Oral human papillomavirus prevalence, persistence and risk-factors in HIV-positive and risk HIV- negative men in southwestern Kenya

The Oral HPV Study

Start:                  August 2022

Status:                Follow ups ongoing

Design:               Clinical Trial

Study Sites:        Anza Mapema Centre of Excellence

Sponsor:             MERCK, SHARP and DOHME  

IRB:                      Kenya Medical Research Institute ERC

Purpose:             To evaluate the prevalence, incidence, persistence and risk-factors of Oral human papillomavirus in HIV-positive and risk HIV- negative men in southwestern Kenya.

Design:               Prospective, longitudinal cohort study to evaluate differences in risk factors for prevalent of oral HPV infection in HIV-positive and HIV-negative men. The study will explore the possible differences in incidence and factors affecting clearance or persistence of Oral HPV. After consent is obtained and locator information documented, to determine eligibility the screening questionnaire will be administered, including socio-demographic information, sexual and risk behavior, clinical history. This will be followed by HIV testing and determination of eligibility. Eligible participants will be enrolled with completion of a detailed medical history, administration of a socio-behavioural questionnaire on social-behavioral, general health, alcohol use disorders, sexual behavior, general anxiety disorder, knowledge of oral HPV infection, physical examination with specimen collection for Blood and oral swabs for HIV testing, Viral Load and CD4 (for HIV positive individuals) and HPV testing. Following completion of enrollment, participants will be followed every 6 months for 24 months with similar study procedures.

Population:        Cisgender Men aged 18 years and above who report to be sexually active with no history of HPV vaccination.

Study Size:          We expect to enroll a total of 398 men (199 HIV positives and 199 HIV negatives) after adjusting for 10% loss to follow-up.

Study Aims:        Aim 1: To describe the prevalence, incidence, persistence and clearance associated with Oral HPV in a cohort of HIV-infected and uninfected men in south western Kenya

Aim 2: To evaluate the natural history of oral HPV infection and disease in HIV-infected men and examine the relationships between HPV infections, antiretroviral treatment, CD4 count and HIV viral load, and the presence of either persistent HPV or abnormal oropharyngeal cytology

Aim 3: To evaluate differences in risk factors for prevalent oral HPV infection in HIV-infected and uninfected men.