Livelihoods Intervention With Urban Refugee Youth in Kampala, Uganda

NCT06270160 | Recruiting

• 1 other identifier: KampalaLivelihoodsStudy
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 1

Brief Summary

Displaced and refugee youth in Uganda are more vulnerable to health risks due to financial insecurity. As such, the investigators aim to explore the utility of an intervention aimed at improving livelihoods, called Creating Futures. Creating Futures is a group intervention that aims to help young people build their livelihoods, and was designed for use with youth (18-24) in urban informal settlements in South Africa. Since there is a dearth of knowledge regarding efficacious interventions in refugee camps/settlements to engage young people in HIV testing and linkage to care, the investigators will harness various health promotion techniques including mHealth, comics, and the Creating Futures livelihoods intervention to address the urgent needs for: 1) HIV testing interventions with refugee/displaced adolescent and young people in Kampala, and 2) innovative HIV self test (HIVST) delivery strategies to increase linkage to confirmatory testing and HIV care. The investigators will conduct a three-arm cluster randomized controlled trial (cRCT) to evaluate the effectiveness of HIVST delivery methods among AYP living in Kampala. The specific objectives are to: Evaluate the feasibility and effectiveness of: 1) HIVST alone; 2) HIVST in combination with mHealth; and 3) HIVST, mHealth and Creating Futures in combination in increasing routine HIV testing, HIV status knowledge, and linkage to confirmatory testing and HIV care. The investigators aim to examine if adding a livelihoods program to HIV self-testing improves HIV prevention outcomes and other facets of well-being among urban refugee youth in Kampala.

Conditions

Financial Stress; Social Functioning; Social Skills

Outcome Measures

Primary Outcomes (1)

• Number of participants engaged in HIV testing

  The primary outcome measured in this trial is routine (every 3 months) HIV testing uptake as a measure of HIV prevention. Participants will be asked to self-report when their last HIV test occurred and where it was received (i.e., HIVST, clinic, point-of-care).

  Every 3 months

Secondary Outcomes (5)

• Number of participants with knowledge of their HIV status

  3- and 6-month follow-up

• Number of participants linked to confirmatory HIV testing

  3- and 6-month follow-up

• Frequency of linkage to HIV care

  3- and 6-month follow-up

• Brief HIV Knowledge Questionnaire

  3- and 6-month follow-up

• Sexual Risk

  3- and 6-month follow-up

Study Arms (3)

Arm 1: HIVST Alone

EXPERIMENTAL

Participants will be provided with HIVST instructions and education from peer navigators, who will also emphasize the importance of receiving a confirmatory test irrespective of HIV positive result. Peer navigators will demonstrate how to use an HIVST kit, including how to 1) open the kit, 2) collect the oral fluid samples, and 3) read the results. In addition to HIVST education, participants will be offered optional pre-test counselling and SMS contact information to connect with their peer navigator. If participants do not want post-test counselling, the PN will follow up within two weeks. If the participants report testing positive, then they will be immediately scheduled for confirmatory testing and enrolled in the support programs at MARPI for young people living with HIV.

Diagnostic Test: HIVST

Arm 2: HIVST + mHealth

EXPERIMENTAL

Participants in this arm will be enrolled into the HIVST intervention (as described above) as well as mHealth. The mHealth intervention is a 5-week program that includes a: 1) weekly SMS check-in moderated by the peer navigator; 2) weekly themed informational SMS and accompanying questions to enhance engagement; 3) WhatsApp group multi-media sharing with peer navigators. The peer navigator and coordinator will review group discussions weekly to incentivize engagement; 4) participatory comic books. The investigators are collaborating with the WelTel non-profit agency for a supportive SMS intervention. Weekly 2-way supportive messages will automatically be sent on the same weekday with WelTel software to Arm 2+3 participants, who should respond within 48 hours.

Diagnostic Test: HIVST; Device: mHealth

Arm 3: HIVST + mHealth + Creating Futures Livelihoods program

EXPERIMENTAL

In addition to HIVST and mHealth access, participants in Arm 3 will also be in enrolled in an 8-week Creating Futures program. This manualized program was developed with youth in South Africa and adapted for the Kenyan context (manual is appended). Topics within the Creating Futures program include: 1) introduction and situating self; 2) sustainable and social resources; 3) peer group meeting; 4) education and learning; 5) getting and keeping jobs; 6) income generating activities; 7) saving and coping with shocks; 8) reflection and looking ahead. This intervention aims to help participants think about, and plan for, their futures to assist them in making a living in the long term. Each workshop is facilitated by pairs of peer navigators and runs from 2-4 hours.

Diagnostic Test: HIVST; Device: mHealth; Behavioral: Creating Futures Livelihoods program

Interventions

HIVST DIAGNOSTIC_TEST

Peer navigators will demonstrate how to use an HIVST kit, including how to 1) open the kit, 2) collect the oral fluid samples, and 3) read the results. In addition to HIVST education, participants will be offered optional pre-test counselling and SMS contact information to connect with their peer navigator. If participants do not want post-test counselling, the PN will follow up within two weeks. If the participants report testing positive, then they will be immediately scheduled for confirmatory testing and enrolled in the support programs at MARPI for young people living with HIV.

Arm 1: HIVST Alone; Arm 2: HIVST + mHealth; Arm 3: HIVST + mHealth + Creating Futures Livelihoods program

mHealth DEVICE

The investigators are collaborating with the WelTel non-profit agency for a supportive SMS intervention. The WelTel system will manage the SMS intervention on their structured mobile phone platform (all SMS interactions are logged). Weekly 2-way supportive messages will automatically be sent on the same weekday with WelTel software to Arm 2+3 participants. The peer navigator will ask Arm 2+3 participants to respond to the SMS within 48 hours to confirm their wellbeing and will follow-up with non-responders. The Arm 2+3 peer navigators and Research Coordinator will access the server every 24-48 hours to triage and respond to participants who express a problem or need.

Arm 2: HIVST + mHealth; Arm 3: HIVST + mHealth + Creating Futures Livelihoods program

Creating Futures Livelihoods program BEHAVIORAL

Creating Futures is a group intervention that aims to help young people build their livelihoods, and was designed for use with youth (18-24) in urban informal settlements in South Africa.

Arm 3: HIVST + mHealth + Creating Futures Livelihoods program

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Living in one of the five selected Kampala informal settlements (Kabalagala, Kansanga, Katwe, Nsambya, or Rubaga)
• Identify as a displaced person, refugee, or as having a refugee or displaced parent(s)
• Aged 16-25 years
• Own or have daily access to a mobile phone
• Speak French, English, Kirundi, Kinyarwanda, or Swahili

You may not qualify if:

• Not living in one of the five selected informal settlements
• Does not identify as a displaced person, refugee, or as having a refugee or displaced parent(s)
• Aged 15 and under or 26 and older
• Does not have access to a mobile phone or shares a phone
• Does not speak one of French, English, Kirundi, Kinyarwanda, or Swahili

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Young African Refugees for Integral Development

Kampala, Uganda

RECRUITING

Related Publications (51)

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  PMID: 39581739 DERIVED

Related Links

• Uganda Population-Based HIV Impact Assessment 2020
• UNAIDS 90-90-90: An Ambitious Treatment Target to Help End the AIDS Epidemic
• UN General Assembly resoluation: Political Declaration on HIV and AIDS: On the Fast-Track to Accelerate the Fight against HIV and to End the AIDS Epidemic by 2030
• UNAIDS: A Super-Fast-Track Framework for Ending AIDS among Children, Adolescent and Young Women by 2020
• Refugee Statistics
• Overview of Refugees and Asylum-seekers in Uganda
• Urban Refugees: Kampala, Uganda
• Refugee livelihoods in Kampala, Nakivale and Kyangwali refugee settlements Patterns of engagement with the private sector.
• UNAIDS: HIV Gap Report
• Insights into potential users and messaging for HIV oral self-test kits in Kenya
• mHealth: New horizons for health through mobile technologies
• COVID-19 socioeconomic impact worsens for refugees in Uganda

MeSH Terms

Conditions

Financial Stress; Social Adjustment; Social Skills

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Social Behavior

Central Study Contacts

Carmen Logie, PhD

CONTACT

6474544203; carmen.logie@utoronto.ca

Moses Okumu, PhD

CONTACT

6476067832; okumu@illinois.edu

Study Design

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

Model Details: The intervention arms will be compared to the control arm of the study using a pre- and post-intervention survey. There will also be a follow-up survey after the study is complete.

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 21, 2024
• Study Start: March 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: December 31, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will become available 12 months after study completion.
• Access Criteria: The final deidentified data set will be available to users who enter a data-sharing agreement with us. Users will need to (1) secure ethics approval from both their institution and the University of Toronto research ethics board; (2) commit to use the data solely for research purposes, and not to identify any individual participant; (3) commit to securing the data using the appropriate computer technology such as encryption; and (4) commit to destroying or returning the data after analyses are complete.

Locations

UG (1)