HIV/AIDS Paediatrics
Conditions
Interventions
Intervention arm
Control arm
Sponsors
University Teaching Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The mother/infant pairs must meet the following criteria: - Mother living with HIV attending the EPI-2 visit Or - Mother diagnosed with HIV after EPI-2 visit while she is still breastfeeding And - Breastfed infant - Mother aged 15 years or above
Exclusion criteria
Exclusion criteria: - Infant having a known allergy to the study drug or its components - Infant with a diagnosis of HIV infection at the time of inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The infant HIV infection incidence between EPI-2 and M18 | — |
Secondary
| Measure | Time frame |
|---|---|
| Interviews to explore the contextual and individual factors influencing achievement of recruiting the target population;EPI-2 attendance of mothers living with HIV compared to the number of recruited participants;Analysis of the data routinely collected on HIV negative mothers to evaluate factors related to mother’s seroconversion during breastfeeding;Interviews to evaluate which factors influencing the effectiveness of the strategy;The high risk period for HIV transmission to infants, defined by the cumulative duration when the mother's viral load is = 1000 copies/mL, and the child is not on PNP (based on registers and missed visits);The proportion of mothers with viral load < 1000 copies/mL at 18 months ;Interviews to explore factors associated with the acceptability of the PROMISE-ZERO intervention;Interviews to explore factors related to the actual delivery of the strategy proposed in the study;Lost to follow-up rate at M18 between both arms (defined as infant with no HIV rapid test at M18);Comparison of time to get the results for viral load and diagnosis in children in the 2 arms;The proportion of observed time on lamivudine (based on registers and missed visits);Direct, medical costs, direct non-medical costs, indirect costs and composite outcomes to estimate the cost-effectiveness and budget impact of the intervention;Carbon footprint of the intervention compared to the standard of care to estimate the environmental impact of the intervention;Interviews to explore setting-level factors related to program maintenance after the clinical trial | — |
Countries
Zambia
Contacts
Public ContactAnais Mennecier
Clinical project manager
Outcome results
None listed