Principal Investigators:

1. Doreen Ramogola-Masire, PhD, MSc, FCOG, BMBS, BMedSci

2. Scott Dryden-Peterson, MD, MSc

Study Objectives:

Primary Objective:

• To assess clinical effectiveness of two management strategies (extended genotyping, only vs. extended genotyping + HPV viral load) among WLWH testing HPV 31/33/35/52/58 positive comparing: 1) immediate treatment of women testing HPV 31/33/35/52/58 positive with a high viral load vs. 2) re-screening.

Secondary Objective:

• To assess clinical effectiveness of two management strategies (extended genotyping, only vs. extended genotyping + viral load) among WLWH testing HPV 31/33/35/52/58 positive comparing: 1) immediate treatment of women testing HPV 31/33/35/52/58 positive with a low viral load vs. 2) re-screening.
• Estimate the rate of overtreatment among WLWH testing HPV 31/33/35/52/58 positive with a high viral load who are triaged to immediate treatment.
• Estimate the rate of undertreatment among WLWH testing HPV 31/33/35/52/58 positive with a high viral load who were triaged to re-screening at Month 6.
• Determine factors associated with successful fidelity of primary HPV testing with triage based on extended genotyping and viral load, using the CFIR framework.
• Describe the organizational readiness for HPV screening and triage among women screened and healthcare workers and related staff (e.g., assessment of availability of HPV testing platform locally, staffing to perform testing, availability of time on the instrument for cervical cancer screening purposes, consistency in procuring reagents, and percent of time platform is down due to maintenance issues). 
• Describe post-HPV testing implementation factors including time for results to get communicated to clinic and patient receipt of HPV test results, time to treatment among those referred for treatment, patient loss to follow-up, and patient and staff acceptability.
• Describe staffing requirements and effort, including laboratory, courier, clinic staff, etc. essential to completing screening and triage strategies.

Study Design:

This is a hybrid, type I effectiveness-implementation trial that will implement and describe outcomes from cervical screening of WLWH using hrHPV testing with triage to treatment based on extended genotyping and HPV viral load. All women will self-collect a vaginal specimen for primary HPV testing to be evaluated on the Cepheid platform. WLWH who test hrHPV negative will exit the study and be referred to standard of care. Women with invalid results after testing three aliquots using their initial sample will be offered repeat testing. WLWH testing HPV 16 and/or 18/45 positive with or without other HPV groups detected, will be referred for immediate treatment and re-screened at Months 6 and 24.

Study population: Women with HIV infection aged 25 years old and above.

Sample size: 1050 women living with HIV to be enrolled in Botswana (2100 study-wide). Enrolment will be sequential among eligible and willing individuals.

Study duration: 3 years (

Sponsor: National Cancer Institute, USA