Financial StressNCT06270160
Livelihoods Intervention With Urban Refugee Youth in Kampala, Uganda
A study testing HIVST, mHealth and Creating Futures Livelihoods program in people with Financial Stress and Social Functioning, run by University of Toronto at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Financial Stress, Social Functioning, Social Skills
- What is being tested?
- HIVST, mHealth and Creating Futures Livelihoods program
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 1 siteUganda
- Study dates
- 1 Mar 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Uganda1 site, 1 recruiting
- Recruiting
Young African Refugees for Integral Development
Kampala
Robert Hakiza, 256 2009 12345, roberthakiza2001@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Financial Stress, Social Functioning, Social Skills
- Being tested
- HIVST, mHealth, Creating Futures Livelihoods program
- Medical subject headings
- Financial Stress, Social Adjustment, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIVSTDiagnostic 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.
mHealthDevice
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.
Creating Futures Livelihoods programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: HIVST; Device: mHealth; Behavioral: Creating Futures Livelihoods program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Every 3 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 3- and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (51)Papers the sponsor has linked to this study.
- Other trials for Financial StressStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 432 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmen Logie, MSW, PhD, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270160
- Sponsor's protocol ID
- KampalaLivelihoodsStudy
- Status last verified
- Feb 2024
- First submitted
- 13 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Culbreth R, Swahn MH, Salazar LF, Ametewee LA, Kasirye R. Risk Factors Associated with HIV, Sexually Transmitted Infections (STI), and HIV/STI Co-infection Among Youth Living in the Slums of Kampala, Uganda. AIDS Behav. 2020 Apr;24(4):1023-1031. doi: 10.1007/s10461-019-02444-5.
PubMed 30825036Swahn MH, Palmier JB, Kasirye R, Yao H. Correlates of suicide ideation and attempt among youth living in the slums of Kampala. Int J Environ Res Public Health. 2012 Feb;9(2):596-609. doi: 10.3390/ijerph9020596. Epub 2012 Feb 16.
PubMed 22470312Swahn MH, Culbreth R, Salazar LF, Kasirye R, Seeley J. Prevalence of HIV and Associated Risks of Sex Work among Youth in the Slums of Kampala. AIDS Res Treat. 2016;2016:5360180. doi: 10.1155/2016/5360180. Epub 2016 Apr 28.
PubMed 27239340Baral S, Logie CH, Grosso A, Wirtz AL, Beyrer C. Modified social ecological model: a tool to guide the assessment of the risks and risk contexts of HIV epidemics. BMC Public Health. 2013 May 17;13:482. doi: 10.1186/1471-2458-13-482.
PubMed 23679953Sawadogo PM, Sia D, Onadja Y, Beogo I, Sangli G, Sawadogo N, Gnambani A, Bassinga G, Robins S, Tchouaket Nguemeleu E. Barriers and facilitators of access to sexual and reproductive health services among migrant, internally displaced, asylum seeking and refugee women: A scoping review. PLoS One. 2023 Sep 14;18(9):e0291486. doi: 10.1371/journal.pone.0291486. eCollection 2023.
PubMed 37708137Spiegel PB, Bennedsen AR, Claass J, Bruns L, Patterson N, Yiweza D, Schilperoord M. Prevalence of HIV infection in conflict-affected and displaced people in seven sub-Saharan African countries: a systematic review. Lancet. 2007 Jun 30;369(9580):2187-2195. doi: 10.1016/S0140-6736(07)61015-0.
PubMed 17604801Warren E, Post N, Hossain M, Blanchet K, Roberts B. Systematic review of the evidence on the effectiveness of sexual and reproductive health interventions in humanitarian crises. BMJ Open. 2015 Dec 18;5(12):e008226. doi: 10.1136/bmjopen-2015-008226.
PubMed 26685020Jewkes R. Comprehensive response to rape needed in conflict settings. Lancet. 2007 Jun 30;369(9580):2140-2141. doi: 10.1016/S0140-6736(07)60991-X. No abstract available.
PubMed 17604782Rubenstein BL, Stark L. The impact of humanitarian emergencies on the prevalence of violence against children: an evidence-based ecological framework. Psychol Health Med. 2017 Mar;22(sup1):58-66. doi: 10.1080/13548506.2016.1271949. Epub 2017 Jan 9.
PubMed 28064522Noble E, Ward L, French S, Falb K. State of the Evidence: A Systematic Review of Approaches to Reduce Gender-Based Violence and Support the Empowerment of Adolescent Girls in Humanitarian Settings. Trauma Violence Abuse. 2019 Jul;20(3):428-434. doi: 10.1177/1524838017699601. Epub 2017 Mar 21.
PubMed 29334024Logie CH, Okumu M, Mwima S, Hakiza R, Irungi KP, Kyambadde P, Kironde E, Narasimhan M. Social ecological factors associated with experiencing violence among urban refugee and displaced adolescent girls and young women in informal settlements in Kampala, Uganda: a cross-sectional study. Confl Health. 2019 Dec 17;13:60. doi: 10.1186/s13031-019-0242-9. eCollection 2019.
PubMed 31867053O'Laughlin KN, Rabideau DJ, Kasozi J, Parker RA, Bustamante ND, Faustin ZM, Greenwald KE, Walensky RP, Bassett IV. Predictors of HIV infection: a prospective HIV screening study in a Ugandan refugee settlement. BMC Infect Dis. 2016 Nov 23;16(1):695. doi: 10.1186/s12879-016-2021-1.
PubMed 27881099O'Laughlin KN, Kasozi J, Rabideau DJ, Parker RA, Mulogo E, Faustin ZM, Greenwald KE, Doraiswamy S, Walensky RP, Bassett IV. The cascade of HIV care among refugees and nationals in Nakivale Refugee Settlement in Uganda. HIV Med. 2017 Aug;18(7):513-518. doi: 10.1111/hiv.12476. Epub 2017 Jan 10.
PubMed 28070923Pai NP, Thomas R. Time for HIV self-testing in Canada: a vision and an action plan. CMAJ. 2020 Nov 2;192(44):E1367-E1368. doi: 10.1503/cmaj.201160. No abstract available.
PubMed 33139426Bogart LM, Kgotlaetsile K, Phaladze N, Mosepele M. HIV self-testing may overcome stigma and other barriers to HIV testing among higher-socioeconomic status men in Botswana: A qualitative study. Afr J AIDS Res. 2021 Dec;20(4):297-306. doi: 10.2989/16085906.2021.2000450.
PubMed 34905451
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tushirikiane-4-Uthabiti (Supporting Each Other For Resilience)
- ClinicalTrials.gov ID
- NCT06270160
- Acronym / sponsor ID
- KampalaLivelihoodsStudy
- Conditions
- Financial Stress, Social Functioning, Social Skills
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 432 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: HIVST Alone | Experimental | Diagnostic Test: HIVSTParticipants 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. |
| Arm 2: HIVST + mHealth | Experimental | Diagnostic Test: HIVST, Device: mHealthParticipants 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. |
| Arm 3: HIVST + mHealth + Creating Futures Livelihoods program | Experimental | Diagnostic Test: HIVST, Device: mHealth, Behavioral: Creating Futures Livelihoods programIn 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. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIVSTPeer 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 | Arm 1: HIVST Alone, Arm 2: HIVST + mHealth, Arm 3: HIVST + mHealth + Creating Futures Livelihoods program |
| mHealthThe 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. | Device | Arm 2: HIVST + mHealth, Arm 3: HIVST + mHealth + Creating Futures Livelihoods program |
| Creating Futures Livelihoods programCreating 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. | Behavioural | Arm 3: HIVST + mHealth + Creating Futures Livelihoods program |
Primary outcome
Number of participants engaged in HIV testing
Time frame: Every 3 months
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).
5 secondary outcomes
Number of participants with knowledge of their HIV status
Time frame: 3- and 6-month follow-up
Number of participants linked to confirmatory HIV testing
Time frame: 3- and 6-month follow-up
Frequency of linkage to HIV care
Time frame: 3- and 6-month follow-up
Brief HIV Knowledge Questionnaire
Time frame: 3- and 6-month follow-up
Sexual Risk
Time frame: 3- and 6-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Background: PubMed 30825036Culbreth R, Swahn MH, Salazar LF, Ametewee LA, Kasirye R. Risk Factors Associated with HIV, Sexually Transmitted Infections (STI), and HIV/STI Co-infection Among Youth Living in the Slums of Kampala, Uganda. AIDS Behav. 2020 Apr;24(4):1023-1031. doi: 10.1007/s10461-019-02444-5.
- Background: PubMed 22470312Swahn MH, Palmier JB, Kasirye R, Yao H. Correlates of suicide ideation and attempt among youth living in the slums of Kampala. Int J Environ Res Public Health. 2012 Feb;9(2):596-609. doi: 10.3390/ijerph9020596. Epub 2012 Feb 16.
- Background: PubMed 27239340Swahn MH, Culbreth R, Salazar LF, Kasirye R, Seeley J. Prevalence of HIV and Associated Risks of Sex Work among Youth in the Slums of Kampala. AIDS Res Treat. 2016;2016:5360180. doi: 10.1155/2016/5360180. Epub 2016 Apr 28.
- Background: PubMed 23679953Baral S, Logie CH, Grosso A, Wirtz AL, Beyrer C. Modified social ecological model: a tool to guide the assessment of the risks and risk contexts of HIV epidemics. BMC Public Health. 2013 May 17;13:482. doi: 10.1186/1471-2458-13-482.
- Background: PubMed 37708137Sawadogo PM, Sia D, Onadja Y, Beogo I, Sangli G, Sawadogo N, Gnambani A, Bassinga G, Robins S, Tchouaket Nguemeleu E. Barriers and facilitators of access to sexual and reproductive health services among migrant, internally displaced, asylum seeking and refugee women: A scoping review. PLoS One. 2023 Sep 14;18(9):e0291486. doi: 10.1371/journal.pone.0291486. eCollection 2023.
- Background: PubMed 17604801Spiegel PB, Bennedsen AR, Claass J, Bruns L, Patterson N, Yiweza D, Schilperoord M. Prevalence of HIV infection in conflict-affected and displaced people in seven sub-Saharan African countries: a systematic review. Lancet. 2007 Jun 30;369(9580):2187-2195. doi: 10.1016/S0140-6736(07)61015-0.
- Background: PubMed 26685020Warren E, Post N, Hossain M, Blanchet K, Roberts B. Systematic review of the evidence on the effectiveness of sexual and reproductive health interventions in humanitarian crises. BMJ Open. 2015 Dec 18;5(12):e008226. doi: 10.1136/bmjopen-2015-008226.
- Background: PubMed 17604782Jewkes R. Comprehensive response to rape needed in conflict settings. Lancet. 2007 Jun 30;369(9580):2140-2141. doi: 10.1016/S0140-6736(07)60991-X. No abstract available.
- Background: PubMed 28064522Rubenstein BL, Stark L. The impact of humanitarian emergencies on the prevalence of violence against children: an evidence-based ecological framework. Psychol Health Med. 2017 Mar;22(sup1):58-66. doi: 10.1080/13548506.2016.1271949. Epub 2017 Jan 9.
- Background: PubMed 29334024Noble E, Ward L, French S, Falb K. State of the Evidence: A Systematic Review of Approaches to Reduce Gender-Based Violence and Support the Empowerment of Adolescent Girls in Humanitarian Settings. Trauma Violence Abuse. 2019 Jul;20(3):428-434. doi: 10.1177/1524838017699601. Epub 2017 Mar 21.
- Background: PubMed 31867053Logie CH, Okumu M, Mwima S, Hakiza R, Irungi KP, Kyambadde P, Kironde E, Narasimhan M. Social ecological factors associated with experiencing violence among urban refugee and displaced adolescent girls and young women in informal settlements in Kampala, Uganda: a cross-sectional study. Confl Health. 2019 Dec 17;13:60. doi: 10.1186/s13031-019-0242-9. eCollection 2019.
- Background: PubMed 27881099O'Laughlin KN, Rabideau DJ, Kasozi J, Parker RA, Bustamante ND, Faustin ZM, Greenwald KE, Walensky RP, Bassett IV. Predictors of HIV infection: a prospective HIV screening study in a Ugandan refugee settlement. BMC Infect Dis. 2016 Nov 23;16(1):695. doi: 10.1186/s12879-016-2021-1.
- Uganda Population-Based HIV Impact Assessment 2020Link provided by the sponsor.
- UNAIDS 90-90-90: An Ambitious Treatment Target to Help End the AIDS EpidemicLink provided by the sponsor.
- 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 2030Link provided by the sponsor.
- UNAIDS: A Super-Fast-Track Framework for Ending AIDS among Children, Adolescent and Young Women by 2020Link provided by the sponsor.
- Refugee StatisticsLink provided by the sponsor.
- Overview of Refugees and Asylum-seekers in UgandaLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIVST, mHealth and Creating Futures Livelihoods program in people with Financial Stress and Social Functioning, run by University of Toronto at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carmen Logie, PhD (6474544203, carmen.logie@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants engaged in HIV testing (time frame: Every 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06270160, which also lists 51 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.