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.: PACTR202008667156862 Date of Approval: 25/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Strategies on improving male involvement in the prevention of mother to child transmission of HIV
Official scientific title Strategies on improving male involvement in the prevention of mother to child transmission of HIV in the Bamenda Health District
Brief summary describing the background and objectives of the trial Paediatric HIV is still a problem in resource limited areas despite the much efforts being made by World Health Organisation, UNICEF and other international organisations to curb the transmission of HIV from mother to child. UNAIDS 2018 factsheets showed that in 2017 out of the 36.9 million people living with HIV, approximately 1.8 million are amongst children below the ages of 15. The main route of transmission being mother to child. Mother to child transmission (MTCT) of Human Immunodeficiency Virus (HIV) have been reduced to low levels with the introduction of antiretroviral therapy (ART) in resource-rich countries and to some extent resource limited countries. With the availability of proven interventions to prevent mother to child transmission of HIV and funds available, HIV/AIDS in children remains a largely uncontrolled epidemic in developed countries. Despite the reduction of MTCT of HIV with ART; in Cameroon only about 54% of pregnant women living with HIV were receiving ARVs and 27% of HIV exposed infants received ARVs in 2010 but PEPFAR reported that ART uptake in the population less than 15 years was only 24% and with no report on pregnant women. The objectives of the trial are 1) To assess the knowledge men possess on the prevention of mother to child transmission of HIV in the health facilities of the Bamenda Health District. 2) To assess the attitude of men on their role towards the prevention of mother to child transmission of HIV in the health facilities of the Bamenda Health District. 3) To determine the proportion of men that are more likely to be involved in one or more PMTCT service/activities in the health facilities of the Bamenda Health District. 4) To investigate the impact of text messages on MI in PMTCT amongst health facilities in Bamenda Health District. 5) To evaluate Male involvement in PMTCT’s impact on the pregnant women uptake of PMTCT services 9 months in the Bamenda health district.
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 18/08/2020
Actual trial start date
Anticipated date of last follow up 18/02/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 203
Actual target sample size (number of participants)
Recruitment status 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Non-randomised Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group No intevention needed Not Applicable Participants will also be followed up for 6months The participants will receives not text messages as opposed to those in the intervention group. They will just be informed that they are part of a study on how to improve male involvement in the prevention of mother to child transmission of HIV. 136 Uncontrolled
Experimental Group SMS Text messages on PMTCT Not applicable 6months The participant will be texted message on the importance of antenatal care (ANC) and prevention of mother child transmission of HIV. These messages will include things like testing for HIV, couple voluntary counseling and testing, importance of attending ANC with wives or partners. 68
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- couples willing to take part in the study - they must have at least a child - must the able to read text messages - must give consent - those who serious problems - those who cannot read text messages - any couple whom one partner refuses to give consent Adult: 19 Year-44 Year 20 Year(s) 50 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 09/03/2020 Cameroon Baptist Convention Health Board Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Bamenda North West Region 0000 Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome - Male involvement in the prevention of mother to child transmission of HIV. Measured at the start of intervention and 6months after intervention
Secondary Outcome knowledge and attitude of men towards prevention of mother to child transmission of HIV will improve. Measured at the end of the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nkwen Baptist Hospital Bamenda central North West Region 0000 Cameroon
Bamenda Regional Hospital Bamenda central North West Region 0000 Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
Ngachangong Victorine Bamenda North West Region 0000 Cameroon
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ngachangong Victorine Bamenda North West Region 0000 Cameroon Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Ngachangong Victorine Mulur epouse Wepngong vickywepngong@gmail.com 000237677542689 Bamenda
City Postal code Country Position/Affiliation
North West Region 0000 Cameroon Student
Role Name Email Phone Street address
Principal Investigator Ngachangong Victorine Mulur epouse Wepngong vickywepngong@gmail.com 000237677542689 Bamenda
City Postal code Country Position/Affiliation
North West Region 0000 Cameroon Student
Role Name Email Phone Street address
Scientific Enquiries Ngachangong Victorine Mulur epouse Wepngong vickywepngong@gmail.com 000237677542689 Bamenda
City Postal code Country Position/Affiliation
North West Region 0000 Cameroon Student
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained during the study will be shared according to WHO’s statement on public disclosure of trial results. The following aspects of data will be shared. Content Will individual participant data be available Yes What data in particular will be shared? All individual participant data collected during the trial What other documents will be available? Study protocol, statistical analysis and informed consent form When will data be available (start and end date)? Immediately after publications With whom? Anyone who wishes to access the data (students, academicians and other researchers, as well as hospital facilities used for the research. For what purpose? For any purpose depending the individual How will data be made available? Data will be stored in school libraries to be accessed by others and also published online. Hospitals used will also have a copy the results to see areas where improvement is needed. Result with be shared within 12months of completion of study The articles from the study will be published using open access journals to allow visibility to all and also copies will be send to the institutions where the research was carried.
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 - 20/08/2020
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information