1. Implementation Research Via Cluster RCT 2. Pathology Validation Via Observational Cohort
Intervention Group
HPV self-collection in the community and clinic
Control Group
HPV self-collection in the clinic
Funding Agency
PEER (NAS/USAID)
Location
Districts: Lilongwe and Zomba Country: Malawi
Setting
Community and Clinic
Beneficiaries
Number of women screened with HPV self-sampling
39,000
Follow up of HPV-positive women
Yes
.
Brief Sumary
Our team has developed a cluster randomized clinical trial (RCT) that will integrate a novel cervical cancer screen-and-treat algorithm into voluntary family planning (VFP) services via two different models.
Model 1 involves: 1) cervico-vaginal self-sampling for high-risk HPV (hr-HPV) while waiting for appointments at the VFP clinic or other clinics, 2) same-day VIA for those women found to be hr-HPV-positive by rapid GeneXpert HPV testing, and 3) same-day thermocoagulation treatment for HPV-positive women who are eligible for ablative therapy by VIA.
Model 2 woll offer women the same services as in Model 1, but they will also be given the option to perform cervico-vaginal self-sampling in the community (at home or through outreach clinics).
We will also be performing a Pathology Validation observational cohort sub-study of 1,250 women (625 HPV+ and 625 HPV-) to assess under/overtreatment rates with our cervical screening algorithm.
Our cluster RCT Objectives are:
–Objective #1: To compare the propotion of eligible women who receive cervical cancer screening (CCS) and VFP services in the catchment areas of health facilities assigned tothe two models.
–Objective #2: To assess the acceptability, appropiateness and feasibility of the two models among key stakeholders, including service provider and clients, during the early, misline and final implementation phases of the project.
–Objective #3: To estimate the cost and budget impact of each model compared to the standard-of-care (VIA and cryotherapy), using information collected for the previous objectives.
–Objective #1: To assess completion of a novel ICC screen-and-treat strategy using sef-collected vaginal brush for hr-HPV testing, followed by same-day VIA and thermocoagulation for HPV-positive/VIA-positive/ablation-eligible (by colposcopy) women.
–Objective #2: To determine the 24-weef efficacy of thermocoagulation among women with CIN 2/3.
–Objective #3: To evaluate performance of the proposed ICC screen-and-treat strategy by estimating overtreatment of women who are HPV-positive /VIA-positive/ablation-eligible, and undertreatment among HPV-positive/VIA-negative women.
–Objective #4: To esplore women’s experiences with the proposed ICC scree-and-treat strategy.
