Comparison of Measures of Adherence to Human Immunodeficiency Virus Preexposure Prophylaxis Among Adolescent and Young Men Who Have Sex With Men in the United States

Koss, Catherine A.; Hosek, Sybil; Bacchetti, Peter; Anderson, Peter L.; Liu, Albert Y.; Horng, Howard; Benet, Leslie Z.; Kuncze, Karen; Louie, Alan K.; Saberi, Parya; Wilson, Craig M.; Gandhi, Monica

doi:10.1093/cid/cix755

Cited by 83 publications

(89 citation statements)

References 31 publications

(55 reference statements)

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…By contrast, in a study of young MSM where hair collection was “opt-out” (Adolescent Trials Network (ATN) studies 110 and 113), the hair collection rate was >95% (personal communication, manuscript under review [31] ). In other studies where hair collection is incorporated early in the protocol and the field staff trained that hair can be collected from very short hair, takes very little time, and does not disrupt hair styles, acceptability has been very high.…”

Section: Discussionmentioning

confidence: 99%

Hair levels of preexposure prophylaxis drugs measure adherence and are associated with renal decline among men/transwomen

Gandhi¹,

Murnane

Bacchetti

et al. 2017

Aids

Self Cite

View full text Add to dashboard Cite

Objective The U.S. PrEP Demonstration Project (Demo) evaluated men-who-have-sex-with-men on pre-exposure prophylaxis (PrEP) post-marketing and found low seroconversion rates. The objective of this study is to examine hair levels as an adherence measure to PrEP. Design Using an “opt-in” design, participants of PrEP Demo were invited to enroll into a substudy where hair was collected quarterly. Methods Tenofovir concentrations were measured in hair by liquid-chromatography/tandem-mass-spectrometry. Hair levels consistent with ≥4 doses per week (protective in other studies) defined adequate adherence. Mixed effects multivariate logistic regression models examined factors associated with ≥4 doses/week. Separate mixed effects models evaluated the relationship between hair PrEP levels and changes in creatinine clearance (CrCl) over time. Results Overall, 58% of Demo participants enrolled into this opt-in study; reasons for non-participation included insufficient hair (61%) and concerns about hairstyle (27%). Hair and DBS levels consistent with ≥4 doses/week were highly concordant (84%). Hair levels showed adequate adherence in 87% of 875 person-visits (among 280 participants). Factors associated with adequate adherence in multivariate models were amphetamine use (aOR 2.59 (0.97–6.9, p 0.06), condomless receptive anal sex (aOR 2.28 (1.19–4.40, p 0.01), and stable housing (aOR 2.63 (1.03–6.67), p 0.04). Hair levels of tenofovir showed a monotonic relationship with decline in CrCl (p 0.01 for trend). Conclusions In this substudy of the PrEP Demonstration Project, hair and DBS levels were highly concordant and hair concentrations demonstrated adequate adherence 87% of the time, with stable housing and high-risk behavior associated with higher adherence. Daily PrEP drug-taking is associated with modest declines in CrCl.

show abstract

Section: Discussionmentioning

confidence: 99%

Hair levels of preexposure prophylaxis drugs measure adherence and are associated with renal decline among men/transwomen

Gandhi¹,

Murnane

Bacchetti

et al. 2017

Aids

Self Cite

View full text Add to dashboard Cite

show abstract

“…Our use of biomarker as an adherence outcome is strength given that there is substantial within-subject variability in adherence based on the measurement method selected among individuals on PrEP [56]. Alternative methods, such as self-report [57] and electronic pill bottles [58] among young MSM have noted limitations. In terms of a future direction, since PrEP adherence scores were already high rate at baseline, future studies are needed that address if mSMART improves PrEP adherence among those with a poor medication adherence history and if this impact on adherence is clinically significant.…”

Section: Discussionmentioning

confidence: 99%

“…However, the sample for the current study was 70% White and did not contain any Black MSM, which limits generalizability. Finally, as PrEP use is extending into adolescent MSM, adherence interventions are needed that address unique challenges that emerge in working with this younger age group than those included in the current study [18].…”

Section: Discussionmentioning

confidence: 99%

“…MSM represent just 2% of the United States (US) population but account for 67% of all new HIV diagnoses, which is driven in part by increased rates in young MSM [17]. In conjunction with trials indicating that younger participants, including MSM, are less likely to be adequately adherent to PrEP [3,18,19], interventions that target PrEP adherence are needed.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Smartphone-Based Contingency Management Intervention to Improve Pre-Exposure Prophylaxis Adherence: Pilot Trial (Preprint)

Mitchell¹,

LeGrand²,

Hightow-Weidman³

et al. 2018

Preprint

View full text Add to dashboard Cite

Background: Pre-exposure prophylaxis (PrEP) provides a strong preventative benefit to individuals at-risk for HIV. While PrEP adherence is highly correlated with its efficacy, adherence rates are variable both across and within persons. Objective: The objective of this study was to develop and pilot test a smartphone-based intervention, called mSMART, that targets PrEP adherence. mSMART provides contingency management (CM) in the form of monetary incentives for daily PrEP adherence based on a real-time adherence assessment using a camera-based medication event-monitoring tool, as well as medication reminders, PrEP education, individualized behavioral strategies to address PrEP adherence barriers, and medication adherence feedback. Methods: This was a four-week open-label, phase I trial in a community sample of young men who have sex with men already on PrEP (n = 10). Results: While adherence composite scores corresponding to PrEP biomarkers indicated 90% of the sample already had an acceptable baseline adherence in the protective range, by the end of the four-week period scores improved for 30% of the sample-adherence did not worsen for any participants. Participants reported mean PrEP adherence rates of 91% via daily entries in mSMART. At the end of the four-week period, participants indicated acceptable ratings of satisfaction, usability, and willingness to recommend mSMART to others. There were no technical difficulties associated with smartphone compatibility, user misunderstandings about mSMART features that interfered with daily use, or study attrition. Conclusion: This research is the first to apply CM to PrEP adherence. Findings indicated that mSMART is feasible and acceptable. Such an adherence intervention administered via a user-friendly smartphone application can allow for widespread dissemination. Future efficacy trials are needed.

show abstract

“…Evidence also suggests that adherence to PrEP is particularly low among the young. 13 Given the challenges with both initiating and potentially adhering to PrEP, combination HIV prevention approaches, including promotion of condom use, are more effective than PrEP alone in high-risk populations. 14 Very few intervention studies have focused on the reduction of sexual risk in transgender women.…”

mentioning

confidence: 99%

Efficacy of an Empowerment-Based, Group-Delivered HIV Prevention Intervention for Young Transgender Women

et al. 2018

View full text Add to dashboard Cite

IMPORTANCEThe incidence of HIV infection among transgender women in the United States is extremely high, with young transgender women (YTW) at highest risk; condomless sex is the primary risk behavior for transmission. However, there are no published randomized clinical trials to date examining interventions to reduce sexual risk for HIV acquisition and transmission within this group.OBJECTIVE To determine the efficacy of a culturally specific, empowerment-based, and group-delivered behavioral prevention intervention to reduce sexual risk for HIV acquisition and transmission in sexually active YTW aged 16 to 29 years. DESIGN, SETTING, AND PARTICIPANTS Randomized clinical efficacy trial of Project LifeSkills, a group-delivered, behavioral HIV prevention intervention, vs standard of care conducted among 190 sexually active YTW between March 26, 2012, and August 15, 2016, at community-based locations in Boston, Massachusetts, and Chicago, Illinois, to reduce sexual risk for HIV acquisition or transmission. Data analysis was by a modified intention-to-treat approach. INTERVENTIONS Participants were randomized (approximately 2:2:1) to the LifeSkills intervention (n = 116), standard of care only (n = 74), or a diet and nutrition time-and attention-matched control (attention control) arm (n = 43). The attention control arm was dropped during active enrollment per the Data Safety and Monitoring Board's recommendation. The LifeSkills intervention was delivered in six 2-hour sessions spanning a 3-week period.MAIN OUTCOMES AND MEASURES Primary outcome was change in the number of self-reported condomless anal or vaginal sex acts in the 4 months before the baseline assessment and that reported at the 4-, 8-, and 12-month visits. RESULTSOf the 190 study participants, the mean (SD) age was 23.4 (3.4) years (range, 16-29 years); 47 (24.7%) were white, 83 (43.7%) were black or African American, 25 (13.2%) were Hispanic or Latina, and 35 (18.4%) were another race/ethnicity. From baseline to 4 months, the LifeSkills group had a 30.8% greater mean (SE) reduction in condomless sex acts (2.26 [0.40] at baseline vs 1.22 [0.22] at 4 months) compared with the standard of care group (2.69 [0.59] at baseline vs 2.10 [0.47] at 4 months) (risk ratio [RR], 0.69; 95% CI, 0.60-0.80; P < .001). Similarly, the LifeSkills group had a 39.8% greater mean (SE) reduction in condomless sex acts at the 12-month follow-up visit compared with the standard of care group (0.71 [0.13] vs 1.40 [0.32]; RR, 0.60; 95% CI, 0.50-0.72; P < .001).CONCLUSIONS AND RELEVANCE Among YTW at sexual risk of HIV acquisition or transmission, the LifeSkills intervention resulted in a 39.8% greater mean reduction in condomless sex acts during the 12-month follow-up in comparison to the standard of care group. This trial is the first to date to demonstrate evidence of efficacy for a behavioral intervention to reduce sexual risk in YTW.

show abstract

Comparison of Measures of Adherence to Human Immunodeficiency Virus Preexposure Prophylaxis Among Adolescent and Young Men Who Have Sex With Men in the United States

Cited by 83 publications

References 31 publications

Hair levels of preexposure prophylaxis drugs measure adherence and are associated with renal decline among men/transwomen

Hair levels of preexposure prophylaxis drugs measure adherence and are associated with renal decline among men/transwomen

Smartphone-Based Contingency Management Intervention to Improve Pre-Exposure Prophylaxis Adherence: Pilot Trial (Preprint)

Efficacy of an Empowerment-Based, Group-Delivered HIV Prevention Intervention for Young Transgender Women

Contact Info

Product

Resources

About