The limited evidence for facility-based individual models, including extending appointment spacing and refill periods, suggests increased cost effectiveness for the health system, improved quality of care and client outcomes and reduction in client time spent accessing health care.
Evidence of the effectiveness of facility-based individual models has been reported from three studies in Uganda. The first was a cost-effectiveness study conducted after implementing a pharmacy-only refill programme (PRP) (6-monthly clinical reviews and 2-monthly ART refills from the pharmacy). The PRP was less costly (US$520 vs. $655 annually) and more cost effective compared with the standard of care (1). The second study assessed clinic efficiencies after implementation of a fast-track system (6-monthly clinical visits with 2-monthly ART refills after seeing a triage nurse). Median waiting time was reduced from 102 to 20 minutes with increased patient and provider satisfaction in the intervention group compared with the standard of care (2). The third was a descriptive study after implementation of a refill pick-up system (6-monthly clinical review and ART refill 30-90 days at clinician discretion). There were significant reductions in missed appointments from 24.4% to 20.3% (AOR: 0.67; CI 0.59-0.77) and medication gaps of three days or more from 20.2% to 18.4% (AOR: 0.69; CI: 0.60-0.79) in the intervention group compared with the standard of care (3).
The SEARCH test and treat trial undertaken in Uganda and Kenya streamlined HIV care (nurse-driven triage and visits with physician referral for complex cases, 3-month combined clinical and ART refill visits for stable patients, consolidation of multiple chronic disease services at encounter; client appointment flexibility and missed appointment tracing) for adults (≥15 years; CD4 ≥350) and children (2-14 years; CD4 ≥500) from ART start at first visit. This resulted in 48 week retention and viral suppression amongst adults of 92% (897/972) and 93% (778/838) and retention and viral suppression among children of 89% (74/83) and 92% (65/71) (4). 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 (5). Costing of streamlined HIV care was similar or lower to standard of care cost estimates after accounting for VL testing and VL result counselling session costs (6).
Data reported from Malawi increasingly relates to a growing cohort of stable patients receiving multi-month ART refills or enrolled in a fast-track clinic system (6-monthly clinical review and 3-monthly ART refills from lay health care workers) known as the six-monthly appointment (SMA) strategy. In a mixed methods process evaluation, 69% of clients at 730 Malawian ART sites were accessing multi-month ART refills. In facilities offering SMA (11/730), 67% of clients were enrolled while in facilities offering community ART groups (CAGS) (34/740), 6% of clients were enrolled. Costs of each model were similar for health service but significantly lower than standard of care. CAGs halved client costs compared with multi-month ART refills or SMA (7).
In Guinea, the SMA model was piloted beginning in 2013 and expanded in 2014 followed the outbreak of the Ebola virus disease. The six-monthly spacing approach Rendez-cous de Six Mois (R6M) was scaled up to 60% of the cohort (n-1166). Clients outside of the capital city of Conakry received 6-monthly clinical visits and ART refills whereas those in Conakry received 3-monthly ART refills and 6-monthly appointments. The R6M group had a 60% reduction in the risk of attrition compared to the standard of care after adjusting for duration on ART and TB co-infection (8).
In a study reporting initial 12-month outcomes, among the 5,800 clients in the SMA model 97% (95% CI 96-97%) were retained (9, 10). A more recent retrospective study that assessed all stable patients eligible for the SMA model between 2008 and 2015 (n=18,957) found 80.8% enrolled with median time from eligibility to enrolment of six months (IQR 0-17 months). Cumulative probability of death or loss to follow up (LTFU) five years after first SMA eligibility was 56.3% (95% CI: 52.4-60.2%) among those never SMA enrolled, 13.9% (95% CI: 12.5-15.6%) among early SMA enrollees (within six months of eligibility) and 8.1% (95% CI 7.2-9.0%) among late SMA enrollees (more than six months after eligibility). In addition, a significantly higher rate of death or LTFU was observed among clients during non-SMA periods compared with those during SMA periods (adjusted rate ratio: 1.87, 95% CI 1.68-2.08, p< 0.001) (11).
There is also evidence for children and adolescents in individual facility-based models. Adolescents in Teen Clubs in Malawi were 3.7 times as likely to be retained in care compared to those not in Teen Clubs (12). Among children and adolescents at a specialised paediatric ART clinic in Tanzania in a facility fast-track model (2 month refills and 4 monthly clinical visits), there was lower LTFU and mortality compared with the pre-model cohort (13).
Three further sub-Saharan African studies are relevant to increasing ART refill periods. A recent Zambian analysis of 62,084 stable patients (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 6 months), the less likely the patient was to be have missed appointments, have a gap in medication or become LTFU (14). A retrospective cohort study of stable children and adolescents in seven urban specialised paediatric clinics across six sub-Saharan countries receiving multi-month ART refills reported low mortality and LTFU with viral suppression of 84.3% (15). Lastly, a study from Rwanda describes national level decision and planning processes for implementing 3 monthly ART refills for all stable clients (16).
Outside of sub-Saharan Africa, a facility-based individual differentiated ART delivery model implemented in Yangon, Myanmar has reported good early outcomes. Clients were differentiated between those unstable, short-term stable (29.15% of cohort) and long-term stable (51.19% of cohort). Short-term stable clients received 3-monthly combined clinical review and ART refills visits alternating between a physician and nurse. Long-term stable clients received 6-monthly clinical reviews from a nurse and 3-monthly fast tracked ART refills from a pharmacist or dispenser. The number of clients a team of a physician, nurse and counsellor could manage increased from 745 in 2011 to 1627 in 2014 averting 41 116 physician visits. Aggregated 12-month retention for both stable groups was 98.7% with clinical treatment failure of 0.8% and immunological treatment failure of 5.8% (17).