Summary of published evidence

The principle of differentiating between the need for a clinical visit versus an ART refill visit, combined with extended ART refills, has been used in a number of facility-based individual models of ART delivery. These models go beyond only extending ART refills to reducing time spent at the facility setting up fast track or quick pick-up service organisation.

Evidence of the effectiveness of facility-based individual models has been reported from four studies in Uganda (1, 2, 3, 4). The first was a cost-effectiveness study conducted after implementing a pharmacy-only refill programme (PRP) (six-monthly clinical reviews and two-monthly ART refills from the pharmacy) (1). The PRP was less costly (US$520/year versus $655/year) and more cost effective than the standard of care (2). The second study assessed clinic efficiencies after implementation of a fast-track system (six-monthly clinical visits with two-monthly ART refills after seeing a triage nurse). Median waiting time was reduced from 102 to 20 minutes, with increased client and provider satisfaction in the intervention group compared with the standard of care The third was a descriptive study after implementation of a refill pick-up system (six-monthly clinical review and ART refill of 30-90 days at clinician discretion) (3). There were significant reductions in missed appointments from 24.4% to 20.3% (adjusted odds ratio, AOR: 0.67; 95% CI: 0.59-0.77) and medication gaps of three days or more from 20.2% to 18.4% (AOR: 0.69; 95% CI: 0.60-0.79) in the intervention group compared with the standard of care. The fourth evaluated PRP revised to six-monthly clinical reviews and three-monthly refills directly from the pharmacy (4). Overall retention was 99.3% and among those who completed 12 months in the PRP, viral suppression was maintained at 98.8%.

Data reported from Malawi describes a growing cohort of clinically stable clients receiving multi-month ART refills (MMD) or enrolled in a fast-track clinic system (six-monthly clinical review and three-monthly ART refills from lay healthcare workers) known as the six-monthly appointment (SMA) strategy. In a 2017 mixed-methods process evaluation, 100% of 730 Malawian ART sites offered multi-month ART refills with 72.9% of eligible clients accessing MMD (5).  Only 11 (1.5%) facilities offered SMA with 77.7% of eligible clients at these facilities enrolled in SMA. A 2018 retrospective study assessed all clinically stable clients eligible for the SMA model between 2008 and 2015 (n=22,633) at these 11 facilities (6).  It found that 81% enrolled in SMA with median time from eligibility to enrolment of twelve months (interquartile range: 3-27 months) and median cumulative time on SMA was 14.5 months.  The cumulative probability of retention in care one year after first SMA eligibility was 86.8% (CI: 85.6-87.8%) among those who never enrolled, 97.3% (CI: 96.8-97.6%) among early SMA enrolees and 99.8% (CI: 99.7-99.9%) among late SMA enrolees. The corresponding figures at five years were 47.4% (CI: 45.0-49.7%), 85.5% (CI: 84.0-86.9%) and 93.4% (CI: 92.8-94.0%). Among eligible clients enrolling for SMA, the adjusted hazard of attrition was 2.4 (95% CI: 2.0-2.8) times higher during periods of SMA discontinuation than during periods on SMA. Male gender, younger age, more recent SMA eligibility and WHO Stage 3/4 conditions in the past year were also independently associated with attrition from SMA. Approximately 26,000 consultations were “saved” during 2014 alone.

The Sustainable East Africa Research in Community Health (SEARCH) study, a test-and-treat trial in Kenya and Uganda, streamlined HIV care for adults (≥15 years; CD4 ≥350 cells/μl) and children (2-14 years; CD4 ≥500 cells/μl), including nurse-driven triage and referral for visits with physician for complex cases; three-month combined clinical and ART refill visits for stable clients; consolidation of multiple chronic disease services at encounter; client appointment flexibility; and missed appointment tracing from ART start at first visit. This resulted in 48-week retention and viral suppression among adults of 92% (897/972) and 93% (778/838) and retention and viral suppression among children of 89% (74/83) and 92% (65/71) in Uganda and Kenya, respectively (7). There were also significant reductions in time spent at the health facility and away from work or other usual activities. Out-of-pocket expenses for clients from baseline to one year later were reduced in Uganda, but not in Kenya (8). Costing of streamlined HIV care was similar or lower to standard of care cost estimates after accounting for viral load (VL) testing and VL result counselling session costs (9). In the Western Cape, South Africa, a “quick pick-up” model for clinically stable clients documented that 12 months after joining the model, 96% of clients were still in care, with 85% of them remaining in the model (10).

Two studies in Zambia evaluated fast-track facility DSD models. In 2020, a study compared all clients in routine facility-based care (n=83,764) with those in the  fast track model (n=3,671)where clients went directly to a dedicated room where they received an expedited clinical visit and ART refill every 3-months.  Those in the fast track model were more likely to be retained at 12 months (RR 1.52;) and maintain viral suppression (RR: 1.07)(11).  An analysis of 62,084 clinically stable clients (on treatment for >6 months with CD4 >200 cells/μl and not on TB treatment or unwell) showed that the longer the appointment interval and ART refill (up to six months), the less likely the client was to have missed appointments, have a gap in medication or become lost to follow up (12). Associated qualitative work to explore healthcare workers and client experiences of a fast-track model demonstrated that healthcare workers and clients viewed the model as being able to decongest the clinic and reduce waiting times (13). Overall, the model was highly applicable and acceptable. There were requests to carry out additional activities, such as taking weight and blood pressure that were continued, in the dedicated fast-track service room.  

One study in Kwa-Zulu Natal, South Africa compared outcomes after providing clients with a choice of differentiated ART delivery model (14). Clients were offered a choice between in-facility individual fast lane pick-up (also known as spaced fast lane appointment), out-of-facility individual pick-up, community adherence groups (CAGs) and community adherence clubs (ACs).  Retention was high at 12, 24 and 36 months across all DSD models when compared with those who qualified for a DSD model but remained in clinic-based care but was highest at 90.6% at 36-months for facility individual pick-up.  Viral suppression was high in both individual DSD models at 36-months (facility individual pick-up: 92.6%, community individual pick-up 93.8% compared with routine clinic care: 88.6%) and significantly lower for those who had participated in the group models.

Importantly, an increasing number of studies are evaluating DSD implementation.  In Zimbabwe a mixed-method DSD model implementation evaluation in a rural district with 26 health facilities found only 31% has implemented a fast track individual facility refill model but that clients spent 0.40 less time at the facility than those in routine care (15)

To date, the majority of differentiated ART delivery models have provided two or three months of ART. In Ethiopia, six-monthly refills were introduced at health facilities with biannual clinical visits. In total, 51% of clients were assessed to be eligible for this model, of whom 49% enrolled (16).

Three qualitative studies explored six-monthly ART refills. In Malawi, assessed provider and client perceptions of six versus three monthly refills.  Both clients and providers reported larger supply had more benefits. Providers concerns regarding medication storage challenges and the risk of sharing ART were not supported by clients (17). A second study, in Zambia, determined provider perceptions only and established that providers perceived multi-month dispending to hold significant benefits with advantages of six over three-monthly dispensing (18).  In Ethiopia,  focus groups were held with clients eligible for six-monthly refills some of whom enrolled and other who had not.  It showed high model satisfaction for those who enrolled but importantly that this model did not suit everyone.  Decreased facility visits, lack of private space for medication storage and mistrust of the healthcare systems were reasons for not enrolling (19)

Appointment spacing has also been shown to have benefits in low-prevalence settings. In Guinea in West Africa, the SMA model was piloted in 2013 and expanded in 2014 followed the outbreak of the Ebola virus disease (20). The six-monthly spacing approach, Rendez-vous de Six Mois (R6M), was scaled up to 60% of the cohort (n=1,166). Clients outside of the capital city of Conakry received six-monthly clinical visits and ART refills, and those in Conakry received three-monthly ART refills and six-monthly appointments. The R6M group had a 60% reduction in the risk of attrition compared with the standard of care after adjusting for duration on ART and TB co-infection.

Outside of sub-Saharan Africa, a facility-based individual differentiated ART delivery model implemented in Yangon, Myanmar, has reported good early outcomes (21). Clients were differentiated between unstable, short-term stable (29.2% of cohort) and long-term stable (51.2% of cohort). Short-term stable clients received three-monthly combined clinical review and ART refills visits alternating between a physician and nurse. Long-term stable clients received six-monthly clinical reviews from a nurse and three-monthly fast-tracked ART refills from a pharmacist or dispenser. The number of clients that a team made up of a physician, nurse and counsellor could manage increased from 745 in 2011 to 1,627 in 2014, averting 41,116 physician visits. Aggregated 12-month retention for both clinically stable groups was 98.7%, with clinical treatment failure of 0.8% and immunological treatment failure of 5.8%.

In politically unstable settings, such as the Central African Republic, South Sudan and the Democratic Republic of the Congo, the ability to provide extended refills of three to six months has also enabled continuity of ART delivery during periods of acute conflict (22).

Extended ART refills and fast-track service delivery models have also shown benefits for children. In a study assessing the implementation of multi-month prescriptions (MMPs) for children across six sub-Saharan African countries, clients aged 0-19 years were transitioned to MMPs when they were defined as clinically stable (23). The study analysed outcomes from more than 22,000 children, 66% of whom were transitioned to MMPs. Of those transitioned, 2.6% were lost to follow up and 2% died. Virological suppression remained high over the first five years in MMPs, ranging by year from 79% to 85%. These results provide reassuring evidence that children and adolescents who are clinically stable can have good outcomes with reduced visit frequencies and extended ART refills. 

A children-focused DSD model implemented in Tanzania utilized MMPs also introduced a fast-track component where children could go directly to the pharmacy to collect their ART refills after an initial triage (24). Clients in this model received ART refills every two months and had a clinical visit every four months. A total of 51.3% of the paediatric, adolescent and young adult ART clients were able to be enrolled in this model, with 98.8% remaining in care. Reduced clinical visits and extended ART refills for clinically stable adults, children and adolescents should be a priority model of differentiated service delivery that can yield benefits in both high- and low-prevalence settings.

References

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