HIV Self-Testing and Comic Intervention With Refugee Adolescents and Youth

NCT05213689 | Unknown

• 1 other identifier: bidibidi_viiv
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS; HIV Infections; Knowledge, Attitudes, Practice

Outcome Measures

Primary Outcomes (2)

• Changes in HIV testing frequency

  To assess changes in past 3 month HIV testing frequencies, participants are asked to self-report when their last HIV test was and where their last HIV test was (if they used the HIVST, clinic, or point-of-care testing).

  Time 1 (month 0), Time 2 (month 3)

• HIV status knowledge

  At the final 3-month visit, a clinician supported by trained peer navigators will offer all participants a completely voluntary rapid point-of-care HIV test (Alere Determine HIV-½) to measure HIV status knowledge. HIV status knowledge will be assessed as correct for participants that agree to take the rapid test and correctly report their HIV status before receiving the result.

  Time 2 (month 3)

Secondary Outcomes (10)

• Linkage to confirmatory HIV testing

  Time 2 (month 3)

• Change in HIV-related stigma

  Time 1 (month 0), Time 2 (month 3)

• Change in HIV knowledge

  Time 1 (month 0), Time 2 (month 3)

• Change in access to other sexual and reproductive health services

  Time 1 (month 0), Time 2 (month 3)

• Linkage to HIV care

  Time 2 (month 3)

Study Arms (4)

HIV self-testing + educational comic book

EXPERIMENTAL

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.

Behavioral: Educational comic book; Diagnostic Test: HIV Self-testing

HIV self-testing

ACTIVE COMPARATOR

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.

Diagnostic Test: HIV Self-testing

Educational comic book

ACTIVE COMPARATOR

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.

Behavioral: Educational comic book

Standard of Care

NO INTERVENTION

PNs will provide information about HIV testing, care and support services at local clinics.

Interventions

Educational comic book BEHAVIORAL

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.

Educational comic book; HIV self-testing + educational comic book

HIV Self-testing DIAGNOSTIC_TEST

Participants will receive HIVST kits so that they can perform their HIV testing.

HIV self-testing; HIV self-testing + educational comic book

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Toronto: lead
• ViiV Healthcare: collaborator

Study Sites (1)

Factor-Inwentash Faculty of Social Work, University of Toronto

Toronto, Ontario, M5S1V4, Canada

Location

Related Publications (9)

• 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.

  PMID: 18599171 BACKGROUND

• 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.

  PMID: 12000234 BACKGROUND

• 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.

  PMID: 28851459 BACKGROUND

• 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.

  PMID: 23617404 BACKGROUND

• 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.

  PMID: 1783705 BACKGROUND

• Pulerwitz J, Gortmaker SL, Dejong W. Measuring Sexual Relationship Power in HIV/STD Research. Sex Roles. 2000;42:637-60.

  BACKGROUND

• 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.

  PMID: 28266874 BACKGROUND

• 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.

  PMID: 31880507 BACKGROUND

• 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.

  PMID: 36418143 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections; Behavior

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Carmen Logie, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carmen Logie, PhD

CONTACT

6474544203; carmen.logie@utoronto.ca

Miranda Loutet, MSc

CONTACT

4166685076; miranda.loutet@mail.utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: January 28, 2022
• Study Start: June 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Locations

CA (1)