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.: PACTR202007654729602 Date of Approval: 22/07/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Use of mobile phones as a strategy to improve compliance to medication and attendance of clinic for HIV-exposed infants
Official scientific title Efficacy Of Mobile Phone Use On Adherence To Nevirapine Prophylaxis And Retention In Care Among The HIV-Exposed Infants In Prevention Of Mother To Child Transmission Of HIV: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial HIV is a major contributor to infant mortality. A significant gap remains between the uptake of infant and maternal antiretroviral regimens and only a minority of HIV-exposed infants receives prophylaxis and safe infant feeding. Losses to follow-up of HIV-exposed infants are associated with shortcomings of facility-based PMTCT models with weak community support of linkages. Use of mobile phones offers an opportunity to improving care and promoting retention for the mother-baby pairs and achievement of an HIV-free generation. Objectives: To compare self-reported adherence to infant Nevirapine (NVP) prophylaxis and retention in care over ten weeks in HIV exposed infants randomized to 2-weekly mobile phone calls (intervention) versus no phone calls (control).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 19/09/2013
Actual trial start date 19/09/2013
Anticipated date of last follow up 31/01/2014
Actual Last follow-up date 31/01/2014
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants) 150
Recruitment status Completed
Publication URL https://drive.google.com/file/d/1QTelUzsN_0b7ncFqlKeSFUWHUBl4dKyg/view?usp=sharing
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Phone calls Every two weeks For ten weeks Every two weeks on a Monday morning, the researcher called each subject in the intervention arm every until the infant was 10 weeks old. Each call was aimed at reminding them and reinforcing key Prevention of Mother to Child Transmission of HIV (PMTCT) messages (Nevirapine prophylaxis, exclusive breastfeeding of the HIV-exposed infants, early infant diagnosis, scheduled immunizations) as well as ascertainment of their overall health. 75
Control Group Standard of care Ten weeks Participants randomized to the control arm received their usual standard of care (SOC) clinic support but were not called by the researcher. They were however free to call the researcher at any time of their own initiative. 75 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-18 years and older, - had a live birth, - owned a mobile phone on which they could receive calls, - willing to stay in the study area for at least 3 months after delivery and - knew that they were HIV infected. - younger than 18 years of age - no access to mobile phone Adult: 19 Year-44 Year,Infant: 0 Month-23 Month 0 Day(s) 45 Year(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 13/08/2013 Kenyatta National Hospital University of Nairobi Ethics and research Committee
Ethics Committee Address
Street address City Postal code Country
P.O.Box. 19676 Nairobi 00202 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adherence to Nevirapine prophylaxis and retention in care Six and Ten weeks, respectively
Secondary Outcome Early infant diagnosis and infant feeding Six and Ten weeks, respectively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Jaramogi Oginga Odinga Teaching and Referral Hospital Off Kakamega Road Kisumu 40100 Kenya
Kisumu East District Hospital Off Angawa Avenue. P. O. Box. 1818 Kisumu 40100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Astrazeneca MEA I Sub Saharan Africa Avenue 5 Building, Rose Avenue, Kilimani. P. O. Box 10107 Nairobi 00100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Astrazeneca MEA I Sub Saharan Africa Avenue 5 Building, Rose Avenue. P.O. Box.10107, Kilimani Nairobi 00100 Kenya Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Lilian Kebaya lilliankebaya@gmail.com +15197021054 860 Commissioners Road East
City Postal code Country Position/Affiliation
London Canada Fellow
Role Name Email Phone Street address
Public Enquiries Dalton Wamalwa dalton@africaonline.co.ke +254721239493 P. O. Box. 19676
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Chair of Department of Paediatrics University of Nairobi
Role Name Email Phone Street address
Scientific Enquiries Ruth Nduati ruth_nduati2000@yahoo.com +254722235323 P. O. Box. 19676
City Postal code Country Position/Affiliation
nairobi 00100 Kenya Professor of Paediatrics
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes At 6 weeks follow-up, 90.7% (n = 68) of participants receiving phone calls reported adherence to infant Nevirapine prophylaxis, compared with 72% (n = 54) of participants in the control group (p = 0.005). Participants in the intervention arm were also significantly more likely to remain in care than participants in the control group [78.7% (n = 59) vs. 58.7% (n = 44), p = 0.009 at 6 weeks and 69.3% (n = 52) vs. 37.3% (n = 28), p < 0.001 at 10 weeks]. 16/07/2020 16/07/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://drive.google.com/file/d/1oxVzj7JwQnKuTiN2px9Zu7LwX0iqKWxU/view?usp=sharing
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 14/07/2020 New information Efficacy Of Mobile Phone Use On Adherence To Nevirapine Prophylaxis And Retention In Care Among The HIV-Exposed Infants In Prevention Of Mother To Chi Use of mobile phones as a strategy to improve compliance to medication and attendance of clinic for HIV-exposed infants
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 14/07/2020 New information Not Applicable
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Publication URL 14/07/2020 New information https://drive.google.com/file/d/1QTelUzsN_0b7ncFqlKeSFUWHUBl4dKyg/view?usp=sharing
Section Name Field Name Date Reason Old Value Updated Value
Study Design Intervention assignment 13/07/2020 Nil Parallel: different groups receive different interventions at same time during study
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation sequence 13/07/2020 Nil Simple randomization using a randomization table created by a computer software program
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation concealment 13/07/2020 Nil Sealed opaque envelopes
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Disease(s) 14/07/2020 New information Paediatrics
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 13/07/2020 Update Experimental Group, Phone calls, Every two weeks, For ten weeks, Every two weeks on a Monday morning, the researcher called each subject in the intervention arm every until the infant was 10 weeks old. Each call was aimed at reminding them and reinforcing key Prevention of Mother to Child Transmission of HIV (PMTCT) messages (Nevirapine prophylaxis, exclusive breastfeeding of the HIV-exposed infants, early infant diagnosis, scheduled immunizations) as well as ascertainment of their overall health., 75,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 13/07/2020 Update Control Group, Standard of care, , Ten weeks, Participants randomized to the control arm received their usual standard of care (SOC) clinic support but were not called by the researcher. They were however free to call the researcher at any time of their own initiative., 75, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 13/07/2020 Nil Primary Outcome, Adherence to Nevirapine prophylaxis and retention in care, Six and Ten weeks, respectively
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 13/07/2020 Nil Secondary Outcome, Early infant diagnosis and infant feeding, Six and Ten weeks, respectively
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 13/07/2020 Update Jaramogi Oginga Odinga Teaching and Referral Hospital, Off Kakamega Road, Kisumu, 40010, Kenya
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 13/07/2020 Nil Jaramogi Oginga Odinga Teaching and Referral Hospital, Off Kakamega Road, Kisumu, 40010, Kenya Jaramogi Oginga Odinga Teaching and Referral Hospital, Off Kakamega Road, Kisumu, 40100, Kenya
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 13/07/2020 Update Kisumu East District Hospital, Off Angawa Avenue. P. O. Box. 1818, Kisumu, 40100, Kenya
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 13/07/2020 Update TRUE, Kenyatta National Hospital University of Nairobi Ethics and research Committee , P.O.Box. 19676, Nairobi, 00202, Kenya, , 13 Aug 2013, +254202726300, uonknh_erc@uonbi.ac.ke, 3449_11528_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 13/07/2020 Update Astrazeneca Pharmaceuticals, P.O. Box 10107, Nairobi, 00100, Kenya, Commercial Sector / Industry,
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 16/07/2020 New information Astrazeneca Pharmaceuticals, P.O. Box 10107, Nairobi, 00100, Kenya, Commercial Sector / Industry, Astrazeneca MEA I Sub Saharan Africa, Avenue 5 Building, Rose Avenue, Kilimani. P. O. Box 10107, Nairobi, 00100, Kenya, Commercial Sector / Industry,
Section Name Field Name Date Reason Old Value Updated Value
Sponsors Sponsors List 13/07/2020 New information Astrazeneca Pharmaceuticals, 17 Georgian Crescent West, Northdowns office, Bryanston, 2191, South Africa, Primary Sponsor, Funding Agency,
Section Name Field Name Date Reason Old Value Updated Value
Sponsors Sponsors List 14/07/2020 New information Astrazeneca Pharmaceuticals, 17 Georgian Crescent West, Northdowns office, Bryanston, 2191, South Africa, Primary Sponsor, Funding Agency, Astrazeneca Pharmaceuticals, P.O. Box.10107, Nairobi, 00100, Kenya, Primary Sponsor, Commercial Sector/Industry,
Section Name Field Name Date Reason Old Value Updated Value
Sponsors Sponsors List 16/07/2020 New information Astrazeneca Pharmaceuticals, P.O. Box.10107, Nairobi, 00100, Kenya, Primary Sponsor, Commercial Sector/Industry, Astrazeneca MEA I Sub Saharan Africa, Avenue 5 Building, Rose Avenue. P.O. Box.10107, Kilimani, Nairobi, 00100, Kenya, Primary Sponsor, Commercial Sector/Industry,
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 13/07/2020 Nil Principal Investigator, Lilian, Kebaya, Dr., lilliankebaya@gmail.com, Lilian.Kebaya@lhsc.on.ca, +15197021054, 860 Commissioners Road East, London, , Canada, Fellow
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 13/07/2020 Nil Public Enquiries, Dalton , Wamalwa, Prof., dalton@africaonline.co.ke, , +254721239493, P. O. Box. 30197, Nairobi, 00100, Kenya, Chair of Department of Paediatrics University of Nairobi
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 13/07/2020 Nil Public Enquiries, Dalton , Wamalwa, Prof., dalton@africaonline.co.ke, , +254721239493, P. O. Box. 30197, Nairobi, 00100, Kenya, Chair of Department of Paediatrics University of Nairobi Public Enquiries, Dalton , Wamalwa, Prof., dalton@africaonline.co.ke, , +254721239493, P. O. Box. 19676, Nairobi, 00100, Kenya, Chair of Department of Paediatrics University of Nairobi
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 13/07/2020 Update Scientific Enquiries, Ruth, Nduati, Prof., ruth_nduati2000@yahoo.com, rnduati@uonbi.ac.ke, +254722235323, P. O. Box. 19676, nairobi, 00100, Kenya, Professor of Paediatrics
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 14/07/2020 New information No
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results summary 14/07/2020 New information At 6 weeks follow-up, 90.7% (n = 68) of participants receiving phone calls reported adherence to infant Nevirapine prophylaxis, compared with 72% (n = 54) of participants in the control group (p = 0.005). Participants in the intervention arm were also significantly more likely to remain in care than participants in the control group [78.7% (n = 59) vs. 58.7% (n = 44), p = 0.009 at 6 weeks and 69.3% (n = 52) vs. 37.3% (n = 28), p < 0.001 at 10 weeks].
Section Name Field Name Date Reason Old Value Updated Value
Reporting Date of results summaries 17/07/2020 New information 23 Feb 2015 16 Jul 2020
Section Name Field Name Date Reason Old Value Updated Value
Reporting Date of results summaries 14/07/2020 Presentation at international conference 23 Feb 2015
Section Name Field Name Date Reason Old Value Updated Value
Reporting Date of the first journal publication 17/07/2020 New information 23 Feb 2015 16 Jul 2020
Section Name Field Name Date Reason Old Value Updated Value
Reporting Date of the first journal publication 14/07/2020 Presentation at international conference 23 Feb 2015
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results & Publication URL 14/07/2020 New information https://drive.google.com/file/d/1QTelUzsN_0b7ncFqlKeSFUWHUBl4dKyg/view?usp=sharing
Section Name Field Name Date Reason Old Value Updated Value
Reporting Baseline characteristics 14/07/2020 New information Maternal characteristics: age, marital status, employment status, antenatal clinic attendance, other living children, education level, other socioeconomic factors. Newborn characteristics: sex, birth weight, place of birth, mode of delivery. HIV-specific information
Section Name Field Name Date Reason Old Value Updated Value
Reporting Participant flow 14/07/2020 New information A total of 241 mothers were screened, 91 were ineligible and 150 were enrolled in a randomized clinical trial, with 75 randomized to each arm. Among the 91 excluded from the study, 15 refused consent, 61 were not from the catchments of the hospital and 15 did not have phone access.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Adverse events 14/07/2020 New information None
Section Name Field Name Date Reason Old Value Updated Value
Reporting Outcome measures description 14/07/2020 New information See description in PDF below
Section Name Field Name Date Reason Old Value Updated Value
Reporting Link to protocol 20/07/2020 New information https://drive.google.com/file/d/1QTelUzsN_0b7ncFqlKeSFUWHUBl4dKyg/view?usp=sharing https://drive.google.com/file/d/1oxVzj7JwQnKuTiN2px9Zu7LwX0iqKWxU/view?usp=sharing
Section Name Field Name Date Reason Old Value Updated Value
Reporting Link to protocol 14/07/2020 New information https://drive.google.com/file/d/1QTelUzsN_0b7ncFqlKeSFUWHUBl4dKyg/view?usp=sharing
Section Name Field Name Date Reason Old Value Updated Value
Reporting Outcome measure document 14/07/2020 New information 3449_10457_4738.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting Participant flow document 14/07/2020 New information 3449_10457_4739.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results Available 14/07/2020 New information No Yes