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.: PACTR202204518779027 Date of Approval: 20/04/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of Psychoeducation based stigma intervention among adolescents living with HIV
Official scientific title Effectiveness of Psychoeducation based stigma intervention among adolescents living with HIV
Brief summary describing the background and objectives of the trial To determine the baseline of stigma, depression and self esteem and also to determine the effectiveness of Psychoeducation based stigma intervention among adolescents living with HOV
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 01/07/2021
Actual trial start date
Anticipated date of last follow up 30/11/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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 Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group no intervention not applicable not applicable 20 Placebo
Experimental Group Psychoeducation based stigma two sessions a month Experimental Group, Psychoeducation based stigma , two sessions, a month, The outcome effect of the intervention was compared between a group of 20 that had the intervention with another group of 20 that didnot have the intervention 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adolescents aged 10 -19 living with HIV Adolescents living with HIV who are to ill to participate 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 30/07/2021 UINHREC
Ethics Committee Address
Street address City Postal code Country
UCH ibadan IBADAN 24025 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Reduction in stigma A month after intervention
Secondary Outcome reduction in depression, improvement in self esteem A month after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
UCH APIN adolescent clinic University college Hospital Ibadan Ibadan 24025 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Tosin Lawal UCH IBADAN IBADAN 24025 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor DR Bella Awusah UCH Ibadan Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rafiat Lawal tosinrafiat@gmail.com 2348033548184 UCH
City Postal code Country Position/Affiliation
ibadan Nigeria Reseacher
Role Name Email Phone Street address
Public Enquiries Lawal Rafiat tosinrafiat@gmail.com 22348033548184 UCH
City Postal code Country Position/Affiliation
ibadan Nigeria doctor
Role Name Email Phone Street address
Scientific Enquiries Rafiat Lawal tosinrafiat@gmail.com 2348033548184 UCH
City Postal code Country Position/Affiliation
Ibadan Nigeria Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes It will be made available online Clinical Study Report,Informed Consent Form,Statistical Analysis Plan within one month open access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not available yet 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