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.: PACTR201806003385587 Date of Approval: 15/05/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Integration of Point of Care Tests to Antenatal Care in Rural Primary Care Facilities
Official scientific title Integration of a Package of Point of Care Tests into Rural Primary Care Facilities to Improve Access to Basic Antenatal Screening; A cluster randomised stepped wedge trial
Brief summary describing the background and objectives of the trial Background Despite centuries of facility based antenatal care (ANC) provision in rural Africa and increasing rates of ANC attendance, many pregnant women still do not access basic antenatal screening tests. Many primary care facilities do not provide tests (except for HIV) and refer women to off-site laboratories for testing. This results in lower coverage of screening, higher losses to follow up and delay in or failure of initiation of treatment for women with abnormal results. Objectives To determine whether integrating a package of point of care tests (POCTs) to rural primary care facilities will result in earlier and wider coverage of screening for pregnant women attending these facilities and to assess whether this intervention will be both feasible and acceptable to pregnant women and health care workers and whether it will be more cost effective compared to the current model of care.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Haematological Disorders,Infections and Infestations,Pregnancy and Childbirth,Syphilis, Anaemia, Screening
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Early detection /Screening
Anticipated trial start date 04/06/2018
Actual trial start date
Anticipated date of last follow up 19/10/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 1600
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomisation using a radomisation table created by a computer software program 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
Control Group Usual Care During the control phase all facilities will provide usual care. Pregnant women will receive antenatal screening that is available at the facilities and will be referred to off-site laboratories to receive additional antenatal screening tests. 800 Historical
Experimental Group Point of Care Tests The intervention will comprise provision of a package of point of care tests to the health facility and training and performance monitoring of health facility staff to provide antenatal screening on-site. 800
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Health facility:A public health care facility Health facility: Provides antenatal care Health facility: No operational on-site laboratory Health facility: Staffed by at least one nurse Participants:Pregnant women regardless of age Participants: Attending the health care facility for first antenatal care visit Participants: Able to provide informed consent Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Infant: 0 Month-23 Month,Infant: 1 Month-23 Month,Middle Aged: 45 Year(s)-64 Year(s),New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 0 Year(s) 130 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 26/04/2018 Research Ethics Committee, Aga Khan University, Kenya
Ethics Committee Address
Street address City Postal code Country
3rd Parklands Avenue, off Limuru Road Nairobi 30270-00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of pregnant women receiving specified screening test(s). Day of first antenatal visit At 6 weeks after first antenatal visit
Secondary Outcome Time interval between first antenatal visit and receiving specified screening test At several time points up to 6 weeks after first antenatal visit
Secondary Outcome Proportion of women with abnormal results who received appropriate treatment interventions Day of first antenatal visit At 6 weeks after first antenatal visit
Secondary Outcome Time interval between receiving specified screening test and receiving appropriate treatment interventions for women with abnormal results At several time points up to 6 weeks after first antenatal visit
Secondary Outcome Feasibility of the intervention In the control and intervention phases of the study
Secondary Outcome Acceptability of the intervention In the control and intervention phases of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Health Facilities in Rabai Subcounty, Kilifi County Department of Health Services Kilifi County Department of Health Services Kilifi 9 - 80108 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Grand Challenges Africa, a scheme of the Alliance for Accelerating Excellence in Science in Africa (AESA). 8 Miotoni Lane, Karen Nairobi 24916-00502 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Aga Khan University 3rd Parklands Avenue, off Limuru Road Nairobi 30270-00100 Kenya University
COLLABORATORS
Name Street address City Postal code Country
Angela Koech Etyang Aga Khan University, 3rd Parklands Avenue, off Limuru Road Nairobi 30270-00100 Kenya
Prof Violet Naanyu Moi University School of Medicine Eldoret 4606-30100 Kenya
Dr. Geoffrey Omuse Aga Khan University, 3rd Parklands Avenue, off Limuru Road Nairobi 30270-00100 Kenya
Margarita Mwai Aga Khan University, 3rd Parklands Avenue, off Limuru Road Nairobi 30270-00100 Kenya
Mukaindo Mwaniki Aga Khan University, 3rd Parklands Avenue, off Limuru Road Nairobi 30270-00100 Kenya
Dr. Umi Bunu Kilifi County Department of Health Services, Kilifi Kilifi 9 - 80108 Kenya
Eva Langat Kilifi County Department of Health Services, Kilifi Kilifi 9 - 80108 Kenya
Dr. Anthony Ngugi Aga Khan University, 3rd Parklands Avenue, off Limuru Road Nairobi 30270-00100 Kenya
Dr. Isaac Wachira Kilifi County Department of Health Services, Kilifi Kilifi 9 - 80108 Kenya
Job Ogutu Kilifi County Department of Health Services, Kilifi Kilifi 9 - 80108 Kenya
Rose Maina Aga Khan Hospital, Mombasa, Vanga Road Mombasa 83013-80100 Kenya
Rachel Odhiambo Aga Khan University, 3rd Parklands Avenue, off Limuru Road Nairobi 30270-00100 Kenya
James Orwa Aga Khan University, 3rd Parklands Avenue, off Limuru Road Nairobi 30270-00100 Kenya
Prof Marleen Temmerman Aga Khan University, 3rd Parklands Avenue, off Limuru Road Nairobi 30270-00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Angela Etyang angela.koech@aku.edu +254 20 366 1135 3rd Parklands Avenue, off Limuru Road
City Postal code Country Position/Affiliation
Nairobi 30270-00100 Kenya Physician Scientist, Aga Khan University
Role Name Email Phone Street address
Public Enquiries Abigael Kenga abigael.kenga@aku.edu +254 20 366 1135 Aga Khan University, Mombasa Research Office, Links Plaza, Links Road
City Postal code Country Position/Affiliation
Mombasa 30270-00100 Kenya Aga Khan University, Study Coordinator
Role Name Email Phone Street address
Scientific Enquiries Angela Etyang angela.koech@aku.edu +254 20 366 1135 3rd Parklands Avenue, off Limuru Road
City Postal code Country Position/Affiliation
Nairobi 30270-00100 Kenya Physician Scientist, Aga Khan University
REPORTING
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