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.

Self- versus physician-collected samples for the follow-up of human papillomavirus-positive women in sub-Saharan Africa.

INTRODUCTION: Human papillomavirus (HPV) testing is a suitable tool for primary cervical cancer (CC) screening and follow-up in low-resource settings. Vaginal samples taken by women themselves (Self-HPV) are an interesting alternative to physician-performed sampling (Dr-HPV). Our aim was to assess the performance of Self-HPV and Dr-HPV at 6 and 12 months following a CC screening campaign. METHODS: This study was carried out at the Dschang District Hospital, Cameroon. Women aged 30-49 years were recruited in a CC screening campaign. HPV-positive women, of whom 2/3 were treated with thermoablation because of abnormal results at baseline screening, were invited to participate in a follow-up study. Self- and Dr-HPV, as well as cytology, were performed at 6 and 12 months. HPV samples were analyzed using the Xpert HPV assay. Sensitivity and specificity for the detection of low-grade squamous intraepithelial lesion or worse and of high-grade squamous intraepithelial lesion or worse were calculated for Self-HPV and Dr-HPV, using cytology as the reference diagnosis. RESULTS: Overall, 188 HPV-positive women were invited to attend follow-up. The obtained follow-up visits' attendance was 154 (81.9%) and 131 (69.7%) at 6 and 12 months, respectively. While the overall performance of Dr-HPV at 6 months was slightly superior, Self-HPV showed an improved sensitivity for HSIL+ detection at 12 months when compared with Dr-HPV (83.3% [95% CI 41.8-98.9] versus 71.4% [95% CI 21.5-95.8], respectively). The overall HPV positivity agreement between Self- and Dr-HPV at 6 and 12 months corresponded to a κ value of 0.62 and 0.52, respectively. Among women treated with thermoablation (n=121) at baseline screening, Self-HPV was as sensitive as Dr-HPV, although less specific (P=0.003). CONCLUSION: Self-HPV is a valuable tool for the follow-up of HPV-positive women in low-resource settings. Larger, randomized trials are needed to confirm the validity of our findings.

Efficacy of thermoablation in treating cervical precancerous lesions in a low-resource setting.

INTRODUCTION: Treating cervical intraepithelial neoplasia (CIN) grades 2 and 3 is the recommended strategy for preventing invasive carcinoma in low- and middle-income countries (LMICs). Our objective was to assess the efficacy of thermoablation in the treatment of CIN2 and CIN3 in a screen-and-treat approach. METHODS: Women aged 30-49 years in Dschang, Cameroon, were invited to undergo vaginal sampling for human papillomavirus (HPV), samples being assessed by an Xpert HPV Assay. HPV-positive women underwent visual inspection with acetic acid (VIA) and visual inspection with Lugol's iodine (VILI), cervical biopsy, and endocervical curettage. Women positive for HPV-16/18/45 or other HPV types with abnormal VIA/VILI were treated by thermoablation on the same day. The primary outcome was persistence of high-grade disease on cytologic examination at 12 months. RESULTS: Of a total of 1,012 recruited women, 188 were HPV-positive, 121 patients required thermoablation, and 99 had a CIN of grade <2, making the overtreatment rate 9.9%. The cure rate for CIN2 and CIN3 at 12 months was 70.6%. Failure (higher risk of persistent disease) was associated with the presence of occult endocervical lesions at baseline diagnosis (adjusted odds ratio [aOR] =128.97 [95% confidence interval [CI], 8.80-1,890.95]; p<0.0001). First sexual intercourse before the age of 15 was also a risk factor (aOR =0.003 [95% CI, 0.001-0.61]; p=0.023). CONCLUSION: In LMICs, use of thermoablation in a screen-and-treat approach is a valuable treatment option for CIN2 and CIN3. Studies comparing thermoablation with cryotherapy are needed to determine the most appropriate treatment for cervical precancer in such countries.

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 .