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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06270160
Other study ID # KampalaLivelihoodsStudy
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date December 31, 2024

Study information

Verified date February 2024
Source University of Toronto
Contact Carmen Logie, PhD
Phone 6474544203
Email carmen.logie@utoronto.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 432
Est. completion date December 31, 2024
Est. primary completion date August 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 25 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Uganda Young African Refugees for Integral Development Kampala

Sponsors (1)

Lead Sponsor Collaborator
University of Toronto

Country where clinical trial is conducted

Uganda, 

References & Publications (50)

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Embleton L, Di Ruggiero E, Logie CH, Ayuku D, Braitstein P. Improving livelihoods and gender equitable attitudes of street-connected young people in Eldoret, Kenya: Results from a pilot evidence-based intervention. Health Soc Care Community. 2021 Jan;29(1):227-240. doi: 10.1111/hsc.13086. Epub 2020 Jul 7. — View Citation

Embleton L, Di Ruggiero E, Odep Okal E, Chan AK, Logie CH, Ayuku D, Braitstein P. Adapting an evidence-based gender, livelihoods, and HIV prevention intervention with street-connected young people in Eldoret, Kenya. Glob Public Health. 2019 Dec;14(12):1703-1717. doi: 10.1080/17441692.2019.1625940. Epub 2019 Jun 4. — View Citation

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Hawk ME, Chung A, Creasy SL, Egan JE. A Scoping Review of Patient Preferences for HIV Self-Testing Services in the United States: Implications for Harm Reduction. Patient Prefer Adherence. 2020 Dec 2;14:2365-2375. doi: 10.2147/PPA.S251677. eCollection 2020. — View Citation

Jewkes R, Gibbs A, Jama-Shai N, Willan S, Misselhorn A, Mushinga M, Washington L, Mbatha N, Skiweyiya Y. Stepping Stones and Creating Futures intervention: shortened interrupted time series evaluation of a behavioural and structural health promotion and violence prevention intervention for young people in informal settlements in Durban, South Africa. BMC Public Health. 2014 Dec 29;14:1325. doi: 10.1186/1471-2458-14-1325. — View Citation

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Johnson CC, Kennedy C, Fonner V, Siegfried N, Figueroa C, Dalal S, Sands A, Baggaley R. Examining the effects of HIV self-testing compared to standard HIV testing services: a systematic review and meta-analysis. J Int AIDS Soc. 2017 May 15;20(1):21594. doi: 10.7448/IAS.20.1.21594. — View Citation

Krasnoryadtseva A, Dalbeth N, Petrie KJ. The effect of different styles of medical illustration on information comprehension, the perception of educational material and illness beliefs. Patient Educ Couns. 2020 Mar;103(3):556-562. doi: 10.1016/j.pec.2019.09.026. Epub 2019 Sep 27. — View 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. — View Citation

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. — View Citation

Logie CH, Okumu M, Berry I, Hakiza R, Baral SD, Musoke DK, Nakitende A, Mwima S, Kyambadde P, Loutet M, Batte S, Lester R, Neema S, Newby K, Mbuagbaw L. Findings from the Tushirikiane mobile health (mHealth) HIV self-testing pragmatic trial with refugee adolescents and youth living in informal settlements in Kampala, Uganda. J Int AIDS Soc. 2023 Oct;26(10):e26185. doi: 10.1002/jia2.26185. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Logie 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. — View Citation

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* Note: There are 50 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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