Extending Dispensing Intervals for Stable Patients on ART

Grimsrud, Anna MPH*; Patten, Gabriela MSc; Sharp, Joseph; Myer, Landon MBChB, PhD*; Wilkinson, Lynne BA, LLB; Bekker, Linda-Gail MBChB, FCP, PhD‡,§

JAIDS Journal of Acquired Immune Deficiency Syndromes:
doi: 10.1097/QAI.0000000000000098
Letters to the Editor
Author Information

*Division of Epidemiology & Biostatistics, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa

Médecins Sans Frontières, Cape Town, South Africa

Desmond Tutu HIV Foundation, Cape Town, South Africa

§Department of Medicine, University of Cape Town, Cape Town, South Africa

These findings were presented at the International Conference on AIDS & STIs in Africa, December 2013, Cape Town, South Africa.

The authors have no conflicts of interest to disclose.

A. G. is supported by funding from the Canadian Institutes of Health Research and the South African Centre for Epidemiological Modeling and Analysis. L. M. is supported by an International Leadership Award from the Elizabeth Glaser Pediatric AIDS Foundation.

Article Outline

To the Editors:

Over the past decade, antiretroviral therapy (ART) programs have been rapidly expanded in resource-limited settings. South Africa has the largest ART program in the world with nearly 2 million people accessing treatment.1 ART Adherence Clubs (ACs) have been implemented in the Western Cape of South Africa to improve long-term retention in care for stable ART patients by providing quick and patient-friendly access to treatment and care while decreasing the burden on overstretched health care facilities.

ACs are facilitated by a lay club facilitator and consist of approximately 30 stable patients who meet every 2 months either at the health facility or in a community venue. Patients are eligible to join an AC if they have been on the same ART regimen for 12 months or more, have had 2 consecutive undetectable viral loads, and do not have any other medical condition requiring more frequent follow-up. Each visit consists of a quick clinical assessment and on-site dispensation of prepacked ART with a nurse available for referral as necessary.2 Early evidence suggests ACs are effective in retaining stable patients in care with high levels of virologic suppression.3

Migration is common in sub-Saharan Africa where patients move away from home for economic reasons. This movement results in circular migration patterns that impact adherence and retention in antiretroviral care. In the Western Cape, many patients return to their province of origin over the holiday period of December/January and do not seek care while away. This migration puts patients at risk of ART interruptions and defaulting care, especially when time away from the Western Cape is extended beyond the period initially intended due to unforeseen circumstances.4 The extent of this seasonal migration has not been quantified, but experience at the clinics suggests that most patients are affected.

Current ART pharmacy guidelines in South Africa require ART scripts to be written every 6 months despite national adult ART guidelines that only require an annual clinical assessment for stable ART patients. Although national policy allows 3-month dispensing, there is great variation between provinces and individual facilities. Accordingly, stable patients in the Western Cape receive a maximum of 2 months of ART per visit. To support ART patients who most commonly migrate over the holiday period, ACs that were scheduled to meet between mid-December 2012 and mid-January 2013 were given 4 months of ART in their October/November 2012 AC visit. Four months of ART were dispensed as two 2 monthly supplies to align with national policy. Data are limited on how long ART dispensing intervals should be to optimize retention in care. The objective was to compare outcomes among AC members who received 2-month ART (normal standard of care) to 4-month ART.

The Hannan Crusaid Treatment Center in Gugulethu and Ubuntu Site B Clinic in Khayelitsha are large treatment facilities in periurban, high-prevalence areas of Cape Town, South Africa. Both services have been described, in detail, previously and are or have previously been supported by the nongovernmental organizations Desmond Tutu HIV Foundation and Médecins Sans Frontières, South Africa, respectively.5–11

All adult ACs at the Hannan Crusaid Treatment Center and Ubuntu Site B Clinic who were enrolled in an AC before the end of 2012 were included in the analysis. Adult ACs include stable patients of 18 years or older. AC procedures at the 2 sites are similar.

Data presented includes the number and proportion of patients receiving each interval of ARVs overall and by site. ACs were assigned to receive either 4 or 2 months of treatment based on when their December/January visit was scheduled. ACs with a scheduled visit between 17 December and 18 January were assigned to the 4-month group. Outcomes of patients who received two 2-month prescriptions simultaneously (ie, 4 months) of ART (group A) are compared with those who received the standard 2 months of ART (group B). Outcomes include the proportion of patients defaulting from ACs 4 months after their final visit in 2012 and for those with blood results in 2013 the proportion of patients who were not virally suppressed (viral load above 400 copies/mL). Associations by group were assessed with χ2 tests.

A total of 1860 patients in 1 of 76 ACs were eligible for the analysis (Table 1). Over the holiday period, 42 ACs were given 4 months of ART and 34 ACs were given 2 months of ART. Four months after the final AC visit in 2012, 4.0% had defaulted care overall [group A, 41 of 1054 (3.9%); group B, 33 of 806 (4.1%)]. There was no difference in the risk of defaulting from an AC in group A who received 4 months of ART compared with group B who received 2 months of ART (risk ratio, 0.95; 95% confidence interval: 0.61 to 1.49; P = 0.82). Of the 1507 of patients with a blood draw at their first or second 2013 visit, 3.6% were not virally suppressed [group A, 31 of 842 (3.7%); group B, 23 of 665 (3.5%)]. No significant associations were observed between viral suppression and group (risk ratio, 1.06; 95% confidence interval: 0.63 to 1.81; P = 0.82). Between the last visit of 2012 and the first schedule visit of 2013, none of the club patients died.

This analysis was limited to 2 sites where 4 months of ART was provided to those clubs whose 2-month return date would have fallen in December or the first part of January. We only compared the short-term outcomes of the 2 groups. There was some variability in the proportion of patients defaulting in the 2 arms between sites. The small sample size restricted our ability to determine if these differences were meaningful. Although both sites were using the standardized AC model, there is potential for some factors to differ at the site level. Clubs in the 2 arms may have been operational for different amounts of time. A limitation of our data is that we only looked at extending 1 refill interval; and therefore, further research is needed to ascertain the impact of regular longer supply intervals.

Short-term outcomes among all AC patients were good with no difference in defaulting or viral suppression between groups. Longer ART supply refill intervals over holiday periods can support the extensive circular migration among patient populations without having a negative impact on patient outcomes. These findings also suggest that less frequent visits for stable ART patients should be evaluated as regular practice to alleviate an unnecessary burden on patients and clinic resources.

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