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.: PACTR202401496790802 Date of Approval: 09/01/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A community-based peer-facilitated psychological and social support model to improve retention in care among Cameroonian adolescents perinatally infected with Human Immunodeficiency Virus
Official scientific title Mental health of adolescents living with HIV in Cameroon: evaluation of a psychological and social intervention model
Brief summary describing the background and objectives of the trial There is increasing survival children perinatally infected with Human Immunodeficiency Virus (HIV) into adolescence, due to improved access to antiretroviral therapy (ART). Most adolescents living with HIV (ALHIV) reside in sub-Saharan Africa, some of whom are orphans or had lost their primary caregivers. There is rising recognition that they require social support to adjust socially and psychologically to living with HIV. Treatment outcomes in adolescents living with HIV (ALHIV) may be improved by addressing the psychological and social challenges they face. Peer-facilitated support groups have been shown to have a positive impact on disclosure, mental health and uptake of HIV services among adolescents. However, the generalizability of these results seems limited due to differences in intervention and study designs. there is a paucity of research exploring social support in adolescents’ HIV care in Central Africa, especially in Cameroon, where most of the existing studies tend to focus on clinical and biomedical outcomes, with little focus on the social support interventions specific to this group. As a result, social support for adolescents living with HIV remains undocumented and unaddressed in Central Africa. The IAS-CIPHER-2021/1214-ATE SMAVI is a randomized controlled trial implementing a model of community-based peer-facilitated psychological and social support for adolescents perinatally infected with HIV, aged 10 to 19 years, on ART and followed in a reference hospital in Yaounde, Cameroon (“Centre Mère et Enfant de la Fondation Chantal Biya à Yaoundé (CME-FCB”). This study aimed at implementing and assessing effectiveness of a community-based peer-facilitated psychological and social support model on improving retention in care among adolescents perinatally infected with HIV, on follow-up in the Day Care Unit of Chantal Biya Foundation, Yaounde, Cameroon (CME-FCB).
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 Psychosocial
Anticipated trial start date 01/09/2021
Actual trial start date 01/09/2021
Anticipated date of last follow up 31/08/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants) 302
Recruitment status Completed
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization 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 Routine care in the health facility Quarterly 18 months clinical examination, management of opportunistic infections, delivery of antiretroviral drugs, enhanced adherence counselling 152 Active-Treatment of Control Group
Experimental Group Routine care and community based peer facilitated psychological and social support Routine care in the health facility quarterly, and community-based peer facilitated psychological and social support twice quarterly 18 months - Community based peer-facilitated psychological and social support (home visits, support groups for adolescents, support groups for parents/guardians, leisure workshops (dance or painting or poetry or music)) - Routine care in the health facility (clinical examination, management of opportunistic infections, delivery of antiretroviral drugs, enhanced adherence counselling) 150
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Adolescents living with HIV (ALHIV) - Aged 10-19 years old -Perinatally infected with HIV - On follow-up at Chantal Biya Foundation -With parent/guardian consent - With ALHIV's assent - Not living with HIV (ALHIV) - Aged 20 years old and beyond - Infected with HIV due to another reason different than mother-to-child transmission - On follow-up another health facility different from Chantal Biya Foundation -No parent/guardian consent - No ALHIV's assent Adolescent: 13 Year-18 Year 10 Year(s) 19 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 09/06/2021 Centre Regional Ethics Committee for Human Health Research
Ethics Committee Address
Street address City Postal code Country
1025, Avenue Konrad Adenauer Yaoundé 0000 Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Mental health Quarterly
Primary Outcome Retention in care Quarterly
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Chantal Biya Foundation Henri Dunant Street, Yaounde Yaounde Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
Collaborative Initiative for Paediatric HIV Education and Research Avenue de France 23 Geneva CH-1202 Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Collaborative Initiative for Paediatric HIV Education and Research Avenue de France 23 Geneva CH-1202 Switzerland Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Francis ATEBA NDONGO atebfranc@gmail.com +237677330055 Nsimeyong 2
City Postal code Country Position/Affiliation
Yaounde Cameroon Day Care Unit Coordinator for Chantal Biya Foundation
Role Name Email Phone Street address
Public Enquiries Patrice Ndzie pat.ndzie@gmail.com +237671863708 Ahala
City Postal code Country Position/Affiliation
Yaounde Cameroon President for KidAIDS Association
Role Name Email Phone Street address
Scientific Enquiries Rogacien KANA kanarogacien@gmail.com +237695353139 Biyemassi
City Postal code Country Position/Affiliation
Yaounde Cameroon Statistician for Media Convergence Consulting Office
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, and the study protocol will be available, beginning 36 months following the study end, with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. Proposal should be directed to atebfranc@gmail.com. To gain access, data requestors will need to sign a data access agreement. Study Protocol The study protocol will be available beginning 36 months following the study end. The study protocol will be available with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https:/doi.org/10.1016/j.respe.2022.101422 Yes 09/01/2024 16/12/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 09/01/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information