2020 CDC Update for Contraceptive Use in Women at High Risk for HIV

What is the significance?

Women who have unprotected sex or have multiple partners have not only an increased the risk of sexually transmitted infections (STIs also known as STDs) but also have a risk of pregnancy. Aside from condoms, other contraceptive methods do not protect against HIV and other STIs but can effectively prevent an unintended pregnancy with potential complications and perinatal transmission associated with HIV infection.  Based on the new 2019 recommendations by the World Health Organization (WHO), the CDC published updated guidelines to the 2016 U.S. Medical Eligibility Criteria (US MEC) for Contraceptive Use regarding women at high risk for HIV infection in April 2020.

 

What changed?

The following updates were made to the US MEC for Contraceptive Use, 20161:

Women at high risk for HIV:

There are no restrictions for use (MEC Category 1) of all contraception methods, now including IUDs and depot medroxyprogesterone acetate (DMPA) injection. Previously, high risk for HIV was a condition for which copper-containing and progesterone-releasing IUD and DMPA use was MEC Category 2 (benefits generally outweigh the risks of the condition).

Women on antiretroviral (ARV) therapy:

The CDC has clarified that their recommendations for contraception in women taking nucleoside reverse transcriptase inhibitors (NRTIs) applies to all NRTI indications: prevention (PrEP) or treatment of HIV infection. Most contraceptive methods are MEC Category 1 except initiation of IUDs in women whose HIV viral loads are not controlled or are not ARV therapy due to the risk of pelvic inflammatory disease due to the risk of pelvic inflammatory disease with IUD insertion (MEC Category 2).

See Table 1 for a summary of recommendation changes.

 

Summary of Clinical Evidence

The US MEC recommendations are based on a review of clinical evidence, the WHO recommendations, and epidemiological information regarding unintended pregnancy, contraceptive use, HIV infection, and maternal morbidity and mortality in the US.2 In the previous 2017 US MEC update, intramuscular DMPA (DMPA-IM) use changed from a category 1 to a category 2 based on evidence of possible increased risk for HIV acquisition in women using DMPA who are already at high risk of infection.2,3 However, in August 2019, the WHO published the following updates regarding recommendations for contraceptive use in this population:

Women with high HIV risk are eligible to use all methods of contraception without restriction (category 1)4

    • All progestin-only methods, including progestin-only pills (POPs), intramuscular and subcutaneous DMPA, levonorgestrel (LNG) implants, and etonogestrel (ETG) implants
    • Copper and LNG intrauterine devices (IUDs)
    • All combined hormonal contraceptive methods, including combined oral contraceptives (COCs), combined contraceptive patches, and combined vaginal rings

These recommendations for this patient population have been made in light of the Evidence for Contraceptive Options and HIV Outcomes (ECHO) trial, which aimed to determine the risk of HIV incidence with the use of DMPA-IM, copper IUD, and LNG implant contraceptives. The randomized, multicenter, open-label trial included 7,839 non-pregnant, HIV-seronegative African females aged 16 to 35 years seeking effective contraception who were placed into 3 groups of contraceptive methods: DMPA-IM, copper IUD, and LNG implant.3 After 18 months, 397 HIV infections were observed: 36% in the DMPA-IM group, 35% in the copper IUD group, and 29% in the LNG implant group with no significant statistical differences between each method.3 Therefore, DMPA-IM copper IUD, or LNG implant use does not further increase the risk of getting HIV in patients already at high risk for HIV. In addition, patients younger than 25 years were associated with higher HIV incidence than those 25 years or older, and herpes simplex virus-2 (HSV-2) seropositive patients were associated with higher HIV incidence than those who were HSV-2 seronegative.3 However, age and HSV-2 status did not significantly alter the relationship between contraceptive use and HIV acquisition.3

Although the ECHO trial did not assess other hormonal methods (e.g., COCs, subcutaneous DMPA, hormonal IUDs), WHO also made their recommendations based on low/low-to-moderate quality studies or extrapolation from other studies indicating no increased risk for HIV acquisition with these methods.3,4 A consensus was also made that “no biological or clinical reasons” were evident “that a lower hormonal dose, different delivery mechanism, or different progestin” would affect HIV risk.”3

 

References

  1. Tepper NK, Curtis KM, Cox S, Whiteman MK. Update to U.S. Medical Eligibility Criteria for Contraceptive Use, 2016: Updated Recommendations for the Use of Contraception Among Women at High Risk for HIV Infection. MMWR Morb Mortal Wkly Rep 2020;69:405–410. Available from:http://dx.doi.org/10.15585/mmwr.mm6914a3
  2. Tepper NK, Krashin JW, Curtis KM, et al. “Update to CDC’s U.S. Medical Eligibility Criteria for Contraceptive Use, 2016: Revised Recommendations for the Use of Hormonal Contraception Among Women at High Risk for HIV Infection.” MMWR Morb Mortal Wkly Rep. 2017;66(37):990-994.
  3. Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial Consortium. HIV incidence among women using intramuscular depot medroxyprogesterone acetate, a copper intrauterine device, or a levonorgestrel implant for contraception: a randomised, multicentre, open-label trial. Lancet. 2019;394(10195):303-313.
  4. Contraceptive eligibility for women at high risk of HIV. Guidance statement: recommendations on contraceptive methods used by women at high risk of HIV. Geneva: World Health Organization; 2019. License: CC BY-NC-SA 3.0 IGO.

Marjorie Valdez Student PharmacistAbout the Authors

Marjorie Valdez is a fourth-year pharmacy student at the UC San Diego School of Pharmacy and Pharmaceutical Sciences.

Cydnee Ng, PharmD completed her pharmacy training at UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences in 2019. She is currently a community pharmacist at Walgreens in the San Francisco Bay Area.

5 Things Pharmacists Need to Know About Preconception Health

Pharmacists have great potential to improve preconception health. As they become increasingly aware and involved in providing preconception care, pharmacists can help close the gaps in such care by being advocates for the expansion of their role in preconception health.

Here are 5 things pharmacists should know about preconception health:

Preconception Pharmacists Birth Control1. We have a big problem with adverse pregnancy outcomes in the United States
The United States has high rates of infant mortality, maternal mortality, and other adverse pregnancy outcomes compared to other developed countries.1 Almost half of all pregnancies (45%) in the United States are unintended.2 In a society with such poor outcomes, health care professionals should provide preconception care within their scope of practice as part of routine health care to women and men of reproductive potential, regardless of pregnancy intention.2,3,4
 
2. Preconception health is all about optimizing the health of people with reproductive potential to ensure any pregnancies are healthy ones.
What is preconception care? Preconception care is the recognition and management of biomedical or behavioral issues that should be addressed before pregnancy to optimize health.3,4 For women of reproductive potential, recommended preconception care interventions can be broadly organized into four categories: counseling, maternal assessment, screening, and vaccinations.5 While preconception health may be more readily associated with women’s health, preconception health in men of reproductive potential is also important. Preconception care for men can help ensure pregnancies are intended, improve pregnancy outcomes, reduce the transmission of sexually transmitted diseases (STDs), and improve men’s health.6
 
3.  Pharmacists have the potential to deliver preconception care services.
Pharmacists are one of the most accessible health care providers and are well positioned to meet patients’ needs in preconception care, and improve health outcomes in the United States.5,7 Pharmacists can provide preconception care in areas such as disease state, and medication management; immunizations, folic acid supplementation, substance use counseling, smoking cessation, and contraceptive counseling.
 
4. Pharmacists want to provide some preconception services more than others.
So what do pharmacists think about providing preconception care to patients? We recently conducted a cross-sectional study of 332 pharmacists, and student pharmacists across the United States and its territories to assess pharmacist experiences, interest, and comfort with preconception care comprehensively.8 Pharmacists, and student pharmacists were already most involved with routine immunizations (54%), diabetes management (53%), and smoking cessation (52%), showing the consistent role pharmacists play in providing these preconception care services.

Pharmacists, and student pharmacists also expressed strong interest in providing STD/HIV screening and management (68%), and medication management services (62%). Examples of STD/HIV screening and management services that could be developed include community pharmacy clinics that provide screening and/or treatment, as well as patient counseling when over-the-counter screening tests are bought.9 In addition, because more than 80% of pregnant women take over-the-counter or prescription medications, pharmacists are well positioned to provide counseling to reduce risk of medication teratogenicity prior to pregnancy.10 These services may be considered initially for implementation to advance the role of pharmacists in providing preconception care.

Pharmacists, and student pharmacists were most comfortable providing services to female adults (88%), and female adolescents (65%) compared to male adults (61%) or male adolescents (32%). Implementing training sessions, and workshops may be beneficial to encourage the provision of preconception care services to male patients, especially male adolescents.
 
5. We need more work to prepare our pharmacists to provide these services.
Pharmacists and student pharmacists alike were interested in receiving more training about preconception care topics, particularly STD/HIV screening and management, minimizing risk of medication teratogenicity, and phenylketonuria management. Developing new and improved education and training programs could expand pharmacists’ knowledge on these preconception care services. In addition to education and training programs, access to patient medical records, patient education materials, and clinical guidelines would be useful resources to facilitate the provision of preconception care.

This article was co-written by Cydnee Ng, a student pharmacist at the University of California San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences.

References

  1. MacDorman MF, Matthews TJ, Mohangoo AD, Zeitlin J. International comparisons of infant mortality and related factors: United States and Europe, 2010. Natl Vital Stat Rep. 2014;63(5):1-6.
  2. Guttmacher Institute. Unintended pregnancy in the United States. Guttmacher Institute website. http://www.guttmacher.org/fact-sheet/unintended-pregnancy-united-states. Published September 2016. Accessed April 24, 2017.
  3. Johnson K, Posner SF, Biermann J, et al. Recommendations to improve preconception health and health care – United States: a report of the CDC/ATSDR preconception care work group and the select panel on preconception care. MMWR Recomm Rep. 2006;55(RR-6):1-23.
  4. Kent H, Johnson K, Curtis M, et al. Proceedings of the preconception health and health care clinical, public health, and consumer workgroup meetings. CDC website. www.cdc.gov/preconception/documents/WorkgroupProceedingsJune06.pdf. Created June 27-28, 2006. Accessed April 24, 2017.
  5. DiPietro Mager NA. Fulfilling an unmet need: roles for clinical pharmacists in preconception care. Pharmacotherapy. 2016;36(2):141-151.
  6. Frey KA, Navarro SM, Kotelchuck M, Lu MC. The clinical content of preconception care: preconception care for men. Am J Obstet Gynecol. 2008;199(6):S389-S395.
  7. El-Ibiary SY, Raney EC, Moos MK. The pharmacist’s role in promoting preconception health. J Am Pharm Assoc (2003). 2014;54(5):e288-e303.
  8. Ng C, Najjar R, DiPietro Mager N, Rafie S. Pharmacist and student pharmacist perspectives on providing preconception care in the United States. J Am Pharm Assoc (2003). 2018. doi: 10.1016/j.japh.2018.04.020.
  9. Dugdale C, Zaller N, Bratberg J, et al. Missed opportunities for HIV screening in pharmacies and retail clinics. J Manag Care Spec Pharm. 2014;20(4):339-345.
  10. Lassi ZS, Imam AM, Dean SV, Bhutta ZA. Preconception care: screening and management of chronic disease and promoting psychological health. Reprod Health.2014;11(suppl 3):S5.

This article was originally published in Pharmacy Times.