How HIV Self-Testing kits should be packaged in Kenya

In order to gain insights on how to package and label the HIV oral self-test kit, which is a new product not yet on the Kenyan market, PSI and IPSOS conducted in-depth interviews and focus group discussions with key stakeholders. These included Kenyan government regulatory officers, HIV oral self-test kit manufacturers, packaging experts, potential distributors and potential users. Potential users included members of the general population and two key populations at high-risk for HIV transmission; men who have sex with men (MSM) and female sex workers (FSW). The variety of participants in the study enabled the researchers to analyze packaging and labeling from various perspectives, including how to approach key decisions that impact distribution, client safety, and product promotion. The study took place in Mombasa (an urban setting) and Siaya, a rural district of Nyanza province in the southwest of Kenya. The study included two phases. During the first phase, potential test-kit users were asked to react to the concept of HIV self-testing and to provide feedback on an existing HIV oral self-test kit called AWARE. AWARE is not currently on the market but has been tested with community health workers in Kenya. Results from the feedback were used to develop two new packaging mock-ups, which were then tested again with potential test-kit users during the second phase of the study. Overall, interviewees responded positively to the idea of HIV self-testing, noting increased privacy, confidence, and personal empowerment as possible advantages of the product. However, pharmacists and community health workers did express several concerns pertaining specifically to the shift of responsibility from the health provider (in a traditional HTC setting) to the end-user (in a HIV self-testing setting); mainly that the end-user is responsible for accurately administering the test, interpreting the results and accessing pre and post-test counseling. Concerns were exacerbated during discussions about the potential for a HIV positive test result. Regulatory officers and packaging experts spoke largely to considerations for tertiary packaging, including the size, weight, and durability of the package and implications of these for different distribution channels. Labeling information such as storage temperature, fragility, batch numbers, expiration date, manufacturing dates and shipment dates were also discussed extensively. Potential users noted the importance of sturdy materials for secondary and primary packaging, in order to communicate a high quality product. They stressed the importance of using simple language on the packaging, particularly with reference to the purpose and contents of the kit. Emphasis was placed on the instructions for use and how to strike a balance between simplicity and comprehensiveness. The insights and recommendations collected through this study can be used to develop an oral HIV self test kit for distribution in Kenya. If packaging and labeling is designed optimally, potential consumers will be able to safely, accurately, and privately test themselves for HIV and access additional services to ensure their own health and the health of others.