A packaged intervention to improve viral load monitoring within a deeply rural health district of South Africa

South Africa has the highest burden of human immunodeficiency virus (HIV) in the world with approximately 7·7 million people living with the disease. Therefore, South Africa, with 4.7 million (62%) people receiving antiretroviral therapy (ART), is home to the largest HIV treatment program in the world. Overall, according to United Nations Programme on HIV/AIDS (UNAIDS), the viral load (VL) suppression rate is 45% with 3·2 million of the 6·1 million people virologically suppressed [1]. The eastern coastal province of KwaZulu-Natal (KZN) experiences the highest burden of HIV infection in the country with 1·2 million people on treatment [2]. With the implementation of the national ‘universal test and treat’ programme, it is projected that nearly 6 million people nationally will be on treatment within the next few years.

With a South African national goal to end the AIDS epidemic by 2030 and with the country adopting the 90–90-90 UNAIDS goals where the third aim requires that 90% of all people on ART achieve and maintain virologic suppression [3], it is critical to optimize ART adherence for all patients in order to ensure this level of virologic suppression. Multiple research studies have validated the use of HIV-1 VL testing for monitoring ART response, determining prognosis [4‐7], and identifying early virological failure which may require ART changes [8]. Therefore, VL monitoring is of critical national importance in the effort to halt HIV transmission, combat the emergence of HIV drug resistance, and decrease morbidity and mortality [9, 10].

Although the rate of virologic suppression is close to 90% for individuals having a VL, the National Health Laboratory System (NHLS) reported only 35 to 60% of patients (depending upon the facility) actually had a VL obtained within 6 months of initiation of ART [11, 12]. Viral load performance rates are low compared to VL suppression rates, and it is possible that a large percentage of those missing a VL are virologically failing or entirely out of care. Part of this disparity could be attributed to reporting, monitoring, and documenting HIV VL testing and results within the clinical setting. This study implemented a package of interventions that sought to enhance record keeping and patient outreach at several clinics within a rural KZN health district in order to determine if (a) VL monitoring could be improved and (b) the impact this change would have on virologic suppression rates.

The majority of reports on HIV clinical outcomes from sub-Saharan Africa are derived from large, well-resourced, urban clinics. As a result, there are large deficiencies in our understanding of the epidemic across entire regions. This report is the first description of actual conditions within one of the most heavily burdened, rural health districts in the world. Despite worrisome deficiencies in virologic monitoring from 2014, implementation of a site-directed package of interventions resulted in significant increases in VL suppression and completion rates that were sustained over the ensuing 3 years. Although most of the clinics evaluated in this report remained below the 90% goal in 2017, continued similar efforts may eventually close the gap.

Data currently show that HIV drug resistance in South Africa is approaching a tipping point with the prevalence of known pre-treatment drug resistance (PDR) estimated at well over 10% [14, 15]. Because HIV drug resistance is associated with virologic failure, increased HIV transmission, and mortality, VL monitoring and suppression are critical goals for the national program. In order to address these goals, South African healthcare providers must identify the full scope of virologic failure in both their clinic and region; however, without enhanced documentation and effective community outreach, such information will remain incomplete. The collection of data and its utilization for clinical and public health purposes are the bedrock of quality healthcare.

There are multiple factors that drive missing VL results including clinic deficiencies, laboratory errors and patient barriers [16]. An initial root-cause analysis of the clinics in this health district identified several areas that required attention. For example, the clinical chart documentation was improperly completed (if at all), medication prescription and duration of medication supply information was often missing, and for many charts, the only documentation of a patient visit was the words “for refill buya [‘to return’ in isiZulu] one month”. Orders requesting VL testing on the appropriate month were missing, and among those who were tested, the majority of charts did not record the VL test results. These scenarios are especially common in critically understaffed and overburdened rural clinics where nurses are multi-tasking and expected to manage several health programs. Tedious, albeit important, documentation is often a convenient sacrifice to accommodate other more urgent tasks [17]. Additionally, it was discovered that family members not infrequently collected medication for patients precluding their ability to have VL testing performed. Finally, lost specimens or technical issues could arise within the laboratory.

There were several aspects of the packaged intervention that could account for the increases in VL monitoring observed in MKC and JZC above the increases observed in their peri-urban counterparts. The introduction of highly trained study nurses into the clinic along with periodic research doctor education for clinic nurses and staff during the Study Implementation period could have had the greatest impact as the most dramatic increase occurred during this time. Additionally, outreach during the Steady State period was effective at identifying and obtaining blood samples from patients who were due or overdue. Finally, a concerted effort to improve documentation during the Chart Intervention period allowed the increases to be sustained over time. These changes were a direct result of a series of collaborative meetings between clinic management and the ADReSS team. These meetings resulted in policy changes at the level of the health district including the introduction of the Viral Load Register and revised FLS. It was evident that a major benefit of the new form was shading one of the columns to “nudge” nurses and doctors for when a VL was due. The district managers also established ward-based outreach teams and community care givers to extend the efforts of the study nurses to the entire clinic population.

Although the peri-urban clinics did not implement the packaged intervention, the significant increase in virologic monitoring that was observed in these sites could be attributed to improved staff-to-patient ratios, assistance from nongovernmental organization partners, better use and monitoring of the VL sample log, easier and more accessible modes of transport, closer monitoring of individuals failing treatment, and tracking patients who fell out of care. The rural district hospital clinic, CDC, already approximated the peri-urban counterpart and did not change much over time. The fact that CDC is smaller and focused on more complicated patients with closer monitoring than in the peripheral primary health clinics could explain this phenomenon.

There were two broader programs which began after the Chart Intervention period that could have also improved virologic monitoring for the rural health clinics. In the first program, patients who were virologically suppressed were put on the Chronic Care Medicines Dispensing and Distribution programme. This is a public-private partnership where patients could collect their medication from private pharmacies at their convenience. Similarly, adherence clubs were established so that patients who were virologically suppressed would assemble at a convenient location close to their home (e.g. local community halls or places of worship) to interact and encourage adherence as well as to collect pre-packaged medications. Both options rewarded optimal adherence and simultaneously helped to reduce the queue in the clinics. In addition to benefiting patients with a convenient pick-up location, this and newer triage algorithms have helped to decompress clinic workload. Other strategies that may assist in reaching the 90 90 90 goals include Fast Queues for virologically suppressed patients, frequent workshops and training of staff on early warning indicators for treatment failure, and appointing a VL champion to maintain and monitor the VL register.

Substantial improvements in virologic monitoring and suppression occurred following implementation of a packaged intervention designed to improve care of persons living with HIV in a rural health district of KZN. Some of these improvements may have resulted from greater attention to VL monitoring in the region as a whole. The greatest change occurred at the earliest phase of this intervention and is likely related to enhanced attention to and focus on obtaining a VL at the appropriate time. Minor adjustments to clinical documentation, targeted outreach, and the introduction of a VL register could have contributed to the sustainability of this change. These findings demonstrate the well-described benefits that research endeavours provide to clinical programs. South Africa, with one of the largest ARV programmes in the world, would not be able to sustain the programme if accurate, reliable and verifiable data are not recorded. With the ever decreasing budget from the conditional grant, the South African government in conjunction with Presidents Emergency Plan For AIDS Relief (PEPFAR) has had to leverage the limited resources available and incorporate the assistance of outreach teams in order to combat the HIV epidemic in South Africa. Focus should also be placed on accurate documentation and data capture using periodic audits to identify which clinics need support and enhanced instruction. Larger sustained efforts will be needed to substantively impact these metrics while remaining cost-effective. Only, then will it be possible to assess exactly where our challenges lie in combating this epidemic.