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A stepped wedge cluster randomized controlled trial to promote Option B+ retention in central Mozambique.

Artigo em Inglês | MEDLINE | ID: mdl-28777263


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: 761 pregnant women tested HIV+, immediately initiated ART, and were followed to track retention at 6 clinics from May 2014 - 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, 3.08). At 60 days, 46.1% control vs. 57.9% intervention were retained (OR: 1.82; CI: 1.06, 3.11), and at 90-days, 38.3% control vs. 41.0% intervention (OR: 1.04; CI: 0.60, 1.82). In pre-specified subanalyses, birth prior to pick-ups was strongly associated with failure - women giving birth prior to ARV pick-up were 33.3 times (CI: 4.4, 250.3), 7.5 times (CI: 3.6, 15.9) and 3.7 times (CI: 2.2, 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.