PrEP in YBMSM Atlanta -. high rates of discontinuation
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Previous data have demonstrated racial disparities in PrEP use,7,24 which may paradoxically worsen racial disparities in HIV infection. We believe that there is an ethical responsibility to optimize PrEP uptake in research studies conducted with YBMSM or other key populations at high risk of HIV acquisition. Given that significant structural barriers exist for YBMSM to access PrEP8 and the low overall PrEP uptake in Atlanta,7 we offered direct access to PrEP for all enrollees within the context of our study.
CID 2019 - The EleMENt study was a longitudinal cohort of YBMSM in Atlanta, Georgia, designed to evaluate the relationship between substance use and HIV/sexually transmitted infection (STI) incidence (NCT02503618). In this study of 298 YBMSM in Atlanta, Georgia, provision of free PrEP clinical services and access to low- or no-cost medication led 44% to initiate PrEP, an increase from only 6% on PrEP at baseline. However, of those who initiated, more than two-thirds (69%) had at least 1 discontinuation. Although many who discontinued PrEP eventually restarted, more than half discontinued a second time, and 40% did not restart PrEP while under observation. Participants faced significant socioeconomic and psychological challenges; the high rates of housing instability and mental health symptoms could contribute to PrEP discontinuation. Although public health efforts are appropriately focused on increasing access to PrEP, we showed that discontinuation was common among YBMSM, even with intensive PrEP navigation services. Simply providing access alone may not translate to the reduced HIV incidence seen among PrEP users in this study.
Of the PrEP initiators, 69% had a first discontinuation and 40% had a final discontinuation. Among the 34/52 participants for whom a reason for final discontinuation could be identified, the most common reason was low perceived HIV risk (31%), followed by problems attending visits or picking up medications (13%) and side effects (10%; Table 2). After receiving a prescription for PrEP, the 131 participants who started PrEP were taking PrEP 67% of the time, with a start/stop pattern shown in Figure 1. The positive predictive value of self-reported adherence to PrEP for finding protective drug levels was 44% (95% CI, 40%-48%).
There were 23 incident HIV infections (5.23/100 person-years; 95% CI, 3.40-7.23). Among the 143 participants on PrEP at baseline or who started PrEP, incidence was 3.15/100 person-years (95% CI, 1.35-6.20). HIV incidence among those who never started PrEP was 8.09/100 person-years (95% CI ,4.53-13.34) (IRR 0.39; 95% CI, .16-.92; P = .03).
Of the 131 participants who started PrEP through the study, the median time to a first discontinuation was 159 days (IQR, 97-237) after taking their first dose of PrEP (Figure 3). In the multivariable model, younger age, cannabis use, STI diagnosis, and fewer sex partners were associated with earlier first PrEP discontinuation (Table 4). When the cannabis use variable was further broken down into frequency of use, the cannabis/discontinuation association was accounted for by daily users only (Supplementary Table 1). Additionally, while there was no association between the composite measure of stimulant use and discontinuation, having a stimulant-positive UDS was associated with discontinuation of PrEP. Using a 30-day cutoff for PrEP discontinuation, 62% had a first discontinuation after a median of 165 days (IQR, 97-243). There was no difference between the 14-day and 30-day survival curves (log-rank test, P = .15).
Similar to first PrEP discontinuation, younger age, cannabis use, and fewer sex partners, but not STI, were associated with final PrEP discontinuation (Table 5). At their last study visit, 31% (93/298) of participants reported currently taking PrEP.
at CROI 2019:
PrEP Persistence and Discontinuation in a Cohort of
Young Black Men who have Sex with Men in Atlanta, GA 63% Discontinued PrEP -
"we continue to observe unacceptably high levels of
HIV incidence in our cohort."
D.P. Serota1, E.S. Rosenberg2, A.L. Thorne1, C del Rio1, N Luisi1, S.R. Cutro3, C.M. Rolle4, A.J. Siegler1, T Sanchez1, P.S. Sullivan1, C.F. Kelley1
1Emory University, Atlanta, GA, USA 2University at Albany, SUNY, Rensselaer, NY, USA 3Kaiser Permanente, Atlanta, GA, USA 4Orlando Immunology Center, Orlando, FL, USA
Challenges in Translating PrEP Interest Into Uptake in an Observational Study of Young Black MSM
2017 Nov. JAIDS
Charlotte-Paige Rolle, MD, MPH,* Eli S. Rosenberg, PhD, Aaron J. Siegler, PhD,
Travis H. Sanchez, DVM, MPH, Nicole Luisi, MS, MPH, Kevin Weiss, MPH, Scott Cutro, MD,
Carlos del Rio, MD,*Patrick S. Sullivan, DVM, PhD,and Colleen F. Kelley, MD, MPH*
• Although we found high PrEP interest among YBMSM in EleMENt, PrEP initiation (34%) and medication start (20%) was lower and may be suboptimal to significantly reduce HIV incidence in this population.26 Previous studies have also shown similar discrepancies between PrEP interest and uptake among Black MSM7 with overall low uptake reported (2.5%-18%).7,24,27-30
• There is a public health urgency for HIV research studies and prevention programs serving YBMSM to offer the best available HIV prevention services, including PrEP.
• Alarming racial disparities in HIV incidence exist between black and white men who have sex with men (MSM) in Atlanta, GA and throughout the United States, with young black MSM (YBMSM) experiencing the highest incidence rates.1,2
• At a minimum, HIV prevention programs and research studies must reduce structural barriers that limit PrEP uptake for YBMSM.
• Kaplan-Meier cumulative probability estimates for PrEP interest, initiation, and medication start reveals that over 50% of the cohort reported interest in PrEP at the baseline study visit; however, there is a marked drop-off in subsequent initiation and medication start (Fig. 3). Despite robust PrEP interest, median time to PrEP initiation was 16 weeks (95% CI: 7 to 36) among interested men. Among those receiving a prescription, 24/63 (38%) men never started taking TDF/FTC including 15 men who remain enrolled in the PrEP program and 9 men who discontinued the program; median time to medication start was 3 weeks (95% CI: 2 to 6).
Challenges in Translating PrEP Interest Into Uptake in an Observational Study of Young Black MSM
2017 Nov. JAIDS
HIV incidence among US young, black men who have sex with men (YBMSM) is high, and structural barriers (eg lack of health insurance) may limit access to Pre-exposure prophylaxis (PrEP). Research studies conducted with YBMSM must ensure access to the best available HIV prevention methods, including PrEP.
We implemented an optional, nonincentivized PrEP program in addition to the standard HIV prevention services in a prospective, observational cohort of HIV-negative YBMSM in Atlanta, GA. Provider visits and laboratory costs were covered; participant insurance plans and/or the manufacturer assistance program were used to obtain drugs. Factors associated with PrEP initiation were assessed with prevalence ratios and time to PrEP initiation with Kaplan-Meier methods.
Of 192 enrolled YBMSM, 4% were taking PrEP at study entry. Of 184 eligible men, 63% indicated interest in initiating PrEP, 10% reported no PrEP interest, and 27% wanted to discuss PrEP again at a future study visit. Of 116 interested men, 46% have not attended a PrEP initiation appointment. Sixty-three men (63/184; 34%) initiated PrEP; 11/63 (17%) subsequently discontinued PrEP. The only factor associated with PrEP initiation was reported sexually transmitted infection in the previous year (prevalence ratio 1.50, 95% confidence interval: 1.002 to 2.25). Among interested men, median time to PrEP initiation was 16 weeks (95% confidence interval: 7 to 36).
Despite high levels of interest, PrEP uptake may be suboptimal among YBMSM in our cohort even with amelioration of structural barriers that can limit use. PrEP implementation as the standard of HIV prevention care in observational studies is feasible; however, further research is needed to optimize uptake for YBMSM.
From July 2015 through December 2016, 192 HIV-negative men enrolled in the EleMENt study, 4% (8/192) of men were already taking PrEP on study entry leaving 184 men eligible for EleMENt's PrEP program (Table 1). The median age of the sample was 24 years (interquartile range 22, 26), most reported at least some college education, median annual income was $20,000/year, and over 50% had health insurance. Most identified as gay or homosexual and were not in a committed relationship. Nearly three-quarters of men reported substance use and condomless anal intercourse (CAI) in the 6 months before study enrollment. One-quarter reported an STI diagnosis in the previous year and the majority reported an HIV test in the last 12 months. Approximately, one-half had heard of PrEP previously.
PrEP was offered to all 184 eligible men. At the most recent study visit when data were censored for this analysis, 64% had expressed interest in initiating PrEP, 10% were not interested in PrEP, and 27% wanted to discuss PrEP at the next study visit (Fig. 2). Of 116 interested men, 46% have not yet attended an initiation visit, despite repeated scheduling attempts for 36% of these men. Thirty-four percent of 184 eligible men received a prescription at a PrEP initiation visit, but only 20% (37/184) have started TDF/FTC to date. Ten percent (6/63) of PrEP initiations were same-day PrEP starts. Those who reported an STI diagnosis in the past year were 50% more likely to initiate PrEP (Table 1). The most popular reason for PrEP interest was the possibility of having sex without condoms in the future; the most common reason for disinterest was consistent condom use. Noninitiators were more likely to endorse the requirement for daily adherence as a reason for PrEP disinterest (Table 2)
Ninety-two percent of men who initiated PrEP (58/63), compared with 74% (90/121) of men who did not initiate PrEP, met one or more CDC indicators for PrEP initiation (P = 0.003; CAI in the previous 6 months, multiple sexual partners, STI diagnosis in the past year, and having an HIV-positive partner20). Two-thirds of men who initiated PrEP had health insurance and used their plan and co-pay assistance to obtain TDF/FTC, and one-third were uninsured and enrolled in the PAP (data not shown). Three men who initiated PrEP and initially used their health insurance to obtain TDF/FTC lost their health insurance within 6 months of PrEP initiation and were subsequently enrolled in the PAP. During the 1-month clinician assessment, 24/37 (65%) men reported missing zero PrEP doses in the preceding week. As of December 2016, 11 men discontinued PrEP. Nine men (81%) voluntarily withdrew from the PrEP program, and reasons for withdrawal included no longer being interested (n = 2), not at enough risk based on self-assessment after discussion with study staff (n = 5), too busy to remain in the study (n = 1), and moving away from Atlanta (n = 1). Two men were administratively withdrawn because of PrEP nonadherence.
Kaplan-Meier cumulative probability estimates for PrEP interest, initiation, and medication start reveals that over 50% of the cohort reported interest in PrEP at the baseline study visit; however, there is a marked drop-off in subsequent initiation and medication start (Fig. 3). Despite robust PrEP interest, median time to PrEP initiation was 16 weeks (95% CI: 7 to 36) among interested men. Among those receiving a prescription, 24/63 (38%) men never started taking TDF/FTC including 15 men who remain enrolled in the PrEP program and 9 men who discontinued the program; median time to medication start was 3 weeks (95% CI: 2 to 6).
Alarming racial disparities in HIV incidence exist between black and white men who have sex with men (MSM) in Atlanta, GA and throughout the United States, with young black MSM (YBMSM) experiencing the highest incidence rates.1,2 Daily oral pre-exposure prophylaxis (PrEP) with tenofovir/emtricitabine (TDF/FTC) effectively prevents HIV transmission among MSM3-6; however, a recent Centers for Disease Control and Prevention (CDC) study found that black MSM were half as likely to report PrEP use compared with white MSM.7 In addition, PrEP uptake was slower in the South, with Atlanta MSM reporting 60% lower PrEP use compared with San Francisco MSM. We have previously shown how racial disparities in health insurance and health care access could lead to lower PrEP uptake for black MSM in Atlanta.8 Therefore, effective PrEP implementation in this group requires innovative strategies to ensure those who may benefit from PrEP are aware of PrEP, educated about risks and benefits, and have adequate access to PrEP services.
There is a public health urgency for HIV research studies and prevention programs serving YBMSM to offer the best available HIV prevention services, including PrEP. Traditionally, the “standard of HIV prevention care” in research studies includes provision of risk reduction counseling, postexposure prophylaxis counseling, free condoms, and sexually transmitted infection (STI) diagnosis and treatment referrals.9 However, the field has struggled to incorporate PrEP as the standard of HIV prevention care, given the significant financial and logistical hurdles associated with this costly medical intervention.9-11 Some argue that research studies should be mandated to offer PrEP to everyone because it is an effective, Food and Drug Administration-approved HIV prevention intervention.11 Although there is a strong ethical obligation to reduce HIV risk among research participants, no formal guidance exists for inclusion of PrEP into research studies
At a minimum, HIV prevention programs and research studies must reduce structural barriers that limit PrEP uptake for YBMSM. Previous studies have relied on external referrals for PrEP outside the research study context.9 A referral-based program may not fully address these barriers for YBMSM as many lack access to health care.8,12-14 Here, we describe the implementation of an optional PrEP program as an addition to a standard package of HIV prevention services in a currently enrolling, HIV/STI incidence cohort of YBMSM in Atlanta, GA. A detailed understanding of facilitators and barriers to PrEP uptake among YBMSM is necessary to inform the development of targeted interventions to promote PrEP uptake and adherence within this population. This implementation framework may serve as a guide for research studies wishing to offer PrEP for HIV prevention.
Our study demonstrates that implementation of PrEP as the standard of HIV prevention care in observational studies is feasible. Previous PrEP demonstration projects and clinical trials that have included PrEP used a full clinical staff including clinicians, laboratory technicians, social workers, and counselors devoted to PrEP education, initiation, and retention.12,13,21-23 Several projects offered regular clinical hours allowing for “drop in” visits and also provided additional support services, including counseling, meal/housing assistance, and leadership/job training courses.12,21 Notably, a few studies were incentivized and recruited individuals already interested in taking PrEP.13,21,23 Other studies offered PrEP using a referral-based system, and provided TDF/FTC free of charge.9 Our study differs significantly in that our study recruitment materials did not contain information about PrEP, and we offered nonincentivized PrEP as the standard of HIV prevention care to all enrolled YBMSM by task-shifting some clinical duties to trained study staff and use of participant health insurance plans and/or the manufacturer assistance programs to access TDF/FTC.
The decision to offer PrEP within the EleMENt PrEP program was guided by 2 core ethical principles: beneficence and social justice. Beneficence refers to the practice of assuring that participants receive the highest standard of care available in the research setting, and PrEP is considered by many to be the standard of HIV prevention care as it is scientifically validated and Food and Drug Administration approved.9,11 The principle of social justice refers to the equitable access of interventions that have the potential to reduce disparities affecting a particular health outcome.10 Previous data have demonstrated racial disparities in PrEP use,7,24 which may paradoxically worsen racial disparities in HIV infection. We believe that there is an ethical responsibility to optimize PrEP uptake in research studies conducted with YBMSM or other key populations at high risk of HIV acquisition. Given that significant structural barriers exist for YBMSM to access PrEP8 and the low overall PrEP uptake in Atlanta,7 we offered direct access to PrEP for all enrollees within the context of our study.
Our study is the first to provide a framework for implementation of PrEP into observational prevention studies. We have outlined key differences between procedures in standard clinical practice and our cohort study, which include the use of lay study staff to initially introduce and educate about PrEP with the use of media tools, task shifting clinical duties to lay study staff, and the incorporation of PrEP visits into the existing study framework. However, this requires extensive staff training, protocol and database development, and consistent monitoring and adjustments for successful PrEP implementation. We encourage future prevention studies to consider offering PrEP using our model and provide guidance on required staffing needs for this service. In addition, uptake estimates from our study may be useful to inform study design and sample size for trials offering PrEP to YBMSM.
Resources to provide PrEP within the context of an observational cohort may serve as a significant barrier to implementation. Estimated costs/year of PrEP delivery within the clinical context are $10,000-11,000 per year with drug costs accounting for 85% of the cost.25 Participants used manufacturer co-pay assistance and the PAP to reduce drug costs; however, significant staff effort (approximately 8-10 hours weekly) was required to counsel participants, navigate, monitor, and renew these mechanisms. Additional costs associated with clinician visits, although minimized in our study framework, and laboratory testing are also important budget considerations in planning future projects. Investigators and funding agencies will need to be cognizant of the additional resources necessary to include PrEP in research studies of high-risk populations.
Although we found high PrEP interest among YBMSM in EleMENt, PrEP initiation (34%) and medication start (20%) was lower and may be suboptimal to significantly reduce HIV incidence in this population.26 Previous studies have also shown similar discrepancies between PrEP interest and uptake among Black MSM7 with overall low uptake reported (2.5%-18%).7,24,27-30 In their “Motivational PrEP Cascade” based on the Transtheoretical Model of Change, Parsons et al show that many MSM are lost in the precontemplative (unwilling to take PrEP or believe they were appropriate PrEP candidates) or contemplative (willing to take PrEP but without real plans to start) stages of behavior change.31 Our baseline PrEP interest survey suggests that initial barriers to willingness may include self-assessed low risk behavior and the requirement for daily adherence, which is consistent with data from previous studies.17,18 However, our results also provide direct evidence of a critical barrier between willingness and uptake of PrEP, and further research is needed to develop interventions to improve progression from willingness to PrEP uptake among YBMSM.
In contrast to our design and findings, HPTN 073 was a PrEP demonstration project which reported 79% PrEP uptake among 226 black MSM using a client-centered care coordination counseling approach (C4).21 These results occurred in the context of an incentivized demonstration project with advertisement materials including information about PrEP. Men enrolled in EleMENt were recruited without regard to PrEP knowledge or willingness and were not incentivized to uptake PrEP. Of significant importance, only half of our cohort had heard of PrEP before enrollment. Our study therefore provides estimates that are more representative of “real-world” PrEP uptake among YBMSM and are notably higher than those cited by previous population-based studies.7,24,27-30 This may be reflective of our intensive PrEP education efforts combined with the convenience of PrEP access and covered costs of PrEP provider visits and laboratory assessments within the study. These data are a necessary first step to fully understand the motivators and barriers to PrEP use among YBMSM that may be experienced in clinical and public health settings and provide insight on key strategies to promote PrEP uptake within this group.
Men reporting an STI diagnosis in the previous year were 50% more likely to initiate PrEP. This is consistent with previous findings, in which higher-risk men were most likely to uptake PrEP.7,27,28 Overall, 92% of men in the EleMENt study who initiated PrEP met CDC guidelines for considering MSM behaviorally eligible for PrEP. Previous studies have consistently shown risk behavior screening to be less accurate when predicting HIV risk within communities with high HIV prevalence.2,32,33 We have previously demonstrated how use of CDC PrEP eligibility guidelines would have missed 30% of HIV seroconverters in a high incidence cohort of Atlanta MSM.2,34 Given these observations, we decided to offer PrEP to all HIV-negative YBMSM in the EleMENt study, regardless of reported risk. This has important implications when developing inclusion criteria for studies and programs offering PrEP to YBMSM and strongly encourages the consideration of local epidemiologic trends when identifying appropriate PrEP candidates.
This study may not be fully generalizable to other populations of YBMSM as our sample originates from a single city in the Southeastern United States. Our lower PrEP uptake estimates as compared to data from other samples of BMSM (eg HPTN 073) may reflect the lack of use of the C4 intervention or other effective interventions to increase PrEP uptake in this group. We were also unable to consistently offer same-day PrEP starts and may have lost men to follow-up during the delay between expression of PrEP interest and scheduling of the initiation visit.35-37 Last, our sample size is relatively small, and we have limited follow-up time to report to date. Additional longitudinal analyses, including formal adherence and PrEP persistence estimates, and qualitative interviews, are ongoing and will be reported once study follow-up is complete in 2019.
We describe the first implementation of optional PrEP as the standard of HIV prevention care in an observational study of YBMSM. We have provided a framework for PrEP integration into future HIV prevention studies and argue that there is an ethical obligation for research studies to provide this effective intervention to communities disproportionately affected by the HIV/AIDS epidemic. In our study, PrEP uptake seems suboptimal among YBMSM despite high levels of PrEP interest and attempts to minimize structural barriers affecting PrEP access. Further research is needed to fully understand the factors that mediate the relationship between interest and uptake of PrEP among YBMSM.