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Table 1 Outcomes and definitions

From: Continuous quality improvement interventions to improve long-term outcomes of antiretroviral therapy in women who initiated therapy during pregnancy or breastfeeding in the Democratic Republic of Congo: design of an open-label, parallel, group randomized trial

Outcomes

Definition

Primary

 Loss-to-follow-up

Proportion of participants for whom the whereabouts is unknown at: delivery, 6 weeks, 12 and 24 months postpartum

 Virological suppression

Proportion of participants with undetectable viral loat at: delivery, 12 and 24 months postpartum.

Secondary

 Timely infant HIV diagnosis

Proportion of HIV-exposed infant with an appropriate HIV test result at 6 weeks, 12 and 24 months postpartum.

 Timely ART initiation

Proportion of HIV-infected participants (mother and infant) initiated on ART within 2 weeks of diagnosis

 Retention in care

Proportion of participants who are known to be receiving HIV care 6 weeks, 12 and 24 months postpartum.

 Non-adherence to scheduled visits

Proportion of participants whose whereabouts is unknown or who are in care but have missed at least one scheduled visit over the evaluation period at: delivery, 6 weeks, 12 and 24 months postpartum.

 Virological suppression

Proportion of participants with undetectable viral load at: delivery, 12 and 24 months postpartum.

 MTCT rates

Proportion of infants born to participating women who tested positive for HIV at 6 weeks, 12 and 24 months postpartum.

 Survival

Proportion of participants known to be alive at 6 weeks, 12 and 24 months postpartum.