01 Nov 2017
Pfeiffer JT, Napúa M, Wagenaar BH, Chale F, Hoek R, Micek M, Manuel J, Michel C, Cowan JG, Cowan JF, Gimbel S, Sherr K, Gloyd S, Chapman RR. (2017) Stepped-Wedge Cluster Randomized Controlled Trial to Promote Option B+ Retention in Central Mozambique. Journal of Acquired Immune Deficiency Syndrome
This randomized trial studied performance of Option B+ in Mozambique and evaluated an enhanced retention package in public clinics.
The study was conducted at 6 clinics in Manica and Sofala Provinces in central Mozambique.
Seven hundred sixty-one pregnant women tested HIV+, immediately initiated antiretroviral (ARV) therapy, and were followed to track retention at 6 clinics from May 2014 to May 2015. Clinics were randomly allocated within a stepped-wedge fashion to intervention and control periods. The intervention included (1) workflow modifications and (2) active patient tracking. Retention was defined as percentage of patients returning for 30-, 60-, and 90-day medication refills within 25–35 days of previous refills.
During control periods, 52.3% of women returned for 30-day refills vs. 70.8% in intervention periods [odds ratio (OR): 1.80; 95% confidence interval (CI): 1.05 to 3.08]. At 60 days, 46.1% control vs. 57.9% intervention were retained (OR: 1.82; CI: 1.06 to 3.11), and at 90 days, 38.3% control vs. 41.0% intervention (OR: 1.04; CI: 0.60 to 1.82). In prespecified subanalyses, birth before pickups was strongly associated with failure—women giving birth before ARV pickup were 33.3 times (CI: 4.4 to 250.3), 7.5 times (CI: 3.6 to 15.9), and 3.7 times (CI: 2.2 to 6.0) as likely to not return for ARV pickups at 30, 60, and 90 days, respectively.
The intervention was effective at 30 and 60 days, but not at 90 days. Combined 90-day retention (40%) and adherence (22.5%) were low. Efforts to improve retention are particularly important for women giving birth before ARV refills.