In light of recent studies and the release of preliminary new WHO guidelines, we are revising the antiretroviral regimens below.  This process will be completed in the coming weeks. 

Current Status of the Program

At present, we are testing all pregnant women for HIV. Those found to be HIV infected are counseled to return to the clinic when in labor for PMTCT. We are administering NVP to women in labor and NVP and AZT to infants in post-partum period. ARVs are being supplied by the government. The DHO of Achham has agreed to provide them; however, they themselves do not have them at this point as PMTCT programs in this regional are largely nonfunctioning. Therefore, at present we are getting them on a case-by-case basis from Doti or Dhangadi hospitals. We are counseling women to use exclusive breast feeding for 6 months since mixed feeding appears particularly dangerous (see counseling guidelines: http://www.nyayahealth.org/Library/counseling_EBF.pdf ). As many transmission events from breastfeeding are not simply from breastmilk transmission per se, but also from fissures or sores around the areola, we will carefully monitor and counsel HIV-positive mothers to prevent and treat breast lesions until the ideal program below is instituted.

Our Ideal Program Protocol (What We're Working Towards)

Antenatal Care:

1. All women presenting for antenatal care receive VCT for HIV

2. Women who are found to be HIV infected have clinical evaluation for HIV staging, as well as CD4 count. They should also undergo a detailed counseling and intake session including demographic and socioeconomic assessment.

3. ART is initiated in pregnant women (see ART protocol): All women in whom ART is indicated by clinical stage or CD4 should be started on ART as soon as possible. In women without indications for starting ART (CD4>350, or WHO Stage I or II), ART should be initiated at 28 weeks gestation. An AZT-containing regimen should be used. Women presenting after 28 weeks gestation should be started on ART immediately (following evaluation).

4. All women have CHW assigned to them who makes home visits several times a week. Nutritional supplementation, albendazole, prenatal vitamins, etc. provided

5. CHWs ensure that women come to clinic for delivery. If impossible due to distance or patient's preferences, home-based PMTCT should be provided.

Peripartum Care

1. We will strongly encourage women to deliver in the clinic. However, the PMTCT protocol applies whether the PMTCT takes place in the clinic or at home. If it takes place at home, it is important that a clinical staff member (ANM, HA or doctor) be present.

2. For women who are already on ART at the time of delivery, they should continue ART before and after delivery.

3. For women who are presenting in labor, they should receive single dose NVP, followed by 7 days of AZT/3TC.

4. For infants, the following two regimens should be used:

a. if the mother did not receive ART prior to 34 weeks gestation, the infant should receive single dose liquid NVP (6mg) at time of delivery, followed by 6 weeks of AZT (4mg/kg BID)

b. if the mother did receve ART prior to 34 weeks gestation, the infant should receive AZT syrup (4mg/kg) for 1 week

Post Partum Care

1. ART for Women:

a. Women who have clinical indications (by WHO stage or CD4 count) should continue ART

b. Women who do not have clinical indications to continue ART can be given choice whether or not to continue ART.

2. HIV Care for Infants - For immediate post partum period, see ART schedule above.

a. Unless HIV PCR becomes available, children should be tested for HIV antibodies (rapid testing) at 6 months, 12 months, and 18 months.

b. All children born to HIV-infected mothers require close clinical monitoring. Monthly visits to the clinic are recommended, with frequent HIV clinical staging. In the first 6 months, it is recommended that CHWs make home visits 2-3 times weekly.

c. Administer TMP/SMX (Bactrim; 7mg/day) liquid twice daily from 4 weeks until confirmation of negative HIV status.

d. Obtain CD4 percentage at 18 months or earlier if indicated by clinical staging.

e. Initiate ART if/when indicated clinically or by CD4 %. See http://model.pih.org/HIVmanual/protocol3_5

3. Breastfeeding - We will recommend exclusive formula feeding for all women, provided that it can be done safely. This decision must be made jointly between the PMTCT counselor and the mother, after a counseling session about the risks and benefits and methods of safe formula feeding.

a. Safe formula feeding - This will involve provision of a 9 month supply of formula, stoves, fuel, baby bottles, and water filters. PMTCT staff will train families in use of these supplies, and CHWs will make frequent visits to reinforce principles. The detailed description of this program will be available elsewhere.

b. If a safe formula-feeding program is not available (until it is operational at our clinic; or if the mother resides outside of our catchment area or is not interested in formula feeding), we will encourage exclusive breast feeding for at least six months. Women should be counseled in exclusive breast feeding (see counseling guidelines: http://www.nyayahealth.org/Library/counseling_EBF.pdf ). CHWs should make frequent visits to households and continue to encourage exclusive breast feeding.

4. Nutritional and Social Support

a. If the mother has BMI < 18.5, or if the staff feels she is in need, then provide food supplements consisting of cooking oil, daal, rice (quantities and duration to be determined)

b. For women who live far from the clinic or must take public transportation, transportation stipends should be provided for every clinic visit. The need and amount should be determined by the PMTCT counselor/manager based upon the initial assessment.

To Do

Urgent Needs

#Obtain 2-3 courses of NVP and AZT/D4T (for mother), liquid NVP and AZT for infant. This way there is no delay or potential for not having meds when an infected woman is in labor. We will probably need to identify a private Cipla distributor for this purpose. The authorized CIPLA distributor is Instyle Trading Concern C/O Kishor Man Pradhan Teku, Kathmandu Tel.No:4242329, 423704 98510 68724 Email : instyle@wlink.com.np

Meeting with Mr. Kishor. Met by Bijay. got the detailed product list. They will be sending over literature from CIPLA to our clinic via Manindra. Was ready to discuss special discounts on drugs direct from the company. Also met the CIPLA rep. More discounts on ARVs too.

#Devise strategy for getting evaluation (CD4) for mothers so that we can provide general ART to women if indicated. This may involve sending patients to Dhangadi, unless we could draw blood and send it to Dhangadi.

#Lobby NCASC for direct provision of HIV test kits and ARVs so that we don't have to have it go through DHO, thus resulting in additional potential for supplies not being available in time.

1. Co-ordinate with the local PLWHA's association and the hospices. fortnightly visit to the hospice could be a starting point.

Needs over next several months (person responsible; timeline)

#Sign MOU with NCASC to recognize us as PMTCT site and provide HIV test kits and ARVs (Bijay/Bibhav/Jason to pursue while they are in KTM; May/June)

#Train one of the ANMs to be in charge of PMTCT program (Jason; July)

#Hold one day training for ANMs and CHWs on PMTCT (ANM program manager, Jason; July)

#Design protocols for antenatal and postpartum home-based PMTCT care by CHWs (?; July)

#Develop electronic database of our PMTCT patients for M and E purposes

#Design protocol for nutritional supplementation

Timeline

Resources

#Visual resources for PMTCT available: http://www.womenchildrenhiv.org/wchiv?page=vc-10-00

References

WHO Guidelines are in NyayaHealth FolderShare

Nepal Guidelines are currently being revised and will likely be released later this year

http://medicine.plosjournals.org/perlserv?request=get-document&doi=10.1371/journal.pmed.0030417#journal-pmed-0030417-t001

Great article on HIV viral load testing in resource limited settings, including use of dried-blood spot PCR for diagnosis of HIV in infants