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Introduction Strategies are needed to curb the increasing HIV incidence in young men who have sex with men (YMSM) and transgender women (YTGW) worldwide. We assessed the impact of youth‐friendly services (YFS) and a mobile phone application (app) on adherence to pre‐exposure prophylaxis (PrEP) in YMSM and YTGW in Thailand. Methods A randomized control trial was conducted in YMSM and YTGW aged 15 to 19 years. Participants were provided daily oral tenofovir disoproxil fumerate/emtricitabine (TDF/FTC), condoms and randomized to receive either YFS or YFS plus a PrEP app (YFS + APP), whose features included self‐assessment of HIV acquisition risk, point rewards and reminders for PrEP and clinic appointments. Clinic visits occurred at zero, one, three and six months and telephone contact at two, four and five months. HIV testing was performed at every clinic visit. PrEP adherence was evaluated with intracellular tenofovir diphosphate (TFV‐DP) concentrations in dried blood spot (DBS) samples at months 3 and 6. The primary endpoint assessed was “PrEP adherence” defined as TFV‐DP DBS concentrations ≥700 fmol/punch (equivalent to ≥4 doses of TDF/week). Results Between March 2018 and June 2019, 489 adolescents were screened at three centres in Bangkok. Twenty‐seven (6%) adolescents tested positive for HIV and 200 (41%) adolescents participated in the study. Of these, 147 were YMSM (74%) and 53 YTGW (26%). At baseline, median age was 18 years (IQR 17 to 19), 66% reported inconsistent condom use in the past month. Sexually transmitted infection prevalence was 23%. Retention at six months was 73%. In the YFS + APP arm, median app use duration was three months (IQR 1 to 5). PrEP adherence at month 3 was 51% in YFS and 54% in YFS + APP (p‐value 0.64) and at month 6 was 44% in YFS and 49% in YFS + APP (p‐value 0.54). No HIV seroconversions occurred during 75 person years of follow‐up. Conclusions Youth‐friendly PrEP services enabled good adherence among half of adolescent PrEP users. However, the mobile phone application tested did not provide additional PrEP adherence benefit in this randomized trial. Adolescent risk behaviours are dynamic and require adaptive programmes that focus on “prevention‐effective adherence.”

Black and Hispanic/Latinx transgender women in the United States (U.S.) are disproportionately affected by HIV. Pre-exposure prophylaxis (PrEP) reduces risk of HIV infection but PrEP uptake remains low among Black and Hispanic/Latinx transgender women. Between July 2018 and August 2019, we conducted individual interviews with 30 Black and Hispanic/Latinx transgender women who were prescribed PrEP through a PrEP demonstration project and 10 healthcare providers who provide PrEP services to transgender women in Los Angeles and San Diego, California. The interviews assessed general attitudes, experiences, and beliefs about PrEP as well as individual-, interpersonal-, community-, and structural-level barriers to PrEP uptake and adherence. PrEP adherence was assessed by collecting quantitative intracellular tenofovir-diphosphate (TFV-DP) levels in retrospect on batched, banked dried blood spot (DBS) samples. We utilized qualitative content analysis to identify themes from the interviews. Findings indicated the presence of individual-level barriers including cost concerns, mental health issues, substance use, and concerns about PrEP side effects including hormone interaction. Interpersonal-level barriers included the influence of intimate/romantic partners and the impact of patient-provider communication. Community-level barriers consisted of experiencing stigma and negative community opinions about PrEP use as well as having negative experiences in healthcare settings. Structural-level barriers included unreliable transportation, employment, and housing insecurity. Interventions aiming to increase PrEP uptake and adherence among Black and Hispanic/Latinx transgender women in the U.S. should employ a multilevel approach to addressing the needs of transgender women, especially the structural barriers that have greatly limited the use of PrEP.

Despite considerable discussion and debate about adherence to preexposure prophylaxis (PrEP) for human immunodeficiency virus (HIV), scant data are available that characterize patterns of adherence to open-label PrEP. The current evidence base is instead dominated by research on adherence to placebo-controlled investigational drug by way of drug detection in active-arm participants of large randomized controlled trials (RCTs). Important differences between the context of blinded RCTs and open-label use suggest caution when generalizing from study product adherence to real-world PrEP use. Evidence specific to open-label PrEP adherence is presently sparse but will expand rapidly over the next few years as roll-out, demonstration projects, and more rigorous research collect and present findings. The current evidence bases established cannot yet predict uptake, adherence, or persistence with open-label effective PrEP. Emerging evidence suggests that some cohorts could execute better adherence in open-label use vs placebo-controlled research. Uptake of PrEP is presently slow in the United States; whether this changes as grassroots and community efforts increase awareness of PrEP as an effective HIV prevention option remains to be determined. As recommended by multiple guidelines for PrEP use, all current demonstration projects offer PrEP education and/or counseling. PrEP support approaches generally fall into community-based, technology, monitoring, and integrated sexual health promotion approaches. Developing and implementing research that moves beyond simple correlates of either study product use or open-label PrEP adherence toward more comprehensive models of sociobehavioral and socioecological adherence determinants would greatly accelerate progress. Intervention research is needed to identify effective models of support for open-label PrEP adherence.

For marginalized populations, county health departments may be important PrEP access points; however, there are little data on successful PrEP programs at these venues outside of incentivized demonstration projects. Therefore, we implemented an open-access, free PrEP clinic at a county health department in Atlanta, GA to promote PrEP uptake among high-risk clients. The Fulton County Board of Health PrEP clinic launched in October 2015, and eligible clients who expressed interest initiated PrEP and attended follow-up visits per CDC guidelines. Clients engaged in quarterly follow-up and seen within the last 6 months were defined as “persistent”, whereas clients with a lapse in follow-up of > 6 months were defined as “not persistent.” Factors associated with PrEP persistence were assessed with unadjusted odds ratios. Between October 2015 and June 2017, 399 clients were screened for PrEP, almost all were eligible [392/399 (98%)]; however, 158/392 (40%) did not return to start PrEP after screening. Of 234 patients, 216 (92%) received a prescription for PrEP. As of June 2017, only 69/216 (32%) clients remained persistent in PrEP care, and the only evaluated factor significantly associated with PrEP persistence was age ≥ 30 years (OR 1.86, 95% CI 1.02, 3.42). Implementation of PrEP in the county health department setting is feasible; however, we have identified significant challenges with PrEP uptake and persistence in our setting. Further research is needed to fully understand mediators of PrEP persistence and inform interventions to optimize health department-based PrEP services.

Optimal adherence to pre-exposure prophylaxis (PrEP) is critical, but challenging. Men who have sex with men and transgender women have high rates of HIV incidence and substance use. Substance use is associated with reduced adherence to other medications, but associations between substance use and adherence to PrEP are less clear. Thus, the current review 1) systematically evaluates the measurement of substance use and PrEP adherence in studies examining both and 2) summarizes reported findings. Peer-reviewed articles published between 2010 - April 2021 examining associations between substance use and PrEP adherence were reviewed. Fifty studies met inclusion criteria. Assessment of substance use (i.e., mostly via self-reports at baseline) and PrEP adherence (i.e., often via tenofovir diphosphate [TFV-DP] concentration levels at follow-up) varied considerably across studies. Many studies used categorical variables (e.g., substance use: yes/no). Studies using TFV-DP levels defined adherence consistently (i.e., TFV-DP ≥ 700 fmol/punch), with slight variations. Qualitative studies (n = 10) indicated that substance use (mainly alcohol) is related to poorer PrEP adherence. While quantitative findings to date are equivocal for alcohol, there is a pattern of findings linking stimulant use with poorer PrEP adherence. This review reveals four methodological gaps, which can be addressed in future research by: 1) use of uniform benchmarks for substance use measures, 2) prospective assessment for substance use, 3) use of continuous outcome variables wherever possible, and 4) more extensive consideration of potential confounders. Addressing these methodological gaps may help us reach more definitive conclusions regarding associations between substance use and PrEP adherence.

Background National guidelines for the provision of HIV pre-exposure prophylaxis (PrEP) to reduce a person's risk of acquiring HIV were made available in 2014. We created a pharmacist-managed HIV PrEP clinic in a community pharmacy setting at Kelley-Ross Pharmacy in Seattle, WA, USA. The clinic operates under a collaborative drug therapy agreement based on these guidelines. This allows pharmacists to initiate and manage tenofovir disoproxil fumarate/emtricitabine under the supervision of a physician medical director. Between March 2015 and February 2018, 714 patients were evaluated and 695 (97.3%) initiated PrEP. Five hundred and thirteen (74%) patients began medication the same day as their initial appointment. Of the prescriptions filled in our pharmacy, 90% of patients had a mean proportion of days covered (PDC) greater than 80%, and 98% had a zero-dollar patient responsibility per month, including uninsured individuals. 19% of patients were lost to follow up, with an effective drop-out rate of 25%. Two hundred and seven diagnoses of sexually transmissible infections were made. There were no HIV seroconversions in the service. The pharmacist-managed PrEP clinic proved to be a successful alternative model of PrEP care, with high initiation rates and low drop-out and lost-to-follow-up rates. This may benefit individuals who do not access PrEP in traditional health care settings or where PrEP access is scarce. Financial sustainability of the model was dependent on the ability of pharmacists in the clinic to bill insurance plans for their services in accordance with Washington State legislative changes requiring commercial insurances to recognise pharmacists as providers.

Introduction Randomized clinical trials have demonstrated the efficacy of antiretroviral pre‐exposure prophylaxis (PrEP) in preventing HIV acquisition among men who have sex with men (MSM). However, limited research has examined initiation and adherence to PrEP among Black MSM (BMSM) in the United States (US) who are disproportionately represented among newly HIV infected and late to care individuals. This research reports on the HIV Prevention Trials Network 073 (HPTN 073) study aimed to examine PrEP initiation, utilization and adherence among Black MSM utilizing the theoretically principled, culturally informed and client‐centered care coordination (C4) model. Methods The HPTN 073 study enrolled and followed 226 HIV‐uninfected Black MSM in three US cities (Los Angeles, CA; Washington DC; and Chapel Hill, NC) from February 2013 through September 2015. Study participants were offered once daily oral emtricitabine/tenofovir (FTC/TDF) PrEP combined with C4 and followed up for 52 weeks. Participants received HIV testing, risk reduction education and clinical monitoring. Results Of the 226 men enrolled, 178 participants initiated PrEP (79%), and of these 64% demonstrated PrEP utilization at week 26 (mid‐point of the study) based on pharmacokinetic testing. Condomless anal sex with an HIV‐infected or unknown status casual male partner was statistically significantly associated with a greater likelihood of PrEP initiation (adjusted odds ratio (OR) 4.4, 95% confidence interval (CI) 1.7, 11.7). Greater age (≥25 vs. <25, OR 2.95, 95% CI 1.37 –6.37), perception of having enough money (OR 3.6, 95% CI 1.7 to 7.7) and knowledge of male partner taking PrEP before sex (OR 2.22, 95% CI 1.03 to 4.79) were statistically significantly associated with increased likelihood of PrEP adherence at week 26. Annualized HIV incidence was 2.9 (95% CI 1.2 to 7.9) among those who initiated PrEP, compared to 7.7 (95% CI 2.5 to 24.1) among those who did not initiate PrEP (p = 0.18). Conclusions Results suggest a high level of PrEP initiation among at‐risk Black MSM, a group historically characterized as hard to reach. The data support the importance of addressing contextual factors that affect PrEP initiation and adherence, and of additional research on the ultimate benefit of PrEP in HIV prevention among Black MSM.

Hope is a powerful psychological construct which is linked to positive health. Greater hope is associated with improved antiretroviral therapy adherence; however, less is known about the impact of hope on oral pre-exposure prophylaxis (PrEP) outcomes. HIV Prevention Trials Network 082, was an open-label PrEP study among young women (ages 16–25) in South Africa and Zimbabwe. Hope was measured at baseline and follow-up using a subset of the Hope for the Future Scale (score range 6–24) and PrEP willingness was measured using a subscale of the HIV Prevention Readiness Measure (score range 6–30). Intracellular tenofovir-diphosphate (TFV-DP) concentrations were obtained from dried blood spot samples at weeks 13, 26, and 52; high PrEP adherence was defined as TFV-DP concentrations ≥ 700 fmol/punch. Persistence was defined as TFV-DP > 16 fmol/punch at weeks 26 and 52. Linear regression and generalized estimating equations were used to assess the relationship between hope and PrEP willingness, adherence, and persistence. The median age of participants (n = 432) was 21 years (interquartile range [IQR]: 19–22). The mean hope score at baseline was 21.0 (SD = 3.4). Although hope was positively associated with PrEP willingness (β = 0.22, 95% CI 0.15, 0.37), it was not associated with high PrEP adherence (aRR = 1.00, 95% CI 0.96, 1.05), or persistence at follow-up (aRR = 1.02, 95% CI 0.99, 1.05). While cultivating hope may be an important strategy in building willingness to take oral PrEP, it may not be enough to sustain PrEP adherence or persistence.

The population-level reductions in HIV incidence attributed to pre-exposure prophylaxis (PrEP) have not been fully realized among sexual, gender, and racial/ethnic minority youth. P3 (Prepared, Protected, emPowered) is a comprehensive mobile application (app) intervention developed to support PrEP adherence through gamification, medication tracking, and social engagement. A randomized controlled trial was conducted with 246 young men who have sex with men (YMSM) and young transgender women who have sex with men (YTWMSM) currently on or planning to begin PrEP. Participants were randomized in a 1:1:1 ratio to: standard of care (SOC), P3 app (P3), or P3 app plus in-app adherence coaching (P3+). Adherence was measured at 3- and 6- months post enrollment by emtricitabine-triphosphate (FTC-TP) and tenofovir-diphosphate (TFV-DP) levels in dried blood spots consistent with PrEP use > 4 days/week. The primary outcome was the difference in the proportion adherent comparing P3/P3+ to SOC. P3/P3+ was associated with a higher proportion adherent compared to SOC for both outcome measures. At 3 months, the estimated increase in the proportion adherent was 0.13 (95% CI: 0.00, 0.27, p: 0.05) and 0.12 (95% CI: -0.03, 0.26, p: 0.11) for TFV-DP and FTC-TP, respectively. Estimated adherence was higher, but not statistically different, in P3+ compared to P3, for both TFV-DP and FTC-TP. Receipt of P3 (P3 or P3+) is associated with an increase in PrEP adherence among YMSM and YTWSM at 3 months. Additional analyses to discern the role of app usage and sociodemographic and behavioral factors on intervention effects are warranted.

Co-creation has the potential to generate people-centered mobile health (mHealth) interventions to improve PrEP adherence. This study generated people-centered mHealth messages with Chinese gay, bisexual and other men who have sex with men (GBMSM) via a structured co-creation approach, and evaluated the messages quality, and assessed the feasibility of the co-creation approach. A three-step co-creation framework was implemented with 19 GBMSM PrEP users and six HIV researchers between 2021 and 2023. Messages were assessed via 10-point scales, and the degree of usefulness by co-creators and 783 participants from a PrEP demonstration trial. Thematic analysis identified PrEP adherence barriers and participants' reflections from meeting notes and materials, with descriptive statistics summarizing evaluation results. Four levels of PrEP adherence barriers were identified (insufficient education, efficacy concerns, inadequate behavioral skills, PrEP stigma). Based on these barriers, 25 mHealth messages (19 posters, three videos, three text messages) were co-created, covering nine themes (e.g. missed dose coping, side-effect management). Seventeen high-quality messages were selected, with mean scores of 8.25 (relevance), 7.86 (appropriateness) and 7.25 (elaboration). Among GBMSM PrEP users who received the messages, 90.4% (708/783) valued the co-created messages as helpful. Reflections from the co-creators highlighted the value of the participatory process, confirming that co-creation effectively engages GBMSM PrEP users. Co-creation groups are feasible for Chinese GBMSM to identify context-specific PrEP adherence barriers and develop people-centered mHealth messages, supporting the value of co-creation for PrEP adherence intervention development in this population.