I found it interesting and enriching to take part in a clinical study.The study is a new anti-retroviral drug that we are testing called Darunavir/Rironavir at the central hospital in Yaounde. Below are my activities in the study.
MY ACTIVITIES AS A CLINICAL RESEARCH NURSE ARE AS FOLLOWS:
First l was trained and certified on the INTERNATIONAL Conference on HARMONISED GOOD CLINICAL PRACTICE( GCP).
RECRUITMENT OF PATIENTS
To recruit patients, I bought an exercise book and kept it at the Hospital pharmacy where all the HIV patients collect drugs, including second line patients (Aluvia/Teno 3TC,AbakavirAluvia 3TC) who will be relevant for our study. First we need to check the eligibility criteria for the study (CD4 above 100 and Viral load less than 60 cells no tuberculosis, no hepatitis B).
Having looked at the criteria, we move to the archive where over 35,000 files are found; l then take the file and look at the name of patient, file number, number of CD4,date CD4s Done, viral load, date viral load done, Type of HIV, Hepatitis test done, results, and date HBV test done).
Patients who match these criteria are called on the phone and the project explained to them; they are invited to come and do a viral load and other tests, so that we can begin to screen if they are eligible. This call is made to all the eligible patients.
Samples are collected and taken to the lab within 2 hours (4 EDTA tubes 1 Red, 3 purples per patient labelled), and we fill the test request forms and record their vital information into the register (file name, name, age, date of birth, telephone number, date of birth, an alternative telephone number as stand by incase the first one does not go when next l call).
The patient’s transport is reimbursed and the patient signs in another register to confirm receipt of transport reimbursement.
Later, l label the plastic bags in which the blood samples will be collected to go to the laboratories (one for diagnostic test and the other one for the research). l then get all the patient’s information into the Case Record form dated and signed.
When the results are out, either the laboratory technician, the project manager or me picks them up, and l look at them with the study doctor and they are now entered into the Case Record forms and sighed as they are under screening 1.
HIV1 are the patients we take alongside other eligibility criteria.
The patient is now called for screening 2, and he or she comes to read and consent (reading a set of questions and signing the paper at the end) to take part in the study, and the vital signs along side urinary analysis are done by me.
Blood is then collected into 7EDTA tubes and packaged into plastic bags for the lab. When results are out they are checked for severe adverse events and reported, if any SAE is found. A treatment plan is drawn by the team for management if there is any adverse event for the patient.
If the patient qualifies for the study, questionnaires are handed to him/her to fill (adherence, physical & emotional wellbeing questionnaires) as he/she comes in for the final phase of screening, he/she in turn hands the rest of the remaining pills that he had to me. I count and record the pills on the pill count sheet, take the vital signs and hand the pill count sheet with the vital signs sheet to the study doctor, then file in the adherence, physical & emotional wellbeing questionnaires for our records. This is followed by randomisation (we use two envelopes are used one has ONE meaning control arm, Lopinavir/retonavir and the other one TWO meaning the trial drug Darunavir/retonavir) and treatment given to the patients (100 patients for Darunavir/ritonavir and 50 for standard of care which is the control arm). Transport reimbursement is handed to the patient and his next visit noted down.
Follow up visits for the patient are done with counselling on any issue, and routine screenings for weeks 4,12,24,36, and 48 while, for weeks 8,16,20,28,32,40,44 patients are seen with only pill count done and observed for any SAE. Again any SAE are corrected and as the study goes on.
If the patient encounters any side effects, he or she calls me on the phone at any hour of the day then l will tell him/her to come to the hospital and see the study doctor if it is serious. Monitoring continues for all the patients by me.
Administration completed by the study nurse includes: Signature of consent forms, case record forms, carrying of documents to the Ministry of health and link with other members of the study team.
Whenever a patient has any other adverse event that needs to be corrected by another specialist, l do the contact, take the patient to that unit and he or she consults and after consultation l follow up to purchase the concomitant drugs that have been written for the patient.
What attributes make a good research nurse?
The research nurse needs to master their knowledge of the recruitment phase, follow up, communication and administration in the entire project. For him/her to do all these adequately; he/she should be interested to learn more about research, read widely after Nursing training, and be trained on GCP/study safety. Global Health Trials’ eLearning Centre has free eLearning courses which can be taken on GCP, clinical research methods, and so on. A nurse also needs to master the protocol to their finger tips. He/she has the responsibility of ensuring that the study moves on well, liaising with other members of the study team. He/she is involved in the operation of the project from start to finish, from opening the study to closing it with the PI. The nurse is the wheels on which the project runs, and for the project to run smoothly he should master his functions fully.