Table 4 Study objectives and justification for the study endpoints
Objectives | Endpoints | Justification for endpoints | Putative mechanisms of action |
|---|---|---|---|
Primary | |||
To evaluate the efficacy of the CombinADO strategy on the rate of HIV viral suppression among AYAHIV receiving HIV care at 12 health facilities in Nampula Mozambique | Viral suppression < 50 copies/mL at 12 months among AYAHIV in care at intervention and control sites | HIV viral suppression is a major goal of effective ART services, is readily measured, and is a well-established as the gold standard outcome to evaluate HIV treatment interventions | The CombinADO strategy is hypothesized to increase viral suppression through increases in retention in care and/or adherence to ART in the target population |
Secondary | |||
To evaluate the efficacy of the CombinADO strategy on the rate of retention in care among AYAHIV receiving HIV care at 12 health facilities in Nampula Mozambique | Retention in care defined as objective evidence of engagement in the preceding 90 days among AYAHIV in care at intervention and control sites | Increases in retention in care is a causal intermediate (mediator) through which the CombinADO strategy may increase HIV viral suppression | Different elements of the CombinADO strategy are likely to support AYAHIV’s retention in care during the intervention period |
To evaluate the efficacy of the CombinADO strategy on the rate of adherence to ART among AYAHIV receiving HIV care at 12 health facilities in Nampula Mozambique | Self-reported using the Wilson measure; TDF levels on a subset of participants in care, selected retrospectively in a case-control substudy comparing AYAHIV who have VL < 50 copies/mL, versus those with VL ≥ 50 copies/mL | Increases in ART adherence is a causal intermediate (mediator) through which the CombinADO strategy may increase HIV viral suppression | Different elements of the CombinADO strategy are likely to support AYAHIV’s adherence to ART during the intervention period |
To assess the uptake, feasibility, and acceptability of the CombinADO strategy at 12 health facilities in Nampula Mozambique | Uptake and utilization of intervention components by AYAHIV among AYAHIV in care at intervention and control sites; implementation fidelity by health care workers and key informants | Uptake and implementation of the intervention is an intermediate (mediator) through which the CombinADO strategy may increase HIV viral suppression | Inadequate uptake and implementation of the intervention and/or components can limit efficacy of the intervention |
To estimate the cost and incremental cost-effectiveness of the CombinADO strategy at 12 health facilities in Nampula Mozambique | Incremental cost per additional case of viral suppression < 50 copies/mL at 12 months | HIV viral suppression provides an objective summary measure of intervention effectiveness | The CombinADO strategy is hypothesized to increase viral suppression through increases in retention in care and/or adherence to ART in the target population |