Sub-Saharan Africa is a priority region for HIV vaccine efficacy trials because of the relatively high burden of HIV, particularly among young women. There is a perceived potential harm by candidate HIV vaccines to the developing fetus in case a vaccine trial participant becomes pregnant. Therefore, investigational product administration is discontinued during pregnancy. To prevent pregnancy in such trials, reliable and user-independent contraceptive methods, such as Long Acting Reversible Contraceptives ((LARC) implants and intrauterine devices) and hormonal injectable methods are required to be used by trial participants of reproductive age.
The Zambia Emory HIV Research Project (ZEHRP) clinical research sites (Ndola & Lusaka, Zambia) are participating in a Phase 2b HIV vaccine efficacy trial, targeting women who are at high risk of acquiring HIV, under the HIV Vaccine Trials Network (HVTN). Over 20 clinical research sites from 6 countries, located in Sub-Saharan Africa, are participating in this trial. To ensure that product administration is not disrupted during the course of the trial due to pregnancy, trial participants need to be on a reliable contraceptive method and this serves as an enrollment requirement. Therefore, promoting uptake of these contraceptive methods is important as having too many disruptions in the administration of the investigational product will limit the ability to prove if they have the ability to produce the intended or desired result.
Kabengele’s project focuses on understanding the uptake and choice of contraceptives among potential trial participants and he anticipates that the information generated from his project will be useful for future trials that will require participating women of reproductive age to be on reliable family planning methods.