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.: PACTR202206622552114 Date of Approval: 21/06/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effectiveness of training models for rural traditional birth attendants in the prevention of mother to child transmission of HIV in Ogun State
Official scientific title Impact of training and use of case managers for traditional birth attendants in the prevention of mother to child transmission of HIV in Southwest, Nigeria: A 3-arm cluster randomized control trial
Brief summary describing the background and objectives of the trial Mother to child transmission (MTCT) accounts for 90% of all new HIV infections in Nigerians and for about 30% of the global burden. In developed countries, MTCT rates have been reduced to <2%, yet high transmission rates persist in sub-Saharan Africa due to low rates (11.7% and 17.1%) of access to HIV testing and antiretroviral prophylaxis respectively. Studies found that about 60% of births occurred in the home of TBAs (Traditional birth attendants), especially in rural Nigeria. Since facility antenatal care is the main vehicle being used for PMTCT services in Nigeria, missed opportunities abound. Previous studies have reported that TBA's involvement in HIV prevention and PMTCT programs could reduce HIV infant infections. This involvement has ranged from training in HIV testing and counseling to some PMTCT services including administering Nevirapine to newborns. The main barriers encountered by TBA's involvement in the PMTCT service cascade are the linkage to care and the follow-up of an identified HIV-positive pregnant woman and their exposed newborns according to the current guidelines. The case manager makes referrals, coordinates care with providers and specialists and manages the exchange of information between providers and human services organizations. This research aims to determine the effectiveness of combining TBAs PMTCT training with HIV-case managers to complete the community PMTCT cascade.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention
Anticipated trial start date 01/10/2019
Actual trial start date 01/10/2019
Anticipated date of last follow up 01/05/2020
Actual Last follow-up date 01/05/2020
Anticipated target sample size (number of participants) 126
Actual target sample size (number of participants) 240
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
D43TW010134 NIH
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 Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Arm 1 Not applicable 5 days The PT group of TBAs will receive PMTCT training only. This will include didactic modules and practical training that will take place for 5 days. It will also include HIV test counseling, information on ART referral centers, patient confidentiality, and the use of the TBA logbook, as this will be a vital instrument for monitoring and evaluation. 80
Experimental Group Arm 2 Not applicable 6 months Arm 2 will receive PMTCT training and case manager support. This will include didactic modules and practical training that will take place for 5 days. It will also include HIV test counseling, information on ART referral centers, patient confidentiality, and the use of the TBA logbook, as this will be a vital instrument for monitoring and evaluation. The case manager is assigned to the TBA and will visit the TBAs in their homes fortnightly to review the TBA logs. The TBA will inform them of all new patients and newly detected HIV-positive pregnant women, CM will facilitate linkage support to pre-determined PMTCT sites in the LGA. 80
Control Group Arm 3 Not Applicable 6 months Did not receive any intervention 80 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
A registered TBA’s not less than 18 years. Should have recorded more than five new patients per month Must have proper record documentation Has not received PMTCT training previously. A non-registered TBA Not the head of the birthing center Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 64 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 07/05/2019 College of Medicine University of Lagos Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
LUTH, Idiaraba Lagos 12003 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome is the proportion of women who complete the PMTCT cascade i.e (HIV exposed infant testing at 6-8 weeks among positive pregnant women) OR (HIV-ve women retested at term/labour for negative pregnant women) At term for Pregnant patients
Secondary Outcome To compare study arms with respect to the degree of changes in knowledge, attitude, PMTCT practices, and efficacy. End of Study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ifo and Ado Odo Ota Local Government Areas Ifo Local Government and Ado Ota Local Government Ogun State Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institutes of Health Bethesda, Maryland, US Maryland United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Adedoyin Ogunyemi College of Medicine, UNILAG Lagos Nigeria Individual
Secondary Sponsor BRAINS College of Medicine, UNILAG Lagos Nigeria Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adedoyin Ogunyemi aoogunyemi@cmul.edu.ng +2348063068858 LUTH, Idiaraba
City Postal code Country Position/Affiliation
Lagos Nigeria Senior Lecturer University of Lagos
Role Name Email Phone Street address
Public Enquiries Sikeade CalebAdepoju sikeadewumi@gmail.com +2348067903773 LUTH Idiaraba
City Postal code Country Position/Affiliation
Lagos Nigeria Program Manager
Role Name Email Phone Street address
Scientific Enquiries Olufemi Hodefe pohodefe@cmul.edu.ng +2348028642463 LUTH Idiaraba
City Postal code Country Position/Affiliation
Lagos Nigeria Research and Sponsored Programme Administrator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Study Protocol Beginning 3 months and ending 5 years following article publication Researchers who provide a methodologically sound proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://drive.google.com/file/d/1em6kc1s7DtNYfLMnNk8v0beBBAO0yNaI/view?usp=sharing Yes 30/05/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 15/06/2022 Result - 15/06/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information