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

Tingler, Ryan C; Connochie, Daniel; Bauermeister, José A.

doi:10.1007/s10461-019-02662-x

Cited by 14 publications

(11 citation statements)

References 23 publications

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“…Rapidly repeated douche PK and safety. We studied repeated douches to test both the TFV PK and safety of a more clinically relevant multiple-douche sequence (25,(41)(42)(43)(44)(45). We subjected monkeys to 5 consecutive high-dose TFV HOsm rectal douches at 5-minute intervals, each of 30 mL followed by pressing fluid out abdominally before administering the next douche.…”

Section: Resultsmentioning

confidence: 99%

Hypo-osmolar rectal douche tenofovir formulation prevents simian/human immunodeficiency virus acquisition in macaques

Xiao¹,

Gumber²,

Marzinke³

et al. 2022

JCI Insight

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In spite of the rollout of oral pre-exposure prophylaxis (PrEP), the rate of new HIV infections remains a major health crisis. In the United States, new infections occur predominantly in men having sex with men (MSM) in rural settings where access to PrEP can be limited. As an alternative congruent with MSM sexual behavior, we have optimized and tested tenofovir (TFV) and analog-based iso-osmolar and hypo-osmolar (HOsm) rectal douches for efficacy against rectal simian/human immunodeficiency virus (SHIV) infection of macaques. Single TFV HOsm high-dose douches achieved peak plasma TFV levels similar to daily oral PrEP, while other formulations yielded lower concentrations. Rectal tissue TFV-diphosphate (TFV-DP) concentrations at the portal of virus entry, however, were markedly higher after HOsm douching than daily oral PrEP. Repeated douches led to significantly higher plasma TFV and higher TFV-DP concentrations in rectal tissue at 24 hours compared with single douches, without detectable mucosal or systemic toxicity. Using stringent repeated intrarectal SHIV exposures, single HOsm high-dose douches delivered greater protection from virus acquisition for more than 24 hours compared with oral PrEP. Our results demonstrate a rapid delivery of protective TFV doses to the rectal portal of virus entry as a potential low-cost and safe PrEP alternative.

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Section: Resultsmentioning

confidence: 99%

Hypo-osmolar rectal douche tenofovir formulation prevents simian/human immunodeficiency virus acquisition in macaques

Xiao¹,

Gumber²,

Marzinke³

et al. 2022

JCI Insight

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“…Sample characteristics are noted in Table 1. Participants' mean age was 21 (range: [16][17][18][19][20][21][22][23][24]. Most participants identified as racial/ethnic minorities (n = 12, 60%) and 75% selfidentified as gay.…”

Section: Resultsmentioning

confidence: 99%

“…While there has been a recent five-fold increase in PrEP uptake among adult MSM in urban areas in the US [1], adolescents account for less than 1% of new PrEP prescriptions [2,3]. This trend is particularly troubling, as young MSM (YMSM; ages [13][14][15][16][17][18][19][20][21][22][23][24] account for nearly one-third of new infections among MSM in the US [4]. Despite their high PrEP need, only 3% of eligible YMSM have been prescribed PrEP, substantially lower than their older peers [5,6]; PrEP uptake among YMSM under 18 years old is even lower, contributing to continued HIV transmission among this group [2].…”

Section: Introductionmentioning

confidence: 99%

“…These next generation PrEP formulations include diverse drug delivery mechanisms (e.g., douches, injectables, implants) that could expand users' HIV prevention choices based on their sociocultural context, behavioral patterns, and desire for episodic or long-acting protection [20]. For example, rectal douches may be congruent with cleansing practices and behaviors regarded as normative prior to participating in activities where the probability of engaging in receptive anal intercourse is high [21,22]. Similarly, infrequent injectable formulations or episodic oral PrEP might be more compatible with a complex lifestyle where taking a pill every day is unrealistic.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2021

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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. Keywords Gay and bisexual men • Adolescents • Pre-exposure prophylaxis • Instrument development • Cognitive interviewing ResumenLas 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

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“…Some academics have demonstrated high levels of interest in rectal microbicides in the MSM population. 28 A gel and douched-based rectal microbicides, which meet the RD need of MSM population, could also provide them an important option for both hygiene and HIV prophylaxis in the future. Future research should also examine the acceptance and potential barriers of rectal microbicides in Chinese MSM.…”

Section: Discussionmentioning

confidence: 99%

Association between rectal douching and HIV acquisition: the mediating role of condom use and rectal bleeding in a national online sample of Chinese men who have sex with men

Mao

Peng

et al. 2020

Sex Transm Infect

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ObjectivesPrevious studies have demonstrated that rectal douching (RD) is associated with HIV acquisition among men who have sex with men (MSM). However, the precise mechanism underlying the association between RD and HIV remains unclear.MethodsWe recruited participants over WeChat from October 2017 to October 2018. Respondents received mailed HIV self-testing kits, uploaded images of HIV self-test results and completed an online electronic questionnaire simultaneously. The questionnaire assessed sociodemographic characteristics, RD practices and sexual risk behaviours. HIV status was measured as the result of the HIV self-testing. The Baron and Kenny statistical method was used to assess the association between RD and HIV, controlling for condomless anal intercourse (CAI) and rectal bleeding.ResultsOf 1365 participants, 39.93% (545/1365) reported RD in the past 6 months, 60.07% had multiple male sexual partners and 43.08% had CAI in the past 6 months. The prevalence of HIV, based on self-testing, was 3.37% (46/1365). Multivariable logistic analysis showed RD was significantly associated with bottom sexual role (adjusted OR (aOR) 14.0; 95% CI 9.8 to 20.2), having multiple male sexual partners (aOR 1.8; 95% CI 1.4 to 2.2), CAI (aOR 1.3; 95% CI 1.0 to 1.6), rectal bleeding (aOR 2.0; 95% CI 1.6 to 2.6) and HIV infection (aOR 1.9; 95% CI 1.0 to 3.4). Baron and Kenny analysis found both CAI (aOR 2.2; 95% CI 1.2 to 4.1) and rectal bleeding (aOR 1.9; 95% CI 1.0 to 3.4) play a mediating role in the association between RD and HIV.ConclusionsOur study results confirmed the relationship between RD and HIV, and found CAI and rectal bleeding mediated HIV infection in Chinese MSM who douched. Strategies should be encouraged to strengthen health education and reduce high-risk sexual behaviour in order to reduce the risk of HIV in MSM who use enemas. Rectal microbicides may represent an efficient means of providing HIV prophylaxis among MSM.

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

Cited by 14 publications

References 23 publications

Hypo-osmolar rectal douche tenofovir formulation prevents simian/human immunodeficiency virus acquisition in macaques

Hypo-osmolar rectal douche tenofovir formulation prevents simian/human immunodeficiency virus acquisition in macaques

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

Association between rectal douching and HIV acquisition: the mediating role of condom use and rectal bleeding in a national online sample of Chinese men who have sex with men

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