Clinician's Guide
Clinician's Guide to Routine HIV Testing During Pregnancy - 2009
Indiana Code (CODE 16-41-6) requires that all pregnant women be tested for HIV testing as a component of routine prenatal care unless they refuse in writing. The Code is supported by the Centers for Disease Control (CDC) Guidelines which recommend that all women who are pregnant, or planning a pregnancy, be tested for HIV regardless of their risk factors or the HIV prevalence rates where they live. As the guidelines indicate, consent should not be a prerequisite for nor a barrier to testing. Women who do not want the HIV screening test can opt out with written refusal. This approach is critical to our public health initiative to prevent mother to baby HIV transmission.
Proper diagnosis and treatment can improve the health of the mother and dramatically reduce the transmission of HIV from mother to infant from 25-30% down to <2%.
Links
Perinatally HIV-exposed infants worksheet
Table of Contents
Algorithm for HIV Testing During Prenatal Care
Algorithm for Rapid HIV Screening Late in Pregnancy and/or Labor & Delivery
Tests for Diagnosis of HIV
Timing of HIV Testing
Interpreting and Giving Test Results
Late Presentation: Screening in Labor and Delivery
Signs and Symptoms of Acute HIV Infection
Documentation – Acceptance and Refusal
Mom Declines – Now What?
Testing Infants – If Mom Declines HIV Testing
Treatment of the HIV Infected Pregnant Woman during Pregnancy
Treatment of the HIV Infected Patient during Labor and Delivery
Treatment of the HIV Exposed Infant after Delivery
Communicable Disease Reporting – Pregnant Women and Exposed Infants
Project Partners
Clinician Resources
Tests for Diagnosis of HIV
HIV Antibody/EIA/ELISA
- The ELISA antibody test (enzyme-linked immunoabsorbent assay) also known as EIA (enzyme immunoassay) was the first HIV test to be widely used and remains the most common screening test for HIV.
- Most appropriate first line test for diagnosis of HIV among adults and children over 18 months of age.
- This test is performed in a batch methodology on serum and usually results can be available in 48-72 hours.
- Inexpensive and 99.5% sensitive making it excellent screening tool
- All positive ELISA tests should be confirmed with the Western Blot due to slightly lesser specificity
- Note that infant ELISA tests can reflect maternal antibody and remain positive until 18 months of age
- May be negative in cases of recent conversion (window period)
Western Blot Assay
- One of the oldest but most accurate confirmatory antibody tests that utilizes a series of protein bands for diagnosis.
- It is complex to administer and may produce indeterminate results if a person has a transitory infection with another virus or is in the window period.
- Every positive ELISA should be confirmed by the more specific Western Blot assay which is done reflexively by most laboratories upon a positive ELISA test; together, this battery of tests is 99.999% accurate
Rapid HIV Tests
- Also detects HIV antibody but much faster (usually in about 20-60 minutes)
- Availability varies between institutions
- This test is based on the same technology as the ELISA but is analyzed singularly
- Increased cost over routine ELISA
- Error rate estimated to be 1-3/1000
- Positive tests are evidence enough to start therapy in pregnant women or newborns but all results should be confirmed by Western Blot
- Some rapid tests are done on blood and some on saliva
- Easy to perform
HIV PCR
- Also referred to as viral load testing
- Detects specific genetic sequences of circulating virus
- Complex and expensive; can be difficult to interpret
- Not suitable as a screening tool except in newborns and infants and in cases of suspected acute retroviral syndrome
- Used to monitor disease progression and control
Timing of HIV Testing
To promote informed and timely therapeutic decisions, health-care providers should test women for HIV as early as possible during each pregnancy generally at initial presentation for prenatal care. For women who decline the test early in prenatal care, the opportunity for testing should be offered at each subsequent visit.
A second HIV test during the third trimester, preferably <36 weeks of gestation, can be cost-effective even in areas of low HIV prevalence and may be considered for all pregnant women. A second HIV test during the third trimester is recommended for women who meet one or more of the following criteria:
- Women who receive health care in facilities in which prenatal screening identifies at least one HIV-infected pregnant woman per 1,000 women screened.
- Women who are known to be at high risk for acquiring HIV (e.g., injection-drug users and their sex partners, women who exchange sex for money or drugs, women who are sex partners of HIV-infected persons, and women who have had a new or more than one sex partner during this pregnancy, women who have a partner who is suspected of not being sexually exclusive, and women who have been diagnosed with an STI during this pregnancy).
- Women who have signs or symptoms consistent with acute HIV infection. (see symptoms later in this document) When acute retroviral syndrome is a possibility, a plasma RNA test should be used in conjunction with an HIV antibody test to diagnose acute HIV infection.
Interpreting and Giving Test Results
A thorough discussion of results must be done after each test. It should not be assumed that if a patient did not hear any results that she is negative. Results should be given in person by the provider.
Result = Negative EIA:
- Could possibly indicate the patient is in the window period or the time between acquisition and development of antibody, particularly if risk behaviors have been identified. This can take anywhere from a few weeks to 6 months. If the patient is deemed to be high risk based on historical factors determined by the clinician, an HIV RNA PCR test may be useful especially if there are symptoms of acute HIV infection or known high risk exposure has been reported acutely. Consultation with an ID physician may be helpful.
- Negative test result does not imply immunity to future infection. However, a negative test result provides an excellent opportunity for risk reduction counseling and prevention education.
- Retest in the future, including the third trimester-before 36 weeks gestation, if evidence of risk (e.g. STD diagnosis, multiple partners).
Result = Positive EIA and Indeterminate WB:
- Consult with ID on how to proceed as further testing may be warranted including HIV RNA PCR
- Counsel to NOT breastfeed
Result = Positive EIA and Positive WB:
- Refer to ID for Treatment for Mother—may require urgent phone consultation if the woman is near her due date or in active labor.
- OB care provider must feel comfortable with issues surrounding care of HIV+ pregnancy including knowledge base, support services, and that the delivery facility will have access to medications necessary for mother and baby including IV and suspension formulations of AZT (zidovudine, retrovir). Counsel to NOT breastfeed and Duty to Warn
- Recommend testing of partners and other children born to this mother in the past.
- Refer to Pediatric HIV Specialist for baby’s follow up care. An appointment should be scheduled prior to the baby’s discharge from the nursery.
- Report New HIV Case (Mom) and Delivery of Exposed Infant to ISDH at (317) 233-7406
Late Presentation: Screening in Labor and Delivery
Women admitted for labor and delivery with unknown or undocumented HIV status should be assessed promptly for HIV infection using the algorithm titled “Rapid Test?” available on this site. This will allow for prompt intervention with prophylactic measures should the test be positive.
The use of Rapid HIV Screening devices is indicated in this situation. If a rapid test is positive in labor and delivery, guidelines recommend a routine HIV ELISA with Western Blot confirmation be sent on serum, that IV AZT (zidovudine, retrovir) is initiated immediately in the mother, and C-section be performed as the preferred mode of delivery in settings where membranes are not ruptured or ruptured for ≤4 hours. The newborn should receive oral AZT (zidovudine, retrovir) as soon as possible after delivery and therapy should be continued pending the results of the ELISA and confirmatory Western Blot.
There are currently six rapid HIV tests approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S.:
FDA-Approved Rapid HIV Antibody Screening Tests
February 4, 2008
|
FDA Approval Received |
Specimen Type |
CLIA Category* |
Sensitivity** (95% CI) |
Specificity** (95% CI) |
Manufacturer |
Approved for HIV-2 Detection? |
List Price Per Device^ |
External Controls | |
|
OraQuick ADVANCE Rapid HIV-1/2 Antibody Test |
Nov 2002 |
Oral fluid |
Waived |
99.3% |
99.8% |
Yes |
$17.50 |
Sold Separately | |
|
Whole Blood (finger stick or venipuncture) |
Waived |
99.6% |
100% | ||||||
|
Plasma |
Moderate Complexity |
99.6% |
99.9% | ||||||
|
Uni-Gold Recombigen HIV |
Dec 2003 |
Whole blood |
Waived |
100% |
99.7% |
No |
$15.75 $8.00 ▪ |
Sold Separately | |
|
Serum & Plasma |
Moderate Complexity |
100% |
99.8% | ||||||
|
Reveal G-3 Rapid HIV-1 Antibody Test |
Apr 2003 |
Serum |
Moderate Complexity |
99.8% |
99.1% |
No |
$14.00 |
Included | |
|
Plasma |
Moderate Complexity |
99.8% |
98.6% | ||||||
|
MultiSpot HIV-1/HIV-2 Rapid Test |
Nov 2004 |
Serum |
Moderate Complexity |
100% |
99.93 |
Yes –differentiates HIV-1 from HIV-2 |
$25.00 |
Included | |
|
Plasma |
Moderate Complexity |
100% |
99.91 | ||||||
|
Clearview HIV 1/2 STAT-PAK |
May 2006 |
Whole Blood |
Waived |
99.7% |
99.9% |
Yes |
$17.50 |
Sold Separately | |
|
Serum & Plasma |
Non-waived |
99.7% |
99.9% | ||||||
|
Clearview COMPLETE HIV 1/2 |
May 2006 |
Whole Blood |
Waived |
99.7% |
99.9% |
Yes |
$18.50 |
Sold Separately | |
|
Serum & Plasma |
Non-waived |
99.7% |
99.9% |
Signs and Symptoms of Acute HIV Infection
As many as 90% of patients will experience viral symptoms associated with acute HIV infection within 1-4 weeks of exposure to HIV. Symptoms most strongly associated with acute HIV infection include: fever, arthralgia, myalgia, pharyngitis, weight loss >2.5 kg, rash, malaise, oral ulcers and night sweats. See Table 22, for a more comprehensive list of signs and symptoms. If acute HIV infection is suspected and symptoms and risk warrant diagnostic laboratory testing, obtain and HIV antibody test and HIV-PCR. If antibody negative, indeterminate or the Western Blot has 3 or fewer positive bands, but the PCR is positive, manage as acute HIV infection (HIV Medicine Association, 2007). Risk of intrauterine fetal transmission is critically high during acute HIV conversion during this time due to extremely high viral loads.
Table 22. Associated Signs and Symptoms of Acute Retroviral
Syndrome and Percentage of Expected Frequency
|
96% |
|
74% |
|
70% |
|
70% |
| |
|
54% |
|
32% |
|
32% |
|
27% |
|
14% |
|
13% |
|
12% |
|
12% |
| |
Source: NiuMT, Stein DS, Schnittman SM. Primary human immunodeficiency
virus type 1 infection: review of pathogenesis and early treatment intervention in
humans and animal retrovirus infections. J Infect Dis 1993;168:1490-501.
Department of Health and Human Services (DHHS) Guidelines Ann Intern Med 2002; 137:381
Documentation – Acceptance and Refusal
HIV testing is routinely performed in all pregnant women after notification. A pregnant woman will receive an HIV test as part of the routine panel of prenatal tests unless she declines (opt-out screening).
- HIV testing must be voluntary and free from coercion. No woman should be tested without her knowledge.
- Pregnant women should receive oral or written information that includes an explanation of HIV infection, a description of interventions that can reduce HIV transmission from mother to infant, and the meanings of positive and negative test results and should be offered an opportunity to ask questions and to decline testing.
- No additional process or written documentation of informed consent beyond what is required for other routine prenatal tests should be required for HIV testing.
- If a patient declines an HIV test, she must do so in writing per Indiana law and this decision should be documented in the medical record.
Patients must be provided the information/education about HIV prior to testing. Information may be presented verbally, using a brochure, a pamphlet, or video as long as they are culturally and linguistically appropriate. Information/Education provided must include the following:
- HIV is the virus that causes AIDS. HIV is spread through unprotected sexual contact and injection-drug use and from mother to baby during pregnancy and delivery. Approximately 25% of HIV-infected pregnant women who are not treated during pregnancy can transmit HIV to their infants during pregnancy, during labor and delivery, or through breast-feeding.
- A woman might be at risk for HIV infection and not know it, even if she has had only one sex partner. She may not be aware of all her risk factors or those of her contacts and risk assessment alone may not be indicative of possible infection.
- Effective interventions (e.g., antiretroviral medication combinations) for HIV-infected pregnant women can decrease transmission risk to baby to as low as 1-2% thereby protecting their infants from acquiring HIV. Early intervention can prolong the survival and improve the health of these mothers and their children.
- Services are available to help women reduce their risk of acquiring HIV and to provide medical care and other assistance to those who are infected.
- Women who decline testing will not be denied care for themselves or their infants.
Documentation should clearly state that information/education was provided and patient accepted or declined an HIV antibody test. If the test was declined, written refusal by the mother must be placed in the medical record.
For further information, please visit the American College of Obstetricians and Gynecologists HIV screening home page at http://www.acog.org/departments/dept_notice.cfm?recno=39&bulletin=4619
Mom Declines – Now What?
Patients may decline HIV testing for a variety of reasons including but not limited to lack of perceived risk, fear of the disease, concerns regarding partner violence, or potential stigma or discrimination. As a healthcare provider, you should help the patient to address these concerns and be certain that all the information regarding the potential life saving benefits of testing have been discussed.
- Women who decline an HIV test because they have had a previous negative test result should be informed of the importance of retesting with each pregnancy.
- Logistical reasons for not testing (e.g., scheduling) should be resolved.
- Certain women who initially decline an HIV test might accept at a later date, especially if their concerns are discussed. Certain women will continue to decline testing, and their decisions should be respected and documented in the medical record at each subsequent visit.
- If a woman continues to decline testing despite adequate information, continue to recommend an HIV test as a routine component of prenatal care at subsequent visits.
Testing Infants – If Mom Declines HIV Testing
Indiana law provides for testing of the newborn infant without parental consent when:
- The mother of a newborn infant has not been tested under Indiana law
- The mother of a newborn infant has refused a test
- Testing the newborn infant is deemed medically necessary by a physician who has reason to believe the infant is at risk for exposure to HIV. All infants whose mothers have not been tested should be considered at risk for HIV exposure.
The test must be ordered at the earliest feasible time not exceeding forty-eight (48) hours after the birth of the infant.
Note that if a parent of the newborn infant objects in writing for reasons pertaining to religious beliefs, the newborn infant is exempt from the test. This should be clearly documented in the medical record.
Treatment of the HIV Infected Pregnant Woman during Pregnancy
Practitioners who provide prenatal care for HIV positive women must have knowledge of the associated care issues, support from ID specialists, access to appropriate medications, lab tests, and knowledgeable personnel within their hospital system.
- Meds—all HIV positive women should be treated with HAART (highly activated antiretroviral therapy) during pregnancy regardless of viral load or CD4 count; therapy should be commensurate with DHHS Guidelines and all regimens should include AZT (zidovudine, retrovir) precluding a documented maternal allergy.
- Maximal adherence is necessary to prevent transmission to baby and development of drug resistance in the mother.
- Side Effects—the major side effects of HAART tend to be gastrointestinal in nature. While this is often challenging, most side effects can be managed with supportive measures and will dissipate after the early stages of treatment. It is of paramount importance that the benefit of therapy is recognized especially in the face of side effects. Lactic acidemia has occurred in pregnant women with certain combinations of drugs. It is critical to follow DHHS guidelines to avoid this serious side effect. ID consultation is often beneficial.
- Labor and Delivery Plan—good planning is the key to a successful labor and delivery. Mode of delivery should be decided before the onset of delivery. C-section is recommended in all women with a HIV RNA PCR (viral load) of >1000 copies. For this group, C-section should be scheduled at 38 weeks gestation. For women with < 1000 copies on HIV RNA PCR (viral load), they may opt for vaginal delivery after thorough discussion with their obstetrical care provider.
- C-section does not appear to show added benefit in women whose membranes have been ruptured for >4 hours regardless of viral load.
- Invasive diagnostic methods such as amniocentesis should be avoided during pregnancy.
Treatment of the HIV Infected Patient during Labor and Delivery
During the actual delivery, certain issues must also be addressed.
- IV AZT(zidovudine, retrovir)—should be started by IV drip 3 hours prior to C-section. The IV should run at a rate of 2mg/kg bolus over 1 hour and then 1mg/kg/hour by continuous infusion until delivery is complete.
- If a woman has elected to have a vaginal delivery, pitocin may be used. IV AZT (zidovudine, retrovir) should be initiated as above before induction with pitocin. IV AZT (zidovudine, retrovir) should be continued until delivery is complete.
- In prolonged labor and delivery, minimal invasive measures should be employed. Fetal scalp electrodes, forceps, and vacuum extraction should be avoided to minimize potential breach of skin barriers.
- HIV positive mothers should be counseled to not breastfeed at all since risk of transmission from breast milk is significant.
Treatment of the HIV Exposed Infant after Delivery
- The infant should receive oral AZT (zidovudine, retrovir) as soon as possible after delivery.
- The first formula feeding should occur in delivery room. AZT (zidovudine, retrovir) should then be initiated at a dose of 2mg/kg orally every 6 hours to continue for 6 weeks.
- For premature infants or babies not receiving oral feedings, IV dosing schemes are available through consultation with infectious disease.
- HIV RNA PCR or HIV DNA PCR should be sent on baby prior to discharge. This sample should not be sent on cord blood due to risk of cross contamination with maternal blood.
- The baby should be scheduled for a follow-up appointment with a pediatric infectious disease -up; prior to baby’s discharge.
- Follow-up testing will proceed according to CDC guidelines and testing information can be accessed here. (view)
Full treatment guidelines for HIV-positive women and HIV exposed infants may be accessed at: AIDSInfo.nih.gov
Communicable Disease Reporting – Pregnant Women and Exposed Infants
Indiana law (IC 16-41-2-1) mandates the reporting of all cases of HIV and AIDS and all perinatal HIV exposures. All pregnant women who test positive for HIV must be reported. All infants born to an HIV-positive mother should be reported, even though their final HIV status is not known until later. All cases should be reported using the appropriate form:
Pediatric Form: http://www.in.gov/isdh/files/hiv_ped_caserpt.pdf
Adult Form: http://www.in.gov/isdh/files/case_report_adult-2007.pdf2007.pdf
Partners
Ryan White Center for Pediatric Infectious Disease
The Ryan White Center for Pediatric Infectious Disease at Riley Hospital for Children, a Clarian Health Partner, follows 90% of Indiana’s HIV+ children. These include children seeking care for documented HIV infection or infants who were exposed at birth and whose HIV status is under active diagnostic investigation. Counseling is provided on site at each visit. Please visit the clinics website using the link above for more information or you can call the clinic at (317)274-7260.
Indiana University School of Medicine
The IU School of Medicine (IUSM) was founded in 1903 – only the fourth medical school in the United States, after Johns Hopkins, Harvard, and Western Reserve, to require two or more years of collegiate work for admission. The school awarded the Doctor of Medicine (M.D.) degree to its first class of 25 in 1907. For a photographic look at our history, visit our award winning centennial celebration web site. And visit the IUSM medical libraries history of medicine collection for bibliographic and other details on medical history in Indiana and around the U.S. Also check out the new History of Women at IUSM site, an informative look at women's role in the history of the School of Medicine.
Indiana University Women’s Center of Excellence
In 1997, Indiana University was awarded support from the U.S. Department of Health and Human Services to become a National Center of Excellence (CoE) in Women's Health. The Centers are located in academic medical centers where they bring together the work of their schools and departments addressing women's health. The CoE at IU subsequently received support to be one of 11 national CoE Ambassadors for Change and to aspire toward the following goals:
- Develop and/or strengthen a framework to bring together a comprehensive array of services for women.
- Train a cadre of diverse health care providers that include allied health professionals and community health worker.
- Promote leadership/career development for diverse women in the health professions, including allied health professions and community health workers, and women/girls in the community.
- Enhance public education and outreach activities in women's health with an emphasis on gender-specific and age-appropriate prevention and/or reduction of illness or injuries that appear controllable through increased knowledge that leads to a modification of behavior.
- Participate in any national evaluation of the CoE program.
- Conduct basic, clinical and/or community-based research in women's health.
- Provide advice and guidance to other organizations interested in learning more about the CoE program.
Although federal funding for the program has ended, IU and the other CoE's retain their designation of National Centers of Excellence in Women's Health and depend upon other sources of support to continue their work. At IUSM, the Dean's Office and Department of Obstetrics and Gynecology are supporting the CoE's ongoing mission through this transition.
Directed by Lee A. Learman, M.D., Ph.D., OB/GYN Chair, the IU CoE works with a collaborative and multidisciplinary group of women's health leaders, enhancing its impact in Indianapolis and statewide.
Indiana Perinatal Network
The mission of the Indiana Perinatal Network (IPN) is to lead Indiana to improve the health of all mothers and babies. They provide resources for mothers and families, offer the latest information to healthcare providers, and promote sound public policies. IPN has a proven ability to bring together diverse disciplines and organizations to reach consensus on complex issues affecting the health of Indiana's mothers and babies.
Indiana State Department of Health Division of HIV/STD
The Division of HIV/STD strives to promote health and enhance quality of life for Indiana residents. Emphasis is placed on prevention, intervention, and early treatment of HIV and other Sexually Transmitted Diseases (STDs). Visit the divisions website using the link above to learn about programs and services. You may also call 1-866-588-4948
Midwest AIDS Training + Education Center (MATEC) - Indiana
MATEC Indiana receives federal funds to provide HIV/AIDS training and support to health care professionals in Indiana. MATEC is connected with the top HIV clinicians and researchers in Indiana and offers health care professionals targeted training and direct access to expert information.
You can contact MATEC Indiana at 317-278-6497 or matec@clarian.org
Health and Hospital Corporation
Health and Hospital Corporation of Marion County is an Indiana municipal corporation and political subdivision of the State of Indiana. The corporation operates the Marion County Health Department and Wishard Health Services. The mission is to promote and protect the health of everyone in the community and provide health care to those who are underserved.The Health and Hospital Coporation is committed to promoting good health throughout the community.
Clinician Resources
National Clinicians Consultation Center (NCCC)
The NCCC offers access to three clinician consultation lines that are staffed by clinicians with HIV/AIDS expertise. Visit the NCCC website using the link above or call one of their consultation lines listed below:
National HIV Telephone Consultation Service |
1-800-933-3413 |
| PEPline National Clinicians' Post-Exposure Prophylaxis Hotline |
1-888-HIV-4911 |
| Perinatal HIV Hotline National Perinatal HIV Consultation and Referral Service |
1-888-448-8765 |
Center for Disease Control (CDC) – HIV Information
For more than 60 years, the CDC has been dedicated to protecting health and promoting quality of life through the prevention and control of disease, injury, and disability. We are committed to programs that reduce the health and economic consequences of the leading causes of death and disability, thereby ensuring a long, productive, healthy life for all people. Visit the CDC website using the link below to get connected to their collection of HIV/AIDS information and resources.
HIV Medicine Association
Infectious Diseases Society of America created the HIV Medicine Association (HIVMA) in fall 2000 to provide an organizational home for medical professionals engaged in HIV medicine. Through its activities, HIVMA supports clinicians in overcoming the challenges inherent in providing high quality health care to patients living with HIV disease. The HIV Medicine Association is an organization of medical professionals who practice HIV medicine and represent the interests of patients through the promotion of quality in HIV care and advocacy for policies that ensure a comprehensive and humane response to the AIDS pandemic informed by science and social justice. http://www.hivma.org/.
