Ever wonder what enrolling participants in a clinical study entails? Here we chronicle the activities of one nurse, Anthonia Osuji with the Walter Reed Program – Nigeria.
Meet Anthonia Osuji, the RV230 study nurse for the Walter Reed Program – Nigeria (WRP-N). Anthonia balances many diverse responsibilities including education, advocacy, care-giving, counseling, administration and data management.
RV230, led by Nigerian researchers, is MHRP's initial effort to assess potential field sites for HIV vaccine studies in Nigeria. Participants are enrolled from “Mammy Markets” which are shopping centers attached to military barracks. Mammy Markets primarily sell products to military personnel and their families.
During what is called “mobilization,” Anthonia meets and explains the study to shop owners at the Mammy Market. If a shop owner is willing to participate, they provide their consent to volunteer. Only then are worker’s names captured in the census and entered into the study Personal Digital Assistant (PDA). Eligible volunteers between the ages of 18 and 40 years are invited to the study site.
When volunteers arrive at the study site, Anthonia directs them to the introductory group session in which the team outlines research procedures and responds to questions from the volunteers.
After the group session breaks, volunteers move onto the informed consent process. Anthonia discusses the purpose of the research, study procedures, participant responsibilities, potential risks and benefits, the quantity of blood to be taken, participant compensation, confidentiality, and time commitment – which is critical since participation is voluntary.
If the volunteer agrees to participate, Anthonia allocates an enrollment number to be used as a unique identifier instead of their name throughout the study to ensure confidentiality. Anthonia gives the volunteer an enrollment card to present at every station, enabling researchers to acknowledge completion of each study activity.
Then, research staff interview volunteers to assess their HIV Knowledge, Attitude, Practices and Behavior (KAPB). Staff enter data directly to the PDA, ensuring complete and timely collection of information.
Participants then undergo pre-test counseling and HIV education, including correct use of condoms, before having blood drawn for HIV testing. The laboratory team uses rapid HIV testing methods, which make the results available quickly. To minimize the interruption to their business, volunteers return to their shops while their HIV test is processed.
Later, participants return for post-test counseling. Staff refer individuals with reactive results to their local President’s Emergency Plan for AIDS Relief (PEPFAR) clinic for confirmatory testing and follow-up care. Finally, Anthonia collects and reviews the participant’s enrollment card before confirming that their involvement in the study is complete.
As a study nurse, Anthonia has proven to be a critical member of the research team. Her leadership, flexibility, tenacity, effective communication and time management are integral to the success of the RV230.