3.5. Recruitment
cancer, CIN, CIN3, Cancer
CANCER, CANCER, CIN
To obtain robust outcomes, all midwives involved in the study would be initially trained in the study procedures. All eligible women attending the HIV clinic would be educated on the different procedures for the collection of samples for HPV testing. Women could prospectively be recruited and randomized as they came to the HIV clinic. The midwives would obtain women’s consent to HPV testing and VIA screening. The women randomized to the clinic-based HPV self-sampling group who had consented to and accepted the screening would be provided with an HPV sample collection kit to collect the vaginal swab and return it to the laboratory for HPV testing. The women randomized to home-based HPV self-sampling, who had consented to, and accepted, the screening, would receive the HPV testing kit from the community linkage personnel (CLP). The CLP could collect all the collected samples from the women and transport them to the laboratory at Luweero Hospital. As recommended by the World Health Organization (WHO,) all women who took up screening in each group would need to first undergo a pregnancy test called human chorionic gonadotropin (HCG). The randomly selected sample of 150 HPV-positive women who took up HPV testing in both arms would further be subjected to a VIA, which is accepted as a gold-standard test for grading CIN in low-income settings such as Uganda. All women with suspected CIN2 and CIN3 could be referred to Uganda Cancer Institute for further management. The study would leverage the existing referral systems for cancer patients. UCI is the only national center for cancer treatment in Uganda and, therefore all identified cases are referred to that center as a norm; hence, there is no need for a memorandum of understanding. This is as shown in 