Site Development and Capacity Building for Therapeutic Clinical Trials Targeting HIV-Positive Pregnant Women in Resource-Limited Settings: Challenges and Solutions
International AIDS Society Abstract (2010) C. Blanchard-Horan 1* , J. Hitti 2 , E.Ferguson 3 , K. L. Klingman 4 and D. McMahon 5
Access to HIV clinical trials is a vital component of HIV care globally. We explored challenges related to implementation of a complex multicenter perinatal research protocol in resource-limited settings. Targeted development areas included community involvement, site staff training safety and HIV laboratory monitoring, pharmaceutical matters, labor and delivery care, and regulatory affairs.
Although diverse with respect to geography, infrastructure, previous research experience and HIV standard of care, research sites experienced similar challenges implementing the study. Engagement of community and site staff demonstrated logistical issues, language differences, and limited knowledge about research methods and medical terminology; At the laboratory level, there were issues around the irregular power supply, difficulty obtaining reagents, lack of qualified technicians, and inexperience with study-mandated tests and validation procedures.
Pharmacies had problems with the supply chain and study drug custody, obtaining and maintaining inventory, and storage conditions. As for labor and delivery care, the sites had difficulty retaining qualified staff, confidentiality, and large patient caseloads.
Regulatory and other site matters, such as IRB review timelines. That is, the length of time it takes the sites to get clearance from their institutional review board and the national government review. There were concerns related to maternal and fetal exposure to antiretrovirals, indemnity insurance, post-treatment antiretroviral access, and limited administrative infrastructure.
Researchers conducting clinical trials in resource-limited settings should:
- Educate community members about the purpose of research, medical terms, and
- Allow sufficient time for laboratory implementation and validation procedures
- Assess drug supply chain and importation, storage, and records;
- Budget for indemnity insurance, which may be substantial for perinatal studies.