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User Wish List for Microarray Patch to Prevent HIV and Pregnancy:
Small, Discreet, Easy to Use, Long-Acting
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HIVR4P Virtual, January 27-28 and February 3-4, 2021
Mark Mascolini|
Panels of potential microarray patch (MAP) users in Africa had consistent messages about what they need in these long-term drug-delivery systems: They want the patches to be small, discreet, easy to use, and long-lasting [1]. Some gay men in Uganda said the smallest microarray dosing device they were shown was still too big for them to consider using.
Researchers from South Africa's Genesis Analytics, who conducted the surveys, explained that each MAP contains hundreds of tiny (under 1 mm) needles affixed to a backing. The minuscule drug-loaded pins dissolve in the skin, delivering their drug burden into the circulation. As soon as the drug-laden pins dissolve, the backing can be peeled off and tossed out. MAPs hold promise for serving up long-acting nanosuspensions, like cabotegravir, that can be used for HIV treatment or prevention [2,3]. Genesis Analytics noted that MAPs could be loaded with an antiretroviral to thwart HIV and a contraceptive to prevent pregnancy.
Genesis investigators planned these surveys of potential users and stakeholders to explore perspectives about MAPS; to assess acceptability, useability, viability for PrEP or PrEP plus contraception; and to explore preferences for key features, like size, application site, and length of protection. At several locations in South Africa and Uganda, researchers held focus groups or interviewed individuals from urban, semi-urban, and rural areas across multiple regions. Groups included adolescent girls and young women, female sex workers, men who have sex with men (MSM), other men, healthcare providers, policymakers, and program managers.
Most respondents wanted a small MAP to promote easy and discreet use. Some people, however, would consider a larger MAP if it worked longer. Some MSM advised that the smallest size shown was still too big for them. Among 122 people surveyed in South Africa, 90 (74%) wanted a MAP that works longer than 1 month, though 30 (25%) would accept a 1-month MAP. Sixty-four of 81 adolescent girls and young women (79%) voiced a preference for more than 1 month of protection.
Among 35 Ugandan participants, 29 (83%) wanted MAPs with 1 month or longer duration. Some Ugandan women compared MAPs to injectable contraceptives, so they thought MAPs should deliver 3 months of protection. But about half of Ugandan adolescent girls and young women leaned toward a 1-month patch, while the other half wanted weekly MAPs.
The most desirable MAP sites were the upper arm and thigh, because respondents thought those sites facilitated discreetness, easy application, self-application, accessibility, and comfort. But some favored other sites, such as forearm, back, stomach, chest, shoulder, buttocks, hip, front of ribcage, and neck.
Most respondents preferred wearing a MAP no longer than 30 minutes, which would help avoid disclosure of use and possible stigma. But many participants would wear a patch up to 1 hour if they thought that would promote longer protection. All groups surveyed preferred to apply the patch themselves, though most wanted training by a healthcare provider first. Respondents felt self-administration favored fewer clinic visits, reduced stigma, and offered greater control, while easing the burden on the healthcare system.
MAPs can include a feedback mechanism that gives a visual or tactile cue confirming that a person applied the map with enough pressure to let the microneedles pierce the skin. The two feedback mechanisms tested in the surveys fell short of satisfying many respondents. They wanted firmer assurance that they had applied the MAP correctly, and they offered suggestions that will be built into future prototypes.
Respondents voiced little concern about red marks that may be left on skin when they peel off the MAP backing-as long as they are told to expect these marks and know the marks will fade. People asked frequent follow-up questions about efficacy, safety, and what happens to the microneedles when they dissolve in the body.
Other concerns arose about PrEP patches or multipurpose MAPs: They're "too good to be true." If they don't cause pain, "how do you know it works?" What proof do we have that the drug gets into the body? What proof do we have that they work? Will drugs in MAPs be safer and cause fewer side effects than the same drugs delivered in the usual ways?
Genesis Analytics plans to review responses received so far and determine whether MAP designs can be improved to address concerns, promote easy use, and ensure confidence in this drug-delivery system.
References
1. Ismail A, Magni S, Fellows T, et al. User assessment of a microarray patch for HIV PrEP and as a multipurpose prevention technology for HIV and pregnancy prevention: perspectives from Uganda and South Africa. HIVR4P (HIV Research for Prevention) Virtual, January 27-28 and February 3-4, 2021. Abstract OA04.01.
2. Trezza C, Ford SL, Spreen W, Pan R, Piscitelli S. Formulation and pharmacology of long-acting cabotegravir. Curr Opin HIV AIDS. 2015;10:239-245. doi: 10.1097/COH.0000000000000168.
3. Donnelly RF, Larraņeta E. Microarray patches: potentially useful delivery systems for long-acting nanosuspensions. Drug Discovery Today. 2018;23:1026-1033.
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