Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202407898537403 Date of Approval: 11/07/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title 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 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
Anticipated date of last follow up 01/04/2027
Actual Last follow-up date
Anticipated target sample size (number of participants) 2100
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL https://promise.w.uib.no/projects-studies-trials/
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intervention arm From EPI-2 (when the infant is about 6 weeks old) to 18 months old. The activities of existing laboratories will be strengthened through the systematic use of POC assays for maternal viral load (Xpert® HIV-1 Viral Load) and early infant diagnosis (Xpert® HIV-1 Qual): - POC HIV-1 Qual at EPI-2 and M9 (and HIV rapid test at 18 months) for the infants - POC HIV-1 Viral Load at EPI-2 and M9 for the mothers HIV exposed uninfected infants whose maternal viral load higher or equal to 40 cp/mL will initiate daily oral lamivudine up to 18 months or until 1 month after complete cessation of breastfeeding, whatever the results of subsequent maternal viral load assessments. 1050
Control Group Control arm From EPI-2 (when the infant is about 6 weeks old) to 18 months-old At the control sites, mother/infant pairs fulfilling the eligibility criteria will have their usual follow-up according to national guidelines 1050 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 - Infant having a known allergy to the study drug or its components - Infant with a diagnosis of HIV infection at the time of inclusion Infant: 1 Month-23 Month 4 Week(s) 18 Month(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 30/05/2024 ERES converge
Ethics Committee Address
Street address City Postal code Country
Plot No. 272, Cnr Olive Tree Meanwood Road, Meanwood Ibex Lusaka Lusaka Zambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The infant HIV infection incidence between EPI-2 and M18 M9 and 18M
Secondary Outcome Interviews to explore the contextual and individual factors influencing achievement of recruiting the target population During the trial
Secondary Outcome EPI-2 attendance of mothers living with HIV compared to the number of recruited participants EPI-2
Secondary Outcome Analysis of the data routinely collected on HIV negative mothers to evaluate factors related to mother’s seroconversion during breastfeeding 6 weeks to 18 months
Secondary Outcome Interviews to evaluate which factors influencing the effectiveness of the strategy during the trial
Secondary Outcome 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) M18
Secondary Outcome The proportion of mothers with viral load < 1000 copies/mL at 18 months M18
Secondary Outcome Interviews to explore factors associated with the acceptability of the PROMISE-ZERO intervention During the trial
Secondary Outcome Interviews to explore factors related to the actual delivery of the strategy proposed in the study During the trial
Secondary Outcome Lost to follow-up rate at M18 between both arms (defined as infant with no HIV rapid test at M18) M18
Secondary Outcome Comparison of time to get the results for viral load and diagnosis in children in the 2 arms EPI-2 to 18 months
Secondary Outcome The proportion of observed time on lamivudine (based on registers and missed visits) EPI-2 to 18 months
Secondary Outcome Direct, medical costs, direct non-medical costs, indirect costs and composite outcomes to estimate the cost-effectiveness and budget impact of the intervention EPI-2 to 18 months
Secondary Outcome Carbon footprint of the intervention compared to the standard of care to estimate the environmental impact of the intervention EPI-2 to 18 months
Secondary Outcome Interviews to explore setting-level factors related to program maintenance after the clinical trial during the trial
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Chawama Chawama Lusaka Zambia
Matero Matero Lusaka Zambia
Chipata Chipata Lusaka Zambia
Kanyama Kanyama Lusaka Zambia
Petauke Urban Health Centre Petauke Petauke Zambia
Kapata Urban Health Centre Kapata Chipata district Zambia
Chibolya Health Post Chibolya Katete district Zambia
Mchini Health Post Mchini Chipata district Zambia
Sinda Rural health center Sinda Sinda Zambia
Namseche Rural Health Centre Namseche Chipata district Zambia
Chipata Hospital Affiliated Health Centre Chipata Chipata Zambia
Miinga Hospital Affiliated Health Centre Miinga Petauke district Zambia
Walela Health Post Walela Chipata district Zambia
Muzeyi Rural Health Centre Muzeyi Chipangali district Zambia
Mwanjawanthu Rural Health Centre Mwanjawanthu Petauke district Zambia
Prisons Health Post Petauke Petauke Zambia
Katete Boma Health Centre Katete Katete Zambia
St Francis Hospital Affiliated Health Centre St Francis Katete district Zambia
Msekera Rural Health Centre Msekera Chipata district Zambia
Chipata Trades Mini Hospital Chipata Chipata Zambia
Katandala Rural Health Centre Katandala Chipata district Zambia
Lunkwakwa Urban Health Centre Lunkwakwa Chipata district Zambia
Mphangwe Health Post Mphangwe Katete district Zambia
Kakwiya Rural Health Centre Kakwiya Petauke district Zambia
Manyane Rural Health Centre Manyane Petauke district Zambia
Nyamphande Rural Health Centre Nyamphande Petauke district Zambia
Kalindawalo Rural Health Centre Kalindawalo Petauke district Zambia
Kaselo Health Post Kaselo Petauke district Zambia
Nyanje Hospital affiliated Health Center Nyanje Sinda district Zambia
Chikando Chikando Chipata district Zambia
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP3 Vlieslaan 56-60 Brussels Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University Teaching Hospital Nationalist Rd Lusaka Zambia Hospital
COLLABORATORS
Name Street address City Postal code Country
Thorkild Tylleskar University of Bergen Bergen Norway
Elly Nuwamanya Infectious Diseases Institute Kampala Uganda
Philippe Vande Perre 60 rue de Navacelles Montpellier 34394 France
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mwiya Mwiya mwiya2002@yahoo.com +260977757501 Nationalist Rd
City Postal code Country Position/Affiliation
Lusaka Zambia Technical director of UTH HAP
Role Name Email Phone Street address
Scientific Enquiries Nicolas Nagot n-nagot@chu-montpellier.fr +33467338970 60, rue de Navacelles
City Postal code Country Position/Affiliation
Montpellier France Director of PCCEI
Role Name Email Phone Street address
Principal Investigator Rachel King rach@vtx.ch +256785304516 60, rue de Navacelles
City Postal code Country Position/Affiliation
Montpellier France Social sciences researcher
Role Name Email Phone Street address
Public Enquiries Anais Mennecier anais.mennecier@inserm.fr +33434359117 60 rue de Navacelles
City Postal code Country Position/Affiliation
Montpellier France Clinical project manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in the articles will be shared after being unidentified Informed Consent Form,Study Protocol Beginning 6 months and ending 5 years following article publication Proposals must be submitted to the investigators
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://promise.w.uib.no/projects-studies-trials/ No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information