Program description
Since 2004, the International Center for AIDS Care and Treatment programs (ICAP) of Columbia University, Mailman School of Public Health (NY, USA), supports the implementation of HIV prevention, care and treatment programs in Rwanda including capacity building of staff, on-site mentoring, renovation of infrastructure, provision of equipment including laboratory machines, technical support to monitoring and evaluation, and operational research. In July 2006, ICAP supported the implementation of PMTCT programs at five health facilities (sites), including four district hospitals (DHs) and one health center (HC), and expanded to 32 sites (four DHs and 28 HCs) by December 2008 in the Western Province (Kibuye and Gisenyi regions) and Kigali, the capital city.
PMTCT services are routinely implemented within MCH services in Rwanda. Opt-out HIV counseling and testing (CT) is routinely provided in the ANC by trained nurses using sequential rapid HIV tests following the national algorithm, with results available the same-day [18]. Partner testing and couple CT is strongly promoted during pregnancy. The ARV regimens recommended for PMTCT are summarized in Figure 1[19]. WHO clinical staging and CD4 cell count assessment is recommended for all HIV-infected pregnant women. PMTCT staff were trained and mentored to assess the clinical stage and interpret the CD4 cell count test results. At the time of writing this report, the prescription of HAART for eligible patients was still limited to trained physicians, mostly working in ART clinics at district or referral hospitals, and could not be initiated by nurses working in PMTCT programs, predominantly at the HC level.
Two models of PMTCT service delivery were defined: "full package" sites where PMTCT and ART services were both located on the same premises and "stand-alone" sites where only PMTCT services were available on-site. Full package and stand-alone sites were authorized to provide md-ARV regimens to pregnant women. However, at the time of writing this report, both stand-alone and full package sites were providing dual ARV and the sd-NVP regimens, but only full package sites offered 'therapeutic' HAART and 'short-course' HAART (Figure 1). Women eligible for HAART in full package sites were initiated as soon as possible during pregnancy by the ART physician, whereas stand-alone sites referred HAART-eligible women to the nearest ART site for enrolment into ART services and the initiation of treatment.
Immunologic assessment during pregnancy
In 2006, of the five PMTCT sites, only one had the equipment required to measure CD4 cell counts (FACSCount [Becton Dickinson, San Jose, CA, USA]), the other four sites processed CD4 samples at the nearest laboratory possessing the necessary equipment. CD4 testing requisition was initially only performed for patients within ART clinics since a unique patient identifier (TRACnet number), only provided in the ART clinic, was required by the lab technician before blood could be taken. All pregnant women identified in PMTCT had to be referred to the ART clinic, within the same premises or via a referral (for stand-alone sites), to receive a TRACnet ID prior to CD4 testing requisition. In addition, because most CD4 blood samples originated from patients in ART services, pregnant women were therefore asked to come back on a different day, generally within a week after receipt of an HIV positive test result, as this allowed for common batching of blood samples from patients in ART services.
Between 2007 and 2008, DH supervisors teamed with mentors from ICAP to support health facilities in assessing and addressing the barriers (Figure 2) to immunologic assessment using an approach described elsewhere [20]. Figure 2 summarizes the changes recommended and gradually implemented at district and site levels.
Capacity building for the delivering of multidrug ARV (md-ARV) regimens initiation during pregnancy
In 2006, few nurses were trained to administer md-ARV regimens for PMTCT. Refresher training and practical sessions were organized and 297 staff were trained or retrained in 32 sites during the period under review. In each district, the site support staff members worked with district health teams to provide regular on-site mentoring following the completion of formal didactic training.
Data collection and statistical analysis
We collected the following routine PMTCT program indicators from the program monitoring database for the period July 2006 through December 2008: number of pregnant women attending first ANC, number of women known to be HIV positive at first ANC, number of women tested for HIV, number of women tested HIV positive, number of male partner counseled and tested for HIV, number of HIV positive women assessed for CD4 cell count during pregnancy, number of women who received CD4 cell count results, number of women with CD4 cell counts < 350 cells/mm3, number of HIV positive women enrolled into HIV care and treatment, number of women with CD4 cell counts < 350 cells/mm3 who initiated HAART for life 'therapeutic' HAART (t-HAART) during pregnancy, number of women who initiated short-course HAART (sc-HAART) for prophylaxis during pregnancy, number of women who initiated dual ARV (AZT/NVP) prophylaxis during pregnancy, number of women who received sd-nvp only (sd-NVP) for PMTCT prophylaxis during pregnancy. These indicators are routinely collected from site registers, and reported monthly to district health offices for compilation and transmission to the central level. In January 2007, the national program revised the PMTCT program monitoring tools, including registers and monthly summary forms, adding new indicators for CD4 cell count assessments and enrolment in HIV care and treatment programs and HAART initiation. We reported changes over time for each indicator, and using chi-square tests of association with two-sided p-values, we compared the performance of the program across each indicator for the period 2007 - 2008, when comprehensive PMTCT program data was available.
Finally, we compared the two model of service delivery (full package vs. stand-alone) across key program indicators using relative risks (RR) with associated 95% confidence intervals (CI) for the year 2008 only. The aggregated format of our data did not allow for controlling the effect of clustering across sites. In our analysis, we defined the following ARV regimens options as "more efficacious" ARV regimens (dual ARV, HAART for life, and sc-HAART). Data analysis was conducted using SAS version 9.1 (SAS Institute Inc., Cary, NC, USA). The data used for this analysis were aggregated site level indicators routinely collected by the national PMTCT program, and therefore did not contain any patient identifier. This secondary data analysis received approval from the Columbia University Institutional Review Board (IRB) and was also granted the non-research status (exempted from ethical review) by the Centers for Disease Control and Prevention (CDC), Atlanta, USA.