Resources for Care Providers

Resources for Care Providers

HIV Care Provider Definitions

New York State Department of Health AIDS Institute, April 2017

Experienced HIV care provider: Practitioners who have been accorded HIV-Experienced Provider status by the American Academy of HIV Medicine (AAHIVM) or have met the HIV Medicine Association’s (HIVMA) definition of an experienced provider are eligible for designation as an HIV Experienced Provider in New York State.

Nurse practitioners and licensed midwives who provide clinical care to HIV-Infected individuals in collaboration with a physician may be considered HIV Experienced Providers provided that all other practice agreements are met (8 NYCRR 79-5:1; 10 NYCRR 85.36; 8 NYCRR 139-6900)

Physician assistants who provide clinical care to HIV-infected individuals under the supervision of an HIV Specialist physician may also be considered HIV Experienced Providers (10 NYCRR 94.2)

Expert HIV care provider: A provider with extensive experience in the management of complex patients with HIV.

All FDA-Approved HIV Medications

Reviewed December 2021

Listed below are all FDA-approved HIV medications as of August 24, 2021, with links to the Clinical Info HIV.gov drug database. For professionals, the links open the FDA label pages, and for consumers, the links open the AIDSinfo patient information pages. The list is organized by drug class, with individual drugs listed in alphabetical order. Combination drugs are also listed in alphabetical order.

Nucleoside Reverse Transcriptase Inhibitors (NRTIs): characteristics
Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs): characteristics
Protease Inhibitors (PIs): characteristics
Fusion Inhibitor: characteristics
CCR5 Antagonist: characteristics
Integrase Strand Transfer Inhibitors (INSTIs): characteristics
Attachment Inhibitor: characteristics
Post-Attachment Inhibitor: characteristics
Pharmacokinetic Enhancer: characteristics
Combination HIV Medications:

ARV Drug Name Abbreviation Key

Abbreviation Full Drug Name
 
3TC lamivudine
ABC abacavir
APV amprenavir
ATV atazanavir
ATV/c atazanavir/cobicistat
ATV/r atazanavir/ritonavir
AZT zidovudine
BIC bictegravir
COBI or c cobicistat
DCV daclatasvir
ddC zalcitabine
DLV delavirdine 
DRV darunavir
DRV/c   darunavir/cobicistat
DRV/r darunavir/ritonavir 
DTG dolutegravir 
EFV efavirenz
EFV/TDF/FTC efavirenz/tenofovir disoproxil fumarate/emtricitabine
ETR etravirine
EVG/c elvitegravir/cobicistat
EVG/c/TAF/FTC elvitegravir/cobicistat/tenofovir alafenamide/emtricitabine
EVG/c/TDF/FTC elvitegravir/cobicistat/tenofovir disoproxil fumarate/ emtricitabine
EVG/r   elvitegravir/ritonavir
FPV fosamprenavir
FPV/r fosamprenavir/ritonavir
FTC emtricitabine 
IBA ibalizumab
LPV lopinavir
LPV/r lopinavir/ritonavir
MVC maraviroc
NVP nevirapine 
PI/c cobicistat-boosted protease inhibitor
PI/r ritonavir-boosted protease inhibitor 
RAL raltegravir
RPV rilpivirine
RTV ritonavir 
SQV saquinavir
SQV/r saquinavir/ritonavir
T-20 enfuvirtide
TAF tenofovir alafenamide
TDF tenofovir disoproxil fumarate
TPV tipranavir 
TPV/r tipranavir/ritonavir
ZDV zidovudine

Online Resources for Education, Information, and Services

August 2021

EDUCATION

GUIDELINES

LAW

SERVICES

TOOLS

Use of Dolutegravir in Individuals of Childbearing Capacity

Lead author: Geoffrey A. Weinberg, MD, with the Medical Care Criteria Committee, May 2021

Potentially increased NTDs and DTG: NTDs are birth defects, including meningomyelocele and spina bifida, thought to occur early after conception during development of the embryonic neural tube. The neural tube closes by approximately 8 weeks gestational age, which is 8 weeks after the last menstrual period or approximately 6 weeks post-conception. Ingestion of folic acid or folate by a pregnant individual significantly lowers the rate of NTDs; all individuals in the United States who are pregnant or trying to conceive and engaged in prenatal care are routinely administered 400 µg of folic acid daily. The background rate of NTDs in the general population in the United States and other countries that routinely fortify food with folate or folic acid is low: approximately 0.07% of all births (7/10,000 births) [Reefhuis, et al. 2020].

In 2018, an unplanned interim analysis of a large observational clinical trial conducted in Botswana, a country where food is not routinely fortified with folate or folic acid, was performed. The researchers found NTDs in 0.94% of 426 infants exposed at conception to maternal DTG-based antiretroviral therapy (ART) compared with 0.12% of 11,300 infants exposed to non–DTG-based ART. Importantly, however, as more data were collected, the rates of infant NTDs markedly declined [Zash, et al. 2018; Zash, et al. 2019; Antiretroviral Pregnancy Registry Steering Committee 2020; Zash 2020; DHHS 2021]. The latest available data, through April 2020, now show that the rate of infant NTDs with maternal DTG-based ART use at conception is not any greater than it is in infants exposed to non–DTG-based ART at conception: 0.19% [Antiretroviral Pregnancy Registry Steering Committee 2020; Zash 2020; DHHS 2021]. No increases have been found in the registry data or through pharmacovigilance database studies from Europe and the United States [Vannappagari and Thorne 2019; van De Ven, et al. 2020]. Nor have any differences been found in the rates of NTDs among infants in a randomized controlled open-label phase 3 trial of DTG-based versus EFV-based ART in pregnant individuals, though the median gestational age at enrollment in this trial was 22 weeks, and all enrollees were at 14 weeks or more gestational age at enrollment [Lockman, et al. 2021].

Benefits of DTG: There are many known benefits of DTG as a component of ART for all adults, pregnant or not, and many children. DTG is potent, rapidly reduces viral load, has a high barrier to HIV genetic resistance, and is generally well-tolerated. Moreover, folate deficiency is uncommon in countries such as the United States. Thus, both the U.S. Department of Health and Human Services and the World Health Organization consider DTG a preferred ARV drug for individuals with HIV in all trimesters of pregnancy, and those with HIV who are trying to conceive. If an alternative ART regimen that does not include DTG is the best choice, alternatives to DTG during pregnancy include raltegravir, ritonavir-boosted atazanavir, or ritonavir-boosted darunavir (see the NYSDOH AI guideline Selecting an Initial ART Regimen > Specific Factors to Consider and Discuss With Patients). No data currently exist to support the use of bictegravir during pregnancy or the period surrounding conception. Further, cobicistat-boosted regimens containing elvitegravir, darunavir, or atazanavir are not recommended due to reduced levels of the integrase inhibitors given with cobicistat during pregnancy.

References

Antiretroviral Pregnancy Registry Steering Committee. Antiretroviral Pregnancy Registry Interim Report for 1 January 1989 – 31 July 2020. 2020 Dec 22. http://apregistry.com/forms/exec-summary.pdf [accessed 2021 Apr 19]

DHHS. Recommendations for the use of antiretroviral drugs in pregnant women with HIV infection and interventions to reduce perinatal HIV transmission in the United States. 2021 Feb 10. https://clinicalinfo.hiv.gov/en/guidelines/perinatal/whats-new-guidelines [accessed 2021 Apr 19]

Lockman S, Brummel SS, Ziemba L, et al. Efficacy and safety of dolutegravir with emtricitabine and tenofovir alafenamide fumarate or tenofovir disoproxil fumarate, and efavirenz, emtricitabine, and tenofovir disoproxil fumarate HIV antiretroviral therapy regimens started in pregnancy (IMPAACT 2010/VESTED): a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet 2021;397(10281):1276-1292. [PMID: 33812487] 

Reefhuis J, FitzHarris LF, Gray KM, et al. Neural tube defects in pregnancies among women with diagnosed HIV infection – 15 jurisdictions, 2013-2017. MMWR Morb Mortal Wkly Rep 2020;69(1):1-5. [PMID: 31917782] 

van De Ven NS, Pozniak AL, Levi JA, et al. Analysis of pharmacovigilance databases for dolutegravir safety in pregnancy. Clin Infect Dis 2020;70(12):2599-2606. [PMID: 31595301] 

Vannappagari V, Thorne C. Pregnancy and neonatal outcomes following prenatal exposure to dolutegravir. J Acquir Immune Defic Syndr 2019;81(4):371-378. [PMID: 30939532] 

Zash R. Update on neural tube defects with antiretroviral exposure in the Tsepamo study, Botswana. 23rd International AIDS Conference; 2020 Jul 6-10; virtual. https://www.natap.org/2020/IAC/IAC_112.htm

Zash R, Holmes L, Diseko M, et al. Neural-tube defects and antiretroviral treatment regimens in Botswana. N Engl J Med 2019;381(9):827-840. [PMID: 31329379] 

Zash R, Makhema J, Shapiro RL. Neural-tube defects with dolutegravir treatment from the time of conception. N Engl J Med 2018;379(10):979-981. [PMID: 30037297]

GOALS Framework for Sexual History Taking in Primary Care

Developed by Sarit A. Golub, PhD, MPH, Hunter College and Graduate Center, City University of New York, in collaboration with the NYC Department of Health and Mental Hygiene, Bureau of HIV, July 2019

Background: Sexual history taking can be an onerous and awkward task that does not always provide accurate or useful information for patient care. Standard risk assessment questions (e.g., How many partners have you had sex within the last 6 months?; How many times did you have receptive anal sex with a man when he did not use a condom?) may be alienating to patients, discourage honest disclosure, and communicate that the number of partners or acts is the only component of sexual risk and health.

In contrast, the GOALS framework is designed to streamline sexual history conversations and elicit information most useful for identifying an appropriate clinical course of action.

The GOALS framework was developed in response to 4 key findings from the sexual health research literature:

  1. Universal HIV/STI screening and biomedical prevention education is more beneficial and cost-effective than risk-based screening [Wimberly, et al. 2006; Hoots, et al. 2016; Owusu-Edusei, et al. 2016; Hull, et al. 2017; Lancki, et al. 2018].
  2. Emphasizing benefits—rather than risks—is more successful in motivating patients toward prevention and care behavior [Weinstein and Klein 1995; Schuz, et al. 2013; Sheeran, et al. 2014].
  3. Positive interactions with healthcare providers promote engagement in prevention and care [Bakken, et al. 2000; Alexander, et al. 2012; Flickinger, et al. 2013].
  4. Patients want their healthcare providers to talk with them about sexual health [Marwick 1999; Ryan, et al. 2018].

Rather than seeing sexual history taking as a means to an end, the GOALS framework considers the sexual history taking process as an intervention that will:

  • Increase rates of routine HIV/STI screening;
  • Increase rates of universal biomedical prevention and contraceptive education;
  • Increase patients’ motivation for and commitment to sexual health behavior; and
  • Enhance the patient-care provider relationship, making it a lever for sexual health specifically and overall health and wellness in general.

The GOALS framework includes 5 steps:

  1. Give a preamble that emphasizes sexual health. The healthcare provider briefly introduces the sexual history in a way that de-emphasizes a focus on risk, normalizes sexuality as part of routine healthcare, and opens the door for the patient’s questions.
  2. Offer opt-out HIV/STI testing and information. The healthcare provider tells the patient that they test everyone for HIV and STIs, normalizing both testing and HIV and STI concerns.
  3. Ask an open-ended question. The healthcare provider starts the sexual history taking with an open-ended question that allows them to identify the aspects of sexual health that are most important to the patient, while allowing them to hear (and then mirror) the language that the patient uses to describe their body, partner(s), and sexual behaviors.
  4. Listen for relevant information and fill in the blanks. The healthcare provider asks more pointed questions to elicit information that might be needed for clinical decision-making (e.g., 3-site versus genital-only testing), but these questions are restricted to specific, necessary information. For instance, if a patient has already disclosed that he is a gay man with more than 1 partner, there is no need to ask about the total number of partners or their HIV status in order to recommend STI/HIV testing and PrEP education.
  5. Suggest a course of action. Consistent with opt-out testing, the healthcare provider offers all patients HIV testing, 3-site STI testing, PrEP education, and contraceptive counseling, unless any of this testing is specifically contraindicated by the sexual history. Rather than focusing on any risk behaviors the patient may be engaging in, this step focuses specifically on the benefits of engaging in prevention behaviors, such as exerting greater control over one’s sex life and sexual health and decreasing anxiety about potential transmission.

Resources for implementation:

  • Script, rationale, and goals: Box 1, below, provides a suggested script for each step in the GOALS framework, along with the specific rationale for that step and the goal it is designed to accomplish.
  • The 5Ps model for sexual history-taking (CDC): Note that the GOALS framework is not designed to completely replace the 5Ps model (partners, practices, protection from STI, past history of STI, prevention of pregnancy); instead, it provides a framework for identifying information related to the 5Ps that improves patient-care provider communication, reduces the likelihood of bias or missed opportunities, and enhances patients’ motivation for prevention and sexual health behavior.
Box 1: GOALS Framework for the Sexual History
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Component Suggested Script Rationale and Goal Accomplished
Give a preamble that emphasizes sexual health. I’d like to talk with you for a couple of minutes about your sexuality and sexual health. I talk to all of my patients about sexual health, because it’s such an important part of overall health. Some of my patients have questions or concerns about their sexual health, so I want to make sure I understand what your questions or concerns might be and provide whatever information or other help you might need.
  • Focuses on sexual health, not risk.
  • Normalizes sexuality as part of health and healthcare.
  • Opens the door for the patient’s questions.
  • Clearly states a desire to understand and help.
Offer opt-out HIV/STI testing and information. First, I like to test all my patients for HIV and other sexually transmitted infections. Do you have any concerns about that?
  • Doesn’t commit to specific tests, but does normalize testing.
  • Sets up the idea that you will recommend some testing regardless of what the patient tells you.
  • Opens the door for the patient to talk about HIV or STIs as a concern.
Ask an open-ended question.

Pick one (or use an open-ended question that you prefer):

  • Tell me about your sex life.
  • What would you say are your biggest sexual health questions or concerns?
  • How is your current sex life similar or different from what you think of as your ideal sex life?
  • Puts the focus on the patient.
  • Lets you hear what the patient thinks is most important first.
  • Lets you hear the language the patient uses to talk about their body, partners, and sex.
Listen for relevant information and probe to fill in the blanks.
  • Besides [partner(s) already disclosed], tell me about any other sexual partners.
  • How do you protect yourself against HIV and STIs?
  • How do you prevent pregnancy (unless you are trying to have a child)?
  • What would help you take (even) better care of your sexual health?
  • Makes no assumption about monogamy or about gender of partners.
  • Avoids setting up a script for over-reporting condom use.
  • Can be asked of patients regardless of gender.
  • Increases motivation by asking the patient to identify strategies/ interventions.
Suggest a course of action.
  • So, as I said before, I’d like to test you for [describe tests indicated by sexual history conversation].
  • I’d also like to give you information about PrEP/contraception/other referrals. I think it might be able to help you [focus on benefit].
  • Allows you to tailor STI testing to the patient so they don’t feel targeted.
  • Shows that you keep your word.
  • Allows you to couch education or referral in terms of relevant benefits, tailored to the specific patient.
References

Alexander JA, Hearld LR, Mittler JN, et al. Patient-physician role relationships and patient activation among individuals with chronic illness. Health Serv Res 2012;47(3 Pt 1):1201-1223. [PMID: 22098418]

Bakken S, Holzemer WL, Brown MA, et al. Relationships between perception of engagement with health care provider and demographic characteristics, health status, and adherence to therapeutic regimen in persons with HIV/AIDS. AIDS Patient Care STDS 2000;14(4):189-197. [PMID: 10806637]

Flickinger TE, Saha S, Moore RD, et al. Higher quality communication and relationships are associated with improved patient engagement in HIV care. J Acquir Immune Defic Syndr 2013;63(3):362-366. [PMID: 23591637]

Hoots BE, Finlayson T, Nerlander L, et al. Willingness to take, use of, and indications for pre-exposure prophylaxis among men who have sex with men-20 US cities, 2014. Clin Infect Dis 2016;63(5):672-677. [PMID: 27282710]

Hull S, Kelley S, Clarke JL. Sexually transmitted infections: Compelling case for an improved screening strategy. Popul Health Manag 2017;20(S1):S1-S11. [PMID: 28920768]

Lancki N, Almirol E, Alon L, et al. Preexposure prophylaxis guidelines have low sensitivity for identifying seroconverters in a sample of young Black MSM in Chicago. AIDS 2018;32(3):383-392. [PMID: 29194116]

Marwick C. Survey says patients expect little physician help on sex. JAMA 1999;281(23):2173-2174. [PMID: 10376552]

Owusu-Edusei K, Jr., Hoover KW, Gift TL. Cost-effectiveness of opt-out chlamydia testing for high-risk young women in the U.S. Am J Prev Med 2016;51(2):216-224. [PMID: 26952078]

Ryan KL, Arbuckle-Bernstein V, Smith G, et al. Let’s talk about sex: A survey of patients’ preferences when addressing sexual health concerns in a family medicine residency program office. 2018;2. https://journals.stfm.org/primer/2018/ryan-2018-0004

Schuz N, Schuz B, Eid M. When risk communication backfires: randomized controlled trial on self-affirmation and reactance to personalized risk feedback in high-risk individuals. Health Psychol 2013;32(5):561-570. [PMID: 23646839]

Sheeran P, Harris PR, Epton T. Does heightening risk appraisals change people’s intentions and behavior? A meta-analysis of experimental studies. Psychol Bull 2014;140(2):511-543. [PMID: 23731175]

Weinstein ND, Klein WM. Resistance of personal risk perceptions to debiasing interventions. Health Psychol 1995;14(2):132-140. [PMID: 7789348]

Wimberly YH, Hogben M, Moore-Ruffin J, et al. Sexual history-taking among primary care physicians. J Natl Med Assoc 2006;98(12):1924-1929. [PMID: 17225835]

Health Equity Competencies for Health Care Providers

August 2021

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