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.: PACTR201809886446171 Date of Approval: 03/09/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Understanding patterns of postpartum maternal mobility in relation to paediatric HIV diagnosis and linkage to HIV care in Gauteng province, South Africa
Official scientific title Understanding patterns of postpartum maternal mobility in relation to paediatric HIV diagnosis and linkage to HIV care in Gauteng province, South Africa
Brief summary describing the background and objectives of the trial The elimination of mother to child transmission (MTCT) of HIV is within reach, given the high coverage of the Prevention of Mother to Child Transmission (PMTCT) programme in South Africa. However to achieve the 90-90-90 targets for children, we need to strengthen the postpartum retention of women the PMTCT programme and improve the uptake of repeat HIV tests both for HIV exposed children and mothers who initially test HIV negative in antenatal care (ANC). The mobility of women in the postpartum period is generally thought to significantly contribute to maternal disengagement from HIV care, resulting in delayed HIV diagnosis among HIV exposed children and ART initiation of those who test HIV positive. However this association is poorly understood and rarely examined in detail due to the challenges associated with community based follow-up activities. This study aims to firstly map out patterns of maternal postpartum mobility and how these relate to the postpartum utilisation of PMTCT services, and secondly to assess the effect of a telephonic tracing and counselling support intervention on postpartum retention and completion of the PMTCT cascade steps by mother-child pairs in the Gauteng province, South Africa. In this study, HIV positive and negative women who give birth at Midwife Obstetrics Units (MOUs) in the Gauteng province (South Africa) will be randomised into three tracing approaches: Passive tracing, Active telephonic tracing and Active telephonic tracing with counselling support. Baseline demographic and psycho-social information will be collected after study enrolment and location information will be collected at baseline and three 6 months intervals. We will follow participants through bi-annual medical record reviews at clinic/s where post-natal care is provided for 18 months. Additionally, electronic laboratory test data, particularly infant HIV Polymerase Chain Reaction (PCR) and viral load test results, will be obtained from the National Health Laboratory Service (NHLS).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PAEDLINK
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 Early detection /Screening
Anticipated trial start date 01/08/2016
Actual trial start date 03/10/2016
Anticipated date of last follow up 05/08/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 1383
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
M151041 Wits University Human Research Etthics Committee
353ONO CIPHER
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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 Active telephonic tracing with Motivation Interviewing counselling support Baseline questionnaire (three to six days after delivery) and face to face MI counselling Six month postpartum telephonic follow-up interview and MI counselling 12 months postpartum telephonic follow-up interview and MI counselling Baseline interview (45 minutes) and 15-30 minutes counselling session Six months follow-up interview (10-15 minutes) and 15-30 minutes counselling session 12 months follow-up interview (10-15 minutes) and 15-30 minutes counselling session Face to face (baseline)/ telephonic survey to note/update details of postpartum clinic of choice and brief MI counselling to encourage participants (mother) to adhere to the PMTCT program and answer any questions that might arise. Counselling support intervention: The counselling support intervention will be structured on the basis of the Motivational Interviewing (MI) approach, a client-centred communication style, where the participants themselves do much of the psychological work. MI relies on specific techniques including reflective listening, autonomy support, and eliciting change talk. 461
Control Group Active telephonic tracing Baseline questionnaire (three to six days after delivery) Six months follow-up telephonic interview 12 months follow-up telephonic interview Baseline interview (45 minutes) Six months follow-up interview (15 to 20 minutes) 12 months follow-up interview (15 to 20 minutes) Interviewer administered baseline (face to face) and follow-up (telephonic) questionnaire. 461 Dose Comparison
Control Group Passive tracing Baseline questionnaire (three to six months after delivery) Baseline interview (45 minutes) Follow up will be done entirely using routine clinical and laboratory data obtained at postpartum clinic of choice (indicated in baseline questionnaire). There will be no direct contact with participants after the completion of the baseline questionnaire. 461 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Eligibility of consenting mother. Women consented to the follow-up of their new-born babies as well • ≥18 years old • Having given birth at the selected MOU up to 2 calendar months prior to enrolment • Not previously enrolled in this study • Well enough to complete a questionnaire • Received ANC at a clinic in the catchment area of the selected MOU • Willing to provide informed consent • Willing to give contact information • <18 years of age • Having given birth at the selected MOU more than 2 months prior to enrolment • Psychologically unable or too sick to participate • Unwilling to provide consent • Previously enrolled in this study • Received ANC at a clinic outside of the catchment area of the selected MOU • Not willing to give contact information Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 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 12/02/2016 Human Research Ethics Committee of the University of the Witwatersrand
Ethics Committee Address
Street address City Postal code Country
Wits Faculty of Health Sciences, Phillip Tobias Building, Cnr York Road and Princess of Wales Terrace, Parktown Johannesburg 2193 South Africa
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 05/07/2016 Tswane Research Committee
Ethics Committee Address
Street address City Postal code Country
427 Hilda Street, 4th Floor, The Fields Building, Hatfield Tswane 0001 South Africa
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 30/08/2016 Mpumalanga Provicial Health Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
3 Government Boulevard, Riverside Park, Ext 2 Mbombela 1200 South Africa
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 06/10/2016 Limpopo Department of Health
Ethics Committee Address
Street address City Postal code Country
18 College Street, Polokwane Polokwane 0700 South Africa
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 11/02/2016 Ekurhuleni Research Committee
Ethics Committee Address
Street address City Postal code Country
West Wing, 40 Catlin Street, Germiston, Ekhuruleni Ekurhuleni 1401 South Africa
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 22/09/2016 North West Department of Health
Ethics Committee Address
Street address City Postal code Country
3801 First Street, New Office Park, Mahikeng Mahikeng 2735 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcomes of the study are postpartum HIV testing both the mother and child. Postpartum infant PCR and antibody test uptake for exposed infants as well as antibody testing of uninfected mothers. Data will be collected from paper and electronic clinincal and laboratory records at six, 12 and 18 month after birth for the baby and delivery for the mother.
Secondary Outcome Linkage to ART and retention in HIV care of diagnosed mother and baby. Data will be collected from paper and electronic clinincal and laboratory records at six, 12 and 18 month after birth for the baby and delivery for the mother.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ethafeni Community Health Centre 43 Bennin Str, Ethafeni section, Tembisa Ekurhuleni 1630 South Africa
Esangweni Community Health Centre 219 Mpilo street, Esangweni section, Tembisa Ekurhuleni 1632 South Africa
Laudium Community Health Centre C/O 6th street and Tangerian avenue, Laudium Tswane 0037 South Africa
Stanza Bopape Community Health Centre Stand 2, Shilovhane Street, Mamelodi East, Mamelodi, Tswane 0122 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
International AIDS Society Avenue de France 23, CH-1202 Geneva 1202 Switzerland
National Research Foundation NRF Building, CSIR Complex, Brummeria Pretoria 0001 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor IAS CIPHER Avenue de France 23, CH-1202 Geneva 1202 Switzerland Funding Agency
Secondary Sponsor Gayle Sherman 1 Modderfontein Road, Sandringham Johannesburg 2131 South Africa Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dorina Onoya donoya@heroza.org +27785065190 39 Empire Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Principal Researcher at the Health Economics and Epidemiology Research Office
Role Name Email Phone Street address
Public Enquiries Nelly Jinga njinga@heroza.org +27100019295 39 Empire Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Research Associate at the Health Economics and Epidemiology Research Office
Role Name Email Phone Street address
Scientific Enquiries Dorina Onoya donoya@heroza.org +27785065190 39 Empire Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Principal Researcher at the Health Economics and Epidemiology Research Office
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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