Design of an Implant for Long-Acting HIV Pre-Exposure Prophylaxis: Input from South African Health Care Providers

Abstract

Implants are in the pre-clinical stage for long-acting HIV pre-exposure prophylaxis (PrEP), with an opportunity to solicit end-users' feedback early in development. Health care providers (HCPs) have been key gatekeepers for contraceptive implant uptake, and uniquely understand both technical considerations and the social context of use. Given their influential role, we gathered South African HCP perspectives on contraceptive implant implementation and features of PrEP implant prototypes that may influence future provider and patient acceptability. We conducted in-depth interviews with 30 HCPs (20 nurses and 10 doctors) in Cape Town and Soshanguve, South Africa. Interviews were conducted by a bioengineer and later transcribed, coded, and analyzed for key themes. HCPs described health system barriers such as understaffed clinics and inadequate training on contraceptive implant removal as major influences to their PrEP implant design preferences. They preferred a PrEP implant that is long lasting (>6 months) to minimize patient-clinic interactions, biodegradable to avoid need for removal, and flexible (but still palpable in case of removal). Commenting on negative experiences with contraceptive implant rollout, they recommended prioritizing both HCP and community education on the PrEP implant, with emphasis on expected side effects, and planning ahead for adequate training of HCPs before rollout. Challenges experienced with past contraceptive implant rollout may taint perspectives on future PrEP implants and must be carefully considered during product development and planning for clinical studies. Particular consideration should be given to the health system context of future distribution, including staff who would be providing and monitoring implants.

Implants for HIV prevention in young women: Provider perceptions and lessons learned from contraceptive implant provision

“…Challenges with the acceptability of new HIV prevention technologies mean that end-user and future-provider research at the early stages of clinical product development are critical. Health care workers (HCWs) act as important gatekeepers to the promotion of new health technologies, providing a critical view of the challenges to the uptake and implementation of new technologies within the public health care setting [ 17 ]. Previous research in urban/peri-urban areas of South Africa highlighted that the design and duration of coverage of PrEP implants were important to HCWs especially for overcoming barriers within health systems like staff shortages and capacity development [ 17 ].…”

Multispecies Evaluation of a Long-Acting Tenofovir Alafenamide Subdermal Implant for HIV Prophylaxis

“…Long-acting (LA) biomedical devices delivering antiretroviral (ARV) drugs locally or systemically reduce dosing frequency and, consequently, may lead to increased product adherence ( Krogstad et al, 2019 ) and effectiveness. The strategy is being exploited in HIV-1 pre-exposure prophylaxis (PrEP) using injectable formulations and subdermal implants delivering ARV agents for four weeks, or longer ( Lykins et al, 2017 ).…”

Characterization of a Reservoir-Style Implant for Sustained Release of Tenofovir Alafenamide (TAF) for HIV Pre-Exposure Prophylaxis (PrEP)

“…By increasing the implant wall thickness (e.g., from 70 to 200 µm) using an extrusion method, the implants were more aesthetically pleasing, exhibited greater mechanical sturdiness during handling and therapeutic use, while simultaneously retaining sustained release kinetics of drug. Moreover, the injection end-sealing method presented here produces an implant suitable for commercially available trocars, and is loaded with enough of the drug to last longer than six months; all considerations that were deemed preferable by end-users [67,68]. With an eye towards product development needs for clinical implementation, compatibility with applicators already clinically employed offers options to adopt existing procedures to support LA-PrEP rollout.…”