Effect of Rectal Hygiene on Sexually Transmitted Infections Among HIV-Negative Men Who Have Sex with Men (MSM)

Abstract Background Rectal gonorrhea (NG) and chlamydia (Connecticut) infections are common among men who have sex with men (MSM). Rectal douching/enema (RDE) is a common practice among MSM that can affect the rectal microbiome. It is unclear if this practice is associated with acquiring rectal infections (RI) with either NG or CT. Methods From 2013–2015, 398 adult HIV-negative MSM and transwomen were enrolled in a randomized controlled study on text messaging for adherence to pre-exposure prophylaxis (PrEP). Participants were surveyed on sexual behavior, frequency of RDE, drug use, and nutritional habits in conjunction with routine sexually transmitted infection testing. Pearson’s χ 2 and two sample t-tests were used to measure significance of RDE and other risk factors with RI. Multivariable logistic regression model was used to control for confounding and assess the association of RDE with RIs. Confounders (i.e., age, number anal receptive sex, number sex partners) were selected a priori for inclusion in the final model based on a causal model and statistical significance. Results Of 397 participants, 262 (67%) performed RDE and 132 (33%) had at least one NG or CT rectal infection over 48 weeks. Number of condomless anal receptive sex acts (mean = 19, P < 0.001), condom use for anal receptive sex (P = 0.017), number of male sex partners in past 3 months (mean = 14, P = 0.001), and the use of poppers (P < 0.001) were associated with RI. There was no significant association between nutritional habits, probiotic foods or supplements and RI, with the exception of energy bars (P = 0.029). Controlling for confounders, RI was associated with RDE less than weekly with OR = 1.02 (95% CI 0.52–1.99) while RDE weekly or more had OR = 2.08 (95% CI 1.03–4.17). Stratified by number of partners, MSMs with more than the median (>6) number of partners had OR = 4.96 (95% CI 1.29–19.03) if performing RDE less than weekly, and OR = 6.03 (95% CI 1.55–23.49) if weekly or more. Conclusion Rectal hygiene with douching/enemas is a common practice among MSMs on PrEP, which increases the odds of acquiring rectal NG and/or CT. This finding is suggestive for the use of rectal hygiene products/practices as potential targets for sexually transmitted infection prevention. Disclosures All authors: No reported disclosures

Frame me if you must: PrEP framing and the impact on adherence to HIV Pre-exposure Prophylaxis

Abstract Background “PrEP whore” has been used both as a pejorative by PrEP opponents in the gay community and, reactively, by PrEP advocates as a method to reclaim the label from stigmatization and “slut-shaming.” The actual prevalence and impact of such PrEP-directed stigma on adherence have been insufficiently studied. Methods CCTG 595 was a randomized controlled PrEP demonstration project in 398 HIV-uninfected MSM and transwomen. Intracellular tenofovir-diphosphate (TFV-DP) levels at weeks 12 and 48 were used as a continuous measure of adherence. At study visits, participants were asked to describe how they perceived others’ reactions to them being on PrEP. These perceptions were categorized a priori as either “positively framed,” “negatively framed,” or both. We used Wilcoxon rank-sum to determine the association between positive and negative framing and TFV-DP levels at weeks 12 and 48. Results By week 4, 29% of participants reported perceiving positive reactions from members of their social groups, 5% negative, and 6% both. Reporting decreased over 48 weeks, but positive reactions were consistently reported more than negative. At week 12, no differences in mean TFV-DP levels were observed in participants with positively-framed reactions compared with those reporting no outcome or only negatively-framed (1338 [IQR, 1036-1609] vs. 1281 [946-1489] fmol/punch, P = 0.17). Additionally, no differences were observed in those with negative reactions vs. those without (1209 [977–1427] vs. 1303 [964–1545], P = 0.58). At week 48, mean TFV-DP levels trended toward being higher among those that report any reaction, regardless if positive (1335 [909–1665] vs. 1179 [841–1455], P = 0.09) or negative (1377 [1054–1603] vs. 1192 [838–1486], P = 0.10) than those reporting no reaction. At week 48, 46% of participants reported experiencing some form of PrEP-directed judgment, 23% reported being called “PrEP whore,” and 21% avoiding disclosing PrEP use. Conclusion Over 48 weeks, nearly half of participants reported some form of judgment or stigmatization as a consequence of PrEP use. However, individuals more frequently perceived positively framed reactions to being on PrEP than negative. Importantly, long-term PrEP adherence does not appear to suffer as a result of negative PrEP framing. Disclosures All authors: No reported disclosures

Perceived Versus Calculated HIV Risk: Implications for Pre-exposure Prophylaxis Uptake in a Randomized Trial of Men Who Have Sex With Men.

BackgroundInaccurate HIV risk perception by men who have sex with men is a barrier to HIV prevention. Providing information about objective HIV risk could improve pre-exposure prophylaxis (PrEP) uptake.MethodsPrEP Accessibility Research & Evaluation 2 (PrEPARE2) was a randomized controlled trial of men who have sex with men to determine whether an objective risk score affects future PrEP uptake. Participants completed a baseline survey to assess demographics, risk behaviors, and HIV self-perceived risk (SPR). The survey generated a calculated HIV risk (CalcR) score, estimating HIV risk based on reported condomless anal intercourse and sexually transmitted infections, and was provided to individuals in the intervention arm. Participants were contacted 8 weeks later to determine whether they initiated PrEP.ResultsOf 171 participants (median age 32 years; 37% Hispanic or non-Hispanic Black; median 5 sexual partners in the past 6 months), 81% had heard of PrEP, and 57% believed they were good PrEP candidates. SPR had poor agreement with CalcR (kappa = 0.176) with 38% underestimating their HIV risk. At week 8, only 14 of 135 participants had initiated PrEP with no difference between arms (CalcR 11%, control 10%, P > 0.99). The most common reason for not starting PrEP was low HIV risk perception. There was a relative decrease in SPR over time (P = 0.06) but no difference between arms (P = 0.29).ConclusionProviding an objective HIV risk score alone did not increase PrEP uptake. HIV testing performed at testing sites may be a crucial time to correct misperceptions about risk and initiate same-day PrEP, given enthusiasm for PrEP on the testing day to facilitate greater uptake

Recent HIV Risk Behavior and Partnership Type Predict PrEP Adherence in Men Who Have Sex with Men

Abstract Background Individuals engaging in higher risk behavior are often more adherent to PrEP but it is unclear if partnership type itself affects PrEP adherence. We examined the effect of recent HIV risk behaviors and partnership type on PrEP adherence in men who have sex with men (MSM) taking PrEP. Methods CCTG 595 is a 48-week PrEP demonstration study of 398 HIV− at-risk MSM. At baseline and week 48, HIV risk score was estimated as the probability of seroconversion over the next year based on number of condomless anal sex acts with HIV+/unknown partners in the last month and any STI diagnosed at study visit. HIV risk score was categorized as low (<0.12), moderate (0.12−0.59) and high (>0.59) risk based on population seroconversion probabilities. Partnership type was assigned as no/single HIV− partner, single HIV+ partner, or multiple partners of any serostatus in the past 3 months. PrEP adherence was estimated by intracellular tenofovir-diphosphate (TFV-DP) levels as a continuous variable at week 48. Statistical methods included McNemar’s test, Wilcoxon rank-sum test, and linear regression model where appropriate. Results Of 313 MSM who completed week 48, there was no significant change in HIV risk category from baseline to week 48 (low: 44 to 42%; moderate: 27 to 24%; high: 28 to 34%; P = 0.25). There was a significant change in partnership type, with the proportion of those with no or single HIV− partnerships increasing (1 to 9%, P < 0.001). In univariate analysis, moderate and high-risk groups had higher TFV-DP levels than the low-risk group at week 48 (P = 0.018). Participants with no/single HIV− partner had significantly lower TFV-DP levels than those with one HIV+ partner or multiple partners (P = 0.007). In a multivariable linear regression model, only low-risk partnerships remained significant where no/single HIV− partnerships were associated with lower TFV-DP levels (mean difference = −344fmol/punch [−617, −71], P = 0.014). Conclusion Although there was a shift in partnership type towards lower risk partnerships, objective HIV risk behavior remained stable over time. Individuals with higher HIV risk behaviors and risk partnerships had higher TFV-DP levels suggesting maintained strong motivation for PrEP adherence. Thus, recent sexual risk behavior and partnership type may be important predictors of PrEP adherence in MSM. Disclosures All authors: No reported disclosures

Characteristics of a cohort of high-risk men who have sex with men on pre-exposure prophylaxis reporting transgender sexual partners.

Transgender people continue to be at high-risk for HIV acquisition, but little is known about the characteristics of their sexual partners. To address this gap, we examined sociodemographic and sexual characteristics of cisgender men who have sex with men (MSM) on pre-exposure prophylaxis (PrEP) reporting transgender sexual partners.A cohort of 392 MSM in southern California in a randomized clinical trial for PrEP adherence were followed from 2013 to 2016. Multivariable generalized estimating equation and logistic models identified characteristics of MSM reporting transgender sexual partners and PrEP adherence.Only 14 (4%) MSM reported having transgender sexual partners. MSM were more likely to report transgender partners if they were African American, had incident chlamydia, reported injection drug-using sexual partners, or received items for sex. Most associations remained significant in the multivariable model: African American (adjusted odds ratio [AOR] 11.20, P = .01), incident chlamydia (AOR 3.71, P = .04), and receiving items for sex (AOR 5.29, P = .04). There were no significant differences in PrEP adherence between MSM reporting transgender partners and their counterpart.MSM who report transgender sexual partners share characteristics associated with individuals with high HIV prevalence. Identifying this group distinct from larger cohorts of MSM could offer new HIV prevention opportunities for this group of MSM and the transgender community

Effect of Rectal Hygiene on Sexually Transmitted Infections Among HIV-Negative Men Who Have Sex with Men (MSM)

Abstract Background Rectal gonorrhea (NG) and chlamydia (Connecticut) infections are common among men who have sex with men (MSM). Rectal douching/enema (RDE) is a common practice among MSM that can affect the rectal microbiome. It is unclear if this practice is associated with acquiring rectal infections (RI) with either NG or CT. Methods From 2013–2015, 398 adult HIV-negative MSM and transwomen were enrolled in a randomized controlled study on text messaging for adherence to pre-exposure prophylaxis (PrEP). Participants were surveyed on sexual behavior, frequency of RDE, drug use, and nutritional habits in conjunction with routine sexually transmitted infection testing. Pearson’s χ 2 and two sample t-tests were used to measure significance of RDE and other risk factors with RI. Multivariable logistic regression model was used to control for confounding and assess the association of RDE with RIs. Confounders (i.e., age, number anal receptive sex, number sex partners) were selected a priori for inclusion in the final model based on a causal model and statistical significance. Results Of 397 participants, 262 (67%) performed RDE and 132 (33%) had at least one NG or CT rectal infection over 48 weeks. Number of condomless anal receptive sex acts (mean = 19, P < 0.001), condom use for anal receptive sex (P = 0.017), number of male sex partners in past 3 months (mean = 14, P = 0.001), and the use of poppers (P < 0.001) were associated with RI. There was no significant association between nutritional habits, probiotic foods or supplements and RI, with the exception of energy bars (P = 0.029). Controlling for confounders, RI was associated with RDE less than weekly with OR = 1.02 (95% CI 0.52–1.99) while RDE weekly or more had OR = 2.08 (95% CI 1.03–4.17). Stratified by number of partners, MSMs with more than the median (>6) number of partners had OR = 4.96 (95% CI 1.29–19.03) if performing RDE less than weekly, and OR = 6.03 (95% CI 1.55–23.49) if weekly or more. Conclusion Rectal hygiene with douching/enemas is a common practice among MSMs on PrEP, which increases the odds of acquiring rectal NG and/or CT. This finding is suggestive for the use of rectal hygiene products/practices as potential targets for sexually transmitted infection prevention. Disclosures All authors: No reported disclosures

Comparing Self-Report Pre-Exposure Prophylaxis Adherence Questions to Pharmacologic Measures of Recent and Cumulative Pre-Exposure Prophylaxis Exposure.

As pre-exposure prophylaxis (PrEP) effectiveness is strongly linked to adherence, we sought to determine if certain self-report measures could be used to inform objective PrEP adherence. We studied participants from the TAPIR study (a multicenter randomized study of daily text messages to support adherence to PrEP In At-Risk), a 48-week randomized controlled trial of HIV-uninfected men who have sex with men (MSM) randomized to receive text message to support adherence versus standard of care. Self-reported medication adherence was assessed using several validated measures modified for PrEP. Objective PrEP adherence was determined through dried blood spot (DBS) measurement of intracellular tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP). A summary of adherence was estimated using responses to the seven adherence items at weeks 12 and 48 using confirmatory factor analysis. Correlations between self-report questions and drug concentrations were estimated with Pearson's correlations for continuous outcomes and point-biserial correlations for dichotomous outcomes. Receiver operating characteristic (ROC) analyses were conducted to assess the performance of self-report measures in predicting protective or perfect TFV-DP concentrations. Of the 369 participants who completed week 12 or 48 visits, the mean age was 35 (standard deviation 9 years), with 79% White, 12% Black, and 29% Hispanic. Correlations between self-report measures of adherence (both individual items and the adherence factor) and quantifiable FTC-TP and continuous TFV-DP concentrations showed that all self-report measures were significantly associated with these objective measures. Compared to a summary measure of self-reported adherence, the 4-week percent taken question medication recall was the only self-report item similarly or more strongly associated with recent adherence and long-term protective and perfect adherence at weeks 12 and 48. ROC analysis also showed that 4-week percent taken question had a reasonable AUC (0.798 at week 12 and 0.758 at week 48) in predicting protective TFV-DP concentrations. All single-item self-report questions assessing PrEP adherence were significantly associated with biomarker quantification, with the 4-week percent taken question performing best. Therefore, in the absence of drug concentration measurements, a 4-week self-report percent taken question may be a good single-item measure of PrEP adherence