Association of Antiretroviral Drug Detection with Behavioral Characteristics of HIV-uninfected Study Participants in Baltimore, MD and Bronx, NY.

<p>The table shows characteristics of HIV-uninfected participants who were enrolled in Baltimore, MD and Bronx, NY (limited to participants whose samples were screened for ARV drugs in this study). Study participants were asked to self-report characteristics within six months of enrollment, unless otherwise specified. Fisher’s exact, chi-square, and Wilcoxon rank sum tests were used to analyze the association between these characteristics and ARV drug detection. P values <0.05 are bolded. Baseline characteristics are defined as follows: Unknown HIV status of last partner: unknown HIV status of man with whom had last vaginal sex; Condom use (vaginal): Condom used with last vaginal sex; Condom use (anal): Condom used with last anal sex; Concurrency: self-report of sex with a man while involved in a sexual relationship with another man during the same period; Self-reported STI: Self-reported sexually-transmitted infection, including gonorrhea, syphilis, or chlamydia infection; Substance use: At least weekly substance use (including drug use or binge-drinking [≥4 drinks on 1 occasion]); Binge drinking: At least weekly binge-drinking (≥4 drinks on 1 occasion); Drug use: At least weekly drug use (excluding cannabis); Depressive symptoms: score ≥7 using the Center for Epidemiologic Studies Depression (CES-D) scale. Abbreviations: ARV: antiretroviral; IQR: interquartile range.</p><p>^aSome participants did not respond to all of the questions asked. In these cases, the percentage was calculated among all of the respondents.</p><p>^bThis percentage was calculated among participants who reported ever having anal sex.</p><p>Association of Antiretroviral Drug Detection with Behavioral Characteristics of HIV-uninfected Study Participants in Baltimore, MD and Bronx, NY.</p

Association of Antiretroviral Drug Detection with Behavioral Characteristics of Partners of HIV-uninfected Study Participants in Baltimore, MD and Bronx, NY.

<p>The table shows characteristics of partners of HIV-uninfected participants who were enrolled in Baltimore, MD and Bronx, NY (limited to participants whose samples were screened for ARV drugs in this study). Study participants were asked to self-report characteristics of partners within six months of enrollment, unless otherwise specified. Fisher’s exact, chi-square, and Wilcoxon rank sum tests were used to analyze the association between these characteristics and ARV drug detection. P values <0.05 are bolded. Baseline characteristics are defined as follows: Reported STI: Reported partner sexually-transmitted infection, including gonorrhea, syphilis, or chlamydia infection; Substance use: At least weekly substance use (including drug use or binge-drinking [≥4 drinks on 1 occasion]); Binge drinking: ≥5 drinks on 1 occasion; Alcohol dependence: Cut Down, Annoyed, Guilty, and Eye Opener (CAGE) score ≥2; Incarceration: incarcerated during the past 5 years. Abbreviations: ARV: antiretroviral.</p><p>Association of Antiretroviral Drug Detection with Behavioral Characteristics of Partners of HIV-uninfected Study Participants in Baltimore, MD and Bronx, NY.</p

Association of Antiretroviral Drug Detection and Demographic Characteristics of HIV-uninfected Study Participants in Baltimore, MD and Bronx, NY.

<p>The table shows the demographic characteristics of HIV-uninfected participants from Baltimore, MD and Bronx, NY whose plasma samples were screened for antiretroviral (ARV) drugs. Fisher’s exact, chi-square and Wilcoxon rank sum tests were used to analyze the association between these characteristics and ARV drug detection. P values <0.05 are bolded. Baseline characteristics are defined as follows: HS grad: high school graduation; sep: separated; div: divorced; cohabitating: not married but living with partner; income: annual household income; food insecurity: concerned about having sufficient food for self and family. Abbreviations: ARV: antiretroviral; IQR: interquartile range.</p><p>Association of Antiretroviral Drug Detection and Demographic Characteristics of HIV-uninfected Study Participants in Baltimore, MD and Bronx, NY.</p

Antiretroviral Drugs Detected in Plasma Samples Collected at the Last Study Visit.

<p>The table shows the patterns of antiretroviral (ARV) drugs detected in plasma samples from HIV-uninfected participants enrolled in the HPTN 064 study. Samples were screened for the presence of five nucleoside/nucleotide reverse transcriptase inhibitors, two non-nucleoside reverse transcriptase inhibitors, and nine protease inhibitors. ARV drugs were detected in samples from participants enrolled at two of ten study communities, Baltimore, MD and Bronx, NY. Abbreviations: ARV, antiretroviral; EFV, efavirenz; NFV, nelfinavir; IDV, indinavir; SQV, saquinavir; TPV, tipranavir; ATV, atazanavir.</p><p>Antiretroviral Drugs Detected in Plasma Samples Collected at the Last Study Visit.</p

Number of adverse events (AEs) reported.

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.</div

MTN-035 protocol.

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.</div

Results from a linear mixed models with logistic link function estimating the odds ratio of reporting High (A) Acceptability to Study Product and (B) Adherence to Study product, for the Rectal Insert and Rectal Suppository, relative to the Rectal Enema, after accounting for site and sequence order.

Results from a linear mixed models with logistic link function estimating the odds ratio of reporting High (A) Acceptability to Study Product and (B) Adherence to Study product, for the Rectal Insert and Rectal Suppository, relative to the Rectal Enema, after accounting for site and sequence order.</p

Participants’ sociodemographic characteristics, overall and by site.

Participants’ sociodemographic characteristics, overall and by site.</p

CONSORT checklist for MTN-035 trial.

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.</div

Randomization sequence order.

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.</div