A conjoint experiment of three placebo rectal products used with receptive anal sex: results from MTN-035.

INTRODUCTION: End-user perspectives are vital to the design of new biomedical HIV prevention products. Conjoint analysis can support the integration of end-user perspectives by examining their preferences of potential pre-exposure prophylaxis (PrEP) products. The Microbicides Trial Network (MTN) 035 protocol examined three placebo rectal dosage forms (insert, enema and suppository) that could deliver PrEP prior to receptive anal sex (RAS). METHODS: Between April 2019 and July 2020, we enrolled 217 HIV-negative, cisgender men who have sex with men (MSM; n = 172; 79.3%) and transgender people (n = 47; 20.7%) ages 18-35 into a randomized cross-over trial across Malawi, Peru, South Africa, Thailand and the United States. Participants used each product prior to RAS over 4-week periods. Participants completed a conjoint experiment where they selected between random profiles using seven features (dosage form, timing of use before sex, side effects, duration of protection, effectiveness, frequency of use and need for a prescription). RESULTS: Effectiveness was the strongest determinant of choice (30.4%), followed by modality (18.0%), potential side effects (17.2%), frequency of use (10.8%), duration of protection (10.4%), timing of use before sex (7.4%) and need for a prescription (5.9%). Relative utility scores indicated that the most desirable combination of attributes was a product with 95% efficacy, used 30 minutes before sex, offering a 3- to 5-day protection window, used weekly, having no side effects, in the form of an enema and available over-the-counter. CONCLUSIONS: Choice in next-generation PrEP products is highly desired by MSM and transgender people, as no one-size-fits-all approach satisfies all the preferences. MTN-035 participants weighed product features differently, recognizing the need for diverse, behaviourally congruent biomedical options that fit the needs of intended end-users.

PrEParing for NextGen: Cognitive Interviews to Improve Next Generation PrEP Modality Descriptions for Young Men Who have Sex with Men.

Next generation PrEP formulations may circumvent factors that impede daily oral pre-exposure prophylaxis (PrEP) use among young men who have sex with men (YMSM). We conducted video-based cognitive interviews with 20 YMSM (age 16-24) recruited in the US Northeast to assess participants' attitudes and comprehension of written descriptions of next generation PrEP modalities. Participants were predominately racial/ethnic minorities and half used daily oral PrEP. We identified four main areas for improvement of descriptions: defining scientific terms and balancing medical jargon and casual language; referencing more established products to contextualize PrEP formulations (e.g., hormonal implants); ensuring clarity and reducing redundancy; and including imagery (e.g., rectal douche applicator). The refined descriptions serve as exemplar text that may be used in future studies examining YMSM's preferences across next generation PrEP modalities. Accurate descriptions of next generation PrEP products strengthen measurement accuracy and can help roll-out products that become approved for clinical use.

RESUMEN: Las formulaciones de próxima generación para la profilaxis pre-exposición (PrEP) pueden eludir los factores que impiden el uso diario del PrEP oral en hombres jóvenes que tienen relaciones sexuales con hombres (YMSM). Realizamos entrevistas cognitivas usando videoconferencia con 20 YMSM (de 16 a 24 años) reclutados del noreste de los Estados Unidos con el fin de evaluar sus actitudes y su comprensión de las definiciones desarrolladas para describir las modalidades de PrEP de próxima generación. Los participantes eran predominantemente minorías raciales/étnicas y la mitad usaba PrEP oral diariamente. Identificamos cuatro áreas principales para mejorar las descripciones: definir términos científicos y equilibrar la jerga médica y el lenguaje casual; hacer referencia a productos más establecidos para contextualizar las formulaciones de PrEP (por ejemplo, implantes hormonales); garantizar la claridad y reducir la redundancia; e incluir imágenes (por ejemplo, aplicador de duchas rectales). Las descripciones refinadas sirven como texto ejemplar y pueden usarse en estudios futuros que examinen las preferencias de modalidades de PrEP de próxima generación entre YMSM. Las descripciones precisas de los productos PrEP de próxima generación fortalecen la precisión de la medición y pueden ayudar a implementar productos que se aprueben para uso clínico.