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Page 3 of 7  Original Research


              TABLE 1: Evolution of the South African prevention of mother-to-child transmission and antiretroviral therapy guidelines, 2002–2015. 18,19,20,21,23,24
                       2002     2004        2008        2010             2012          2013            2015
              PMTCT    Intrapartum   Intrapartum   Option A –   Integration of ART   Withdrawal of free   Option B – triple therapy   Option
              guidelines  single-dose   single-dose NVP  zidovudine   initiation within   infant formula for   for all PWLHIV, with   B+ – lifelong ART
                       NVP                  monotherapy for   antenatal clinics  WLHIV who elect   postpartum withdrawal   for all PWLHIV,
                                            PMTCT, for                   not to breastfeed  of therapy in those not   regardless of level
                                            pregnant women                             eligible for lifelong   of immune
                                            not eligible for                           treatment       suppression
                                            lifelong treatment
              Infant   Single-dose   Single-dose NVP   7 days of AZT, or   6 weeks of NVP and   -  6 weeks of NVP and   6 weeks NVP and
              prophylaxis  NVP after   after birth  28 days if the   extended for the   extended for the   extended to 12
                       birth                mother received   duration                 duration of     weeks if infant at
                                            less than 4 weeks   of breastfeeding if    breastfeeding if   high risk of MTCT†
                                            of AZT or ART  mother not on ART           mother not on ART
              ART      -        Triple therapy  Triple therapy  ART eligibility criteria for   ART eligibility   ART eligibility criteria for   ART for all PWLHIV,
              guidelines        Eligibility criteria:   Eligibility criteria:   pregnant women: CD4 ≤   criteria for pregnant   pregnant women: CD4 ≤   regardless of level
                                CD4 < 200 cells/µL,  CD4 < 200 cells/  350 cells/µL, or WHO   women: CD4 ≤ 350   350 cells/μL, or WHO   of immune
                                or WHO stage 4   μL, or WHO stage   stage 3 or 4 disease  cells/μL, or WHO   stage 3 or 4 disease  suppression
                                disease     4 disease                    stage 3 or 4 disease
              PMTCT, prevention of mother-to-child transmission of HIV; ART, antiretroviral therapy; AZT, zidovudine; WLHIV, women living with HIV; PWLHIV, pregnant women living with HIV; MTCT, mother-to-
              child transmission of HIV; NVP, nevirapine.
              †, Infants at high risk of MTCT: mother had no ART or less than 4 weeks of ART during pregnancy and infant breastfed, HIV-positive diagnosis made during breastfeeding.
              In 2013, WHO Option B, where all pregnant and postpartum   The indicators that we collected data for include the following:
              WLHIV were initiated on an efavirenz-based fixed-dose   pregnant women presenting for their first antenatal visit and
              combination, was introduced.  Treatment was stopped   gestational age at first visit; pregnant women tested for HIV
                                       23
              postpartum  if  not breastfeeding,  or  after  cessation  of   during pregnancy and those presenting already known to be
              breastfeeding, if the woman was not eligible for lifelong ART   living with HIV and whether already on ART; PWLHIV who
              for her own health.  The most recent PMTCT guideline   were issued with single-dose NVP prophylaxis antenatally;
                              23
              change was in 2015 when all pregnant and postpartum   PWLHIV who had a CD4 count done during pregnancy and
              women living with HIV became eligible for lifelong treatment   those who had a CD4 count of < 200 cells/µL and ≤ 350 cells/
              regardless of CD4 count level, Option B+. 24          µL; the number of ART-eligible pregnant women who were
                                                                    initiated on  ART;  and the number of  HIV-exposed  infants
              The 2013 PMTCT guideline reinforced the recommendation   who were tested for HIV and those found to be HIV-positive.
              that was first made in the 2010 guideline that pregnant women
              who initially tested HIV-negative were to be routinely retested   The prevalence  of human immunodeficiency  virus among
              during pregnancy at around 32 weeks’ gestation. For women   pregnant  women  was  calculated  using  the  number of
              who presented intrapartum with an unknown HIV status, or   pregnant women presenting at the first antenatal visit already
              with a negative HIV test done prior to 32 weeks’ gestation,   known to be living with HIV and those newly diagnosed as
              or  done more than 12 weeks prior to delivery, the    HIV-positive during pregnancy as the numerator and the
              recommendation was for retesting intrapartum. Postpartum,   total number of first visits as the denominator. The proportion
              the recommendation was to repeat the HIV test at 6 weeks   of ART-eligible pregnant women was calculated using the
              postpartum and every 3 months during breastfeeding. In the   number of PWLHIV who had a CD4 count of < 200 cells/µL
              2015 guidelines, the recommendation is for routine repeat HIV   or ≤ 350 cells/µL, depending on the CD4 count threshold at
              testing every 3 months during pregnancy, intrapartum and   the time, divided by the total number who had a CD4 count
              postpartum as per the 2013 guidelines. Routine testing of HIV-  done. For the 2013–2015 data, all PWLHIV who were not on
              exposed infants, using HIV polymerase chain reaction (PCR),   ART at the first antenatal visit were regarded as eligible for
              became standard of care from 2004, and was offered at around   treatment, in line with the guidelines. The number of HIV-
              6 weeks of age. Also, as part of routine care, an HIV antibody   exposed infants who were found to be HIV-positive at around
              test was  done  at  18  months  in  infants  who  initially  tested   6 weeks of age was used to calculate the MTCT rate, using as
              negative at early infant diagnosis. Since 2015, routine testing of   the denominator the number of HIV-exposed infants tested
              HIV-exposed infants was done at birth, 10 weeks of infant age,   in the 13 facilities. Data were analysed using Stata® version
              6 weeks post-cessation of breastfeeding and at 18 months.  14.0 (Stata Corporation, College Station, TX, USA).

              It is in this background of evolving guidelines and the
              changing focus of donor funding that we evaluated the   Ethical consideration
              Soweto PMTCT programme.                               The study was approved by the University of the
                                                                    Witwatersrand Human Research Ethics Committee
              Data management and analysis                          (Reference  No.  M140461),  and  access  to  the  facilities  was
                                                                    granted by the Johannesburg Health District Office.
              As  part  of  routine reporting to the District  Health  and
              Information System (DHIS), PMTCT data were collected on   Results
              PWLHIV and HIV-exposed infants, and the indicators
              collected changed over time with evolving PMTCT guidelines.   From January 2002 to December 2008, around 30 000 pregnant
              We extracted aggregate data from paper-based and electronic   women presenting for their first antenatal visit were seen in
              registers on core PMTCT indicators for the period 2002–2015.   the programme annually (Table 2).  As services became

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