Study Objectives: 

• Aim 1 (primary): To characterize incident anogenital cancers. Implement augmented data collection of variables among male anal and penile cancer patients included in the Botswana Prospective Cancer Cohort (BPCC) (N=60). Variables will include detailed pathologic description, stage, HIV history, sexual history, and circumcision status.  Conduct HPV-serotype testing in these patients. Describe survival and predictors.
• Aim 2 (primary): To define barriers to diagnosis and treatment. Host focus groups and develop questionnaires to explore barriers to access and engagement in care for male anogenital cancers. Use questionnaires to administer semi-structured interviews to consenting male anal and penile cancer patients enrolled in the BPCC cohort, and to age- and HIV-matched community controls.  From findings, explore possible models of care enhancement to promote male patient engagement such as male sexual health clinics, job site outreach and community awareness activities.
•  Aim 3 (secondary): To expand clinical expertise and diagnostic venues. Develop a training program to facilitate appropriate evaluation, triage, and referral of patients with anogenital complaints, targeting generalist doctors and nurses at primary and secondary level facilities, as well as clinicians at tertiary facilities in non-oncology departments. Identify opportunities for US- and South Africa-based rotations to facilitate advanced skills training of selected local clinicians within the oncology teams. 

Study Design: 

This is a multifaceted study aimed at characterizing HPV-associated cancers among men, and defining barriers to care engagement for patients in Botswana with a view of helping to identify strategies for early detection among these cancers. Participants in the study were male patients with penile or anal cancer enrolled in existing prospective cancer cohorts, along with community based controls. Participants also included key informants who participated in focus groups and support review of training material to be developed. 

• Aim 1. Design - In-depth characterization of male anogenital cancers will be conducted through combined retrospective analysis of existing cohort data, augmented phone survey-based collection of additional data, as well as HPV subtype testing of archived tissue specimens. 
• Aim 2. Design - Barriers to access and engagement in care for anogenital cancer-related (and general) complaints will be assessed through administration of a semi-structured questionnaire to male anal and penile cancer patients and matched controls. We will identify and elucidate elements to be measured in the structured questionnaire through focus group consultations.

Study Population and Size: 

Individuals who meet the following inclusion criteria will be eligible to participate in the study as case subjects:

• Male, AND
• Aged 18 years or older, AND
• Citizen of Botswana, AND
• Diagnosed with penile or anal cancer, AND
• Has been seen at PMH, GPH, NRH
• Has been enrolled in Botswana Prospective Cancer Cohort (BPCC) or HPV-associated cancers cohort (HACC) 

Individuals who meet the following inclusion criteria will be eligible to participate in the study as control subjects: 

• Male, AND
• Aged 18 years or older, AND
• Citizen of Botswana, AND
• Residing in locations listed in Table XX above and enrolled in BCPP

Controls will be Age- and HIV-status matched to cases. Patients who do not meet any of the inclusion criteria above, who die prior to presentation to PMH or NRH Oncology department (for cases) or given facility (for controls) will be excluded.

Focus groups - A spectrum of key informants such as oncologists, generalist doctors, nurses, social workers, peer counselors, patients, and community leaders. Identification and recruitment of focus group participants will occur through health facility and research team networks.

For Aim 1, all patients who meet eligibility criteria upon retrospective review of cohorts data and during the study period will be included in the study. We estimate that this will be approximately 60 patients.

For Aim 2, three focus groups will be held involving up to 30 participants in total. Semi-structured questionnaires will be administered to 60-100 participants (30-50 participants in each case and control group), given the anticipated number of cases that will be available during study period as well as estimated sample size to achieve saturation of identified themes.

Study Duration:12 months

Sponsor:

• Botswana Harvard AIDS Initiative Partnership (BHP).
• Botswana University of Pennsylvania Partnership (BUP).