A case-control study to identify risk factors associated with Human Papilloma Virus (HPV) associated lesions within the female reproductive tract
Cervical cancer, which is caused by persistent infection by High Risk HPV types, is the most frequent cancer in Tanzanian females, particularly affecting those co-infected with HIV. This study investigates risk factors associated with high-grade squamous intraepithelial lesion (HSIL) or squamous cell carcinoma (SCC) within the reproductive tract of Tanzanian women and identify High Risk (HR) HPVs that most frequently cause such disease in HIV +ve and HIV -ve women. This study focuses on HPV and HIV related factors, particularly on infecting HPV genotype(s) and immune system related factors, such as CD4 T-cell count, antiretroviral therapy (ART) status and HIV induced dysfunction of HPV-specific adaptive immunity. In addition, quality of life for cancer patients and socio-economic factors (such as sexual behaviour, age and smoking) will be studied.
A longitudinal follow up of selected HIV +ve and HIV -ve 2H study participants will allow to study viral persistence and clearance rates, and lesion recurrence after treatment of precancerous lesions. Highly Active Antiretroviral Treatment (HAART) associated reconstitution of HPV-specific immunity will be studied in relation to viral clearance and disease progression in HIV +ve 2H study participants initiating HAART.
A maximum of 600 adult women will be enrolled in four groups: 100 HIV positive and 100 HIV negative women with HSIL/SCC (Cases); 200 HIV positive and 200 HIV negative women with no cytological abnormalities or lower grade lesions (ASCUS, LSIL) will be enrolled as controls.
The anticipated results of this study will provide the basis for rational improvement of immunotherapeutic interventions in a patient population most heavily affected by HPV associated cancers and precancerous lesions.