Clinical trial NCT05213689: HIV Self-Testing and Comic Intervention With Refugee Adolescents and Youth
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV/AIDS
HIV Infections
Knowledge, Attitudes, Practice
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: ViiV Healthcare
First posted: 2022-01-28
Enrollment: 120
Sex: ALL
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This cluster-randomized controlled trial (RCT) will evaluate the effectiveness of HIVST delivery approaches on HIV testing uptake among refugee youth in the Bidi Bidi Refugee Settlement. Participants from two villages within each of the two zones (i.e., four geographically different areas) will be randomized together to one of 4 study arms: Arm 1-HIVST, Arm 2- HIVST+ educational comic book, Arm 3-educational comic book, and Arm 4 - standard of care(control). Data collectors will administer tablet-based surveys (baseline and at 3 months).
Primary purpose: PREVENTION

Brief summary: HIV is the leading cause of death for adolescents and young people (AYP) in sub-SaharanAfrica (SSA). Uganda hosts 1.4 million refugees/displaced 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 displaced/refugee 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 displaced/refugee 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 200,000 refugees.This 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 (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.

Eligibility criteria: Inclusion Criteria:

* living in one of the selected villages in Zone 3 \& 4 Annex in the Bidi Bidi Refugee Settlement
* identify as a refugee/displaced person or have refugee parents
* aged 16-24 years

Exclusion Criteria:

* do not identify as a refugee or do not have refugee parents
* do not live in the selected villages in Zone 3 \& 4 Annex

Primary outcomes:
measure: Changes in HIV testing frequency
timeFrame: Time 1 (month 0), Time 2 (month 3)
measure: HIV status knowledge
timeFrame: Time 2 (month 3)
Secondary outcomes:
measure: Linkage to confirmatory HIV testing
timeFrame: Time 2 (month 3)
measure: Change in HIV-related stigma
timeFrame: Time 1 (month 0), Time 2 (month 3)
measure: Change in HIV knowledge
timeFrame: Time 1 (month 0), Time 2 (month 3)
measure: Change in access to other sexual and reproductive health services
timeFrame: Time 1 (month 0), Time 2 (month 3)
measure: Linkage to HIV care
timeFrame: Time 2 (month 3)
measure: HIV self-test kit use
timeFrame: One month after Time 2
measure: Safer sex efficacy
timeFrame: Time 1 (month 0), Time 2 (month 3)
measure: Condom use
timeFrame: Time 1 (month 0), Time 2 (month 3)
measure: Adolescent sexual and reproductive health stigma
timeFrame: Time 1 (month 0), Time 2 (month 3)
measure: Sexual relationship power
timeFrame: Time 1 (month 0), Time 2 (month 3)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Factor-Inwentash Faculty of Social Work, University of Toronto
state: Ontario
Study officials:
affiliation: University of Toronto
name: Carmen Logie, PhD
role: PRINCIPAL_INVESTIGATOR
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