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Acceptability of Potential Rectal Microbicide Delivery Systems for HIV Prevention: a Randomized Crossover Trial

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Acceptability of Potential Rectal Microbicide Delivery Systems for HIV Prevention: a Randomized Crossover Trial AIDS Behav DOI 10.1007/s10461-012-0358-z ORIGINAL PAPER Acceptability of Potential Rectal Microbicide Delivery Systems for HIV Prevention: A Randomized Crossover Trial Heather A. Pines • Pamina M. Gorbach • Robert E. Weiss • Kristen Hess • Ryan Murphy • Terry Saunders • Joelle Brown • Peter A. Anton • Ross D. Cranston Ó Springer Science+Business Media New York 2012 Abstract We assessed the acceptability of three of over- acceptability and should be considered early in RM devel- the-counter products representative of potential rectal opment to enhance potential use. microbicide (RM) delivery systems. From 2009 to 2010, 117 HIV-uninfected males (79 %) and females (21 %) who Keywords Anorectal products Á Receptive anal engage in receptive anal intercourse participated in a 6-week intercourse Á HIV prevention randomized crossover acceptability trial. Participants received each of three products (enema, lubricant-filled applicator, suppository) every 2 weeks in a randomized Introduction sequence. CASI and T-ACASI scales assessed product acceptability via Likert responses. Factor analysis was used to Rectal microbicides (RM) can be formulated as gels, creams, identify underlying factors measured by each scale. Random or enemas for application inside the rectum to prevent HIV effects models were fit to examine age and gender effects on infection during anal intercourse (AI). Among 24,787 men product acceptability. Three underlying factors were identi- who have sex with men (MSM) who completed an online fied: Satisfaction with Product Use, Sexual Pleasure,and survey in the United States in 2010, 36 and 34 % reported Ease of Product Use. For acceptability, the applicator ranked having receptive anal intercourse (RAI) and insertive anal highest; however, differences between product acceptability intercourse (IAI) at last sex, respectively [1]. Further, of scores were greatest among females and younger participants. those who reported having AI at last sex, 55 % reported not These findings indicate that RM delivery systems impact their using condoms. Although AI is more frequently practiced among MSM, many heterosexual males and females also engage in AI. In a nationally representative survey conducted & H. A. Pines ( ) Á P. M. Gorbach Á K. Hess Á R. Murphy Á among adults and adolescents in 2009, 12.7 % of females J. Brown Department of Epidemiology, Fielding School of Public Health, reported having AI in the past year while 3.6 and 15.9 % of University of California-Los Angeles, 650 Charles E. Young Dr., males reported having RAI and IAI, respectively, in the past South CHS 41-295A, P.O. Box 951772, Los Angeles, year [2]. However, among males 25–49 years of age and CA 90095-1772, USA females 20–39 years of age, [20 % reported having AI in e-mail: [email protected] the past year [3]. Further, among those who reported R. E. Weiss engaging in RAI at last sex, only 44 % of males and 11 % of Department of Biostatistics, Fielding School of Public Health, females reported using condoms [2]. Compared to unpro- University of California-Los Angeles, Los Angeles, CA, USA tected vaginal and IAI, unprotected RAI confers a greater T. Saunders Á P. A. Anton risk of HIV infection per sex act [4, 5]. Given the low rate of David Geffen School of Medicine, University of California-Los condom use during AI and the risk associated with unpro- Angeles, Los Angeles, CA, USA tected RAI, methods to prevent HIV infection during AI, such as RMs, are greatly needed. R. D. Cranston Department of Medicine, University of Pittsburgh School The potential impact of RMs on HIV infection rates will of Medicine, Pittsburgh, PA, USA depend on whether high-risk individuals are willing to use 123 AIDS Behav them [6]. While early RM acceptability studies evaluated the Mucosal Immunology Core’s registry, and through adver- acceptability of a single placebo product among MSM [7, 8], tisements posted on the UCLA campus, at local commu- more recent studies have measured the acceptability of active nity-based organizations, on social networking sites (e.g., microbicide products among both males and females who GRINDR) and classifieds (e.g., LA Weekly and craigs- practice RAI [9–11]. One study evaluated the safety and list.org) websites. Potential participants were consented acceptability of UC781 gel relative to a placebo gel and and screened at Visit 1. Eligible participants were C 18 - observed high acceptability of the active gel [9]. In the recent years of age, HIV and STI (syphilis, rectal Neisseria RMP-02/MTN-006 trial of rectally applied but vaginally gonorrhea, and rectal Chlamydia trachomatis ) negative, formulated 1 % tenofovir gel, fewer participants found the had recently engaged in RAI (past month for males; past active gel acceptable compared to HEC placebo (25 vs. year for females), had a personal telephone for completing 50 %, respectively) [10]. However, rectal application of a telephone questionnaires, understood local HIV/STI reduced glycerin formulation of 1 % tenofovir gel in MTN- reporting requirements, and were willing and able to give 007 was well tolerated and highly acceptable relative to HEC informed consent, try all three anorectal products at least placebo gel, 2 % nonoxynol-9, and no treatment [11]. once, meet study visits, and complete study questionnaires. A range of delivery systems, (i.e., formulations and Final eligibility was determined 2 weeks later at the devices), can be used to administer RMs, and in many enrollment visit (Visit 2). Potential participants were cases the device used is dependent on the substance or excluded if they were homeless, pregnant or breastfeeding consistency of the formulation to be applied. Yet, despite (females only), had an active rectal infection, reported a this range, few studies have compared the acceptability of a symptomatic anorectal herpes outbreak in the past month, variety of potential RM delivery systems [12]. Carballo- reported anorectal pain or bleeding at Visit 1 or 2 (Grade 2 Dieguez et al. were the first to measure the acceptability of or higher, based on DAIDS rectal adverse events grading more than one candidate RM delivery system in a ran- tables for microbicides studies, addendum 3 at http://rsc. domized crossover trial. They reported that 75 % of par- tech-res.com/safetyandpharmacovigilance), had anorectal ticipants preferred using a lubricant (35 mL) inserted using signs detected by visual and/or high resolution anoscopy an enema bottle compared to only 25 % who preferred examination at Visit 1 or 2 (Grade 2 or higher), had known using a suppository (8 g) (p \ 0.001) [12]. However, this allergies to any of the study products or components of the was a small study restricted to MSM (N = 77). No studies study products, were currently participating in another have compared the acceptability of multiple RM delivery clinical trial of an investigational anorectal product, and/or systems among females [9, 13]. had any other clinical conditions or prior therapy that The goal of this study was to measure the acceptability would make them unsuitable for the study or unable to of three candidate RM products representing distinct rectal comply with study requirements. delivery systems among males and females who practice RAI and examine the effects of various characteristics on Study Products product acceptability within this population. The following non-prescription, over-the-counter (OTC) anorectal products were compared in this study: (i) a dis- Methods posable enema bottle, similar to FleetsÒ, pre-filled with 125 mL of a clear isotonic liquid (Normosol-R), (ii) a Study Design and Population disposable vaginal applicator pre-filled with 4 mL of a clear, water-based, water-soluble, condom compatible Between February 2009 and September 2010, 117 HIV- isotonic gel (Pre-SeedTM), and (iii) a 1.4 g anorectal sup- uninfected males and females were enrolled in the Anorectal pository (TucksTM). AstroglideTM (0.4 mL packets), a Microbicide Product (AMP) Study, a randomized crossover water-based, water-soluble, condom compatible, OTC clinical trial, at the UCLA Center for Clinical AIDS Research lubricant was also distributed with the enema and appli- and Education. The AMP Study was part of UCLAs ongoing cator to facilitate insertion. Although neither the enema nor U19 Microbicide Development Program (MDP), a DAIDS- the applicator under study are widely used in the commu- supported Integrated Pre-Clinical/Clinical Program (IPCP) nity, they represent potentially acceptable RM products as focused on the development of RMs (#AI0606414). All par- many MSM use enemas or rectal douches in preparation ticipants signed written informed consents approved by the for RAI [14] and lubricants similar to that contained in Pre- UCLA Human Subjects Review Committee. SeedTM are widely used by both males and females during Participants were recruited from the Network for AIDS RAI [15–19]. Moreover, 73 % of males and 39 % of Research in Los Angeles’ research registry, ongoing MDP females who practice RAI participating in the Rectal studies conducted at UCLA, from the UCLA CFAR Health and Behaviors Study (RHBS), completed as the first 123 AIDS Behav phase of our project under UCLAs U19 MDP in Los Study Procedures Angeles and Baltimore, reported rectal douching in the past 6 months [20]. TucksTM suppositories are commonly used Eligible participants were assigned to one of six potential to treat hemorrhoids, and 38 % of males and 40 % of product sequences at enrollment (Visit 2) using a crossover females enrolled in the RHBS reported ever
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