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.: PACTR201312000678196 Date of Approval: 15/10/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Towards eMTCT: Innovative strategies for improving mother-child pair retention and access to essential PMTCT care in Malawi
Official scientific title Towards eMTCT: Innovative strategies for improving mother-child pair retention and access to essential PMTCT care in Malawi
Brief summary describing the background and objectives of the trial Poor mother-child pair retention has been documented as one of the main challenges in delivering HIV Prevention of Mother-to-child (PMTCT) programs. The overall research objective of this study is to compare the effectiveness of three mother-child pair retention strategies, namely; Mother¿Infant¿Pair (MIP) Clinic, MIP Clinic plus SMS Frontline Technology and the current standard of care [status quo], on retention of mother¿infant pairs in HIV care and treatment.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) PRIME
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Supportive care
Anticipated trial start date 13/05/2013
Actual trial start date 13/05/2013
Anticipated date of last follow up 31/08/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 2310
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
RPC521 World Health Organization Ethics Review Committee
P.02/12/1192 College of Medicine Research and Ethics Committee
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 block randomisation Statistician conducting randomization situated off-site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Status Quo Not applicable 24 months Standard of Care 10
Experimental Group Mother Infant Pair Clinic Not applicable 24 months Seamless provision of integrated HIV, maternal and child health services 10
Experimental Group Mother Infant Pair Clinic plus SMS texting Not applicable 24 months Seamless provision of integrated HIV, maternal and child health services plus sending sms reminders to defaulters 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All HIV-positive pregnant women who attend antenatal clinics in the selected study health centers and babies born to them. 1. Those who not permanent residents of catchment villages surrounding the health facilities and who plan to move out of the catchment villages in the following 6-9 months. 2. Those who at the time of enrollment intend to relocate to other districts, 3. Those who cannot independently give informed consent because of immediate life¿threatening illness or mental disorders. 4. Those who did not receive ANC care, including the initial visit, at the randomized health centers or received their first HIV test in the postnatal period. This is to make sure that we are assessing retention of the mother¿infant pairs from the first point of entry into the PMTCT cascade. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 45 Year(s) Female
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 04/06/2012 College of Medicine Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Mahatma Gandhi Road Blantyre BT3 Malawi
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 19/07/2012 WHO Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
20 Avenue Appia Geneva 27 CH-1211 Switzerland
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of HIV-exposed infants retained in HIV care and treatment at 12 months postpartum 12 months postpartum
Primary Outcome Proportion of HIV-positive women retained in care and treatment (Option B+ regimen) at 12 months postpartum. 12 months postpartum
Secondary Outcome Proportion of HIV-exposed infants who have received HIV DNA PCR test by 2 months of age and received results 2 months postpartum
Secondary Outcome Proportion of HIV exposed infants receiving all cotrimoxazole refills from 6 weeks to 6 months of age 6 months postpartum
Secondary Outcome Mean number of scheduled visits made by mother and infant from first ANC visit to 12 months postpartum. 12 months postpartum
Secondary Outcome Proportion of HIV-exposed infants retained in care and treatment at 24 months postpartum. 24 months postpartum
Secondary Outcome Proportion of women alive and on Option B+ ART regimen at 24 months postpartum 24 months postpartum
Secondary Outcome Cost per Mother Infant Pair (MIP) retained at 12 months of age 12 months postpartum
Secondary Outcome Cost per early infant diagnosis test (HIV DNA PCR) result received. 4 months
Secondary Outcome Cost per infant initiated on ART 24 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mangochi District Health Office Mangochi Boma Mangochi Malawi
Salima District health Office Salima Boma Salima Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
World Health Organization (WHO) Block 3510, Jalan Technokrat 6 Cyberjaya 63000 Malaysia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor College of Medicine 1 Mahatma Gandhi Road Blantyre BT3 Malawi University
COLLABORATORS
Name Street address City Postal code Country
Clinton Health Access Initiative Area 10, Plot 1129 Lilongwe Malawi
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Victor Mwapasa vmwapasa69@gmail.com +265 999981496 1 Mahatma Gandhi Road
City Postal code Country Position/Affiliation
Blantyre BT3 Malawi Associate Professor
Role Name Email Phone Street address
Public Enquiries Emily Churchman-Kobayashi echurchman@clintonhealthaccess.org +265 884 765 471 Plot 11/29
City Postal code Country Position/Affiliation
Lilongwe LL3 Malawi Senior Programs Manager
Role Name Email Phone Street address
Scientific Enquiries Victor Mwapasa vmwapasa69@gmail.com +265 999981496 1 Mahatma Gandhi Road
City Postal code Country Position/Affiliation
Blantyre BT3 Malawi Associate Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial type 15/10/2013 Modified RCT Others
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial type 02/12/2013 Modified Others Others
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial type 10/07/2018 pactr update Others CCT
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 10/07/2018 pactr update Not Applicable
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 10/07/2018 pactr update Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s)