Trial no.:
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PACTR202407898537403 |
Date of Approval:
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11/07/2024 |
Trial Status:
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Registered in accordance with WHO and ICMJE standards |
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TRIAL DESCRIPTION |
Public title
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Implementation of an upgraded strategy to reach zero HIV transmission by breastfeeding in Zambia: The PROMISE-ZERO study |
Official scientific title |
Implementation of an upgraded strategy to reach zero HIV transmission by breastfeeding in Zambia: The PROMISE-ZERO study |
Brief summary describing the background
and objectives of the trial
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Maternal HIV acquisition during late pregnancy or postpartum, chronic untreated maternal HIV infection or sub-optimal adherence to maternal ART postnatally increase the relative contribution of breastfeeding to the overall vertical transmission. Zambia is one of 21 priority countries for VT elimination due to high HIV prevalence among pregnant women . In 2019, breastfeeding contributed to the majority of vertical transmission events (5% of perinatal infection and 6% of breastfeeding transmission) according to UNAIDS estimates.
We have recently conducted a phase 3 randomized controlled clinical trial funded by EDCTP-2 in Burkina Faso and Zambia, which aimed at evaluating the efficacy and tolerance of an improved strategy to prevent postnatal HIV transmission through breastfeeding, the PROMISE-EPI trial. The intervention included a point of care GeneXpert® test for infant HIV diagnosis and maternal viral load monitoring, and rapid initiation of lamivudine oral solution as infant PNP in case of maternal viral load ≥1000 cp/mL until the end of the study or the end of breastfeeding.
PROMISE-ZERO is an implementation research aiming to demonstrate that this health intervention can be equally efficient when implemented in more challenging and 'real-life' settings, such as semi-urban and rural districts in Zambian provinces.
The ambition of PROMISE-ZERO study is to reach a near zero postnatal transmission while improving roll out performance, compared with standard of care (application of national prevention of vertical HIV transmission guidelines) in Zambia. PROMISE-ZERO study will be composed of a randomized trial clustered by Maternal and Child Health centers (MCHs), a health economic component, a qualitative component, and an environmental impact evaluation. |
Type of trial |
RCT |
Acronym (If the trial has an acronym then please provide) |
PROMISE ZERO |
Disease(s) or condition(s) being studied |
Infections and Infestations,Paediatrics |
Sub-Disease(s) or condition(s) being studied |
HIV/AIDS |
Purpose of the trial |
Prevention |
Anticipated trial start date |
01/10/2024 |
Actual trial start date |
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Anticipated date of last follow up |
01/04/2027 |
Actual Last follow-up date |
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Anticipated target sample size (number of participants) |
2100 |
Actual target sample size (number of participants) |
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Recruitment status |
Not yet recruiting |
Publication URL |
https://promise.w.uib.no/projects-studies-trials/ |
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