[Spotlight originally posted September, 2010]
It all has not been an easy road for the ACTG clinical research site team at the University of North Carolina (UNC) Project in Lilongwe, Malawi, but our team is one of the proudest to have been involved in this network’s studies. The UNC Project is located on the Kamuzu Central Hospital premises. The project undertakes studies for various NIH Division of AIDS networks, including the ACTG, HPTN, IMPAACT, MTN, and the Center for HIV-AIDS Vaccine Immunology, PATH Malaria Vaccine Initiative, and International Partnership for Microbicides. The CRS was started in 2006 with the ACTG study A5175 and its associated studies; the A5185, A5190, and A5199. Thereafter, the team has also participated in other ACTG studies including A5208, A5221, and A5230. Notably, our site was the highest accruing site for both A5221 and A5230.
Currently, we are actively following patients on A5230 and are anxiously awaiting the opening of 5253, 5271, and 5264, for which we are awaiting site activation or are under review with the ethics committee. In the coming year, we hope to participate in A5274 (our own site PI, Dr. Mina Hosseinipour is the co-chair of the protocol), A5263, A5273, and A5288. The site’s choice of protocols closely mirrors the greatest research needs of Malawi.
Each of the members of the study team has their own experiences of working in the ACTG studies. According to Dalitso Mzinganjira, the primary research nurse for the A5230, what he has liked most about this study is that the retention rate has always been 100%. This male nurse was the only one conducting the study, and he just recruited the last client in July 2010. “Among some of the challenges that this study encountered was lack of viral test kits at some moments in the study when I had to wait for at least two weeks,” for supply of kits he said.
Another research nurse, Esnart Mtika, who was responsible for A5175, was very positive about her experiences when she says she was happy to see some clients who joined the study while having a very low CD4 count regaining healthy bodies over the course of the study. “Of course we also had the challenge of poor adherence by some clients to the study drugs. This adversely affected their health, which was also not good for the study outcome,” she says. Mtika’s views on poor adherence are also shared by another nurse, Charity Potani, who has been conducting A5208. “When clients didn’t adhere to the study drugs, we had to use more energy to bring them back into the right track. We had to involve a lot of counseling.”
However, Regina Mwausegha, a nurse who has been conducting the A5221 study, likes the fact that her site was the first one to complete enrollment among the other sites. She is optimistic about getting actively involved in the upcoming A5271 and A5264 studies for this site. “This (A5221) study has been a success, for in the study we have received clients from the Kamuzu Central Hospital who came in very poor health but picked up very well when they were in the study,” she says. For Mwausegha, one of the challenges that quickly comes to mind is that there were so many people to screen, making enrollment a slow process. She also says others were not willing to have their blood samples taken for lab tests since the volume of blood seemed high.
The Lilongwe ACTG team is also proud to have worked with other departments that have contributed to the smooth running of the studies. These are: the community department which has been instrumental in the tracing of study clients, the pharmacy which dispensed prescribed drugs, the laboratory which carried out the tests, and even the drivers, among others.