Adolescent Pre-exposure Prophylaxis Research Articles

Perceptions and practices of healthcare providers in providing HIV pre-exposure prophylaxis to trans adolescents and young adults and men who have sex with men.

This study aims to understand the perceptions and practices of healthcare providers regarding the offer of HIV pre-exposure prophylaxis (PrEP) to gay and trans adolescents and young adults. This qualitative research was developed as part of the PrEP1519 study, which was conducted from 2018 to 2021 to analyze the effectiveness of PrEP in adolescents and young adults. Data were collected from July 2020 to February 2021 at the municipality of São Paulo by combining participant observations and semi-structured interviews. The analytical process involved immersion in the empirical material and coding and categorizing it with the support of NVivo®. Interpretation followed the hermeneutic-dialectical principle and had the concept of Care in health practices as its horizon. The construction of trust-based relationships followed practices that acknowledge the uniqueness of youth and their demands and sought to strengthen their autonomy. Sensitive and supportive listening was pointed out as a welcoming practice that propelled care actions. Welcoming attitudes and support in facing stigma and violence (related or not to the use of PrEP) acknowledged the need to support adolescents and young adults to develop autonomy for prevention. The use of language close to young people's everyday life favored the construction of relationships of trust and positively influenced the development of autonomy and adherence to PrEP. The tension between technical and practical success occurred in the idealized search for adult-centric normativity as opposed to intersubjectivity. The perceptions and practices of healthcare providers are aligned with the concept of Care as they include actions beyond technical knowledge and recognize the contexts that increase the vulnerability of adolescents and young adults to HIV.

Implementation Facilitators and Barriers for Primary Care Providers Prescribing Daily Oral PrEP to Adolescents in the United States.

Primary care providers (PCPs) are critical in prescribing human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) to adolescents at risk of HIV. More research is needed to identify facilitators and barriers PCPs encounter in prescribing PrEP to eligible adolescents post-Food and Drug Administration (FDA) approval. This online cross-sectional survey examined the PrEP implementation facilitators and barriers among a national sample of PCPs in the United States. PCPs (n = 502) specializing in family medicine or pediatrics were recruited from a Qualtrics panel from July 15 to August 9, 2022. We analyzed the collected data using content analysis and applied the Expert Recommendations for Implementing Change (ERIC) to codebook creation and data analysis. We conducted a Fisher's exact chi-square test of independence to compare facilitator and barrier prevalence differences between participants who had and had not prescribed PrEP to an adolescent patient. Results demonstrate that (1) distributing prescriber-focused educational materials, (2) involving parents, (3) changing liability laws, (4) enhancing adolescent PrEP uptake and adherence, (5) changing clinical resources, and (6) using mass/social media to change community norms might be strategies that influence PCPs prescribing PrEP to eligible adolescent patients. Results from this study could facilitate the planning of hybrid implementation-effectiveness trials designed to determine the acceptability, feasibility, and effectiveness of implementation strategies in improving the practices of PCPs prescribing PrEP to at-risk adolescents.

A qualitative study to explore daily versus on-demand oral pre-exposure prophylaxis (PrEP) in young people from South Africa, Uganda and Zimbabwe.

Adolescents in sub-Saharan Africa (SSA) remain vulnerable to HIV infection. While pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV transmission as a daily or on-demand regimen, tailored approaches are necessary. The Combined HIV Adolescent PrEP and Prevention Study (CHAPS) is a mixed-methods research program investigating the acceptability and feasibility of implementing daily and on-demand PrEP among young people in SSA. It also aims to determine an on-demand dosing schedule for insertive sex. For this paper, we explored preferences for daily versus on-demand PrEP amongst adolescents as part of CHAPS. Purposive sampling was used to recruit participants from Soweto and Cape Town (South Africa), Wakiso district (Uganda) and Chitungwiza (Zimbabwe). At the time of the study in 2018/2019, Uganda had not rolled out PrEP to the general population; in Zimbabwe, PrEP for young people was only available at selected sites with one located within the study recruitment area. In South Africa, PrEP was made available to selected high-risk groups. We conducted 60 in-depth interviews and 24 group discussions amongst young people aged 13-24 without HIV in South Africa, Uganda, and Zimbabwe. All in-depth interviews and group discussions were audio-recorded, transcribed verbatim and translated to English. Data were analysed using framework analysis. The main themes were centered around preferences for daily and on-demand PrEP. Reasons for on-demand preferences included stigma, pill fatigue, adherence and side effects. Reasons for daily PrEP preferences included factors related to sexual risk behaviour, continuous protection against incidents of unintentional exposure, and the increased efficacy of a daily dose. Participants at all sites preferring daily PrEP identified the same reasons, with more males than females citing inadvertent blood contact or perceived increased efficacy. Similarly, participants at all sites preferring on-demand PrEP gave the same reasons for their preferences for on-demand PrEP; the exception was South Africans who did not mention the hope of having fewer side effects by not taking daily PrEP. Additionally, more males than females cited intermittent sex as a reason for opting for on-demand PrEP. Our study is the first known to explore and describe youth preferences for daily versus on-demand PrEP. While the choice is clear-cut, the reasons cited in the different options provide invaluable insights into their decisions, and the actual and perceived facilitators and barriers to access to PrEP. Further education is needed amongst young people, not only about PrEP but also in other areas of comprehensive sexuality education. Exploring all options of HIV prevention is crucial to provide a tailored, one-size-does-not-fit-all approach to adolescent care in SSA to reduce and, the continued and increasing risk of this preventable infection.

Correlations between oral Pre-Exposure Prophylaxis (PrEP) initiations and policies that enable the use of PrEP to address HIV globally.

Policies facilitating access to HIV prevention services, specifically for pre-exposure prophylaxis (PrEP), can foster enabling environments for service uptake. This analysis aims to establish whether policies enabling broad PrEP eligibility, HIV self-testing, and lowered age of consent to HIV testing and treatment services are correlated with PrEP uptake. Ages of consent vary by country, therefore this analysis focused on how age of consent policies, in general, affect adolescent PrEP uptake. Data was collected from the HIV Policy Lab and AVAC's Global PrEP Tracker, a database of approximately 334 PrEP projects operating across 95 countries, and linear regression and correlation analyses were conducted via STATA to examine relationships amongst national oral PrEP eligibility, HIV self-testing, lowered age of consent, and national cumulative oral PrEP initiations, as of December 2021. Of all 194 countries tracked by the HIV Policy Lab, only about 7% have adopted all three policies (HIV self-testing, lowered age of consent, and PrEP eligibility policies). Less than 50% have adopted have adopted at least one of these policies. Of the 54 countries that have fully adopted PrEP eligibility policies, less than 30% have co-adopted HIV self-testing or lowered age of consent policies. About 30% of these 194 countries have yet to adopt any of these policies, of which about 14% have indicated information is "unavailable" for at least one of the policies. Analyses conducted for the 91 countries tracked by both the HIV Policy Lab and the Global PrEP Tracker revealed a significant and positive relationship between cumulative individuals initiated on oral PrEP and adoption of HIV self-testing policies (p = 0.01, r = 0.26), lowered age of consent policies (p = 0.01, r = 0.25), and PrEP eligibility policies (p = 0.01, r = 0.26). Stronger advocacy efforts towards approving public health policies, such as those outlined in our analysis, that enshrine and enable access to HIV prevention are necessary.

Injectable Cabotegravir: A New Approach to HIV Pre-exposure Prophylaxis

Pre-exposure prophylaxis (PrEP) involves use of antiretroviral medications to prevent HIV infection in higher-risk adolescent and adult populations. PrEP regimens conventionally used daily oral emtricitabine/tenofivir fumarate (FTC/TDF) or emtricitabine/tenofivir alafenamide (FTC/TAF). However, on December 20, 2021, the United States Food and Drug Administration approved use of injectable cabotegravir for PrEP in adolescents and adults. This article discusses indications and contraindications of injectable cabotegravir as PrEP, provides an overview of injectable cabotegravir’s safety, efficacy, and regimen, contrasts traditional oral PrEP regimens with the injectable cabotegravir regimen, and examines cost and accessibility.

69. Identifying and Connecting Adolescent Patients to HIV Pre-Exposure Prophylaxis

In the United States, approximately 34,800 people were diagnosed with HIV in 2019 and approximately 22% of those persons aged 13-24. HIV pre-exposure prophylaxis (PrEP), or use of antiretroviral medication for prevention of new HIV infection, has been a highly effective method of new HIV infection used in adults since 2012. In 2018, the FDA approved tenofivir disoproxil fumarate (TDF)/emtricitabine (FTC) for PrEP in adolescents weighing at least 35 kilograms and in 2019 expanded to include tenofivir alafenamide (TAF)/FTC for at-risk patients assigned male at birth.

Provider Comfort with Prescribing HIV Pre-Exposure Prophylaxis to Adolescents.

In the United States, Black and Latinx youth remain disproportionately affected by HIV. Oral antiretroviral pre-exposure prophylaxis (PrEP) is a proven effective HIV prevention strategy. PrEP is approved for use in people younger than the age of 18 years, but little is known about provider comfort and preparedness with prescribing it to adolescents. In this study, physicians provide their perspectives on the facilitators and barriers to PrEP access among adolescents. Focus groups (n = 23) were conducted with pediatric and family practitioners practicing in an urban community hospital setting to assess PrEP awareness and receptivity to use among adolescents. Most providers were unfamiliar with clinical guidelines for PrEP use, especially in determining adolescent candidates for PrEP use, including appropriate dosing regimen and follow-up procedures. Overall, providers had low intent on prescribing PrEP, citing concerns about consent, medication adherence, and appropriateness of primary care providers in prescribing and managing adolescent PrEP use. Strategies that will address provider education and comfort in prescribing PrEP to adolescents are required to increase PrEP access and uptake among communities disproportionally affected by HIV.

A qualitative study to identify critical attributes and attribute-levels for a discrete choice experiment on oral pre-exposure prophylaxis (PrEP) delivery among young people in Cape Town and Johannesburg, South Africa

BackgroundThe uptake and adherence of daily oral PrEP has been poor in high-risk populations in South Africa including young people. We used qualitative research methods to explore user preferences for daily and on-demand oral PrEP use among young South Africans, and to inform the identification of critical attributes and attribute-levels for quantitative analysis of user preferences, i.e. a discrete choice experiment (DCE).MethodsData were collected between September and November 2018 from eight group discussions and 20 in-depth interviews with young people 13 to 24 years in Cape Town and Johannesburg. Using a convenience sampling strategy, participants were stratified by sex and age. Interviewers used a semi-structured interview guide to discuss several attributes (dosing regimen, location, costs, side effects, and protection period) for PrEP access and use. Group discussions and in-depth interviews were audio-recorded, transcribed verbatim and translated to English. We used framework analysis to explore context-specific attributes and attribute-levels for delivering oral PrEP in South Africa. The adolescent community advisory board, expert and study team opinions were consulted for the final DCE attributes and levels.ResultsWe enrolled 74 participants who were 51% (n = 38/74) male, had a median age of 18.5 [Interquartile range = 16–21.25] years, 91% (n = 67/74) identified as heterosexual and 49% (n = 36/74) had not completed 12th grade education. Using the qualitative data, we identified five candidate attributes including (1) dosing regimen, (2) location to get PrEP, (3) cost, (4) route of administration and (5) frequency. After discussions with experts and the study team, we revised the DCE to include the following five attributes and levels: dosing regime: daily, and on-demand PrEP; location: private pharmacy, public clinic, mobile clinic, ATM); cost: free-of-charge, R50 (~2GBP), R265 (~12GBP); side effects: nausea, headache, rash; and duration of protection: fulltime protection versus when PrEP is used).ConclusionsThere is limited literature on qualitative research methods describing the step-by-step process of developing a DCE for PrEP in adolescents, especially in resource-constrained countries. We provide the process followed for the DCE technique to understand user preferences for daily and on-demand oral PrEP among young people in South Africa.

Ethics and pre-exposure prophylaxis (PrEP) in adolescents: an integrative review

Introduction: Worldwide estimates suggest an increase in the number of deaths by AIDS among adolescents. The Pre-Exposure Prophylaxis (PrEP) has been considered a potential intervention of major impact on new HIV infections. However, the discussion on PrEP in the adolescent population needs to expand mainly regarding ethical issues that emerge with its implementation. Objective: The objective of this research was to identify ethical issues related to PrEP in adolescents in the current scientific literature and discuss their impact in the implementation of this preventive strategy. Methods: An integrative review of the literature was performed on Medline, Scopus, and Web of Science databases using descriptors Ethic and PrEP. Results: The search retrieved 284 articles, of which 16 was related to adolescents and were kept in the sample after analysis. The issues detected were classified into two categories: 1) Ethics in research and 2) Ethical problems regarding access to PrEP. Conclusion: It seems that the issues discussed could diminish the potential impact of PrEP on new HIV infections among adolescents. Discussions on the theme must be deepened, as gaps regarding Ethics and HIV prevention in adolescents are evident, especially when it comes to sexual minorities, both in research and assistance.

Combined HIV Adolescent Prevention Study (CHAPS): comparison of HIV pre-exposure prophylaxis regimens for adolescents in sub-Saharan Africa\u2014study protocol for a mixed-methods study including a randomised controlled trial

BackgroundHIV remains a major public health issue, especially in Eastern and Southern Africa. Pre-exposure prophylaxis is highly effective when adhered to, but its effectiveness is limited by cost, user acceptability and uptake. The cost of a non-inferiority phase III trial is likely to be prohibitive, and thus, it is essential to select the best possible drug, dose and schedule in advance. The aim of this study, the Combined HIV Adolescent PrEP and Prevention Study (CHAPS), is to investigate the drug, dose and schedule of pre-exposure prophylaxis (PrEP) required for the protection against HIV and the acceptability of PrEP amongst young people in sub-Saharan Africa, and hence to inform the choice of intervention for future phase III PrEP studies and to improve strategies for PrEP implementation.MethodsWe propose a mixed-methods study amongst young people aged 13–24 years. The first component consists of qualitative research to identify the barriers and motivators towards the uptake of PrEP amongst young people in South Africa, Uganda and Zimbabwe. The second component is a randomised clinical trial (ClinicalTrials.gov NCT03986970, June 2019) using a novel ex vivo HIV challenge method to investigate the optimal PrEP treatment (FTC-TDF vs FTC-TAF), dose and schedule. We will recruit 144 amongst HIV-negative uncircumcised men aged 13–24 years from voluntary male medical circumcision clinics in two sites (South Africa and Uganda) and randomise them into one of nine arms. One group will receive no PrEP prior to surgery; the other arms will receive either FTC-TDF or FTC-TAF, over 1 or 2 days, and with the final dose given either 6 or 20 h prior to surgery. We will conduct an ex vivo HIV challenge on their resected foreskin tissue.DiscussionThis study will provide both qualitative and quantitative results to help decide the optimum drug, dose and schedule for a future phase III trial of PrEP. The study will also provide crucial information on successful strategies for providing PrEP to young people in sub-Saharan Africa.Trial registrationClinicalTrials.gov NCT03986970. Registered on 14 June 2019

Initiation of HIV pre-exposure prophylaxis in adolescents and young adults: Barriers and opportunities

Adolescents and young adults (AYA) ages 13 to 24 years comprise a quarter of the new HIV diagnoses in the United States. Lack of access to HIV-preventive biomedical tools such as pre-exposure prophylaxis (PrEP) reduces opportunities to prevent HIV infection in this population. Initiating PrEP in AYA significantly reduces the negative health outcomes of HIV, but many providers are still reluctant to initiate PrEP in their AYA patients based on perceived threats and barriers. This review aims to highlight the barriers and opportunities for initiating PrEP services in AYA and provides recommendations for PrEP services in this population. Ten scholarly articles rated levels IIA through IIIB were identified using the Johns Hopkins Evidence-Based Practice ratings. These included quasi-experimental and nonexperimental publications. Both quantitative and qualitative data contributed to identifying perceived barriers, opportunities, and recommendations for increased PrEP access and prescription in AYA. Pre-exposure prophylaxis is a vital component of a robust HIV prevention program. Themes that emerged hindering optimal PrEP utilization in AYA included provider-related barriers (e.g., knowledge deficit, lack of familiarity with PrEP guidelines, and protocols), patient-related barriers (e.g., lack of awareness, confidentiality issue, and HIV stigma), and structure-related barriers (e.g., lack of AYA-friendly clinics and insurance coverage). Providers in any setting should be able identify at-risk AYA and prescribe PrEP accordingly. Nurse practitioners should make PrEP accessible to AYA by addressing the barriers to PrEP utilization, prescribing, and continuity of care. Nurse practitioner curriculum, training, and continuing education should include PrEP for AYA.

Interest in HIV pre-exposure prophylaxis (PrEP) among adolescents and their caregivers in Malawi

ABSTRACTOver a third of new HIV infections occur in adolescents aged 10–19 globally. Pre-exposure prophylaxis (PrEP) could be a powerful tool for prevention. Understanding more about the drivers of PrEP interest could inform implementation strategies among this age group. Moreover, family dynamics may play a uniquely critical role for this younger age group, thus it is important to gauge whether caregivers would support their children’s use of PrEP. We surveyed 2,089 adolescents (aged 10–16) and their caregivers in Malawi during 2017–2018. Data were collected on PrEP interest, factors that may facilitate PrEP use, and preferences for PrEP modality. We used multivariate logistic regression to estimate the association between the above characteristics and PrEP interest. We find that young adolescents are engaging in behaviors that would put them at substantial risk of acquiring HIV, would likely benefit from PrEP, are largely (82%) interested in using such, would prefer to get an injection over taking a daily pill, and are considerably discouraged by the prospect of side effects. Endorsement by caregivers was even greater (87%). Our findings demonstrate initial support for adolescent PrEP, and suggest parents may be a surprising advocate.

1277. Retention Among Adolescents with Mental Health Diagnoses on Pre-Exposure Prophylaxis (RAMP) Study

BackgroundThe CDC reported in 2017 that 21% of new HIV diagnoses were composed of persons 13–24 years old. New York State (NYS) is addressing this with the Ending the Epidemic initiative, started in 2014, which emphasized pre-exposure prophylaxis (PrEP) for persons at risk of acquiring HIV. Though PrEP can effectively prevent HIV transmission, NYS minors were only granted capacity to accept PrEP in 2017. The Adolescent Medicine Trials Network found clinicians had varying perceptions on whether mental health diagnoses (MHD) were a barrier to adolescent PrEP utilization. This study aims to test the hypothesis that patients with MHD do not differ in PrEP retention length when compared with adolescents without MHD.MethodsThis is a retrospective single-center study analyzing self-reported visit data for adolescent enrolled on PrEP (n = 27) in the Capital District, NY. MHD were confirmed with clinician notes and retention to PrEP was defined as attending appointments. Between-group differences were compared using Fisher’s Exact Test (FET). Kaplan–Meier curves were compared using the log-rank test.ResultsOf the 27 adolescents enrolled on PrEP between Sep 2015-March 2019, most self-identified as males (93%), MSM (85%), white (74%), and 13 (48%) had a MH diagnosis. Anxiety was the most common MHD (69%), followed by depression (38%). The mean age was 20.3 years (16–24). The average PrEP retention for patients with and without MHD were 262±136 and 292±138 days, respectively (P = 0.575). For patients with MHD, follow-up at 1-month, 3-months and 1-year was 10 (77%), 8 (62%), and 5 (39%), respectively. For patients without MHD, follow-up at 1-month, 3-months, and 1-year was 11 (79%), 10 (71%), 5 (36%), respectively. Follow-up between adolescents with and without MHD was compared at 1-month (P = 0.086, FET), 3-months (P = 0.695, FET), and 1-year (P = 1.0, FET). Adolescents’ retention on PrEP was depicted on Kaplan–Meier curves (Figure 1). Log-rank test indicated that PrEP retention is not significantly associated with MHD (χ2(1) = 0.1, P = 0.727).ConclusionAdolescents with and without MHD did not significantly differ in PrEP retention outcomes. The RAMP study elucidates a potentially incorrect provider bias regarding PrEP retention and MHD. Future investigation should be done prospectively with larger sample size. Disclosures All authors: No reported disclosures.

Acceptability and Barriers to HIV Pre-Exposure Prophylaxis in Atlanta's Adolescents and Their Parents.

Adolescents aged 13-24 years account for 23% of new HIV infections in Atlanta, indicating need for better HIV prevention strategies in this population. Pre-exposure prophylaxis (PrEP) is now approved for adolescent use. This study aims to understand the acceptability of and barriers to PrEP in adolescents and parents. We administered PrEP acceptability and barrier measures to HIV(-) 13-17 year olds and their parents from January to April 2016 in an adolescent clinic and emergency department in Atlanta, GA, stratifying by adolescent sexual activity. Acceptability scores (AS) and barrier scores (BS) were calculated by averaging survey answers 1-3. For AS, 1 was very unlikely to accept PrEP; concomitantly, BS near 3 indicated fewer barriers. Two-sample hypothesis testing, Pearson correlations, and linear regression were used. Of the 102 adolescent/parent dyads, 67% of adolescents were female, 94% black, with a mean age of 15.7 ± 1.5 years, and 31% were sexually active. Parents were 94% female, 96% black, with a mean age of 42.4 ± 8.9 years. AS averaged between somewhat to very likely to accept PrEP (2.4 ± 0.5 and 2.2 ± 0.6) in adolescents and parents, respectively. BS averaged between unlikely and somewhat likely to perceive barriers to PrEP (2.0 ± 0.4 and 1.9 ± 0.5) in adolescents and parents, respectively. The adolescent/parent dyad is likely to accept PrEP, regardless of sexual activity. Limitations include that nearly 70% of adolescents were not sexually active, and the study was conducted before PrEP approval by the Food and Drug Administration for those who are younger than 18 years. These results support future parent and adolescent education on PrEP.

Getting youth PrEPared: adolescent consent laws and implications for the availability of PrEP among youth in countries outside of the United States.

IntroductionYouth under the age of 25 are at high risk for HIV infection. While pre‐exposure prophylaxis (PrEP) has the potential to curb new infections within this population, it is unclear how country‐specific laws and policies that govern youth access to sexual and reproductive health (SRH) services impact access to PrEP. The purpose of this review was to analyse laws and policies concerning PrEP implementation and SRH services available to youth in countries with a high HIV incidence. To the best of our knowledge this is the first systematic assessment of country‐level policies that impact the availability of PrEP to adolescent populations.MethodsWe conducted a review of national policies published on or before 12 June 2018 that could impact adolescents’ access to PrEP, SRH services and ability to consent to medical intervention. Countries were included if: (1) there was a high incidence of HIV; (2) they had active PrEP trials or PrEP was available for distribution; (3) information regarding PrEP guidelines were publicly available. We also included a selected number of countries with lower adolescent HIV incidence. Internet and legal database searches were used to identify policies relevant to adolescent PrEP (e.g. age of consent to HIV testing).Results and DiscussionFifteen countries were selected for inclusion in this review. Countries varied considerably in their respective laws and policies governing adolescents’ access to PrEP, HIV testing and SRH services. Six countries had specific polices around the provision of PrEP to youth under the age of 18. Five countries required people to be 18 years or older to access HIV testing, and six countries had specific laws addressing adolescent consent for‐ and access to‐ contraceptives.ConclusionsAdolescents’ access to PrEP without parental consent remains limited or uncertain in many countries where this biomedical intervention is needed. Observational and qualitative studies are needed to determine if and how adolescent consent laws are followed in relation to adolescent PrEP provisions. Intensified efforts to amend laws that limit adolescent access to PrEP and restrict the establishment of national guidelines supporting adolescent PrEP are also needed to address the epidemic in this group.

Assessing risk for HIV infection among adolescent girls in South Africa: an evaluation of the VOICE risk score (HPTN 068).

IntroductionTo maximize impact and minimize costs, antiretroviral pre‐exposure prophylaxis (PrEP) interventions should be offered to those at highest risk for HIV infection. The risk score derived from the VOICE trial is one tool currently being utilized to determine eligibility in adolescent PrEP trials in sub‐Saharan Africa. This study is aimed at evaluating the utility of the risk score in predicting HIV incidence among a cohort of adolescent girls in rural South Africa.MethodsWe utilized data from HIV Prevention Trials Network (HPTN) 068, a phase III randomized controlled trial conducted in rural Mpumalanga province, South Africa. School‐attending young women aged 13 to 20 years were enrolled into the trial from 2011 to 2012 and followed for up to three years. A risk score based on individual‐level risk factors measured at enrolment was calculated for HPTN 068 participants who completed a one‐year follow‐up visit and were HIV seronegative at enrolment. Possible scores ranged from 0 to 10. A proportional hazards model was then used to determine if risk score at enrolment was predictive of incident HIV infection at follow‐up and an area under the curve analysis was used to examine the predictive ability of the score.Results and DiscussionThe risk score had limited variability in the HPTN 068 sample. Scores ≥5 identified 85% of incident infections from 94% of the sample, compared to the VOICE sample in which scores ≥5 identified 91% of incident infections from only 64% of participants. The risk score did not predict HIV incidence after one year of follow‐up (hazard ratio = 1.029; 95% confidence interval (CI): 0.704, 1.503, p = .884) and showed poor predictive ability (area under the curve = 0.55; 95% CI: 0.44, 0.65). Certain individual risk factors that comprise the risk score may be context specific or not relevant for adolescent populations. Additional factors should be considered when assessing risk for the purposes of determining PrEP eligibility.ConclusionsThe VOICE risk score demonstrated low utility to predict HIV incidence in the HPTN 068 sample. Findings highlight the need for an age and developmentally appropriate tool for assessing risk for HIV infection among adolescents. Use of the VOICE risk score for determining PrEP eligibility in younger populations should be carefully considered.

Adolescent Preexposure Prophylaxis Administration: An Education Curriculum for Health Care Providers

On May 15, 2018, the Federal Drug Administration amended the approval of preexposure prophylaxis (PrEP) to include minors (>35 kgs). Adolescent providers are now in need of access to a comprehensive education curriculum on the administration of PrEP to adolescents. This paper outlines such a curriculum with the goal of reaching adolescent providers unfamiliar with PrEP assessment, administration, and monitoring. A comprehensive adolescent PrEP curriculum was designed using a literature review. An expert panel of seven reviewed the curriculum for content validity. A pilot implementation of the curriculum was conducted with staff from eight school-based health clinics located in Upper Manhattan and the Bronx. A formal content-validated curriculum was established providing adolescent health care providers with the tools needed to administer PrEP in their clinical setting. Clinical providers can access our curriculum to aid in their administration of PrEP to an adolescent population.

Primary Care Physician Attitudes and Intentions Toward the Use of HIV Pre-exposure Prophylaxis in Adolescents in One Metropolitan Region

PurposeUnderstanding the attitudes of physicians toward the use of pre-exposure prophylaxis (PrEP) for HIV prevention among youth is critical to improving access to PrEP. We examined PrEP-related attitudes among physicians who provide primary care to 13- to 21-year-old adolescents. MethodsIndividual, in-depth, semistructured interviews were conducted with 38 physicians from adolescent medicine, family practice, internal medicine/medicine-pediatrics, obstetrics/gynecology, and pediatrics who care for any adolescents younger than 18 years. Interviews assessed familiarity with PrEP, perceived benefits and barriers to providing PrEP to adolescents, facilitating factors for prescribing PrEP, and likelihood of recommending and prescribing PrEP to adolescents. ResultsMean age was 44.6 years (standard deviation 10.9). Fourteen physicians (37%) reported being somewhat or very familiar with PrEP. Perceived benefits of prescribing PrEP included decreased acquisition/rates of HIV, improved provision of sexual health services, and improved patient awareness of HIV risk. Barriers to PrEP were reported at the patient (e.g., lack of acceptability to patients), provider (e.g., concerns about patient adherence, safety/side effects, parents as a barrier to PrEP use), and system (e.g., high cost) levels. Facilitating factors for prescribing PrEP included low cost/coverage by insurance, physician education about PrEP, patient educational materials, and clinical guidelines for PrEP use in youth. A higher proportion of physicians reported being highly or somewhat likely to recommend (N = 16, 42%) than prescribe PrEP (N = 13, 34%). ConclusionsIn this study of primary care physician attitudes toward PrEP prescribing for adolescents, physicians identified numerous barriers to providing PrEP. Addressing these barriers may increase adolescents' access to PrEP.

"Where Did This [PrEP] Come From?" African American Mother/Daughter Perceptions Related to Adolescent Preexposure Prophylaxis (PrEP) Utilization and Clinical Trial Participation.

Despite the demonstrated effectiveness of preexposure prophylaxis (PrEP) to reduce incident HIV infections, PrEP's potential as an HIV prevention strategy for adolescent populations is unknown. This study assessed perceptions of adolescent PrEP use and clinical trial participation among African American women and their adolescent daughters. We conducted focus group discussions with 15 African American mother/daughter pairs ( N = 30). Findings suggest a general lack of PrEP awareness, favorable attitudes toward adolescent PrEP use, altruistic attitudes regarding research participation among daughters, and less favorable attitudes toward adolescent clinical trial participation among mothers. Study findings have the potential to inform strategies that provide equitable access to HIV scientific advances among African American women and girls and promote informed parent-child research decision making.

Parents' Perspectives About Adolescent Boys' Involvement in Biomedical HIV Prevention Research.

Research on the use of pre-exposure prophylaxis (PrEP) among adolescents at high risk for HIV is urgently needed, and parents' perspectives on these studies are essential for guiding the responsible conduct of adolescent PrEP research. We conducted interviews with 30 parents of adolescent boys (50% known/presumed heterosexual; 50% sexual minority) to understand their views of research risks and benefits and parental permission regarding their son's involvement in a hypothetical PrEP adherence trial. Parents identified several health and educational benefits of the study and expressed that waiving parental permission would overcome barriers to accessing PrEP, particularly for youth who may benefit most. Among their concerns were medication non-adherence and risk compensation. Parents provided suggestions to facilitate informed, rational, and voluntary participation decisions and protect youth's safety if parental permission was waived. These findings can inform ways to increase parental trust in PrEP research and create adequate protections for adolescent participants.