PROJECT SUMMARY/ABSTRACT Worldwide, 70% of new HIV infections every year occur in Sub-Saharan Africa (SSA), home to 74% of people living with HIV/AIDS (PLWHA), of whom over 50% are women. Furthermore, the highest rates of cervical cancer (CC) incidence and related death also occur in SSA, where approximately 60% of all CC cases are in women living with HIV/AIDS (WLWHA). Human Papillomavirus (HPV), amajor cause of CC, is the most common sexually transmitted infection in SSA and nearly all WLWHA worldwide who develop CC are co- infected with HPV. CC is largely preventable by HPV vaccination and cervical screening for early detection and treatment. In high income countries (HICs), these strategies have led to a steep decline in CC; however they remain largely inaccessible to women in low- and middle-income countries (LMICs). Self-sampling-based HPV (SS-HPV) tests have been shown to be a cost-effective and feasible approach to identifying women infected with high-risk HPV strains (hr-HPV) who need more advanced diagnostic tests and treatment. However, SS- HPV testing has not been widely implemented in most LMICs, including SSA despite high HIV prevalence. Leveraging our decade-long, extensive, and successful training partnership and research collaborations in Mali and Nigeria, we propose to implement a novel West African Self-Sampling HPV-Based Cervical Cancer Control Program (WA-SS-HCCP). The project capitalizes on existing strengths and resources including the HIV systems of care with Community Health Workers (CHWs) who have established relationships with WLWHA and can provide HPV and CC education/counseling and SS specimen collection guidance, rapid transportation of specimens to hospital laboratories, personalized delivery of test results directly to the women, and facilitation of clinic referrals for women with hr-HPV for advanced diagnostics and treatment. The study will conduct in-depth assessment of barriers, challenges, and needs to contextually adapt, implement, and evaluate the effectiveness and success of WA-SS-HCCP. The specific aims are to (1) Assess barriers and needs for contextual adaptations of WA-SS-HCCP among WLWHA in Mali and Nigeria, using qualitative risk assessment and observation methods; (2) Contextually adapt, using a learning collaborative approach (e.g., monthly webinars, rapid-cycle small tests of change) and an implementation framework (e.g., training to competency of CHWs, data coordination across settings, implementation dashboard) to optimize the WA-SS- HCCP across all four sites; and (3) Conduct a dual evaluation of the effectiveness (e.g., % WLWHA fully screened and % change in) and implementation (e.g., reach, adoption, implementation fidelity, and maintenance or sustainability) and develop a “WA-SS-HCCP Scale-Up Toolkit” for wide dissemination of this “detect-to-treat” program that can be expanded to HIV- women and across LMICs.

NARRATIVE This proposed research is responding to RFA-CA-21-056 and aims to leverage our decade-long, extensive, and successful training partnership and research collaborations in Mali and Nigeria to implement a novel West African Self-Sampling Human Papillomavirus (HPV)-Based Cervical Cancer Control Program in these two countries. The project capitalizes on existing strengths and resources including the HIV systems of care with Community Health Workers who have established relationships with women living with HIV/AIDS and can provide HPV and cervical cancer education/counseling, guidance for Self-Sampling by women, rapid collection and transport of vaginal swab specimens to hospital laboratories, personalized delivery of test results directly to the women, and facilitation of clinic referrals for those with high-Risk HPV infection for advanced diagnostics and treatment. The study will conduct an in-depth assessment of barriers, challenges, and needs to implement, contextually adapt, and evaluate the effectiveness of the proposed program.