aged between 30 and 49 years, were enrolled in a CC screening study. HPV self-sampling was performed as a primary screening test and women who were either "HPV 16/18/45-positive" or "positive to other HPV types and to VIA" were considered screen-positive, thus requiring further management. The primary outcome was the percentage of screen-positive patients who met the criteria to undergo thermocoagulation. The secondary outcome was the assessment of the procedure's side effects immediately after treatment and at the 1-month follow-up visit. RESULTS: A total of 1012 women were recruited in the study period. Among 121 screen-positive women, 110 of them (90.9%) were eligible to be treated with thermocoagulation. No patients discontinued treatment because of pain or other side effects. The mean ± SD (Standard Deviation) score measured on the 10-point Visual Analogue Scale (VAS) was 3.0 ± 1.6. Women having less than 2 children were more likely to report a higher pain score than those with more than two (4.2 ± 2.0 versus 2.9 ± 1.5, respectively; p value = 0.016). A total of 109/110 (99.1%) patients came to the 1-month follow-up visit. Vaginal discharge was reported in 108/109 (99.1%) patients throughout the month following treatment. Three patients (2.8%) developed vaginal infection requiring local antibiotics. No hospitalizations were required. CONCLUSION: The majority of screen-positive women met the criteria and could be treated by thermocoagulation. The procedure was associated to minor side effects and is overall feasible in the context of a CC screen-and-treat campaign in sub-Saharan Africa. TRIAL REGISTRATION: The trial was retrospectively registered on November 11, 2015 with the identifier: ISRCTN99459678 .