Box 10.4: Key implementation considerations: moving to lifelong ART for all pregnant and breastfeeding women (option B+)

Consolidated ARV guidelines, June 2013

Key implementation considerations

Consider the appropriate approach to scaling up. The infrastructure and operational implications of providing lifelong ART to all pregnant and breastfeeding women living with HIV must be carefully reviewed. Countries may consider a phased approach with an early learning phase before full scale-up.

Assure linkages to care and patient transfer. The location in which ARV drugs are provided to pregnant and breastfeeding women and the provision of long-term ART should be considered and decided before the programme is implemented. Will women continue to receive ART at the site providing ARV drugs for PMTCT or will they be transferred to an existing ART site? What strategies will be put in place to minimize the risk of women being lost to care as they are transferred to various ART service locations?

Review human resource requirements. Many staff at PMTCT sites have had limited training in and experience with providing ART, especially in settings in which Option A has been implemented for PMTCT. Capacity-building, task shifting and potential expansion of health personnel may be needed to allow PMTCT sites to successfully take on the additional responsibility of providing lifelong ART.

Promote adherence and retention. Adherence to therapy and retention in care of mother–baby pairs may be especially difficult in the postpartum breastfeeding period. What strategies will be put in place to monitor and support adherence and retention and re-engage in care those lost to follow-up, including both the mother and the HIV-exposed children?

Consider ethical issues. Initiating lifelong ART for all pregnant and breastfeeding women regardless of CD4 count may result in temporary disparities in access to treatment. For example, a pregnant woman with a high CD4 count may continue to receive ART after delivery, whereas her husband, other family members, neighbours or other women intending to get pregnant with a lower CD4 count may not yet be eligible for treatment. What process and strategies will be put in place at the policy and service delivery levels to address such possible disparities? How can the enrolment of all pregnant and breastfeeding women into lifelong treatment be leveraged to enhance a family approach, including getting partners and other household members tested for HIV and treatment?

Assure the quality of HIV testing. Developing quality-assurance programmes, including for HIV rapid testing (which in some settings may be the only test used to determine the initiation of lifelong ART) and appropriate use of testing algorithms, will be important to ensure optimal implementation in all areas of the country.

Assess laboratory monitoring needs. Although CD4 testing may not be required to initiate ART among pregnant women, toxicity and ART response monitoring, including viral load (which is key for assessing viral suppression), should be available, similar to all people receiving ART. Infant diagnosis is also essential to identify infants infected with HIV and to link them to the necessary treatment and care. Surveillance systems (which can be sentinel sites) should be established to evaluate the impact of ART on birth defects, pregnancy outcomes, safety among infants and young children exposed to breastfeeding as well as transmission outcomes and tolerance of first-line ART.

Implement adequate monitoring and evaluation frameworks. New strategies are needed to ensure high quality and longitudinal cohort data on the mothers and their HIVexposed infants across a range of service delivery entry points and across the continuum of care. For breastfeeding mothers and infants, the true effectiveness of a PMTCT programme depends on infant infection status and HIV-free survival at the end of the breastfeeding period and not on early infection status at age six weeks.

Provide infant prophylaxis. Infant prophylaxis is particularly critical for PMTCT in situations of late HIV diagnosis in the mother, limited or no antepartum maternal ART or if maternal ART is interrupted due to toxicity, intolerance or lack of adherence.

Assure continuous drug supply. An uninterrupted supply of maternal ART during pregnancy and breastfeeding is critical for PMTCT as well as maternal health. Adequate drug forecasting and drug supply chain is essential.