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.: PACTR202404851907736 Date of Approval: 22/04/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Feasibility, Acceptability and Preliminary Effect of a Community-Led HIV Self-Testing Intervention Among Adolescent Girls and Young Women in Rural Northern Uganda.
Official scientific title Feasibility, Acceptability and Preliminary Effect of a Community-Led HIV Self-Testing Intervention Among Adolescent Girls and Young Women in Rural Northern Uganda.
Brief summary describing the background and objectives of the trial Adolescent girls and young women (AGYW) in low-resource settings like rural Northern Uganda face a disproportionately high HIV/AIDS burden, despite the global incidence decline. Existing interventions often fail to adequately address their unique social, economic, and cultural challenges, limiting access to essential HIV/AIDS services. Emerging evidence indicates that HIV self-testing, a user-friendly and confidential method, enhances HIV diagnosis and linkage to care by targeting these barriers. This study aims to assess the feasibility, acceptability, and preliminary impact of a peer-delivered, community-health worker (CHW)-facilitated HIV self-testing intervention for AGYW in Northern Uganda. This mixed-methods quasi-experimental implementation science study will employ a three-fold approach. Firstly, we will conduct baseline formative research using community consultations, key-informant interviews, and focus group discussions to inform the design of a peer-delivered CHW-facilitated HIV self-testing intervention tailored to AGYW's needs in Northern Uganda. This stage will utilize the COM-B model, social cognitive theory, and the health belief model. Secondly, we will implement a mixed-methods pilot study to assess the intervention's acceptability, appropriateness, and feasibility, involving 415 AGYW and multiple stakeholders in selected parishes and villages in Omoro district, Northern Uganda. Lastly, we will evaluate the preliminary impact of the intervention on HIV self-testing rates and linkage to care by collecting and analyzing quantitative data pre- and post-intervention, laying the groundwork for a future robust randomized controlled trial. Successful completion of this project will provide a scalable model to be evaluated in a randomized trial and potentially replicated in similar contexts. The goal is to enhance HIV self-testing rates and linkage to care, reducing HIV prevalence and contributing to improved health outcomes.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide) CARE HIV Study
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 03/06/2024
Actual trial start date
Anticipated date of last follow up 31/08/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 415
Actual target sample size (number of participants) 415
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
Single Group Non-randomised Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Peer led HIV self testing 3 months With the guidance of the community leaders and ten purposively selected CHWs, we will identify 30 AGYW from the five parishes to serve as peer leaders. The peer leaders and CHWs will undergo comprehensive training on the project, their roles, and the technical aspects of HIV/AIDS, HIVST procedures, basic counselling, and linkage to care. We will also train them in community mobilisation, communication, and engagement. The CHWs will allocate oral HIVST kits (OraQuick™) to peer leaders, who will distribute them to AGYW selected by systematic random sampling in their respective villages over three months. Each AGYW peer leader will then be instructed to distribute HIVST kits to 13 of the selected AGYW from their villages within three months. Adolescent girls and young women who desire to receive additional HIV self-testing kits for their partners/spouses will also be provided. The kit will also contain informational material in English and Acholi, containing the testing instructions, a confidential results card, and mobile contacts of CHWs, counsellors, and health facility focal persons to support confirmatory testing and ART initiation for those who test positive. Distributions will take place through various strategies, including door-to-door, community group meetings, and at other preferred locations. They will be carried out at different times, including weekends and evenings, to maximise accessibility for AGYW with varied schedules. The peer leaders will demonstrate the HIVST kit usage to the AGYW and remind them to perform the test for up to two weeks following the initial distribution. 415
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All adolescent girls and young women; i. Aged 15 – 24 years; ii. Who have lived in the selected parishes in Omoro district for at least 3 months; iii. And do not plan to leave their respective villages in the next one year will be eligible to participate in this study, after providing informed consent. Eligible peer leaders will be; i. Adolescent girls and young women aged 15 – 24 years; ii. Who have lived in their communities for at least six months with no intention to migrate within three months; iii. Have basic English and Luo comprehension; iv. With good communication skills; v. And are viewed as role models with integrity in their communities. i. Adolescent girls and young women who do not comprehend Luo or English languages. ii. Participants whose parents, guardians or partners actively decline their participation in the study. iii. Participants who are unable to respond to the study questionnaires due to incapacitation. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 15 Year(s) 24 Year(s) Female
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 26/03/2024 Makerere University School of Health Sciences Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Makerere Hill Road, Makerere University Kampala 7072 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Acceptability and feasibility Before and one month after the intervention.
Secondary Outcome Appropriateness, fidelity, implementation cost and preliminary effectiveness. Before and one month after the intervention.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Akidi Akidi-Lakwana Road Omoro Uganda
Lalogi Moroto Road Omoro Uganda
Lakwaya Lakwaya-Minja Road Omoro Uganda
Lakwana Opit-Awoo Road Omoro Uganda
Odek Lalogi-Bario Road Omoro Uganda
Orapwoyo Acet-Orapwoyo Road Omoro Uganda
Aremo Moroto Road Omoro Uganda
Bobi Gulu-Kampala Highway Omoro Uganda
Abuga Gulu-Arua Road Omoro Uganda
Labora Koro Road Omoro Uganda
Koro Gulu-Kampala Highway Omoro Uganda
Ongako Gulu-Arua Road Omoro Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Gilead Sciences Research Scholars Program in Global Public Health 8537 Six Forks Rd - Forum V Suite 200 Raleigh. Raleigh NC 27615 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Makerere University School of Public Health Upper Mulago Hill Road, Mulago Hospital Complex Kampala 7072 Uganda University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ronald Olum olum.ronald@gmail.com +256775512540 Upper Mulago Hill Road
City Postal code Country Position/Affiliation
Kampala 7072 Uganda Makerere University School of Public Health
Role Name Email Phone Street address
Public Enquiries Ronald Olum olum.ronald@gmail.com +256775512540 Upper Mulago Hill Road
City Postal code Country Position/Affiliation
Kampala 7072 Uganda Makerere University School of Public Health
Role Name Email Phone Street address
Scientific Enquiries Ronald Olum olum.ronald@gmail.com +256775512540 Upper Mulago Hill Road
City Postal code Country Position/Affiliation
Kampala 7072 Uganda Makerere University School of Public Health
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All de-identified data and materials arising from this study will be available upon reasonable request from the corresponding author (Dr. Ronald Olum) and relevant institutional approval. Results arising from this study will be published in peer-reviewed journals and presented in scientific meetings, as soon as they are available. Analytic Code,Statistical Analysis Plan,Study Protocol The study protocol with the statistical analysis plan will be published in an open access peer-reviewed journal. The de-identified data will be available immediately after the findings are published in a peer-reviewed journal. Researchers who provide a methodologically sound proposal on how the data will be analyzed.
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