Literature DB >> 28777263

Stepped-Wedge Cluster Randomized Controlled Trial to Promote Option B+ Retention in Central Mozambique.

James T Pfeiffer1, Manuel Napúa, Bradley H Wagenaar, Falume Chale, Roxanne Hoek, Mark Micek, João Manuel, Cathy Michel, Jessica Greenberg Cowan, James F Cowan, Sarah Gimbel, Kenneth Sherr, Stephen Gloyd, Rachel R Chapman.   

Abstract

BACKGROUND: This randomized trial studied performance of Option B+ in Mozambique and evaluated an enhanced retention package in public clinics.
SETTING: The study was conducted at 6 clinics in Manica and Sofala Provinces in central Mozambique.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.

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Year:  2017        PMID: 28777263      PMCID: PMC7055502          DOI: 10.1097/QAI.0000000000001515

Source DB:  PubMed          Journal:  J Acquir Immune Defic Syndr        ISSN: 1525-4135            Impact factor:   3.731


  39 in total

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