Microarray patch for HIV prevention and as a multipurpose prevention technology to prevent HIV and unplanned pregnancy: an assessment of potential acceptability, usability, and programmatic fit in Kenya

Abstract

BackgroundMicroarray patches (MAPs), a novel drug delivery system, are being developed for HIV pre-exposure prophylaxis (PrEP) delivery and as a multipurpose prevention technology (MPT) to protect from both HIV and unintended pregnancy. Prevention technologies must meet the needs of target audiences, be acceptable, easy to use, and fit health system requirements.MethodologyWe explored perceptions about MAP technology and assessed usability, hypothetical acceptability, and potential programmatic fit of MAP prototypes using focus group discussions (FGD), usability exercises, and key informant interviews (KII) among key populations in Kiambu County, Kenya. Adolescent girls and young women (AGYW), female sex workers (FSW), and men who have sex with men (MSM) assessed the usability and acceptability of a MAP prototype. Male partners of AGYW/FSW assessed MAP acceptability as partners of likely users. We analyzed data using NVivo, applying an inductive approach. Health service providers and policymakers assessed programmatic fit. Usability exercise participants applied a no-drug, no-microneedle MAP prototype and assessed MAP features.ResultsWe implemented 10 FGD (4 AGYW; 2 FSW; 2 MSM; 2 male partners); 47 mock use exercises (19 AGYW; 9 FSW; 8 MSM; 11 HSP); and 6 policymaker KII. Participants reported high interest in MAPs due to discreet and easy use, long-term protection, and potential for self-administration. MAP size and duration of protection were key characteristics influencing acceptability. Most AGYW preferred the MPT MAP over an HIV PrEP-only MAP. FSW saw value in both MAP indications and voiced need for MPTs that protect from other infections. Preferred duration of protection was 1–3 months. Some participants would accept a larger MAP if it provided longer protection. Participants suggested revisions to the feedback indicator to improve confidence. Policymakers described the MPT MAP as “killing two birds with one stone,” in addressing AGYW needs for both HIV protection and contraception. An MPT MAP is aligned with Kenya's policy of integrating health care programs.ConclusionsMAPs for HIV PrEP and as an MPT both were acceptable across participant groups. Some groups valued an MPT MAP over an HIV PrEP MAP. Prototype refinements will improve usability and confidence.

A Bilayer Microarray Patch (MAP) for HIV Pre-Exposure Prophylaxis: The Role of MAP Designs and Formulation Composition in Enhancing Long-Acting Drug Delivery

“…Alternatively, when this result is viewed in tandem with the data shown in Figure 8 , it is possible to postulate that the CAB Na-loaded dissolving MAPs could also be administered as a monthly dose. However, the reduction in dosing frequency from once weekly to once monthly would necessitate a larger patch size in humans, which is likely to be larger than would be acceptable to potential users [ 40 , 41 ]. Additionally, the reduction in dosing frequency to once a month may also result in a large dynamic range of CAB plasma levels relative to a weekly patch application.…”

Synthesis of end-user research to inform future multipurpose prevention technologies in sub-Saharan Africa: a scoping review

“…Having the option to use a product discreetly was a key component of product acceptability among end users ( 6 , 18 , 27 , 28 , 30 , 37 , 38 , 49 , 52 ), some of whom described that their preferences for discreet products were driven primarily by concerns about a partner's inadvertent discovery of product use ( 40 , 51 ) and potential disapproval ( 37 ). End users frequently noted that ideally they would like to talk to their partners about using an MPT ( 21 ) but that having the option of discreet use was essential because navigating discreet use or disclosing use to a partner was something unique to each individual and relationship ( 6 , 25 ).…”

“…Frequency of administration or duration of use was a salient aspect of product acceptability for end users, and, when assessed, for their partners ( 26 – 28 , 30 , 40 , 42 , 51 ). Across studies and products, end users expressed a range of preferences for an ideal dosing frequency that most often ranged from 1 month to 1 year, with the ideal target duration varying by delivery form, study population, and location ( 6 , 18 , 19 , 27 , 28 , 30 , 32 , 38 , 40 – 43 , 46 , 50 , 51 ). Preferences for ideal product duration were also often based on experience with HIV prevention or contraceptive products.…”

“…Few studies examined how community stakeholders impacted MPT acceptability and uptake potential. Stakeholders and policymakers acknowledged the benefits of overall MPTs and reported that their development (such as the ring or patch) could be particularly useful for AGYW ( 22 , 28 ). Some participants were wary of the potential HIV-related and sexual activity related stigma that would coincide with using an MPT product (such as a tablet or diaphragm), particularly if it looked like ARV medication or was advertised as an HIV prevention product rather than a dual-indication product or pregnancy prevention product ( 6 , 20 , 21 , 34 , 47 , 51 ).…”

Biomedical, socio-behavioral, and implementation science gaps in multipurpose prevention technology research

“…Qualitative studies have found that factors such as discreetness, reversibility, longer duration of protection, and community acceptance are important characteristics of MPTs ( 25 , 26 , 27 , 28 ). A discrete choice survey of couples conducted in Uganda and Zimbabwe investigated couple preferences for an MPT, as well as how individual preferences for an MPT differ from couple preferences.…”