Ignite Creation Date:
2024-05-06 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05213689
Status:
UNKNOWN
Last Update Posted:
2022-06-01
First Post:
2022-01-27
Brief Title:
HIV Self-Testing and Comic Intervention With Refugee Adolescents and Youth
Sponsor:
University of Toronto
Organization:
University of Toronto
Study Overview
Official Title:
Kuwawezesha Vijana Empowering Youth An HIV Self-Testing and Comic Intervention With Refugee Adolescents and Youth in a Refugee Settlement in Northern Uganda
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
HIV is the leading cause of death for adolescents and young people AYP in sub-SaharanAfrica SSA Uganda hosts 14 million refugeesdisplaced persons and the Bidi Bidi refugee camp in Northern Uganda is the second-largest refugee settlement in the world and the largest in Africa There are reports of high sexual and gender-based violence SGBV among refugees during the journey from South Sudan to Uganda and in the refugee settlements yet low rates of HIV testing and access to HIV prevention services particularly tailored for gender age and the refugee settlement context This study aims to develop implement and evaluate an oral HIV-self testing HIVST intervention with displacedrefugee AYP aged16- 24 in Bidi Bidi HIVST is acceptable and properly used with AYP in other SSA regions yet there are knowledge gaps regarding the best way to link HIVST to HIV care This study aims to explore how user-developed educational comic books can improve linkage to care with HIVST This trial focuses on implementing a randomized trial with displacedrefugee AYP aged 16-24 living in Bidi Bidi Arm1 HIVST Arm 2 HIVST comic book Arm 3 comic book Arm 4 standard of care The study will assess changes in HIV testing practices HIV status knowledge and linkage to HIV prevention and care between the 4 arms
Detailed Description:
The proposed study will take place in Bidi Bidi Refugee Settlement within Yumbe district in northwestern Uganda hosting over 200000 refugeesThis research will be conducted in Zone 3 and 5 in Bidi Bidi The proposed intervention involves a randomized controlled trial RCT to evaluate the effectiveness of HIVST delivery approaches on HIV testing uptake among refugee youth aged 16-24 in Bidi Bidi Participants will be cluster-randomized in one of four study arms Arm 1 HIVST Arm 2 HIVST comic book Arm 3 comic book Arm 4 standard of care Participants from specific villages within two Bidi Bidi zones will be randomized to an arm together
HIVST Interventions Arm 1 and 2 At the first visit study participants are provided with a HIVST kit Oraquick approved and used in Uganda by the Ministry of Health that is an oral swab test stick and tube solutions and a written detailed step by step description of how to correctly use the HIVST kits pictorial and written guide for HIVST kits information on HIV and testing referral cards with addresses and phone numbers to local clinics for confirmatory testing The cards will also have a peer navigator PNs phone numbers for participants to call or text message SMS if they need additional information on how to use the kits or support to go to confirmatory tests at the clinics Instructions for the kits are in English Bari and Juba Arabic and reflect the context of the rural displaced adolescent and young people The Research Coordinator and PN team will rotate being on-call to respond to any issues by text and will offer to phone or text support the participant and offer to make an appointment to see them andor support them to attend a collaborating clinic for further support
Educational comic book Arm 2 and 3 Participants will receive an educational comic book focused on HIV testing information and decision making that was developed with qualitative data collected from an earlier study phase PNs will meet with small groups of participants to read through and discuss the comic book together
Standard of Care PNs will provide information about HIV testing care and support services at local clinics
Participant retention Community collaborators will facilitate recruitment and retention PNs will use multiple study reminder strategies eg social media texts to maintain engagement and we will utilize existing outreach and services by Uganda Refugee and Disaster Management Council URDMC
Research Team Training This research involves collaborations with local clinics and URDMC in Bidi Bidi Clinic staff will provide technical assistance for HIVST and train PN and the research team in a using HIV rapid test kits Alere Determine HIV-12 b using OraQuick a rapid oralHIVST used in Uganda c prepost HIV test counselling and d linkages to confirmatory testing and HIV care
Linkage to testing and care Participants across all study arms will meet with PN at two timepoints t0 baseline t1 3 months to complete surveys Each participant will have a study identification ID number printed on movie coupons they can bring these coupons to clinics for HIV testing confirmatory testing linkage to HIV care sexual and reproductive health servicesThe survey ID will be linked to resources accessed Persons who test positive will be linked with local support groups and services which have been identified and will the linkage be facilitated by local collaborators URDMC
HIVST Interventions Arm 1 and 2 At the first visit study participants are provided with a HIVST kit Oraquick approved and used in Uganda by the Ministry of Health that is an oral swab test stick and tube solutions and a written detailed step by step description of how to correctly use the HIVST kits pictorial and written guide for HIVST kits information on HIV and testing referral cards with addresses and phone numbers to local clinics for confirmatory testing The cards will also have a peer navigator PNs phone numbers for participants to call or text message SMS if they need additional information on how to use the kits or support to go to confirmatory tests at the clinics Instructions for the kits are in English Bari and Juba Arabic and reflect the context of the rural displaced adolescent and young people The Research Coordinator and PN team will rotate being on-call to respond to any issues by text and will offer to phone or text support the participant and offer to make an appointment to see them andor support them to attend a collaborating clinic for further support
Educational comic book Arm 2 and 3 Participants will receive an educational comic book focused on HIV testing information and decision making that was developed with qualitative data collected from an earlier study phase PNs will meet with small groups of participants to read through and discuss the comic book together
Standard of Care PNs will provide information about HIV testing care and support services at local clinics
Participant retention Community collaborators will facilitate recruitment and retention PNs will use multiple study reminder strategies eg social media texts to maintain engagement and we will utilize existing outreach and services by Uganda Refugee and Disaster Management Council URDMC
Research Team Training This research involves collaborations with local clinics and URDMC in Bidi Bidi Clinic staff will provide technical assistance for HIVST and train PN and the research team in a using HIV rapid test kits Alere Determine HIV-12 b using OraQuick a rapid oralHIVST used in Uganda c prepost HIV test counselling and d linkages to confirmatory testing and HIV care
Linkage to testing and care Participants across all study arms will meet with PN at two timepoints t0 baseline t1 3 months to complete surveys Each participant will have a study identification ID number printed on movie coupons they can bring these coupons to clinics for HIV testing confirmatory testing linkage to HIV care sexual and reproductive health servicesThe survey ID will be linked to resources accessed Persons who test positive will be linked with local support groups and services which have been identified and will the linkage be facilitated by local collaborators URDMC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None