HIV Self-Testing and Comic Intervention With Refugee Adolescents and Youth
NCT ID: NCT05213689
Last Updated: 2022-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2022-06-30
2022-10-31
Brief Summary
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Detailed Description
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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 (PN)'s 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 and/or 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 (e.g. 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-1/2); b) using OraQuick, a rapid oralHIVST used in Uganda; c) pre/post 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 services.The 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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HIV self-testing + educational comic book
At the first visit participants will receive a HIVST kit and a detailed description of how to use the HIVST kits, pictorial and written guide for HIVST kits, in addition to contact information for confirmatory testing and linkage to care at local clinics. Participants will also 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.
Educational comic book
An educational comic book was developed with qualitative data collected from an earlier study phase involving focus groups with youth from Bidi Bidi. The comic book is focused on HIV testing information and decision making as it follows the story of youth in Bidi Bidi who are seeking out HIV testing. Each youth in the appropriate arm with receive a copy of the comic book and together with 5-10 other youth will meet with a PN to read through and discuss the comic book. The comic will also include blank pages so that the youth can participate in the dialogue of the comic book. The comic will be available in English, Bari and Juba Arabic.
HIV Self-testing
Participants will receive HIVST kits so that they can perform their HIV testing.
HIV self-testing
At the first visit participants will receive a HIVST kit and a detailed description of how to use the HIVST kits, pictorial and written guide for HIVST kits, in addition to contact information for confirmatory testing and linkage to care at local clinics.
HIV Self-testing
Participants will receive HIVST kits so that they can perform their HIV testing.
Educational comic book
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.
Educational comic book
An educational comic book was developed with qualitative data collected from an earlier study phase involving focus groups with youth from Bidi Bidi. The comic book is focused on HIV testing information and decision making as it follows the story of youth in Bidi Bidi who are seeking out HIV testing. Each youth in the appropriate arm with receive a copy of the comic book and together with 5-10 other youth will meet with a PN to read through and discuss the comic book. The comic will also include blank pages so that the youth can participate in the dialogue of the comic book. The comic will be available in English, Bari and Juba Arabic.
Standard of Care
PNs will provide information about HIV testing, care and support services at local clinics.
No interventions assigned to this group
Interventions
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Educational comic book
An educational comic book was developed with qualitative data collected from an earlier study phase involving focus groups with youth from Bidi Bidi. The comic book is focused on HIV testing information and decision making as it follows the story of youth in Bidi Bidi who are seeking out HIV testing. Each youth in the appropriate arm with receive a copy of the comic book and together with 5-10 other youth will meet with a PN to read through and discuss the comic book. The comic will also include blank pages so that the youth can participate in the dialogue of the comic book. The comic will be available in English, Bari and Juba Arabic.
HIV Self-testing
Participants will receive HIVST kits so that they can perform their HIV testing.
Eligibility Criteria
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Inclusion Criteria
* identify as a refugee/displaced person or have refugee parents
* aged 16-24 years
Exclusion Criteria
* do not live in the selected villages in Zone 3 \& 4 Annex
16 Years
24 Years
ALL
Yes
Sponsors
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ViiV Healthcare
INDUSTRY
University of Toronto
OTHER
Responsible Party
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Carmen Logie, MSW, PhD
Associate Professor
Principal Investigators
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Carmen Logie, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Toronto
Locations
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Factor-Inwentash Faculty of Social Work, University of Toronto
Toronto, Ontario, Canada
Countries
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Central Contacts
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References
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Steward WT, Herek GM, Ramakrishna J, Bharat S, Chandy S, Wrubel J, Ekstrand ML. HIV-related stigma: adapting a theoretical framework for use in India. Soc Sci Med. 2008 Oct;67(8):1225-35. doi: 10.1016/j.socscimed.2008.05.032. Epub 2008 Jul 1.
Carey MP, Schroder KE. Development and psychometric evaluation of the brief HIV Knowledge Questionnaire. AIDS Educ Prev. 2002 Apr;14(2):172-82. doi: 10.1521/aeap.14.2.172.23902.
Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
Shaweno D, Tekletsadik E. Validation of the condom use self-efficacy scale in Ethiopia. BMC Int Health Hum Rights. 2013 Apr 23;13:22. doi: 10.1186/1472-698X-13-22.
Brafford LJ, Beck KH. Development and validation of a condom self-efficacy scale for college students. J Am Coll Health. 1991 Mar;39(5):219-25. doi: 10.1080/07448481.1991.9936238.
Pulerwitz J, Gortmaker SL, Dejong W. Measuring Sexual Relationship Power in HIV/STD Research. Sex Roles. 2000;42:637-60.
Hall KS, Manu A, Morhe E, Harris LH, Loll D, Ela E, Kolenic G, Dozier JL, Challa S, Zochowski MK, Boakye A, Adanu R, Dalton VK. Development and Validation of a Scale to Measure Adolescent Sexual and Reproductive Health Stigma: Results From Young Women in Ghana. J Sex Res. 2018 Jan;55(1):60-72. doi: 10.1080/00224499.2017.1292493. Epub 2017 Mar 7.
Logie CH, Okumu M, Mwima SP, Kyambadde P, Hakiza R, Kibathi IP, Kironde E, Musinguzi J, Kipenda CU. Exploring associations between adolescent sexual and reproductive health stigma and HIV testing awareness and uptake among urban refugee and displaced youth in Kampala, Uganda. Sex Reprod Health Matters. 2019 Dec;27(3):86-106. doi: 10.1080/26410397.2019.1695380.
Logie CH, Okumu M, Loutet MG, Coelho M, Berry I, Gittings L, Odong Lukone S, Kisubi N, Atama M, Kyambadde P. Todurujo na Kadurok (empowering youth): study protocol of an HIV self-testing and edutainment comic cluster randomised trial among refugee youth in a humanitarian setting in Uganda. BMJ Open. 2022 Nov 23;12(11):e065452. doi: 10.1136/bmjopen-2022-065452.
Other Identifiers
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bidibidi_viiv
Identifier Type: -
Identifier Source: org_study_id
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