Effectiveness of interventions for unstable patients on antiretroviral therapy in South Africa: results of a cluster‐randomised evaluation

Abstract

Background As loss from HIV care is an ongoing challenge globally, interventions are needed for patients who don't achieve or maintain ART stability. The 2015 South African National Adherence Guidelines (AGL) for Chronic Diseases include two interventions targeted at unstable patients: early tracing of patients who miss visits (TRIC) and enhanced adherence counselling (EAC). Methods As part of a cluster‐randomised evaluation at 12 intervention and 12 control clinics in four provinces, intervention sites implemented the AGL interventions, while control sites retained standard care. We report on outcomes of EAC for patients with an elevated viral load (>400 copies/ml) and for TRIC patients who missed a visit by >5 days. We estimated risk differences (RD) of 3 and 12‐month viral resuppression (<400 copies/ml) and 12‐month retention with cluster adjustment using generalised estimating equations and controlled for imbalances using difference‐in‐differences compared to all eligible in 2015, prior to intervention roll‐out. Results For EAC, we had 358 intervention and 505 control site patients (61% female, median ART initiation CD4 count 154 cells/μl). We found no difference between arms in 3‐month resuppression (RD: −1.7%; 95%CI: −4.3% to 0.9%), but <20% of patients had a repeat viral load within 3 months (19.8% intervention, 13.5% control). Including the entire clinic population eligible for EAC with a repeat viral load at all evaluation sites (n = 934), intervention sites showed a small increase in 3‐month resuppression (28% vs. 25%, RD 3.0%; 95%CI: −2.7% to 8.8%). Adjusting for baseline differences increased the RD to 8.1% (95% CI: −0.1% to 17.2%). However, we found no differences in 12‐month suppression (RD: 1.5%; 95% CI: −14.1% to 17.1% but suppression was low overall at 40%) or retention (RD: 2.8%; 95% CI: −7.5% to 13.2%). For TRIC, we enrolled 155 at intervention sites and 248 at control sites (44% >40 years, 67% female, median CD4 count 212 cells/μl). We found no difference between groups in return to care by 12 months (RD: −6.8%; 95% CI: −17.7% to 4.8%). During the study period, control sites continued to use tracing within standard care, however, potentially masking intervention effects. Conclusions Enhanced adherence counselling showed no benefit over 12 months. Implementation of the tracing intervention under the new guidelines was similar to the standard of care. Interventions that aim to return unstable patients to care should incorporate active monitoring to determine if the interventions are effective.

HIV viral resuppression following an elevated viral load: a systematic review and meta‐analysis

“…A study from Zimbabwe found that patients undergoing three sessions of enhanced adherence counselling were more likely to resuppress compared to non‐attendance to enhanced counselling (relative risk of resuppression 2.8, 95% CI 1.8 to 4.2) . A study from South Africa found only a small benefit to EAC in terms of viral suppression within three months (8.1% increase compared to those not receiving EAC in adjusted analysis), and this difference was not sustained over 12 months .…”

Mortality estimates by age and sex among persons living with HIV after ART initiation in Zambia using electronic medical records supplemented with tracing a sample of lost patients: A cohort study

“…While optimum strategies are not well known, these may include improved access to self-testing [51], use of incentives [8], and male-friendly services that emphasize confidentiality and include flexible hours, integrated care, and reduced visit frequency [52,53], as well as decentralization of services such as through community adherence groups [1,8,51,54]. Furthermore, effective retention support mechanisms-such as undertaking early and intensive tracing among patients LTFU from ART services (as soon as 1 week after loss to follow-up) via phone calls, text messages, or community visits-may be an important strategy towards improving HIV outcomes among men, but require further study [55][56][57][58][59][60][61]. The recently published SEARCH Study may provide clues as to how better to reach and retain men [62].…”

HIV-1 re-suppression on a first-line regimen despite the presence of phenotypic drug resistance

“…Efforts should be intensified to identify patients at risk of poor adherence, and establish the support that is needed to overcome the most important barriers to adherence [41]. Enhanced adherence counselling alone, however, may not provide sufficient additional support than the current standard of care [42] and several successful interventions have been used to improve adherence and viral suppression [43,44]. This includes regimen simplification [45], use of single-tablet regimens [46], short message service (SMS) text messages [47], and communitybased ART programs [48,49].…”

“…This includes regimen simplification [45], use of single-tablet regimens [46], short message service (SMS) text messages [47], and communitybased ART programs [48,49]. Although adherence intensification is likely to increase the probability of re-suppression on the same regimen, this does not always hold true [42,50,51]. Resistance testing, where feasible, has been proposed for those with higher levels of viremia at failure to improve discernment between patients in need of a switch to second-line therapy versus those in need of adherence support interventions [51].…”