Livelihoods Intervention With Urban Refugee Youth in Kampala, Uganda

Tushirikiane-4-Uthabiti (Supporting Each Other For Resilience)

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.

Study Overview

• Status: Recruiting
• Conditions: Social Skills; Financial Stress; Social Functioning
• Intervention / Treatment: Diagnostic test: HIVST; Behavioral: Creating Futures Livelihoods program; Device: mHealth

Detailed Description

As of March 2021, the prevalence of HIV among Ugandan youth aged 15-24 years was estimated at almost 2%, with young women and adolescent girls having an HIV prevalence over three times that of young men and adolescent boys (2.9% vs. 0.8%). The prevalence of HIV among youth living in Kampala's slums is even higher, at an estimated 13.9-37.2%. This high prevalence may be driven by factors such as food scarcity, limited infrastructure, lack of social support, stigma, and gender norms, which may limit the condom negation and use of HIV testing services among youth. Uganda hosts over 1.5 million refugees, 8% of which reside in Kampala, and many living within slums or informal settlements. While the UNAIDS Gap report identified displaced persons and adolescent girls and young women as populations at high-risk for HIV infection, the HIV prevalence among Uganda's refugees is largely unknown due to the lack of standardized surveillance of refugees.

One approach to improve HIV testing among displaced persons in Uganda is through HIV self-testing (HIVST). HIVST involves a person collecting their own specimen (blood or saliva), conducting the test, and interpreting the results. HIVST has the potential to reduce testing barriers such as stigma and privacy, while enhancing confidentiality and convenience, which are important considerations for adolescents and young people. Innovative HIVST delivery strategies are urgently needed to link persons with positive HIVST results to confirmatory testing and HIV care. As such, identifying strategies to promote linkage to HIV care is essential to realize the public health impact of HIVST. 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 HIVST delivery strategies to increase linkage to confirmatory testing and HIV care.

The investigators will 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.

Mobile health (mHealth) can be used to facilitate HIVST adherence among displaced youth through mobile phone (mHealth) reminders. mHealth approaches are germane to low and middle-income countries (LMIC), where cell phone ownership is rising rapidly, but access to health care is often limited. In Uganda, over 13 million persons have access to mobile phones, and data suggest that HIV prevention messages through mobile phones are beneficial to supplement traditional modalities such as schools for adolescents. Educational comics offer a youth-friendly, low-cost, scalable approach for providing education and health promotion on health topics such as HIV, sexually transmitted infections, vaccines, and dementia. Comics have been used to educate both the general population and healthcare providers to improve care and patient experiences, as they are accessible, do not require high levels of literacy, and can encourage participants to envision and share solutions to sexual violence through facilitating dialogue around emotionally difficult and often stigmatized issues.

Creating Futures is a group intervention that aims to help young people build their livelihoods and was designed for use with youth in urban informal settlements in South Africa. Previous researchers have implemented the Creating Futures intervention in South Africa and found that after the intervention, men's earnings increased, women's experiences of intimate partner violence decreased, men and women scored better on gender attitudes, and depression and suicidal thoughts decreased amongst men.

The investigators will conduct a three-arm cluster randomized controlled trial (cRCT) to evaluate the effectiveness of HIVST delivery methods among youth living in Kampala. The five informal settlements in Kampala will be randomized in a 1:1:1 approach to one of the three study arms. The five informal settlements will be grouped into three sites based on close geographic proximity (1: Kabalagala and Kansanga, 2: Katwe and Nsambya, and 3: Rubaga). The investigators used the following criteria to select informal settlements: 1) settlements that host a large number of refugees or displaced persons; 2) communities with similar measures of socioeconomic status, healthcare access, languages, and living conditions; and 3) evidence of a high prevalence of depressive symptoms among urban refugee youth. Participants will be allocated to a study arm based on their informal settlement of residence. Youth living in slums and informal settlements have shared socio-physical environments. As such, except for individual-level outcome data, the investigators will use a cluster-randomized approach to limit challenges posed by experimental contamination and threats to internal validity. Data collection will be performed at baseline, and 3- and 6-months post-intervention implementation.

The investigators are working with study collaborators from Young African Refugees for Integral Development (YARID), a nongovernmental youth refugee organization in Kampala, who have been involved since the initial research question and focus development stage. The study protocol was developed after a formative qualitative research phase (Phase 1), which included semi-structured interviews with peer navigators and other key informants (e.g., refugee health professionals, migrant workers, teen mothers). Refugee youth aged 18-24 years (12: 6 men, 6 women), living in the same informal settlements who are trained in research methods and ethics will act as peer navigators and enroll other youth in the study after obtaining written informed consent. The investigators employed purposive methods to recruit participants, such as word-of-mouth and venue-based sampling at community events and refugee agencies, beginning with participants who belonged to the Tushirkiane cohort and participated in previous trials on HIVST, COVID-19 prevention, and mental health interventions. The investigators will refresh the cohort with additional purposive recruitment of 16- and 17-year-old participants. The use of SMS and WhatsApp reminders from peer navigators and outreach events allows for the continued engagement and retention of study participants.

Data collection will be conducted by research assistants trained by the Ministry of Health in pre- and post-test counselling. Data will be collected using a structured survey accessed via mobile phones or tablets in all study languages via the SurveyCTO app (Dobility). This app houses a secure platform and automatically encrypts data, which are then uploaded with a Secure Sockets Layer (SSL) certificate to a password-protected server. The use of SurveyCTO allows for multilingual and offline data collection with branching logic and consistency checks. All participants are assigned a unique ID number without any personal identifying information to enhance confidentiality.

The analysis and reporting of this study will be conducted following the CONSORT (Consolidated Standards of Reporting Trials) guidelines. The study analyst will be blinded to group allocation. Participant flow (screening, randomization, allocation, follow-up) will be illustrated using a flow diagram. The investigators will report baseline data for all groups summarized using mean (standard deviation) or median (first and third quartiles) for continuous variables and counts and frequencies (percent) for categorical variables. The investigators will use an intention-to-treat approach with a complete data set whereby participants will be analyzed according to their initial group allocation irrespective of whether they received said intervention.

• Study Type: Interventional
• Enrollment (Estimated): 432
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carmen Logie, PhD; Phone Number: 6474544203; Email: carmen.logie@utoronto.ca
• Study Contact Backup: Name: Moses Okumu, PhD; Phone Number: 6476067832; Email: okumu@illinois.edu

Study Locations

• Uganda
  • Kampala, Uganda
    • Recruiting
    • Young African Refugees for Integral Development
    • Contact: Robert Hakiza; Phone Number: 256 2009 12345; Email: roberthakiza2001@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: HIVST Alone; 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; 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.
Experimental: Arm 3: HIVST + mHealth + Creating Futures Livelihoods program; 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; 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.; Behavioral: Creating Futures Livelihoods program; 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.; Device: mHealth; 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.
Experimental: Arm 2: HIVST + mHealth; 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; 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.; Device: mHealth; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with knowledge of their HIV status	Since HIV status is self-reported, the investigators will use multiple steps to overcome challenges of social desirability bias. First, interviewers will ask participants to report their current HIV status at 3- and 6-month follow-up. Second, the trained interviewer will offer participants a voluntary rapid HIV test (Alere). Knowledge of HIV status will be assessed as correct for participants who agree to take the rapid test and correctly report their HIV status. The investigators will also record if participants were willing to take the interviewer administered rapid test.	3- and 6-month follow-up
Number of participants linked to confirmatory HIV testing	Participants will be asked if they used their HIVST kit at 3- and 6-month follow-up. For those who affirm use of HIVST kits with a positive test result, the investigators will ask if and where they received a confirmatory test. Participants can receive confirmatory testing without reporting to the interviewer and can submit coupons at MARPI or to local clinics.	3- and 6-month follow-up
Frequency of linkage to HIV care	The investigators will ask participants who seroconvert during the study to report the frequency of HIV care services. In addition, participants can present coupons when accessing MARPI or local clinic services.	3- and 6-month follow-up
Brief HIV Knowledge Questionnaire	The investigators will use the18-item dichotomous response (true/false) to assess HIV Knowledge. A score of 0 is recorded for 'false' responses and 1 for 'true responses. A higher total score indicates better knowledge of HIV.	3- and 6-month follow-up
Sexual Risk	The investigators will assess sexual risk through self-reported measures of consistent condom use (anal, vaginal sex) with regular, causal, and paid sex partners in the past month, as well as the number of sex partners in the past month, condom use self-efficacy, and selling sex in the past 3 months	3- and 6-month follow-up

Collaborators and Investigators

• Sponsor: University of Toronto

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• Logie CH, Okumu M, Kortenaar JL, Gittings L, Khan N, Hakiza R, Kibuuka Musoke D, Nakitende A, Katisi B, Kyambadde P, Khan T, Lester R, Mbuagbaw L. Mobile Health-Supported Virtual Reality and Group Problem Management Plus: Protocol for a Cluster Randomized Trial Among Urban Refugee and Displaced Youth in Kampala, Uganda (Tushirikiane4MH, Supporting Each Other for Mental Health). JMIR Res Protoc. 2022 Dec 8;11(12):e42342. doi: 10.2196/42342.
• Lyytinen E. Informal places of protection: Congolese refugees' 'communities of trust' in Kampala, Uganda. Journal of Ethnic and Migration Studies. 2017 Apr 26;43(6):991-1008.
• Logie CH, Berry I, Okumu M, Loutet M, McNamee C, Hakiza R, Musoke DK, Mwima S, Kyambadde P, Mbuagbaw L. The prevalence and correlates of depression before and after the COVID-19 pandemic declaration among urban refugee adolescents and youth in informal settlements in Kampala, Uganda: A longitudinal cohort study. Ann Epidemiol. 2022 Feb;66:37-43. doi: 10.1016/j.annepidem.2021.11.005. Epub 2021 Nov 14.
• Logie CH, Okumu M, Mwima S, Hakiza R, Chemutai D, Kyambadde P. Contextual factors associated with depression among urban refugee and displaced youth in Kampala, Uganda: findings from a cross-sectional study. Confl Health. 2020 Jul 10;14:45. doi: 10.1186/s13031-020-00289-7. eCollection 2020.
• 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.
• Logie CH, Okumu M, Berry I, Hakiza R, Kibuuka Musoke D, Kyambadde P, Mwima S, Lester RT, Perez-Brumer AG, Baral S, Mbuagbaw L. Kukaa Salama (Staying Safe): study protocol for a pre/post-trial of an interactive mHealth intervention for increasing COVID-19 prevention practices with urban refugee youth in Kampala, Uganda. BMJ Open. 2021 Nov 22;11(11):e055530. doi: 10.1136/bmjopen-2021-055530.
• Schober P, Vetter TR. Adjustments for Multiple Testing in Medical Research. Anesth Analg. 2020 Jan;130(1):99. doi: 10.1213/ANE.0000000000004545. No abstract available.

Helpful Links

• Uganda Population-Based HIV Impact Assessment 2020
• Uganda Demographic and Health Survey 2016 Key Indicators Report
• 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
• 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

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: February 13, 2024
• First Posted (Actual): February 21, 2024

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Financial Stress
• Other Study ID Numbers: KampalaLivelihoodsStudy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will become available 12 months after study completion.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No