1. Introduction
cancer, CIN
VIRUS, HPV INFECTION, CERVICAL LESIONS, CANCER, DISEASE, CIN, CERVICAL CANCER, CERVICAL CANCER, REGRESSION
In Uganda, the uptake of cervical cancer (CC) screening services is low, at 46.7%, among HIV-infected women, and only 9% of these women adhere to annual CC screening. Some studies have evaluated the possibility of community or home-based human papillomavirus (HPV) self-collected vaginal swabs, but not clinic-based HPV self-collected vaginal swabs. Therefore, we propose a study to determine the efficacy of clinic-based versus home-based HPV DNA self-sampling among HIV-infected women attending a rural HIV clinic in Uganda. We believe that a randomized, single-blinded trial would achieve this objective, and so we have chosen it to guide the study. Including a total of 382 participants from a rural HIV clinic, randomized into a ratio of 1:1 for clinic- and home-based HPV self-sampling, would allow us to appropriately ascertain the difference in the uptake of HPV self-sampling between the two arms. The Integrated Biorepository of H3 Africa Uganda Laboratory would be used as a reference laboratory for the HPV DNA extraction, typing, and sequencing. At baseline, modified Poisson regression models would be used to measure factors associated with the prevalence of HPV and uptake in both arms at baseline. Visual inspection under acetic acid (VIA), as a gold-standard test for CC to grade for CIN, would be performed at 0 and 6 months among a random sample of 75 women with a self-collected HPV sample. The difference in uptake could be determined using the intention-to-treat analysis. The difference in the groups by each variable would be summarized as the standardized mean difference (i.e., the mean difference divided by the pooled standard deviation). The predictors of the time for which participants would continue with HPV self-sampling in both arms, recovery, and Cox proportional hazards regression would be used. At the bivariate level, the associations between each independent variable and time, with the time of continuing HPV self-sampling, would be computed. Crude hazard ratios and their 95% confidence interval would be used in the presentation of the results, with The highest burden of cervical cancer (CC) disease is mainly observed in Sub-Saharan Africa [Cervical cancer is the commonest cancer among Ugandan women. Annually, 3915 women in Uganda are afflicted by CC and, of these, 2160 die [Cervicography, Pap smears, and VIA are mainly performed by health providers via a colposcopy [Uganda faces many barriers to provider-led CC screening, and these include health workers who do not know the importance of CC screening [HPV testing is globally recommended instead of Pap testing, because it is also conducted on patient-collected samples [Countries in SSA, such as Uganda, bear a high burden of the HIV/AIDS epidemic, and 50% of HIV-infected women barely access CC screening. Repeated HPV infection, and the cervix’s inability to shade off the HPV virus due to reduced immunity, occur mostly in HIV-positive women. As a result, they easily progress to pre-invasive cervical lesions [This increased risk among HIV-infected women requires them to screen for CC annually. However, there is a paucity of studies that have determined the effectiveness of clinic-based versus home-based HPV self-sampling approaches among HIV-infected women. It is anticipated that HPV patient-led CC screening would be effective, and would increase the uptake of CC screening and, hence, the early detection and treatment of CC. Additionally, there is no clear policy or organized structure for a nationwide cervical cancer screening program in Uganda. Therefore, there is an opportunity to increase the interest among rural HIV-infected women in going for HPV testing, through the promotion of programs that involve self-sampling approaches to HPV sampling among women. This could contribute to a reduction in the incidence of invasive CC, and in the health and community consequences of the disease. There is a lack of studies determining the effectiveness of patient-led HPV screening at an HIV clinic, compared to home-based vaginal HPV self-sampling, among HIV-infected women. We predict that if HIV-infected women conducted self-sampling at the HIV clinic using a vaginal collection kit method that was reliable, efficient, and acceptable, it would reduce the waiting time to access CC screening from the HW, enhance the prompt receipt of results, reduce attrition, and further address barriers to CC screening in rural communities. The results from the study will direct us to the appropriate HPV self-sampling approach for disease stratification, which will be published, and used to design policy briefs. Additionally, the findings will also be used to develop health promotion programs related to the prevention of HPV and CC among women. 