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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607484257298 Date of Registration: 24/07/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Determinants of Hepatitis B Vaccination and the Effect of a Theory of Planned Behavior–Based Educational Intervention on Knowledge and Intention to Vaccinate Among People Living with HIV in the Dodoma Region, Tanzania
Official scientific title Determinants of Hepatitis B Vaccination and the Effectiveness of a Theory of Planned Behavior–Based Educational Intervention on Knowledge and Intention to Receive Hepatitis B Vaccination Among People Living with HIV in the Dodoma Region, Tanzania: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial People living with HIV (PLHIV) are at increased risk of hepatitis B virus (HBV) infection, which is associated with significant morbidity and mortality. Although hepatitis B vaccination is an effective strategy for preventing HBV infection, vaccination coverage among PLHIV remains low in many settings, including Tanzania. Limited knowledge, negative attitudes, perceived barriers, and social influences may contribute to poor vaccine uptake. The Theory of Planned Behavior (TPB) provides a useful framework for understanding and influencing vaccination behavior by targeting attitudes, subjective norms, perceived behavioral control, and behavioral intention. This study aims to investigate the determinants of hepatitis B vaccination and evaluate the effectiveness of a TPB-based educational intervention among PLHIV in the Dodoma Region, Tanzania. Specifically, the study will determine the proportion of PLHIV who have received hepatitis B vaccination; identify psychosocial factors associated with vaccination uptake; assess the effect of the educational intervention on participants' knowledge of HBV; evaluate its effect on intention to receive hepatitis B vaccination; and examine whether TPB constructs (attitude, subjective norms, and perceived behavioral control) mediate the relationship between the educational intervention and intention to vaccinate. The findings will provide evidence to guide the design and implementation of interventions aimed at improving hepatitis B vaccination among PLHIV in Tanzania and similar settings.
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 Education /Training
Anticipated trial start date 13/07/2026
Actual trial start date
Anticipated date of last follow up 30/09/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 104
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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 Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Theory of Planned Behavior based Educational Intervention one session 45minutes to 1 hr Theory of Planned Behaviour based educational intervention; this intervention will be developed in accordance with the core constructs of the TPB framework. The intervention addresses essential aspects of HBV infection, including its definition, modes of transmission, prevention strategies and the vaccination schedule, with particular emphasis on vaccination uptake and completion of the recommended schedule. It is specifically designed to target participants’ attitudes toward vaccination, perceived social norms, and confidence in completing the vaccination schedule (perceived behavioral control). This educational program serves as the primary intervention and is intended to enhance participants’ knowledge and strengthen their intention to receive the Hepatitis B vaccine 52
Control Group Routine care counselling According to the routine counselling practices of the respective health facility. 5-15minutes People living with HIV (PLHIV) in the control group will receive routine HIV care and treatment services in accordance with national guidelines. Hepatitis B-related information is provided through routine health counselling during clinic visits as part of standard clinical care. This counselling is generally passive and non-standardized, consisting of brief verbal health education delivered by healthcare providers. The content, duration, and frequency of counselling vary across health facilities depending on routine service delivery, available time, staffing, and individual patient needs. Routine counselling does not include the structured Theory of Planned Behavior (TPB)-based educational intervention being evaluated in this study. Consequently, participants in the control group will receive usual care only. 52 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.People living with HIV (PLHIV) aged 18 years and above and willing to participate in the study. 2.People living with HIV (PLHIV) who are unvaccinated (have received zero doses of the hepatitis B vaccine) or have incomplete vaccination status due to missed vaccination appointments. 1.People living with HIV (PLHIV) attending Care and Treatment Clinics (CTCs) in the Dodoma Region who are critically ill. 2.People living with HIV (PLHIV) with self-reported hepatitis B infection will be excluded from the study. 80 and over: 80+ Year,Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 10/06/2026 University of Dodoma Insitutional Research Review Committee
Ethics Committee Address
Street address City Postal code Country
Directorate of Research, Publications and Consultancy The University of Dodoma P.O. Box 259 Dodoma Tanzania Dodoma 41107 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Hepatitis B knowledge One month post intervention
Secondary Outcome Intention to uptake the Hepatitis B Vaccine One month post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Makole Health Centre P.O Box 1249,Dodoma city Dodoma N/A United Republic of Tanzania
Makole dispensary P.O Box 1249,Dodoma city Dodoma N/A United Republic of Tanzania
Uhuru Hospital P.O Box 1126,Chamwino Dodoma N/A United Republic of Tanzania
Chamwino health centre P.O Box 1126,Chamwino Dodoma N/A United Republic of Tanzania
Bahi Hospital P.O Box 2993,Bahi Dodoma N/A United Republic of Tanzania
Bahi Health Centre P.O Box 2993,Bahi Dodoma N/A United Republic of Tanzania
Kongwa District Hospital P.O Box 57,Kongwa Dodoma N/A United Republic of Tanzania
Ugogoni health centre P.O Box 57,Kongwa Dodoma N/A United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Judith Mwerero Kiliani P.o. Box 259 Dodoma N/A United Republic of Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor self sponsored N/A NA N/A United Republic of Tanzania Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Judith Mwereo Kiliani judithkiria64@gmail.com 0756327035 P.O. Box 259
City Postal code Country Position/Affiliation
Dodoma 41107 United Republic of Tanzania student
Role Name Email Phone Street address
Public Enquiries Judith Mwereo Kiliani judithkiria64@gmail.com 0756327035 P. O. Box 259
City Postal code Country Position/Affiliation
Dodoma 41107 United Republic of Tanzania Student
Role Name Email Phone Street address
Scientific Enquiries Saada Ali Seif saadudat@gmail.com 0756327035 P. O. Box 259
City Postal code Country Position/Affiliation
Dodoma 41107 Tanzania Seniour lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will not be shared publicly. Only aggregated summary results will be published. De-identified data may be shared upon reasonable request and subject to approval by the principal investigator and ethics committee Informed Consent Form Individual participant data will be made available from November 2026 onwards, after study completion. IPD will be available upon reasonable request after study completion and publication, subject to approval by the principal investigator and ethics committee, in de-identified form only.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A 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
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 17/07/2026 I mistakenly stated that the experimental group size was 13. The value of 13 refers to the number of participants per facility. The correct total number of participants in the experimental group is 52 Experimental Group, Theory of Planned Behavior based Educational Intervention, one session, 45minutes to 1 hr, Theory of Planned Behaviour based educational intervention; this intervention will be developed in accordance with the core constructs of the TPB framework. The intervention addresses essential aspects of HBV infection, including its definition, modes of transmission, prevention strategies and the vaccination schedule, with particular emphasis on vaccination uptake and completion of the recommended schedule. It is specifically designed to target participants’ attitudes toward vaccination, perceived social norms, and confidence in completing the vaccination schedule (perceived behavioral control). This educational program serves as the primary intervention and is intended to enhance participants’ knowledge and strengthen their intention to receive the Hepatitis B vaccine, 13, Experimental Group, Theory of Planned Behavior based Educational Intervention, one session, 45minutes to 1 hr, Theory of Planned Behaviour based educational intervention; this intervention will be developed in accordance with the core constructs of the TPB framework. The intervention addresses essential aspects of HBV infection, including its definition, modes of transmission, prevention strategies and the vaccination schedule, with particular emphasis on vaccination uptake and completion of the recommended schedule. It is specifically designed to target participants’ attitudes toward vaccination, perceived social norms, and confidence in completing the vaccination schedule (perceived behavioral control). This educational program serves as the primary intervention and is intended to enhance participants’ knowledge and strengthen their intention to receive the Hepatitis B vaccine, 52,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 17/07/2026 I mistakenly stated that the control group size was 13. The value of 13 refers to the number of participants per facility. The correct total number of participants in the control group is 52 Control Group, Routine care counselling , According to the routine counselling practices of the respective health facility., 15minun to 1hr, People living with HIV (PLHIV) in the control group will receive routine HIV care and treatment services in accordance with national guidelines. Hepatitis B-related information is provided through routine health counselling during clinic visits as part of standard clinical care. This counselling is generally passive and non-standardized, consisting of brief verbal health education delivered by healthcare providers. The content, duration, and frequency of counselling vary across health facilities depending on routine service delivery, available time, staffing, and individual patient needs. Routine counselling does not include the structured Theory of Planned Behavior (TPB)-based educational intervention being evaluated in this study. Consequently, participants in the control group will receive usual care only., 13, Active-Treatment of Control Group Control Group, Routine care counselling , According to the routine counselling practices of the respective health facility., 15minun to 1hr, People living with HIV (PLHIV) in the control group will receive routine HIV care and treatment services in accordance with national guidelines. Hepatitis B-related information is provided through routine health counselling during clinic visits as part of standard clinical care. This counselling is generally passive and non-standardized, consisting of brief verbal health education delivered by healthcare providers. The content, duration, and frequency of counselling vary across health facilities depending on routine service delivery, available time, staffing, and individual patient needs. Routine counselling does not include the structured Theory of Planned Behavior (TPB)-based educational intervention being evaluated in this study. Consequently, participants in the control group will receive usual care only., 52, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 17/07/2026 I mistakenly stated that the control group size was 13. The value of 13 refers to the number of participants per facility. The correct total number of participants in the control group is 52 Control Group, Routine care counselling , According to the routine counselling practices of the respective health facility., 15minun to 1hr, People living with HIV (PLHIV) in the control group will receive routine HIV care and treatment services in accordance with national guidelines. Hepatitis B-related information is provided through routine health counselling during clinic visits as part of standard clinical care. This counselling is generally passive and non-standardized, consisting of brief verbal health education delivered by healthcare providers. The content, duration, and frequency of counselling vary across health facilities depending on routine service delivery, available time, staffing, and individual patient needs. Routine counselling does not include the structured Theory of Planned Behavior (TPB)-based educational intervention being evaluated in this study. Consequently, participants in the control group will receive usual care only., 52, Active-Treatment of Control Group Control Group, Routine care counselling , According to the routine counselling practices of the respective health facility., 5-15minutes, People living with HIV (PLHIV) in the control group will receive routine HIV care and treatment services in accordance with national guidelines. Hepatitis B-related information is provided through routine health counselling during clinic visits as part of standard clinical care. This counselling is generally passive and non-standardized, consisting of brief verbal health education delivered by healthcare providers. The content, duration, and frequency of counselling vary across health facilities depending on routine service delivery, available time, staffing, and individual patient needs. Routine counselling does not include the structured Theory of Planned Behavior (TPB)-based educational intervention being evaluated in this study. Consequently, participants in the control group will receive usual care only., 52, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 17/07/2026 Thank you for pointing this out. The phrase 1 month was unclear because it did not specify the reference point. Secondary Outcome, Intention to uptake the Hepatitis B Vaccine , one month post intervention Secondary Outcome, Intention to uptake the Hepatitis B Vaccine , One month post intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 17/07/2026 Thank you for pointing this out. The phrase 1 month was unclear because it did not specify the reference point. Primary Outcome, Hepatitis B knowledge, 1 month Primary Outcome, Hepatitis B knowledge, One month post intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 17/07/2026 Thank you for pointing this out. The phrase "1 month" was unclear because it did not specify the reference point. We will revise the manuscript to state "1 month post-intervention" to clarify that the follow-up assessment was conducted one month after completion of the intervention. Secondary Outcome, Intention to uptake the Hepatitis B Vaccine , 1 month Secondary Outcome, Intention to uptake the Hepatitis B Vaccine , 1 month post intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 17/07/2026 Thank you for pointing this out. The phrase "1 month" was unclear because it did not specify the reference point. We will revise the manuscript to state "1 month post-intervention" to clarify that the follow-up assessment was conducted one month after completion of the intervention. Secondary Outcome, Intention to uptake the Hepatitis B Vaccine , 1 month post intervention Secondary Outcome, Intention to uptake the Hepatitis B Vaccine , one month post intervention
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 17/07/2026 I did not mention the name of the specific clinic. Dodoma Region Care and Treatment Clinics , Care and Treatment Clinics , health facilities within Dodoma Region, Dodoma, N/A, United Republic of Tanzania Makole Health Centre, P.O Box 1249, Dodoma, N/A, United Republic of Tanzania
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 17/07/2026 I did not mention the name of the specific clinic. Makole Health Centre, P.O Box 1249, Dodoma, N/A, United Republic of Tanzania Makole Health Centre, P.O Box 1249,Dodoma city, Dodoma, N/A, United Republic of Tanzania
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 17/07/2026 I did not mention the name of the specific Clinic Makole dispensary, P.O Box 1249, Dodoma, N/A, United Republic of Tanzania
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 17/07/2026 I did not mention the name of the specific Clinic Makole dispensary, P.O Box 1249, Dodoma, N/A, United Republic of Tanzania Makole dispensary, P.O Box 1249,Dodoma city, Dodoma, N/A, United Republic of Tanzania
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 17/07/2026 I did not mention the name of the specific Clinic Uhuru Hospital, P.O Box 1126,Chamwino, Dodoma city , N/A, United Republic of Tanzania
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 17/07/2026 I did not mention the name of the specific Clinic Uhuru Hospital, P.O Box 1126,Chamwino, Dodoma city , N/A, United Republic of Tanzania Uhuru Hospital, P.O Box 1126,Chamwino, Dodoma , N/A, United Republic of Tanzania
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 17/07/2026 I did not mention the name of the specific Clinic Chamwino health centre, P.O Box 1126,Chamwino, Dodoma, N/A, United Republic of Tanzania
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 17/07/2026 I did not mention the name of the specific Clinic Bahi Hospital, P.O Box 2993, Dodoma, N/A, United Republic of Tanzania
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 17/07/2026 I did not mention the name of the specific Clinic Bahi Hospital, P.O Box 2993, Dodoma, N/A, United Republic of Tanzania Bahi Hospital, P.O Box 2993,Bahi, Dodoma, N/A, United Republic of Tanzania
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 17/07/2026 I did not mention the name of the specific Clinic Bahi Health Centre, P.O Box 2993,Bahi, Dodoma, N/A, United Republic of Tanzania
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 17/07/2026 I did not mention the name of the specific Clinic Kongwa District Hospital, P.O Box 57,Kongwa, Dodoma, N/A, United Republic of Tanzania
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 17/07/2026 I did not mention the name of the specific Clinic Kongwa health centre, P.O Box 57,Kongwa, Dodoma, N/A, United Republic of Tanzania
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 17/07/2026 I did not mention the name of the specific Clinic Kongwa health centre, P.O Box 57,Kongwa, Dodoma, N/A, United Republic of Tanzania Ugogoni health centre, P.O Box 57,Kongwa, Dodoma, N/A, United Republic of Tanzania
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 17/07/2026 I didn't indicate the name of the principal investigator self funded, N/A, NA, N/A, United Republic of Tanzania, Self Funded, Judith Mwerero Kiliani, P.o. Box 259, Dodoma, N/A, United Republic of Tanzania, Self Funded,