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.: PACTR202307507643283 Date of Approval: 26/07/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Improving access to HIV/AIDS and Sexual and Reproductive Health (SRH) information among adolescents with hearing impairment in Ibadan, Nigeria: A Randomised controlled trial
Official scientific title Improving Knowledge of HIV among adolescents with hearing impairment: A Randomised controlled trial
Brief summary describing the background and objectives of the trial Most intervention packages for HIV and SRH fail to provide special services for adolescents living with disabilities. The Family Life and HIV Education curriculum is not implemented among this group of adolescents despite the fact that consistent empirical data reveal poor access to HIV/AIDS information and services among them. Most knowledge and awareness-oriented programs are audio-visual and therefore leaves out adolescents with hearing impairment. Adolescents living with disabilities are mostly ignored and left behind when interventions and programs are designed. There are programs that care for their wellbeing, but very few that focus on their sexual and reproductive health. Yet this population adds to the burden of HIV morbidity and mortality. This study seeks to pilot an intervention for hearing impaired adolescents by providing them with information and linkage to existing HIV/AIDS and SRH services. This study will employ a randomised controlled trial study and utilize mixed methods (qualitative and quantitative methods) of data collection to obtain information from participant. The study will be carried out in two phases. Phase one will be a baseline data collection to explore the access to HIV information and services and to understand the SRH behaviours among adolescents with hearing impairment and map existing HIV and SRH services. Phase two will involve providing hearing impaired adolescents with health education to improve their comprehensive HIV/AIDS knowledge and link them with HIV/AIDS services available within the state. Data will be analysed using SPSS and Atlas.Ti. The immediate outcomes of this study include (1) An in-depth description of access to HIV/AIDS and SRH information and services among adolescents with hearing impairments and (2) the effect of a health education intervention using interpreters (sign language) and linkage with existing services on access to information and services among adolescents with hearing impairment
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 17/10/2022
Actual trial start date 07/11/2022
Anticipated date of last follow up 27/01/2023
Actual Last follow-up date 17/02/2023
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
Recruitment status Completed
Publication URL https://journals.lww.com/nbcs/fulltext/2023/20020/improving_access_to_hiv_aids_and_sexual_and.9.aspx?context=latestarticles
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Increasing the HIV knowledge of adolescents with hearing impairment Three sessions 2hours per session The HIV component of the Family Life and HIV Curriculum was adapted for this intervention. Teachers of the schools randomised to the experimental group will be trained first. Then the students will be trained by the teachers for three sessions. Participants (students) will also receive same information in the form of a flier. Participants 40
Control Group Increasing the HIV knowledge of adolescents with hearing impairment Once - one time distribution of fliers with HIV information Once HIV information from the FLHE curriculum will be adapted and condensed. This information will then be produced as a flier and distributed to students 40 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. The study will be carried out among students in the registered schools for adolescents with hearing impairment located in Ibadan, Oyo State. 2. Hearing-impaired adolescents in the four special schools in Ibadan, Oyo State 3. Further, key informants comprising adults who work with hearing-impaired adolescents and young persons in Ibadan will be interviewed. 4. Health workers of Primary health care centers will be interviewed to provide insight on the activities of the health care centers in providing services for adolescents with hearing impairment 1. Adolescents who were unable to get consent from their parents 2. Adolescents who are too ill within the period of the intervention to participate in the study 3. Teachers who are not hearing impaired, can understand and communicate in English but have been in the school for less than one complete session Adolescent: 13 Year-18 Year,Adult: 19 Year-44 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 28/02/2022 Oyo State Research Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Oyo state secretariat Ibadan PMB 5027 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome HIV/AIDS comprehensive knowledge of the participants, Before intervention, immediate post intervention and one month post intervention
Primary Outcome willingness to seek HIV information and services, before, immediate after, and one month post intervention
Secondary Outcome Primary sources of SRH information and services, Before, immediate after and one month post intervention
Secondary Outcome health-seeking behavior of the adolescents Before, Immediate-post and one month post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Institute of Child Health Queen Elizabeth Street, Ibadan Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Fogarty International Center and the National Institute of Child Health and Human Development 9000 Rockville Pike, Bethesda, Maryland Maryland 20892 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Medical Education Partnership in Nigeria University of Ibadan Ibadan Nigeria University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Emmanuel Adebayo emmanueladebayo2002@gmail.com 07060766707 University of Ibadan
City Postal code Country Position/Affiliation
Ibadan Nigeria Research Fellow Institute of Child Health College of Medicine University of Ibadan
Role Name Email Phone Street address
Public Enquiries Babatunde Oluwagbayela theophilos2yk@gmail.com +2348130667213 University of Ibadan
City Postal code Country Position/Affiliation
Ibadan Nigeria Research Staff Institute of Child Health
Role Name Email Phone Street address
Scientific Enquiries Emmanuel Adebayo emmanueladebayo2002@gmail.com 07060766707 University of Ibadan
City Postal code Country Position/Affiliation
Ibadan Nigeria Research Fellow Institute of Child Health College of Medicine University of Ibadan
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The individual participant data will be made available including the data dictionaries All of the individual participant data collected during the trial will be made available after de-identification The study protocol will be published on Research Gate The Data will be available 3months and ending 5years following article publications The data will only be available to researchers or investigators whose proposed use of the data has been approved by an independent review committee Study Protocol The Data will be available 3months and ending 5years following article publications The data will only be available to researchers or investigators whose proposed use of the data has been approved by an independent review committee
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