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.: PACTR201906626382151 Date of Approval: 11/06/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title An investigation of the impact of an HIV peer mentoring intervention on antiretroviral treatment retention in adults living with HIV/AIDS in Cameroon
Official scientific title An investigation of the impact of an HIV peer mentoring intervention on antiretroviral treatment retention in adults living with HIV/AIDS in Cameroon
Brief summary describing the background and objectives of the trial The HIV test-and-treat [T&T] global strategy posits that expanded testing and earlier treatment of HIV infection could markedly decrease ongoing HIV transmission, stemming the HIV epidemic. Success of this strategy requires sustained engagement of people living with HIV/AIDS [PLWHIV] in antiretroviral treatment [ART] programs. Unfortunately, consistently low ART uptake, adherence and retention rates continue to be reported in Sub Saharan Africa.The aim of this trial is to assess the impact of an HIV peer mentorship care model on improving ART uptake, adherence and retention outcomes in the study facilities.
Type of trial CCT
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 Supportive care
Anticipated trial start date 21/05/2018
Actual trial start date 28/05/2018
Anticipated date of last follow up 04/12/2018
Actual Last follow-up date 04/05/2019
Anticipated target sample size (number of participants) 400
Actual target sample size (number of participants) 400
Recruitment status Closed to recruitment,follow-up continuing
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
Non-randomised Open-label(Masking Not Used)
Non-randomised Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Non-randomised Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group HIV peer mentoring HIV peer mentors will provide HIV counselling and psychosocial support to their mentees for a six months period. This will be achieved through monthly or bi-monthly meetings (depending of the mentees specific needs) between the mentors and the mentees and regular telephone communications. During such meetings, mentees discuss their challenges with their peer mentors and the peer mentor, based on his or her experiences, advice the mentees accordingly or refer them to the appropriate persons six months interaction between the mentor and the mentee Participants in the intervention group will receive HIV mentoring from trained HIV peer mentors. During such meetings, mentees discuss their challenges with their peer mentors and the peer mentor, based their experiences, advice the mentees accordingly or refer them to the appropriate persons. During mentor/mentee meetings, topics covered include: ART adherence, ARV side effects, HIV disclosure status, social support systems, stigma, and any other topic addressing the identified needs of the mentee 200
Control Group the control group The control group will not receive any intervention. The will be subjected to routine HIV care provided at the HIV clinics. Note that this routine care is also received by the control in addition to the intervention 6 months No intervention for the control arm, apart from routine clinic care 200 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients diagnosed HIV positive in the study sites during the study implementation period Patients who refuse to give consent patients less than or equal to 21 years of age Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 21 Year(s) 70 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 16/07/2018 University of Buea Faculty of Health Sciences Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
University of Buea Buea 0063 Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Weight Every month for 6 to 9 months
Primary Outcome ART adherence adherence will be measured every four weeks
Primary Outcome Retention in ART at 3, 6 and 9 month
Secondary Outcome CD4 count at 6th month
Secondary Outcome viral suppression at 6th month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bamenda Regional Hospital Hospital round about, Bamenda Bamenda Cameroon
Limbe Regional Hospital Mile 1 street, Limbe Limbe Cameroon
Yaounde Jamot Hospital Carrifou Jamot Yaounde 30883 Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
Personnal funds University of Buea Buea Cameroon
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ajeh Rogers Buea Buea Cameroon Charities/Societies/Foundation
Secondary Sponsor Kathryn Anastose New York City United States of America University
COLLABORATORS
Name Street address City Postal code Country
Assob Jules University of Buea Cameroon
Egbe O. Thomas University of Buea Cameroon
Halle Ekane University of Buea Cameroon
Dzudie Anastase University of Buea Cameroon
Adebola Adedimiji New York City United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ajeh Rogers Awoh ajehrogers@gmail.com 237677254337 Tam Tam Yaounde
City Postal code Country Position/Affiliation
Yaounde Cameroon PhD candidate university of Buea
Role Name Email Phone Street address
Scientific Enquiries Halle E. Ekane halle-ekane.edie@ubuea.cm 237699934402 Buea
City Postal code Country Position/Affiliation
Buea Cameroon Vice dean in charge of research University of Buea
Role Name Email Phone Street address
Public Enquiries Assob N. Jules juleclement@yahoo.fr 237679239483 Buea
City Postal code Country Position/Affiliation
Buea Cameroon Coordinator post graduate studies University of Buea
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial will be shared, after de-identification Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication. No end date Proposal should be directed to ajehrogers@gmail to gain access. To gain access the data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (link to be included)
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