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.: PACTR202205869061299 Date of Approval: 16/05/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A controlled Study on the Effectiveness of Education Intervention Based on Theory of Planned Behavior (TPB) on HIV Preventive Sexual Behaviors among Polytechnic College Students in Addis Ababa, Ethiopia
Official scientific title The Effectiveness of Education Intervention Based on Theory of Planned Behavior (TPB) on HIV Preventive Sexual Behaviors among Polytechnic College Students in Addis Ababa, Ethiopia: A Quasi-Experimental Study
Brief summary describing the background and objectives of the trial Review of the studies showed that risky sexual behaviors among College and University Students in Ethiopia are high, 40.65% and 42.12%, respectively (Amare, Yeneabat and Amare, 2019). Most conducted studies were cross-sectional and targeted high school and University. There is lack of strong evidences that help to understand what is actually happening among the students of polytechnic colleges and no sufficient numbers of evidences are existed on effectiveness of education interventions based on Theory of planned Behaviors (TPB) in improving HIV preventive sexual behaviors among the students in the polytechnic colleges in developed world context in general and in Ethiopia in particular The specific objectives of the current interventional study are 1), to explore and identify salient behavioral, normative and control beliefs related to targeted HIV preventive sexual behaviors (abstain from sex, condom use, and having only one sex partner) among the students in the polytechnic colleges in Addis Ababa at baseline, 2) to assess the magnitudes of knowledge of HIV, attitude, subjective norm, Perceived behavioral control (PBC), and behavioral intentions, and actual targeted HIV preventive sexual behaviors and determine if TPB variables (attitude, subjective norm & PBC) will predict behavioral intentions and actual targeted HIV preventive sexual behaviors at baseline, 3) to measure effectiveness of education intervention on knowledge of HIV, and TPB variables towards targeted HIV preventive sexual behaviors among polytechnic colleges students in intervention group in comparison with control group, 4), to evaluate effectiveness of education intervention on behavioral intention and actual HIV preventive sexual behaviors of the students and 5) to conduct moderation and mediation analysis and identify which selected background factors will moderate and which TPB variables will mediate the effects of intervention on intention to targeted HIV preventive sexual behaviors.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) TPB HIV
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 11/04/2022
Actual trial start date 13/04/2022
Anticipated date of last follow up 12/07/2022
Actual Last follow-up date 15/07/2022
Anticipated target sample size (number of participants) 442
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 Non-randomised Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Sex and HIV education based on Theory of planned behaviors Education/training/ intervention based on Theory of Planned Behavior on HIV Preventive Sexual Behaviors will be provided for 60 minutes every two weeks for 6 times. In total, 360 minutes (6 hours) education/training will be provided for 221 intervention group participants by trained facilitator/health educator/. Three months Theory of Planned Behaviors (TPB) concepts and behavioral change techniques (BCTs) that previously have been proven linked with TPB constructs (attitude, subjective norm, PBC/self-efficacy/skills and intention), and knowledge of HIV are used to develop contents of the current education modules on HIV preventive sexual behaviors. The training will use various behavior change techniques (BCTs), participatory and interactive approaches (e.g. role play, group discussion, demonstration) and complement some short videos that are appropriate for the sessions (e.g. how to insert condom on erected penis) to enhance skills. The manual has 5 modules. These includes Module I, Program Introduction and Building Knowledge about HIV/AIDS, module II, improve positive Attitude towards HIV Preventive sexual behaviors (abstain from sex, condom use, and having one sex partner), module III, improving perceived norm/ social support/ of the students about performance of HIV preventive sexual behaviors, module IV, Identify barriers and facilitators about HIV preventive sexual behaviors, then mitigate the barriers and strengthen facilitators so that Perceived Behavioral Control/skills of the students will be increased to perform HIV preventive sexual behaviors and module V, improving intentions to perform HIV preventive sexual behaviors and students will be encouraged to develop three months individual plan to lower their risky sexual behaviors. Each module lasts for 72 minutes on average but 60 minutes training will be provided every two weeks for three months. The education/training will be provided by trained health educators/facilitators/. Concerning sample size, we will assign 221 participants for intervention group & 221 for control group. In total 442 participants. The survey will be conducted at baseline/pre-intervention/ and at end line/post intervention/ of the study in both groups. 221
Control Group No specific intervention There is no intervention and dose Three months Just observing their status. The study participants for control group is 221 students. Baseline survey will be conducted before intervention and end line survey after intervention. 221 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Students who are attending regular education program in the two selected polytechnic college during the study period • Regular students who are age of 18-24 years • Students who are volunteer to participate in the two pre-post test surveys and the intervention will be included in the study trial • Students who are physically, and mentally incapable (severely ill) • Students who are participating in other similar interventional study • The students who are less than 18 years of age will be excluded Adult: 19 Year-44 Year 18 Year(s) 24 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 16/04/2021 Jimma University Institute of Health Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
FerenjiArada street in Jimma Town Jimma 378 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • Intention to abstain from sex, • Intention to use condom if having sex • Intention to have only one sex partner • Intention to HIV preventive sexual behaviors • Abstain from sex • Consistent condom use • Having only one sex partner • HIV preventive sexual behaviors At pre and post intervention
Secondary Outcome • Salient beliefs related to HIV preventive sexual behaviors (abstain from sex, condom use, and having only one sex partner) • Knowledge about HIV, • Attitude towards HIV preventive sexual behaviors (abstain from sex, condom use, and having only one sex partner) • Perceived subjective norms about HIV preventive sexual behaviors (abstain from sex, condom use, and having only one sex partner) and • Perceived behavioral control (PBC) of HIV preventive sexual behaviors (abstain from sex, condom use, and having only one sex partner) At pre and post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Misrak Polytechnic College Togo St, Addis Ababa, Ethiopia Addis Ababa 785 Ethiopia
Tegebarid Polytechnic College Mexico street, Addis Ababa, Ethiopia Addis Ababa 40223 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
PhD Research grant FerenjiArada street, Jimma Jimma 378 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ministry of Health of Ethiopia Sudan Street Addis Ababa 1234 Ethiopia Ministry of Health, Ethiopia pays salary to me during the study periods
COLLABORATORS
Name Street address City Postal code Country
Addis Ababa Technical Vocational Training and Technology Development Bureau Ras Mekonen Street Addis Ababa 11129 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shemsedin Bamboro Arebo shemsedin15@gmail.com +251938738261 Haile G/Selassie Street
City Postal code Country Position/Affiliation
Addis Ababa 1234 Ethiopia PhD student in Public Health and senior Public Health expert in Ministry of Health of Ethiopia
Role Name Email Phone Street address
Public Enquiries Gobena Godena Boku gobenaboku@yahoo.com +251911545441 SebetaAlemgana Street
City Postal code Country Position/Affiliation
Addis Ababa 1234 Ethiopia Final Year PhD candidate in Public Health at Jimma University Ethiopia and Public Health specialist at Ministry of Health of Ethiopia and Senior member of Ethiopian Public Health Association
Role Name Email Phone Street address
Scientific Enquiries Zewdie Birhanu Koricha zkoricha@yahoo.com +251917025852 FerenjeArada, Jimma
City Postal code Country Position/Affiliation
Jimma 378 Ethiopia Associate Professor of infectious and Tropical diseases at Jimma University Ethiopia
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 de-identification will be shared. Other documents including study protocol, statistical analysis plan, informed Consent form, and study/trial report will be available. The data will be available immediately following publication and there is no end date. Anyone who wishes can access the data and for any types/purpose/ of analyses. The findings of the study will be published in reputable peer review scientific journal through consultation with Jimma University and will also be presented on scientific meetings and conferences, as necessary. Data will be available indefinitely at specified link. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The Data will be available/shared immediately following publication, No end date Anyone who wishes can access the data
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