Principal Investigator - Dr. Rebecca Luckett, MD, MPH
Name of the Study: Evaluation of cervical cancer screening algorithms using primary high risk human papillomavirus (HPV) in Gaborone and South East District, Botswana
Completed: Recruitment of 300 women living with HIV in Gaborone, and one year follow-up of this cohort.
On-going: Recruitment of a new cohort of 3000 women in South East District is currently underway. 50% of the cohort will be women living with HIV.
Study Objectives:
- Evaluate 2-stage cervical cancer screening algorithms using primary high risk HPV testing, including triage testing with visual inspection with acetic acid, colposcopy and automated visual evaluation.
- Evaluate safe and effective screening intervals in an HPV based program in a high HIV prevalence setting.
- Evaluate the performance of HPV testing alone using an affordable new assay in a high burden HIV setting.
- Evaluate the cost effectiveness of HPV based 2-stage cervical cancer screening strategies
Study Design: These two cohorts are prospective cohort studies of women seeking care in health facilities in Gaborone and South East District, respectively. Participants collect vaginal self swabs for HPV testing and undergo triage testing according to HPV results.
Study Population: 3000 women (50% positive and 50% negative for HIV) in South East District, Botswana.
Study Duration: The study is expected to run over a 3-year period (October 2019 – September 2022).
Sponsor: Harvard University CFAR and Beth Israel Deaconess Medical Center Department of Obstetrics and Gynecology.
In a high-risk HIV population in Gaborone, HPV testing followed by colposcopy demonstrated the highest sensitivity and positive predictive value in detecting high-grade cervical dysplasia.
There is a high incidence and persistence of HPV and high-grade cervical dysplasia in women living with HIV after one round of HPV-based screening.
