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.: PACTR202009503991085 Date of Approval: 01/09/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title HIV Testing Health Education and counseling Trial
Official scientific title The impact of scaling up HIV Services for men within the Buea Health District in the South West Region of Cameroon
Brief summary describing the background and objectives of the trial The impact of scaling up HIV Services for men within the Buea Health District in the South West Region of Cameroon Having the right knowledge about the causes and consequences of diseases has proven to be effective in helping people take the right decision regarding prevention. Looking at sex disaggregate in relation to HIV services uptake, studies have revealed that men are less likely than women to engage in HIV services across the care cascade, especially HIV testing and therefore resulting in poorer clinical outcome and this is also affecting the engagement of women and their children. Out of the estimated 35 100 000 adults aged 15+ who were living with HIV in 2017 globally, 16 800 000 occurred in men and 850 000 new infection in men out of a total of 1 600 000 new infections in adult. Approximately 830 000 deaths due to AIDS occurred among adults aged 15 + in 2017, with 480 000 occurring in men alone. Face to face health education can be used to give the right information on HIV among men, get feedback and counseling session to help men engage better in HIV Services, especially texting which is the entry point in the HIV cascade. Our objective is to assess the effectiveness of a face to face health education intervention in community based groups on male response to HIV Services in the Buea Health District. We are testing the effectiveness of giving the right information on HIV, benefits of treatment and viral load suppression on how men will response to HIV testing.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) NA
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Education /Training
Anticipated trial start date 01/11/2019
Actual trial start date 03/12/2019
Anticipated date of last follow up 14/08/2020
Actual Last follow-up date 28/08/2020
Anticipated target sample size (number of participants) 305
Actual target sample size (number of participants) 292
Recruitment status Completed
Publication URL Not yet
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Face to face health education and interaction Once weekly 6 months We conducted face to face health education and interaction on HIV and its services in community men’s groups. Health talks developed on HIV cause, the signs and symptoms, prevention benefits of testing and the importance of linkage to treatment and care if someone test positive. We explained the concept of viral load suppression and its importance in reducing transmission 150
Control Group No intervention will be applied Nothing will be given to this group 6 months They will be left only under the usual care 155 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Men who will reside in the area for the period of study Men willing to continue to participate even if they change place of residence Those who can communicate in English or Pidgin language Men who will give signed or verbal consent Visitors who will be in the area for a period less than the intervention period Men who refuse to give signed or verbal consent to participate Those who have resided in the area for less than a month Those outside the require age range Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 21 Year(s) 75 Year(s) Male
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 25/09/2019 Faculty of Health Sciences Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Faculty of Health Sciences, University of Buea Buea 0012 Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome An improvement in correct Knowledge on HIV, HIV Services available and the importance of testing to individuals, their families and the general community Monthly Revision questions and answer sessions
Primary Outcome HIV Testing uptake After 6 months
Secondary Outcome Satisfaction At first month and 6th month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Buea Health District Communities Muea, Mile 16, Tole, Buea town Buea Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Samba Melvis Bora University Street Molyko Buea 0012 Cameroon Individual
COLLABORATORS
Name Street address City Postal code Country
Professor Njamnshi Alfred N. Yaounde Central Hospital and lecturer at the Universities of Buea and Yaounde Yaounde Cameroon
Professor Nsagha Dickson Shey Faculty of Health Sciences, University of Buea Campus B Buea 0012 Cameroon
Dr. Verla Vincent Faculty of Health Sciences, University of Buea Campus B Buea 0012 Cameroon
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Samba Melvis Bora borathestar1@gmail.com +237675560673 University Street Molyko
City Postal code Country Position/Affiliation
Buea 0012 Cameroon P.h.D candidate in Public Health
Role Name Email Phone Street address
Public Enquiries Samba Melvis Bora borathestar1@gmail.com +237675560673 University Street Molyko
City Postal code Country Position/Affiliation
Buea 0012 Cameroon P.h.D candidate in Public Health
Role Name Email Phone Street address
Scientific Enquiries Nsagha Dickson Shey nsaghads@hotmail.com +23767799429 Faculty of Health Sciences, University of Buea Campus B
City Postal code Country Position/Affiliation
Buea 0012 Cameroon Associate Professor of Epidemiology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We plan to share the de-identified individual participant data set to the University of Buea Library in which a copy will be kept for public reference, the principal results will be written up for publication in a peer reviewed scientific journal; Oral presentations at scientific conferences and at seminars and the study sites as feedback to the participating community male groups. Also will share with Public Health offices for policy innovation Informed Consent Form,Study Protocol Nov 30 2020 to November 30 2021 There will be controlled access to the data/documents accessible only to the Principal Investigator (PI), the scientific protocol team, who will be responsible for deciding who may have access.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not available now 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