# data[].attributes.body
While PrEP is effective it will be more effective with a condom to prevent the spread of HIV.

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There is a common misconception that PrEP is MSM but that not true anyone could be at risk at getting HIV, that includes women.

# data[].attributes.body
On the December 20,2021 the FDA approved the first injectable PrEP, the first two are given a month apart and then the injection must be received every two months after that.

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FDA News Release

Drug Given Every Two Months Rather Than Daily Pill is Important Tool in Effort to End the HIV Epidemic
"Today's approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill," said Debra Birnkrant, M.D., director of the Division of Antivirals in the FDA's Center for Drug Evaluation and Research. "This injection, given every two months, will be critical to addressing the HIV epidemic in the U.S., including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option."
Today, the U.S. Food and Drug Administration approved Apretude (cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents weighing at least 35 kilograms (77 pounds) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV. Apretude is given first as two initiation injections administered one month apart, and then every two months thereafter. Patients can either start their treatment with Apretude or take oral cabotegravir (Vocabria) for four weeks to assess how well they tolerate the drug.

According to the U.S. Centers for Disease Control and Prevention, notable gains have been made in increasing PrEP use for HIV prevention in the U.S. and preliminary data show that in 2020, about 25% of the 1.2 million people for whom PrEP is recommended were prescribed it, compared to only about 3% in 2015. However, there remains significant room for improvement. PrEP requires high levels of adherence to be effective and certain high-risk individuals and groups, such as young men who have sex with men, are less likely to adhere to daily medication. Other interpersonal factors, such as substance use disorders, depression, poverty and efforts to conceal medication also can impact adherence. It is hoped that the availability of a long-acting injectable PrEP option will increase PrEP uptake and adherence in these groups.

The safety and efficacy of Apretude to reduce the risk of acquiring HIV were evaluated in two randomized, double-blind trials that compared Apretude to Truvada, a once daily oral medication for HIV PrEP. Trial 1 included HIV-uninfected men and transgender women who have sex with men and have high-risk behavior for HIV infection. Trial 2 included uninfected cisgender women at risk of acquiring HIV.

Participants who took Apretude started the trial with cabotegravir (oral, 30 mg tablet) and a placebo daily for up to five weeks, followed by Apretude 600mg injection at months one and two, then every two months thereafter and a daily placebo tablet.

Participants who took Truvada started the trial taking oral Truvada and placebo daily for up to five weeks, followed by oral Truvada daily and placebo intramuscular injection at months one and two and every two months thereafter.

In Trial 1, 4,566 cisgender men and transgender women who have sex with men received either Apretude or Truvada. The trial measured the rate of HIV infections among trial participants taking daily cabotegravir followed by Apretude injections every two months compared to daily oral Truvada. The trial showed participants who took Apretude had 69% less risk of getting infected with HIV when compared to participants who took Truvada.

In Trial 2, 3,224 cisgender women received either Apretude or Truvada. The trial measured the rate of HIV infections in participants who took oral cabotegravir and injections of Apretude compared to those who took Truvada orally. The trial showed participants who took Apretude had 90% less risk of getting infected with HIV when compared to participants who took Truvada.

Side effects occurring more frequently in participants who received Apretude compared to participants who received Truvada in either trial include injection site reactions, headache, pyrexia (fever), fatigue, back pain, myalgia and rash.

Apretude includes a boxed warning to not use the drug unless a negative HIV test is confirmed. It must only be prescribed to individuals confirmed to be HIV-negative immediately prior to starting the drug and before each injection to reduce the risk of developing drug resistance. Drug-resistant HIV variants have been identified in people with undiagnosed HIV when they use Apretude for HIV PrEeP. Individuals who become infected with HIV while receiving Apretude for PrEP must transition to a complete HIV treatment regimen. The drug labeling also includes warnings and precautions regarding hypersensitivity reactions, hepatotoxicity (liver damage) and depressive disorders.

Apretude was granted a Priority Review and Breakthrough Therapy designation. The FDA granted the approval of Apretude to Viiv.

Related Information

###

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FDA Approves First Injectable Treatment for HIV Pre-Exposure Prevention

# data[].attributes.attachment_link.description
FDA News Release "Today's approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill," said Debra Birnkrant, M.D., director of the Division of Antivirals in the FDA's Center for Drug Evaluation and Research.

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How Cisgender black women make up 60% of HIV cases 

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How Cisgender black women make up 60% of HIV cases 

# data[].attributes.body
2/3 cases in women are black women, taking PrEP that can reduce those cases. Because of the lack of marketing of PrEP to certain demographics, this causes more cases in specific monority groups.

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Prep can be taken daily or taken on demand, just a few hours before having sex, one tablet 24 hours after sex, and 48 hours after sex. STD/STI screening are still recommended as well as kidney function screenings every few months.

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PrEP should be used by anyone at risk of getting HIV regardless of sexual orientation, gender, or relationship statues.

# data[].attributes.wish_content.attachment_props.text
This is your reminder that #PrEP is #primarycare 

It is a USPSTF A Recommendation 

The CDC now recommends discussing PrEP with ALL sexually active adults

#HIV does not care about sexual orientation,  gender identity, or marital status

This is a #HealthJustice issue

# data[].attributes.wish_content.attachment_props.original_text
This is your reminder that #PrEP is #primarycare 

It is a USPSTF A Recommendation 

The CDC now recommends discussing PrEP with ALL sexually active adults

#HIV does not care about sexual orientation,  gender identity, or marital status

This is a #HealthJustice issue

# data[].attributes.attachment_link.embed_code
This is your reminder that #PrEP is #primarycare

It is a USPSTF A Recommendation

The CDC now recommends discussing PrEP with ALL sexually active adults#HIV does not care about sexual orientation, gender identity, or marital status

This is a #HealthJustice issue
— Margaret Russell, MD, MA, AAHIVS (@Margaret1473) September 9, 2022

# data[].attributes.attachment_link.metadata.attachment_props_source.data.text
This is your reminder that #PrEP is #primarycare 

It is a USPSTF A Recommendation 

The CDC now recommends discussing PrEP with ALL sexually active adults

#HIV does not care about sexual orientation,  gender identity, or marital status

This is a #HealthJustice issue

# data[].attributes.attachment_link.metadata.attachment_props.original_text
This is your reminder that #PrEP is #primarycare 

It is a USPSTF A Recommendation 

The CDC now recommends discussing PrEP with ALL sexually active adults

#HIV does not care about sexual orientation,  gender identity, or marital status

This is a #HealthJustice issue

# data[].attributes.attachment_link.metadata.attachment_props.text
This is your reminder that #PrEP is #primarycare 

It is a USPSTF A Recommendation 

The CDC now recommends discussing PrEP with ALL sexually active adults

#HIV does not care about sexual orientation,  gender identity, or marital status

This is a #HealthJustice issue

# data[].attributes.body
PrEP is for people who are a HIV negative but at risk of getting HIV. This includes people who do not usually wear a condom , have more than one sex partner, have a HIV positive partner, or use intravenous drugs.

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This article is a clinical consideration to expand PrEP labeling to adolescence. Adolescence from the age 16-17 are at the risk of getting HIV, expanding the labeling could help reduce the spread of HIV in communities at risk.

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Centers for Disease Control and Prevention

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Summary

Preexposure prophylaxis (PrEP) with antiretroviral medication has been proven effective in reducing the risk for acquiring human immunodeficiency virus (HIV). The fixed-dose combination tablet of tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) was approved by the U.S. Food and Drug Administration (FDA) for use as PrEP for adults in 2012. Since then, recognition has been increasing that adolescents at risk for acquiring HIV can benefit from PrEP. In 2018, FDA approved revised labeling for TDF/FTC that expanded the indication for PrEP to include adolescents weighing at least 77 lb (35 kg) who are at risk for acquiring HIV. In 2019, FDA approved the combination product tenofovir alafenamide (TAF)/FTC as PrEP for adolescents and adults weighing at least 77 lb (35 kg), excluding those at risk for acquiring HIV through receptive vaginal sex. This exclusion is due to the lack of clinical data regarding the efficacy of TAF/FTC in cisgender women.

Clinical providers who evaluate adolescents for PrEP use must consider certain topics that are unique to the adolescent population. Important considerations related to adolescents include PrEP safety data, legal issues about consent for clinical care and confidentiality, the therapeutic partnership with adolescents and their parents or guardians, the approach to the adolescent patient's clinical visit, and medication initiation, adherence, and persistence during adolescence. Overall, data support the safety of PrEP for adolescents. PrEP providers should be familiar with the statutes and regulations about the provision of health care to minors in their states. Providers should partner with the adolescent patient for PrEP decisions, recognizing the adolescent's autonomy to the extent allowable by law and including parents in the conversation about PrEP when it is safe and reasonable to do so. A comprehensive approach to adolescent health is recommended, including considering PrEP as one possible component of providing medical care to adolescents who inject drugs or engage in sexual behaviors that place them at risk for acquiring HIV. PrEP adherence declined over time in the studies evaluating PrEP among adolescents, a trend that also has been observed among adult patients. Clinicians should implement strategies to address medication adherence as a routine part of prescribing PrEP; more frequent clinical follow-up is one possible approach.

PrEP is an effective HIV prevention tool for protecting adolescents at risk for HIV acquisition. For providers, unique considerations that are part of providing PrEP to adolescents include the possible need for more frequent, supportive interactions to promote medication adherence. Recommendations for PrEP medical management and additional resources for providers are available in the U.S. Public Health Service clinical practice guideline Preexposure Prophylaxis for the Prevention of HIV Infection in the United States - 2017 Update and the clinical providers' supplement Preexposure Prophylaxis for the Prevention of HIV Infection in the United States - 2017 Update: Clinical Providers' Supplement ( https://www.cdc.gov/hiv/clinicians/prevention/prep.html).

Introduction

Clinicians caring for adolescents should be aware of special considerations relevant to providing PrEP for this population. Current evidence indicates that many adolescents are not aware of PrEP, and many do not know how they could access PrEP if needed ( 19). In addition, certain providers who feel that they lack knowledge about providing PrEP to young persons might be unwilling to provide PrEP to adolescents and young adults ( 20).

Adolescence is a unique developmental stage, which is particularly germane to medication adherence. Overall, existing data for adults indicate that PrEP efficacy is a function of adherence ( 21). Compared with adults, adolescents are at increased risk for poor adherence to medications ( 8). Some factors that place adolescents at risk for poor medication adherence include biologic and behavioral co-occurring transitions (e.g., increasing autonomy, increasing importance of peers, and corresponding vulnerability to peer influence and stigma) and emerging but undeveloped cognitive capacity for organization and long-term planning ( 22, 23). Clinical providers evaluating adolescents for PrEP use must be aware of the developmental changes occurring during adolescence and the additional considerations associated with providing PrEP in this context ( 24). Despite these challenges, clinical trials and real-world medical experience have determined that adolescents can successfully take PrEP ( 25- 27). A recent study of MSM and transgender women aged 16-29 years found that at least three fourths of current PrEP users reported being ≥90% adherent to PrEP ( 28). Clinicians should be prepared to address and support medication adherence as a routine part of prescribing PrEP.

This report provides an overview of key topics about providing PrEP to adolescents on the basis of expert opinion and published literature. The topics covered in this review include PrEP safety data related to adolescents, legal issues about consent for clinical care and confidentiality, the therapeutic partnership with adolescents and their parents or guardians, approach to the adolescent patient's clinical visit, and medication initiation, adherence, and persistence ( Box 1). This report is intended for use by clinical providers who treat adolescent patients and for other health professionals and public health officials who provide referrals and supportive services related to adolescent health. The U.S. Public Health Service clinical practice guideline Preexposure Prophylaxis for the Prevention of HIV Infection in the United States - 2017 and clinical providers' supplement Preexposure Prophylaxis for the Prevention of HIV Infection in the United States - 2017 Update: Clinical Providers' Supplement ( https://www.cdc.gov/hiv/clinicians/prevention/prep.html) include recommendations for providing PrEP to adolescents ( 1).

Methods

This report was developed through collaboration between CDC subject matter experts and experts from other federal agencies. Input into this report came from subject matter expert recommendations, peer-reviewed literature, published guidelines, and a legal research database. The authors reviewed relevant peer-reviewed literature by conducting iterative searches in PubMed, beginning with broad search terms and then focusing on specific topics as guided by review of pertinent publications. English-language articles were reviewed without regard to date of publication if they addressed relevant topics and were focused on care of adolescents in the United States.

Published guidelines from other expert groups related to the medical care of adolescents, including the American Academy of Pediatrics, the Society for Adolescent Health and Medicine, and the U.S. Preventive Services Task Force, were reviewed. PubMed and ClinicalTrials.gov were used to identify sources relevant to adherence among participants in randomized PrEP trials, including interventions enrolling adolescent participants, and strategies to monitor and support adherence among adolescents. A review of legal issues related to provision of PrEP to adolescents was conducted during August-December 2017.

An online legal research service (Westlaw next) was searched using broad terms ("consent" and "minors") to find any statute or regulation in all 50 states and the District of Colombia that addressed minors' consent to health care services and diagnosis, treatment, or prevention of HIV, sexually transmitted infections (STIs), or both. A panel of assessors was created, consisting of an attorney and manuscript co-author and two epidemiologists. Each law was assessed using a questionnaire that addressed topics such as the age of majority, types of family planning services a minor may receive, and exceptions to the age of majority to consent to health care services (Supplementary Material, https://stacks.cdc.gov/view/cdc/86247). Results were then summarized to describe legal issues related to PrEP services for adolescents in each state and the District of Columbia.

Prescribing Considerations for HIV PrEP Among Adolescents

PrEP Safety Data

Limited safety data from trials of TDF/FTC among HIV-uninfected adolescents further assist in the risk-benefit assessment of PrEP among adolescents. Two open-label trials of TDF/FTC for PrEP among adolescents have been conducted: 1) the Adolescent Trials Network 113 (ATN 113) study among persons aged 15-17 years in the United States ( 26) and 2) the Choices for Adolescent Methods of Prevention in South Africa (CHAMPS) PlusPills study among persons aged 15-19 years in South Africa ( 25). Both studies found that TDF/FTC for PrEP was safe and well tolerated among different adolescent populations at risk for HIV acquisition ( 25, 26).

Published data from ATN 113 indicate that no confirmed laboratory abnormalities were considered to be related to TDF/FTC ( 26). One participant permanently discontinued the study drug because of grade 3 weight loss, which was assessed and determined to be possibly related to TDF/FTC; unintentional weight loss was the only grade 3 or 4 adverse event reported in more than one participant. No renal adverse events, elevations in serum creatinine levels, or bone fractures were reported in this study. Dual-energy x-ray absorptiometry (DXA) tests, used to assess BMD, indicated substantial increases from baseline BMD in the spine, hip, and total body at 48 weeks, as would be expected in growing adolescents. Although BMD Z-scores in the hip and spine did not change from baseline to 48 weeks, the total body Z-score decreased (-0.20; interquartile range: -0.3 to 0.0; p<0.001). Interpretation of these safety results might be affected by the overall low adherence to the study drug observed in ATN 113, particularly after week 12.

In addition to data from the open-label trials of TDF/FTC among uninfected adolescents, clinical experience with use of this medication for treatment of children and adolescents with HIV is substantial. The extrapolation of safety data from trials of TDF and FTC in adolescents with HIV is permissible because acquiring HIV does not affect the pharmacokinetics of TDF or FTC and the dosage for adolescents weighing at least 77 lb (35 kg) is the same whether used for treatment or prevention (i.e., 200 mg/300 mg once daily) ( 29). In treatment trials, TDF and FTC were well tolerated in adolescents with HIV ( 39, 40). Adverse events of skin hyperpigmentation and anemia, which are described as common adverse drug reactions for pediatric patients in FTC and TDF/FTC labeling ( 41), were not reported among adolescents. The incidence of discontinuation due to adverse events was consistently low across all TDF and FTC trials with no specific treatment-limiting adverse effects or laboratory abnormalities identified. The renal and bone safety profiles among adolescents with HIV receiving TDF through 48 weeks were consistent with those among adults with and without HIV. No adverse events of Fanconi syndrome or tubulopathy were reported. All reported fractures were trauma related. Increases from baseline in spine and total body BMD were seen at weeks 24 and 48, although the mean rate of BMD gain at week 48 was less with TDF compared with placebo. Skeletal growth (i.e., height) appeared unaffected.

Clinical trials to evaluate TAF/FTC safety, efficacy, and adherence in adolescents have not been performed. Efficacy and safety data to support the FDA approval of TAF/FTC for PrEP were extrapolated from the DISCOVER trial in adult MSM and transgender women and from trials of TAF/FTC in adolescents with HIV ( 42).

Overall, the available data support the safety of PrEP in adolescents. As outlined in the U.S. Public Health Service clinical practice guideline, ongoing clinical and laboratory-based monitoring (e.g., HIV testing, creatinine monitoring, and STI screening) is recommended for persons prescribed PrEP ( 1). Additional research is needed to assess potential clinical impacts of TDF-related effects on bone density in adolescents. Evidence is insufficient to inform specific recommendations about vitamin D levels or vitamin D supplementation for all adolescents starting PrEP. The U.S. Public Health Service 2017 guidelines do not recommend routine use of DXA tests for persons taking PrEP; however, persons with a history of pathologic fracture or other bone health risk factors should be referred for consultation and management ( 1).

Familiarity with the available safety data allows for effective counseling to adolescents and, when appropriate, their parents or guardians. This knowledge will allow PrEP providers to effectively weigh benefits and risks, address safety-related questions, and explain the importance of the recommended evaluations for monitoring PrEP patients.

Legal Issues

Legal issues about consent for clinical care, status as a legal minor, and confidentiality are important considerations for providing PrEP to adolescents. The legal framework varies considerably by state. In 2017, potentially applicable laws were reviewed to clarify issues of consent for clinical care and confidentiality about providing PrEP for adolescents ( 43). Minors' legal ability to autonomously access PrEP was assessed on the basis of two elements in a state's laws: 1) whether the state either explicitly included HIV infection in the law or designated HIV infection as an STI through another law and 2) whether the state explicitly included prevention in the law allowing minors to autonomously consent to care for STIs ( 43). Minors can still be legally allowed to autonomously consent to PrEP in certain states with laws lacking the two elements because other mechanisms, such as case law, might be used to categorize HIV infection as an STI, define treatment broadly to include prevention, or both.

The review determined that no states explicitly prohibit minors' autonomous consent to PrEP ( 43). All states have statutes, regulations, or both that explicitly allow certain minors to consent to STI diagnosis and treatment ( 43). Seven states explicitly include HIV infection in the law allowing minors to autonomously consent to the service, or designate HIV infection as an STI through another law, and explicitly include prevention in the law allowing minors to autonomously consent to the services ( 43) ( Table 1). Nine states broadly allow minors to autonomously consent to any health care services or procedures, arguably including PrEP; some states define minimum ages for minors consenting to health care services ( 43) ( Table 2).

Allowing minors to autonomously consent to PrEP does not mean that access to the health care service will remain confidential. Providers are permitted to disclose a minor's autonomous access to HIV and STI services to the minor's parents or guardians in 23 states ( 43). In addition, billing documentation from commercial health insurance companies in an explanation of benefits provides a potential mechanism of disclosure of services provided to adolescents covered under their parents' or guardians' health insurance ( 44).

Even in states that allow minors to consent to certain aspects of their medical care, in certain circumstances a provider might need to breach an adolescent's confidentiality. In several states, mandatory reporting laws require providers to report child abuse and neglect, including sexual abuse and sex trafficking ( 48).

PrEP providers have to be familiar with the statutes and regulations regarding the provision of health care to minors in their jurisdictions. State and local health departments might be able to serve as resources for questions about these topics.

Therapeutic Partnership

Approach to the Clinical Visit for Prevention Services

A clinical approach tailored for the adolescent patient can enhance patient-provider communication about PrEP or other health-related topics. Obtaining a comprehensive history, including social and sexual history, is important to identifying adolescents' health needs and providing individualized recommendations and counseling ( 61).

Providers can set the tone for the visit by introducing themselves to adolescents before the parents or guardians ( 62). If a parent or guardian is present, the adolescent patient should have the opportunity to have time alone with the provider. A helpful approach is to conduct the interview while the patient is still clothed and seated somewhere other than the examination table. The provider should inform the adolescent of the confidentiality of the provider-patient conversation, including the circumstances that might require confidentiality to be breached.

During the confidential interview with the adolescent patient, the provider might consider beginning with less sensitive topics. One well-described approach is the HEEADSSS (or HE ²ADS ³) format: asking the adolescent about home, education or employment, eating, activities (peer related), drugs, sexuality, suicide or depression, and safety ( 62, 63). One approach to taking the adolescent's sexual history is the five Ps method: asking the adolescent about partners, practices, protection from STIs, past history of STIs, and prevention of pregnancy ( 64). An important aspect of the sexual history includes screening for transactional sex to evaluate whether adolescents are engaging in sex in exchange for money, shelter, food, drugs, hormones (for transgender adolescents), or other resources. In all instances, the provider can use open-ended questions to facilitate effective communication. During certain parts of the history, including questions about substance abuse, the provider could begin the conversation by asking about activities of the adolescent's friends ( 62). Active listening techniques (e.g., reflection, restatement, clarifying, and supportive statements) might encourage open discussion ( 44). Respectful, nonjudgmental language should be used, including avoiding assumptions about sexual orientation, gender identity, or the sex of the patient's sex partners. Affirming the patient's gender identity by using the preferred name and gender terms is also important. Training and resources are available to help providers gain skills in effective communication and provision of culturally competent care ( 65, 66).

Certain youths might have serious challenges such as mental illness, substance use, juvenile justice system involvement, unstable housing, food insecurity, transactional sex, or other concerns. PrEP is only one of a number of interventions that might be indicated for an adolescent's needs. Reports of abuse, neglect, or sex trafficking must be reported to the relevant authorities. Adolescents with evidence of mental health concerns might require referral to mental health resources. Adolescents who are using drugs illicitly need to receive clinical counseling and referral for services as indicated. Those who disclose homelessness or other needs can benefit from referral to social services or links to community-based resources.

Medication Initiation, Adherence, and Persistence

Because of the dynamic physical, cognitive, psychological, and social shifts occurring during adolescence, PrEP use patterns among U.S. adolescents and young adults enrolled in the ATN PrEP studies demonstrated challenges with achieving the high levels of adherence needed for efficacy ( 76, 77). In these studies, quarterly clinic visits were associated with poorer medication adherence among both younger ( 26) and older youths than the initial monthly visits ( 35).

Despite the evidence demonstrating that adolescents commonly experience difficulties with adherence, efficacious adherence support interventions for clinical practice are limited. Youths with diagnosed HIV have benefited from youth-friendly mobile technologies, including cell phone support ( 78) and short message service (SMS) reminders ( 79). The interventions that have been developed specifically for PrEP include combinations of enhanced counseling, feedback of objective adherence measures, and SMS ( 80). The adherence challenges noted in the ATN PrEP studies occurred although youths received integrated next step counseling (iNSC), which is an interactive, client-centered motivational approach used to support adherence among participants in the Preexposure Prophylaxis Initiative (iPrEx) trial ( 81). This finding suggests that further interventions are needed to help adolescents adhere to PrEP. Real-time adherence feedback via dried blood spot tenofovir concentration measurements is the focus of several clinical trials under way to determine its utility in tailoring support to improve adherence outcomes ( 82, 83). Urine tenofovir concentration as a possible point-of-care assay is also under study ( 84, 85) ( Box 2).

Conclusion

PrEP is a safe and effective intervention to reduce the risk for HIV acquisition. Adolescents should be screened for behaviors that put them at risk for acquiring HIV. In adolescents for whom PrEP is indicated, PrEP can be offered as part of a comprehensive approach tailored to their specific needs. In addition to the recommendations provided in the U.S. Public Health Service clinical practice guideline ( 1), providers prescribing PrEP for adolescents also should consider the relevant legal framework in their states; the importance of optimizing a therapeutic partnership with adolescents, and when possible, their parents or guardians; techniques to optimize adolescents' clinical visits; and the importance of managing medication adherence. The data available from PrEP trials in adolescents suggest that adolescents might benefit from more frequent contact with clinical staff to support medication adherence. Resources are available to assist clinical providers with navigating issues related to prescribing PrEP. The Clinician Consultation Center offers a PrEP clinical consultation line for health care providers (855-448-7737) ( 95). The U.S. Public Health Service PrEP clinical practice guideline and clinician's supplement ( https://www.cdc.gov/hiv/clinicians/prevention/prep.html) provide guidance and references to other resources.

Corresponding author: Mary Tanner, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, CDC. Telephone: 404-639-6376; E-mail: klt6@cdc.gov.

¹Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, CDC; ²Division of Antiviral Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Washington, DC; ³Division of Adolescent and School Health, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, CDC; ⁴ Maternal and Pediatric Infectious Disease Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland

References

1. CDC. Preexposure prophylaxis for the prevention of HIV infection in the United States-2017 update: a clinical practice guideline. Atlanta, GA: US Department of Health and Human Services, CDC; 2018. https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdfpdf icon

2. Descovy (emtricitabine and tenofovir alafenamide) [Package insert]. Foster City, CA: Gilead Sciences Inc.; 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208215s011lbl.pdfpdf icon external icon

3. CDC. HIV surveillance report, 2018 (preliminary); vol. 30. Atlanta, GA: US Department of Health and Human Services, CDC; 2019. https://www.cdc.gov/hiv/library/reports/hiv-surveillance.html

4. Gill K, Dietrich J, Gray G, et al. PlusPills: an open label, safety and feasibility study of oral pre-exposure prophylaxis (PrEP) in 15-19 year old adolescents in two sites in South Africa [Abstract]. Presented at the 9th IAS Conference on HIV Science, Paris, France; July 23-26, 2017.

5. Emtriva (emtricitabine) [Package insert]. Foster City, CA: Gilead Sciences Inc.; 2017. https://www.gilead.com/~/media/Files/pdfs/medicines/hiv/emtriva/emtriva_pi.pdfpdf icon external icon

6. CDC. Minors' consent laws for HIV and STI services. Atlanta, GA: US Department of Health and Human Services, CDC; 2018. https://www.cdc.gov/hiv/policies/law/states/minors.html

7. Burda JP. PrEP and our youth: implications in law and policy. Columbia J Gend Law 2016;30:295-363.

8. Goldenring JM, Rosen DS. Getting into adolescent heads: an essential update. Contemp Pediatr 2004;21:64-90.

9. CDC. Pre-exposure prophylaxis (PrEP) [Internet]. Atlanta, GA: US Department of Health and Human Services, CDC; 2019. https://www.cdc.gov/hiv/risk/prep/index.html

10. CDC. Paying for PrEP [Internet]. Atlanta, GA: US Department of Health and Human Services, CDC; 2019. https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-PayingforPrEP-flyer.pdfpdf icon

BOX 1. Key clinical considerations when prescribing HIV preexposure prophylaxis to adolescents

Medical management

PrEP safety

Overall, the available data support the safety of PrEP in adolescents.

Clinical and laboratory-based monitoring is recommended for persons prescribed PrEP (https://www.cdc.gov/hiv/clinicians/prevention/prep.html).

Additional research is needed to assess potential clinical impacts of TDF-related effects on bone density in adolescents.

Legal issues

As of a broad legal review in 2017, no states specifically prohibit minors' autonomous consent to PrEP.

All states have statutes, regulations, or both that explicitly allow certain minors to consent to STI diagnosis and treatment.

Allowing minors to autonomously consent to PrEP does not necessarily mean that care will remain confidential. Potential limitations to confidentiality include billing documentation, mandated reporting laws for child abuse and neglect, and others depending on the state.

PrEP providers have to be familiar with the statutes and regulations regarding the provision of health care to minors in their jurisdictions.

Therapeutic partnership

Adequate time for adolescents and their providers to discuss sensitive topics without parents or guardians present, also called time alone, is recommended beginning at age 11 years.

PrEP providers must recognize adolescents' autonomy to the extent allowable by law and include parents or guardians in the conversation about PrEP when it is safe and reasonable to do so.

Clinical visits for preventive services

Obtaining a comprehensive history, including social and sexual history, is important to identifying adolescents' needs. PrEP is only one of a number of interventions that might be indicated to address an adolescent's health concerns.

One approach to the history is the HEEADSSS (or HE2ADS3) format: asking adolescents about home, education or employment, eating, activities (peer related), drugs, sexuality, suicide or depression, and safety.

One approach to the sexual history is the five Ps method: asking adolescents about partners, practices, protection from STIs, past history of STIs, and prevention of pregnancy.

All adolescents need to receive developmentally appropriate sexual health education.

Medication initiation, adherence, and persistence

Providers and clinical support staff can help adolescents prescribed PrEP by screening for barriers and providing pertinent guidance and support.

Resources to overcome barriers related to medication and health care costs are available (https://www.cdc.gov/hiv/risk/prep/index.html).

Adequate medication adherence is required for PrEP to prevent HIV acquisition. In PrEP clinical trials among adolescents, initial monthly clinic visits were associated with higher adherence than the later quarterly visits.

Adolescents prescribed PrEP might benefit from more frequent, supportive interactions.

Studies evaluating technology-focused interventions and other strategies to enhance adherence are ongoing.

Regular screening for the need and desire to continue with PrEP is part of the ongoing care of adolescents prescribed PrEP. For adolescents who plan to continue taking PrEP, screening for barriers (e.g., transportation problems and insurance changes) and providing guidance and support for overcoming barriers can help them persist with PrEP.

Abbreviations: HIV = human immunodeficiency virus; PrEP = preexposure prophylaxis; STI = sexually transmitted infection; TDF = tenofovir disoproxil fumarate.

State

Consent

HIV

Type of prevention

California

Allows minors to autonomously consent to preventive or prophylactic STI services
Minors must be aged ≥12 years to autonomously consent to preventive services

Specifies that HIV infection is an STI through another law

Not specified

Colorado

Allows minors to autonomously consent to preventive or prophylactic STI services

Specifies that HIV infection is an STI through another law

Not specified

Delaware

Allows minors to autonomously consent to preventive or prophylactic STI services
Minors must be aged ≥12 years to autonomously consent to preventive services

Specifies that HIV infection is an STI through another law

Not specified

Iowa

Allows minors to autonomously consent to preventive or prophylactic HIV services

Explicitly includes HIV infection prevention in law

Not specified

Montana

Allows minors to autonomously consent to preventive or prophylactic STI services

Specifies that HIV infection is an STI through another law

Not specified

North Carolina

Allows minors to autonomously consent to preventive or prophylactic STI services

Specifies that HIV infection is an STI through another law

Not specified

Oklahoma

Allows minors to autonomously consent to preventive or prophylactic STI services

Specifies that HIV infection is an STI through another law

Not specified

State

Provision

Alabama

Minors must be aged ≥14 years to autonomously consent to health care services.

Alaska

No age restriction defined.

Arkansas

No age restriction defined.

Idaho

Minors must be aged ≥14 years to autonomously consent to health care services.

Kansas

Minors must be aged ≥16 years to autonomously consent to health care services.

Louisiana

No age restriction defined.

Mississippi

Minors must be aged ≥18 years to autonomously consent to health care services. (Age of majority is 21 years.)

Pennsylvania

Minors must be aged ≥18 years to autonomously consent to health care services. (Age of majority is 21 years.)

South Carolina

Minors must be aged ≥16 years to autonomously consent to health care services.

BOX 2. Clinical trials related to HIV preexposure prophylaxis adherence among adolescents*

Trial name ClinicalTrails.gov URL

*As of September 2019.

Suggested citation for this article: Tanner MR, Miele P, Carter W, et al. Preexposure Prophylaxis for Prevention of HIV Acquisition Among Adolescents: Clinical Considerations, 2020. MMWR Recomm Rep 2020;69(No. RR-3):1-12. DOI: http://dx.doi.org/10.15585/mmwr.rr6903a1external icon .

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Preexposure Prophylaxis for Prevention of HIV Acquisition Among Adoles

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Altmetric: Citations: Views: Views equals page views plus PDF downloads Preexposure prophylaxis (PrEP) with antiretroviral medication has been proven effective in reducing the risk for acquiring human immunodeficiency virus (HIV). The fixed-dose combination tablet of tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) was approved by the U.S.

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If taking daily PrEP, the person would take on pill a day, everyday

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PrEP works by creating "walls" around the CD4 cell. This then prevents the HIV cell from entering and/or replicating itself in the body.