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.: PACTR202205641023383 Date of Approval: 06/05/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Using a Theory-Based Intervention to Improve Diagnosis and Management of Hypertension among Adolescents Living with HIV; A Cluster-randomized Study
Official scientific title Using a Theory-Based Intervention to Improve Diagnosis and Management of Hypertension among Adolescents Living with HIV; A Cluster-randomized Study
Brief summary describing the background and objectives of the trial Background Recent studies have shown a relatively higher incidence of cardiovascular diseases and related deaths among persons living with HIV than uninfected persons. The adverse effects of some antiretroviral medication, chronic vascular inflammation, and immune activation from persistent HIV replication leading to arterial stiffness contribute to this. The duration of exposure to the virus plays a vital role in the pathogenesis, putting perinatally infected children and adolescents at higher risk than behaviorally-infected individuals. This, therefore, supports the calls for increased surveillance of NCDs, especially hypertension among them. Several guidelines have been developed to support hypertension surveillance among high-risk children and adolescents with some adopted in Ghana's Standard Treatment Guidelines. Healthcare workers however do not check the blood pressures(BPs) of adolescents living with HIV. The theory of planned behavior(TPB) has been successfully used to predict healthcare work intentions to adhere to other clinical practice guidelines and has guided the development of interventions to improve healthcare worker adherence. Aim and objectives The overall aim of the study is to improve the adherence of healthcare workers to the guidelines for screening and management of hypertension among adolescents living with HIV(ADLHIV) at selected ART sites in the Greater Accra Region of Ghana. The objectives are to 1. Determine the TPB-based factors influencing health care workers' adherence to the guidelines for screening and management of hypertension among ADLHIV. 2. Assess the effect of a TPB-based intervention on healthcare workers' adherence to guidelines for screening & management of hypertension among ADLHIV. 3. Assess the effect of a TPB-based intervention on the arterial stiffness and blood pressure of ADLHIV.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CALDIGHA
Disease(s) or condition(s) being studied Circulatory System,Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Early detection /Screening
Anticipated trial start date 03/07/2022
Actual trial start date
Anticipated date of last follow up 30/06/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 96
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomization 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 Guideline orientation Once Five hours All control facilities will be given an orientation on the guidelines for screening and managing hypertension among children and adolescents. This will be done by trained facilitators using PowerPoint presentations, group discussions, and case scenarios. 48 Dose Comparison
Experimental Group Theory of planned behavior based health worker empowerment once The orientation will last for five hours but the monthly feedback( as described below) will be for three months. All intervention facilities will also experience the control condition, which involves being given an orientation on the guidelines for screening and managing hypertension among children and adolescents. This will be done by trained facilitators using PowerPoint presentations, group discussions, and case scenarios. In addition, they will receive a multi-component intervention package based on the theory of planned behavior constructs( attitude, subjective norms, and perceived behavioral control). To change negative health care worker attitude toward adolescent BP screening, they will be oriented on the risk of hypertension among adolescents living with HIV. To change the negative subjective norms toward checking the blood pressures of adolescents, demand for BP screening will be created by orienting adolescents living with HIV and their caregivers on the need for BP surveillance at each clinical visit. They will also be provided with posters to serve as reminders, offered the support of an opinion leader in their facility, and given monthly feedback on their degree of adherence to the guidelines. To change the perceived behavior control of health workers, they will be oriented on BP measurement techniques, provided pediatric-friendly sphygmomanometers, and given clinical decision support tools to guide the interpretation of measured BPs. 48
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Registered clinical staff(Prescribers, Pharmacy staff, Nurses, and Midwives) 2. Must be working in participating health facilities. 3. Must have valid licenses from relevant regulatory bodies in Ghana will be eligible for inclusion in the study. • Less than 18 years of age • They do not provide antiretroviral services to clients or work at the outpatient clinic • Their practical post qualification experience in providing client care is less than one year. • They are not available throughout the study period • They do not agree to participate in the study by signing a consent form. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 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 12/07/2022 Ghana Health Service Ethical Review Committee
Ethics Committee Address
Street address City Postal code Country
Ghana Health Service Ethical Review Committee, Research and Development Division P. O. Box MB 190 Accra, Ghana Accra MB Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Healthcare workers' adherence to guidelines will be assessed from the antiretroviral records of adolescents living with HIV who received care at the participating health facilities. Using a data extraction tool, it will assess i. Frequency of BP screening ii. Detection of elevated or high BP, iii. Investigation of high BP and iv. Management of elevated or high BP. At baseline and six months after enrolment into study.
Secondary Outcome These will be assessed among adolescents living with HIV who receive care at the participating facilities. It will involve the following 1. The number of adolescents who reported adhering to cardio-protective behavior using WHO STEPS questionnaire for chronic disease surveillance 2. The number of adolescents with elevated BP 3. The number of adolescents with arterial stiffness as measured by VASCERA. At baseline and 6 months after enrolment into the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Ghana School of Public Health School of Public Health, College of Health Sciences, P.O. Box LG 13, University of Ghana, Legon Accra Accra LG Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institute for Health through the Yale University and University of Ghana Collaborative 9000 Rockville Pike Maryland United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Institute for health 9000 Rockville Pike Mary Land United States of America Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Elijah Paintsil Yale University School of Public Health New Haven United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Raphael Adu Gyamfi radu-gyamfi2@st.ug.edu.gh +233267075458 Alexander Avenue
City Postal code Country Position/Affiliation
Accra KB547 Ghana PhD student University of Ghana School of Public Health
Role Name Email Phone Street address
Public Enquiries Naana Ama Akyiamaa Agyemang yesubanaana@yahoo.co.uk +233504518170 Population Family Reproductive Health Department School of Public Health
City Postal code Country Position/Affiliation
Accra LG13 Ghana HIV Comorbidity Research Training Programme Administrator School of Public Health University of Ghana
Role Name Email Phone Street address
Scientific Enquiries Emmanuel Kwasi Torpey ktorpey@hotmail.com +233244563322 University of Ghana School of Public Health
City Postal code Country Position/Affiliation
Accra LG13 Ghana Head of Department and Director for HIV Comorbidity Research Training Program Program
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the study, after deidentification, will be available for sharing. The study protocol, statistical analysis plan, informed consent form, and analytic codes will also be available. The data will be available beginning 2 months and ending 10 years following study publication to anyone who wishes to access the data for individual participant meta-analysis. Requests for the data should be directed at radu-gyamfi2@st.ug.edu.gh. Analytic Code,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data collected during the study will be available for sharing two months after publication for up to 10 years. Some of the data used for manuscripts will however be available immediately they get published. Persons interested in any data collected as part of this study will have to 1. Provide the objectives for which the data will be used. 2. Be willing to share the final work that comes out from the data prior to its publication. These will be reviewed by the Principal Investigator and his supervisor before access is granted.
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