Clinical trial NCT04504097: Tushirikiane HIV-self Testing Intervention With Urban Refugee Youth in Kampala, Uganda
Official title: Tushirikiane (Supporting Each Other): Development, Implementation and Evaluation of Novel HIV Self-Testing Delivery Approaches With Urban Displaced and Refugee Adolescents and Youth in Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
HIV Infections
Knowledge, Attitudes, Practice
Keywords: HIV self testing
Forcibly displaced youth
mhealth
HIV prevention
Uganda
informal settlements
linkage to confirmatory testing
routine HIV testing
HIV status knowledge
HIV care
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 454
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 (cRCT) will evaluate the effectivness of HIVST delivery approaches on HIV testing uptake among refugee youth in Kampala. Clusters include 3 sites, informal settlements. Sites will be randomized in a 1:1:1 method to one of 3 study arms: Arm 1-HIVST, Arm 2- HIVST+ m-health, and Arm 3-standard of care (control). We propose a cRCT design of randomizing by slums to reduce the possibility of experimental contamination due to the shared social and physical environment in slums. Data collectors will administer tablet-based surveys (baseline, t1: 8 months, t2: 12 months). Arms 1 \& 2 will receive HIVST kits at each time-point.
Primary purpose: SCREENING

Brief summary: HIV is the leading cause of death for adolescents and young people (AYP) in sub-Saharan Africa (SSA). Uganda hosts 1.3 million refugees/displaced persons, and more than 80,000 live in Kampala, most in slums, yet little is known of HIV testing and prevention needs with displaced/refugee AYP living in Kampala's slums. This study aims to develop, implement and evaluate an oral HIV-self testing (HIVST) intervention with displaced/refugee AYP aged 16- 24 in Kampala. 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 m-health (healthcare delivered on mobile-phones), congruent with how AYP learn and socialize, can improve linkage to care with HIVST. This trial focuses on implementing a cluster randomized trial with displaced/refugee AYP aged 16-24 living in informal settlements in Kampala (Arm1: HIVST; Arm 2: HIVST + m-health; Arm 3: standard of care). The study will assess changes in HIV testing practices, HIV status knowledge, and linkage to HIV prevention and care between the 3 arms.

Detailed description: The proposed study will take place in Kampala, Uganda, hosting over 80,000 refugees. This research will be conducted in 5 informal settlements ('slums') grouped into 3 clusters based on proximity (1: Kabalanga and Kasanga, 2: Katwe and Nsambya, 3: Rubaga) where most displaced/refugee persons in Kampala live.

The proposed intervention involves a cluster randomized controlled trial (cRCT) to evaluate the effectivness of HIVST delivery approaches on HIV testing uptake among refugee youth aged 16-24 in Kampala. Clusters include 3 sites, slums of: Kabalanga/kasanga, Katwe/Nsambya and Rubaga. Sites will be randomized in a 1:1:1 method to one of 3 study arms:

Arms 1 \& 2: HIVST Interventions: 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, condoms and lubricant, information booklets on HIV and testing, referral cards with addresses and phone numbers to MARPI clinics for confirmatory testing. The cards will also have a peer navigator (PN)'s phone numbers for participants to text message (SMS) if they need additional information on how to use the kits, or support to go to confirmatory tests at the MARPI clinics. Instructions for the kits are in French, Swahili, Luganda and English and reflect the context of the urban displaced adolescent and young people. There is a 24-hour contact number for participants to text if/when they have questions. These texts will be managed through WelTel system that will flag these messages in real-time. The Research Coordinator and PN team will rotate being on-call to respond to these issues by text and will offer to phone, text, or WhatsApp support the participant and offer to make an appointment to see them and/or support them to attend MARPI or collaborating agency for further support. At follow-up visits PN will check in with participants about the HIVST kits, distribute another HIVST kit and condoms/lubricant, and screen for adverse events (e.g. negative HIVST related experiences).

Arm 2: HIVST + m-Health: Participants will receive weekly text messages via WelTel that check in with their wellbeing. Arm 2 PNs will discuss the weekly two-ways messages with participants, and request participants to respond to the message (detailed above) within 2 days.

Arm 3: Standard of Care: PNs will provide information about HIV testing, care and support services at MARPI clinics and provide a pamphlet of information about HIV \& HIV prevention strategies (written in French, English, Luganda and Swahili).

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 MARPI, YARID, Interaid Uganda, Tomorrow Vijana and community partners.

Research Team Training: This research involves collaborations with the Ministry of Health's Most At Risk Population Initiative (MARPI) clinics, YARID's women empowerment centre, Tomorrow Vijana's and Interaid Uganda's urban outreach programs in Kampala. MARPI 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 oral HIVST used in Uganda; c) pre/post HIV test counseling; and d) linkages to confirmatory testing and HIV care.

m-Health training: This research involves a collaboration with WelTel's non-profit agency for the supportive SMS intervention (Arm 2). WelTel staff will conduct SMS training with: Research Coordinator, Logie, Okumu, and the research team, including the PN. The WelTel system will manage the SMS intervention on their structured mobile-phone platform (all SMS interactions are logged). Weekly 2-way supportive messages (how are you? In Swahili: Habari Yako?) will automatically be sent on the same weekday with WelTel software to Arm 2 participants. PN ask Arm 2 participants to respond within 48 hours if they are well (Mzuri sana) or have a problem (Nina shida), and will follow-up with non-responders. The Arm 2 PN and Research Coordinator will access the server every 24-48 hours to triage and respond to participants who express a problem or need.

Linkage to testing and care: Participants across all study arms will meet with PN at 3 time points (t0: baseline, t1: 8 months, t2: 12 months) to complete surveys. Each participant will have a study identification (ID) number printed on 'movie coupons'; they can bring these coupons to MARPI for HIV testing, confirmatory testing, linkage to HIV care, SRH services. The survey ID will be linked to resources accessed. Persons who test positive will be linked with the collaborator Uganda Network of Young People Living with HIV \& AIDS (UNYPA)'s support groups and services.

Eligibility criteria: Inclusion Criteria:

* live in one of the 5 slum/informal settlement sites (Kabalanga, Kasanga, Katwe, Nsambya Rubaga)
* identify as a refugee/displaced person or have refugee parents
* aged 16-24
* report HIV negative status at baseline
* own or have access to a mobile phone for the study.

Exclusion criteria:

* report HIV-positive status at baseline
* do not identify as refugee or do not have refugee parents have no mobile phone do not live in the 5 selected slums

Primary outcomes:
measure: Changes in HIV testing Frequency
timeFrame: Time 1 (month 0), Time 2 (month 9), Time 3 (month 12)
measure: Change in Knowledge of HIV status
timeFrame: Time 1 (month 0), Time 2 (month 9), Time 3 (month 12)
measure: Changes in Linkage to confirmatory HIV testing
timeFrame: Time 2 (month 9), Time 3 (month 12)
measure: Changes in Linkage to HIV care
timeFrame: Time 2 (month 9), Time 3 (month 12)
measure: HIVST kit use
timeFrame: Time 3 (month 12)
Secondary outcomes:
measure: Changes in HIV stigma
timeFrame: Time 1 (month 0), Time 2 (month 9), Time 3 (month 12)
measure: Changes in Safer Sex Self-Efficacy.
timeFrame: Time 1 (month 0), Time 2 (month 9), Time 3 (month 12)
measure: Changes in Consistent Condom Use Frequency.
timeFrame: Time 1 (month 0), Time 2 (month 9), Time 3 (month 12)
measure: Changes in Sexual Relationship Power
timeFrame: Time 1 (month 0), Time 2 (month 9), Time 3 (month 12)
measure: Changes in adolescent sexual and reproductive health stigma.
timeFrame: Time 1 (month 0), Time 2 (month 9), Time 3 (month 12)
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, Canada
name: Carmen Logie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Logie C, Okumu M, Hakiza R, Kibuuka Musoke D, Berry I, Mwima S, Kyambadde P, Kiera UM, Loutet M, Neema S, Newby K, McNamee C, Baral SD, Lester R, Musinguzi J, Mbuagbaw L. Mobile Health-Supported HIV Self-Testing Strategy Among Urban Refugee and Displaced Youth in Kampala, Uganda: Protocol for a Cluster Randomized Trial (Tushirikiane, Supporting Each Other). JMIR Res Protoc. 2021 Feb 2;10(2):e26192. doi: 10.2196/26192.