A randomized trial of safety, acceptability and adherence of three rectal microbicide placebo formulations among young sexual and gender minorities who engage in receptive anal intercourse (MTN-035).

Efforts to develop a range of HIV prevention products that can serve as behaviorally congruent viable alternatives to consistent condom use and oral pre-exposure prophylaxis (PrEP) remain crucial. MTN-035 was a randomized crossover trial seeking to evaluate the safety, acceptability, and adherence to three placebo modalities (insert, suppository, enema) prior to receptive anal intercourse (RAI). If participants had no RAI in a week, they were asked to use their assigned product without sex. We hypothesized that the modalities would be acceptable and safe for use prior to RAI, and that participants would report high adherence given their behavioral congruence with cleansing practices (e.g., douches and/or enemas) and their existing use to deliver medications (e.g., suppositories; fast-dissolving inserts) via the rectum. Participants (N = 217) were sexual and gender minorities enrolled in five different countries (Malawi, Peru, South Africa, Thailand, and the United States of America). Mean age was 24.9 years (range 18-35 years). 204 adverse events were reported by 98 participants (45.2%); 37 (18.1%) were deemed related to the study products. The proportion of participants reporting "high acceptability" was 72% (95%CI: 65% - 78%) for inserts, 66% (95%CI: 59% - 73%) for suppositories, and 73% (95%CI: 66% - 79%) for enemas. The proportion of participants reporting fully adherent per protocol (i.e., at least one use per week) was 75% (95%CI: 69% - 81%) for inserts, 74% (95%CI: 68% - 80%) for suppositories, and 83% (95%CI: 77% - 88%) for enemas. Participants fully adherent per RAI-act was similar among the three products: insert (n = 99; 58.9%), suppository (n = 101; 58.0%) and enema (n = 107; 58.8%). The efficacy and effectiveness of emerging HIV prevention drug depends on safe and acceptable delivery modalities that are easy to use consistently. Our findings demonstrate the safety and acceptability of, and adherence to, enemas, inserts, and suppositories as potential modalities through which to deliver a rectal microbicide.

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.

Rectal Douching and Microbicide Acceptability among Young Men who Have Sex with Men.

Men who have sex with men (MSM) commonly report engaging in rectal douching (RD) practices prior to receptive anal intercourse. Researchers are interested in the possibility of designing a RD with a microbicide component. In our analyses, we examined whether YMSM who engaged in RD behaviors differ in HIV prevention behaviors from their non-RD peers. We then examined whether RD frequency was associated with rectal microbicide acceptability. Half the participants (47.8%) reported having ever douched. Participants were more likely to douche if they were racial/ethnic minorities (AOR = 2.24, p = 0.02) and had recently tested for HIV (AOR = 1.96, p = 0.04). Greater douching frequency was associated with racial/ethnic minorities (ß = 0.20, p = 0.009) and recent HIV testing (ß = 0.19, p < 0.01). Participants who reported frequently douching indicated greater microbicide acceptability (ß = 0.32, p < 0.001). Designing behaviorally congruent products remains a priority in next generation Pre-Exposure Prophylaxis (PrEP) and a rectal douche might be an additional tool if found to be efficacious.