Prior to study implementation, the study staff conducted consultative meetings with traditional leaders, community health workers (CHWs) and the UNCPM Community Advisory Board (CAB). The leaders and CHWs then shared information about our study at community gatherings including in churches and at funerals. The study information included study start date and designated study sites in their communities. Study nurses, clinicians, HIV counselors and community workers conducted educational talks targeting both men and women through a public address system; at the study sites and by driving around in the communities; about ICC prevention and HIV; screening with VIA and thermal ablation; and the referral cascade for those who may not have lesions treatable through thermal ablation or those who test HIV-positive. VIA-based ICC screening and same-day thermal ablation were offered to women who met the following eligibility criteria: age 25 to 49 years; nonpregnant; no history of hysterectomy, cervical, vaginal or vulvar cancer or dysplasia; not screened in the past 1 year; no known allergy to acetic acid; and more than 12 weeks postpartum if recently pregnant. HIV testing and counseling were also offered to women whose HIV status was unknown.
Study staff prescreened women for eligibility, and eligible women who were interested to participate were asked to provide written informed consent. Using an interviewer-administered questionnaire, study staff collected sociodemographic data including sexual and contraceptive history. Women were then offered individual counseling for VIA and thermal ablation. A urine pregnancy test was done to rule out pregnancy prior to VIA. Study nurses with prior practical experience in screening and certified through the national cervical cancer screening training program, which includes supervised mentorship, and underwent refresher training prior to the study performed VIA and interpreted results as per WHO International Agency for Research in Cancer guidelines.21 The same nurses performed same-day thermal ablation if the VIA was positive and if the cervical lesion met the following criteria: visible in its entire extent on the ectocervix; covered less than three quarters of the ectocervix; no extension to the vagina and/or endocervix; not suspicious for ICC or glandular dysplasia; did not extend more than 3 mm into the canal; and no clinical evidence of pelvic inflammatory disease. Prior to treatment, a cervical biopsy was collected. Women with lesions not amenable to thermal ablation were referred to KCH for further care.
Follow-up visits for women who received treatment were conducted at Weeks 6 and 12. At Week 6, an interval medical history was collected and reviewed for thermal ablation safety outcomes, including adverse events such as moderate to severe bleeding, fever, increased pelvic pain, abnormal vaginal discharge and any disorder requiring admission after treatment. Histologic results of cervical biopsies collected prior to thermal ablation were also reviewed with the women. At Week 12, VIA was performed on women who had CIN diagnosed at the time of thermal ablation. A directed cervical biopsy was performed if a lesion was present, or a random cervical biopsy if no lesion, to determine the histological resolution of CIN. Women were reimbursed for transport costs for follow-up visits as approved by the Malawi National Research Ethics Committee.
Study staff prescreened women for eligibility, and eligible women who were interested to participate were asked to provide written informed consent. Using an interviewer-administered questionnaire, study staff collected sociodemographic data including sexual and contraceptive history. Women were then offered individual counseling for VIA and thermal ablation. A urine pregnancy test was done to rule out pregnancy prior to VIA. Study nurses with prior practical experience in screening and certified through the national cervical cancer screening training program, which includes supervised mentorship, and underwent refresher training prior to the study performed VIA and interpreted results as per WHO International Agency for Research in Cancer guidelines.21 The same nurses performed same-day thermal ablation if the VIA was positive and if the cervical lesion met the following criteria: visible in its entire extent on the ectocervix; covered less than three quarters of the ectocervix; no extension to the vagina and/or endocervix; not suspicious for ICC or glandular dysplasia; did not extend more than 3 mm into the canal; and no clinical evidence of pelvic inflammatory disease. Prior to treatment, a cervical biopsy was collected. Women with lesions not amenable to thermal ablation were referred to KCH for further care.
Follow-up visits for women who received treatment were conducted at Weeks 6 and 12. At Week 6, an interval medical history was collected and reviewed for thermal ablation safety outcomes, including adverse events such as moderate to severe bleeding, fever, increased pelvic pain, abnormal vaginal discharge and any disorder requiring admission after treatment. Histologic results of cervical biopsies collected prior to thermal ablation were also reviewed with the women. At Week 12, VIA was performed on women who had CIN diagnosed at the time of thermal ablation. A directed cervical biopsy was performed if a lesion was present, or a random cervical biopsy if no lesion, to determine the histological resolution of CIN. Women were reimbursed for transport costs for follow-up visits as approved by the Malawi National Research Ethics Committee.
