This clinical trial evaluates the feasibility and acceptability of a community-based strategy for screening eligible women living with HIV in Uganda for cervical cancer, compared to standard in-clinic screening activities. Commonly-used cervical cancer screening techniques like visual inspection with acetic acid require seeing skilled providers during in-clinic visits. Lack of clinic access remains a key barrier to implementing screening and has contributed to low rates of cervical cancer screening, especially among women living with HIV in Uganda. Human papillomavirus (HPV) testing is recommended as the primary screening test for cervical cancer due to its high sensitivity in detecting high-grade cervical precancer and cancer. Self-collection for HPV testing is an evidence-based intervention that has been increasingly used to improve access to cervical cancer screening as it has an accuracy similar to provider-collected sampling. While self-collection is a highly acceptable and feasible option, it is necessary to create new opportunities for self-collection to happen outside of clinic facilities in order to reduce barriers to clinic access. In this trial, a community-based strategy that uses trusted community healthcare workers to distribute HPV self-collection kits to women living with HIV in the community outside of the clinic setting is evaluated. Providing the option of receiving HPV self-collection kits in their own homes or other community-based settings may improve cervical cancer screening rates among eligible women living with HIV in Uganda.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07428330.
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PRIMARY OBJECTIVE:
I. To compare cervical cancer monthly screening rates in screen-eligible women living with HIV (WLWH) between the two screening models: standard-of-care for cervical cancer screening through static clinics only (Model 1) versus HPV self-collection through both static clinics and a community-based screening strategy by facility link facilitators (FLFs) (Model 2).
EXPLORATORY OBJECTIVES:
I. To compare the monthly rates of HPV test results delivery (eligible WLWH who complete primary cervical cancer screening and receive their results), between Model 1 and Model 2.
II. To compare the monthly rates of completion of the cervical cancer screening cascade during the current screening visit between Model 1 and Model 2.
III. To evaluate the acceptability, feasibility, and appropriateness of the implementation of Models 1 and 2, through interviews with WLWH, key stakeholders, providers, FLFs, and laboratory staff.
IV. To estimate the costs of implementing the intervention, comparing Model 2 relative to Model 1, and relative to visual inspection with acetic acid (VIA)-based screening.
OUTLINE: Clinics are cluster randomized to 1 of 2 models. Participants are assigned to the model to which their clinic was randomized.
MODEL 1: Patients seen in-clinic are offered standard of care cervical cancer screening by HPV self-collection and testing, if available, or VIA. Patients receive their test results and, if indicated, may receive referral for additional follow-up or treatment.
MODEL 2: Patients seen in-clinic are offered standard of care cervical cancer screening by HPV self-collection and testing. Patients in the community who are due or overdue for screening receive education about HPV self-collection and are offered community-based HPV self-collection for testing. Patients receive their test results and, if indicated, may receive referral for additional follow-up or treatment.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationUNC Lineberger Comprehensive Cancer Center
Principal InvestigatorBetty Mwesigwa
