HIV/AIDSTushirikianeNCT04504097
Tushirikiane HIV-self Testing Intervention With Urban Refugee Youth in Kampala, Uganda
A study testing m-Health and HIV self-testing in people with HIV/AIDS and HIV Infections, run by University of Toronto at 1 site in Canada.
Trial summary
HIV is the leading cause of death for adolescents and young people (AYP) in sub-Saharan Africa (SSA). Uganda hosts 1.3 million refugees/displaced persons, and more than 80,000 live in Kampala, most in slums, yet little is known of HIV testing and prevention needs with displaced/refugee AYP living in Kampala's slums. Read more about this study
- Who is it for?
- Ages 16 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS, HIV Infections, Knowledge, Attitudes, Practice
- What is being tested?
- m-Health and HIV self-testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 454 participants
- Where
- 1 siteCanada
- Study dates
- 13 Nov 2019to 20 Sep 2021
- 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 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- live in one of the 5 slum/informal settlement sites (Kabalanga, Kasanga, Katwe, Nsambya Rubaga)
- identify as a refugee/displaced person or have refugee parents
- aged 16-24
- report HIV negative status at baseline
- own or have access to a mobile phone for the study.
Who cannot join
- report HIV-positive status at baseline
- do not identify as refugee or do not have refugee parents have no mobile phone do not live in the 5 selected slums
Trial locations and contacts
1 site in 1 country.
Canada1 site
Factor-Inwentash Faculty of Social Work, University of Toronto
Toronto, Ontario, M5S1V4
About this study
Official title: Tushirikiane (Supporting Each Other): Development, Implementation and Evaluation of Novel HIV Self-Testing Delivery Approaches With Urban Displaced and Refugee Adolescents and Youth in Uganda
HIV is the leading cause of death for adolescents and young people (AYP) in sub-Saharan Africa (SSA). Uganda hosts 1.3 million refugees/displaced persons, and more than 80,000 live in Kampala, most in slums, yet little is known of HIV testing and prevention needs with displaced/refugee AYP living in Kampala's slums. This study aims to develop, implement and evaluate an oral HIV-self testing (HIVST) intervention with displaced/refugee AYP aged 16- 24 in Kampala. HIVST is acceptable and properly used with AYP in other SSA regions, yet there are knowledge gaps regarding the best way to link HIVST to HIV care. This study aims to explore how m-health (healthcare delivered on mobile-phones), congruent with how AYP learn and socialize, can improve linkage to care with HIVST. This trial focuses on implementing a cluster randomized trial with displaced/refugee AYP aged 16-24 living in informal settlements in Kampala (Arm1: HIVST; Arm 2: HIVST + m-health; Arm 3: standard of care). The study will assess changes in HIV testing practices, HIV status knowledge, and linkage to HIV prevention and care between the 3 arms.
Read the detailed description
The proposed study will take place in Kampala, Uganda, hosting over 80,000 refugees. This research will be conducted in 5 informal settlements ('slums') grouped into 3 clusters based on proximity (1: Kabalanga and Kasanga, 2: Katwe and Nsambya, 3: Rubaga) where most displaced/refugee persons in Kampala live.
The proposed intervention involves a cluster randomized controlled trial (cRCT) to evaluate the effectivness of HIVST delivery approaches on HIV testing uptake among refugee youth aged 16-24 in Kampala. Clusters include 3 sites, slums of: Kabalanga/kasanga, Katwe/Nsambya and Rubaga. Sites will be randomized in a 1:1:1 method to one of 3 study arms:
Arms 1 \& 2: HIVST Interventions: At the first visit study participants are provided with a HIVST kit (Oraquick: approved and used in Uganda by the Ministry of Health) that is an oral swab test stick and tube solutions, and a written detailed step by step description of how to correctly use the HIVST kits, pictorial and written guide for HIVST kits, condoms and lubricant, information booklets on HIV and testing, referral cards with addresses and phone numbers to MARPI clinics for confirmatory testing. The cards will also have a peer navigator (PN)'s phone numbers for participants to text message (SMS) if they need additional information on how to use the kits, or support to go to confirmatory tests at the MARPI clinics. Instructions for the kits are in French, Swahili, Luganda and English and reflect the context of the urban displaced adolescent and young people. There is a 24-hour contact number for participants to text if/when they have questions. These texts will be managed through WelTel system that will flag these messages in real-time. The Research Coordinator and PN team will rotate being on-call to respond to these issues by text and will offer to phone, text, or WhatsApp support the participant and offer to make an appointment to see them and/or support them to attend MARPI or collaborating agency for further support. At follow-up visits PN will check in with participants about the HIVST kits, distribute another HIVST kit and condoms/lubricant, and screen for adverse events (e.g. negative HIVST related experiences).
Arm 2: HIVST + m-Health: Participants will receive weekly text messages via WelTel that check in with their wellbeing. Arm 2 PNs will discuss the weekly two-ways messages with participants, and request participants to respond to the message (detailed above) within 2 days.
Arm 3: Standard of Care: PNs will provide information about HIV testing, care and support services at MARPI clinics and provide a pamphlet of information about HIV \& HIV prevention strategies (written in French, English, Luganda and Swahili).
Participant retention: Community collaborators will facilitate recruitment and retention; PNs will use multiple study reminder strategies (e.g. social media, texts) to maintain engagement, and we will utilize existing outreach and services by MARPI, YARID, Interaid Uganda, Tomorrow Vijana and community partners.
Research Team Training: This research involves collaborations with the Ministry of Health's Most At Risk Population Initiative (MARPI) clinics, YARID's women empowerment centre, Tomorrow Vijana's and Interaid Uganda's urban outreach programs in Kampala. MARPI clinic staff will provide technical assistance for HIVST and train PN and the research team in: a) using HIV rapid test kits (Alere Determine HIV-1/2); b) using OraQuick, a rapid oral HIVST used in Uganda; c) pre/post HIV test counseling; and d) linkages to confirmatory testing and HIV care.
m-Health training: This research involves a collaboration with WelTel's non-profit agency for the supportive SMS intervention (Arm 2). WelTel staff will conduct SMS training with: Research Coordinator, Logie, Okumu, and the research team, including the PN. The WelTel system will manage the SMS intervention on their structured mobile-phone platform (all SMS interactions are logged). Weekly 2-way supportive messages (how are you? In Swahili: Habari Yako?) will automatically be sent on the same weekday with WelTel software to Arm 2 participants. PN ask Arm 2 participants to respond within 48 hours if they are well (Mzuri sana) or have a problem (Nina shida), and will follow-up with non-responders. The Arm 2 PN and Research Coordinator will access the server every 24-48 hours to triage and respond to participants who express a problem or need.
Linkage to testing and care: Participants across all study arms will meet with PN at 3 time points (t0: baseline, t1: 8 months, t2: 12 months) to complete surveys. Each participant will have a study identification (ID) number printed on 'movie coupons'; they can bring these coupons to MARPI for HIV testing, confirmatory testing, linkage to HIV care, SRH services. The survey ID will be linked to resources accessed. Persons who test positive will be linked with the collaborator Uganda Network of Young People Living with HIV \& AIDS (UNYPA)'s support groups and services.
- Conditions
- HIV/AIDS, HIV Infections, Knowledge, Attitudes, Practice
- Being tested
- m-Health, HIV self-testing
- Keywords
- HIV self testing, Forcibly displaced youth, mhealth, HIV prevention, Uganda, informal settlements, linkage to confirmatory testing, routine HIV testing, HIV status knowledge, HIV care
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
m-HealthBehavioural
Participants receive a weekly bidirectional text message (SMS) asking how they are doing. They are requested to reply fine, or not fine, in which case they will be contacted with support by a peer navigator. If they do not reply to the message within the specified timeframe a peer navigator will follow up with them.
HIV self-testingDiagnostic test
Participants will receive HIVST kits so that they can perform their HIV testing.
| Study group | Role | What they receive |
|---|---|---|
| HIV self-testing + m-Health | Experimental | At the first visit participants will receive a HIVST kit and a detailed description of how to use the HIVST kits, pictorial and written guide for HIVST kits, condoms and lubricant, in addition to contact information for confirmatory testing and linkage to care at MARPI clinics. We will provide a 24-hour contact number to text, managed through WelTel system that will flag these messages in real-time. Participants will also receive a weekly bidirectional SMS hosted by WelTel to check how they are. Receives: Behavioral: m-Health; Diagnostic Test: HIV self-testing |
| HIV self-testing | Active comparator | At the first visit participants will receive a HIVST kit and a detailed description of how to use the HIVST kits, pictorial and written guide for HIVST kits, condoms and lubricant, in addition to contact information for confirmatory testing and linkage to care at MARPI clinics Receives: Diagnostic Test: HIV self-testing |
| Standard of Care | No intervention | Participants will receive information about HIV testing, care and support services at MARPI clinics and provide a pamphlet of information about HIV \& HIV prevention strategies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in HIV testing Frequency
To assess changes in past 3 month HIV testing frequencies, participants are asked to self-report when their last HIV test was and where their last HIV test was (if they used the HIVST, clinic, or point-of-care testing).
Measured: Time 1 (month 0), Time 2 (month 9), Time 3 (month 12)
Change in Knowledge of HIV status
To address social desirability bias challenges regarding self-reported HIV serostatus there are multiple steps employed. First, at Time 1 and Time 2 participants are asked their current HIV status.
Second, participants are offered a completely voluntary rapid HIV test (Alere). Knowledge of HIV status will be assessed as correct for persons who agree to take the rapid test and correctly report their HIV status.
Measured: Time 1 (month 0), Time 2 (month 9), Time 3 (month 12)
Changes in Linkage to confirmatory HIV testing
For arms 1 \& 2 participants at Time 2 and Time 3 are asked if they used their HIVST kit; for those who respond affirmatively they will be asked the result, and those who report a positive result will be asked if and where they received confirmatory testing.
Measured: Time 2 (month 9), Time 3 (month 12)
Changes in Linkage to HIV care
Participants who seroconvert during the study are asked the frequency of accessing HIV care services.
Measured: Time 2 (month 9), Time 3 (month 12)
HIVST kit use
To understand the frequency of kit use by m-health arm, and to reduce social desirability bias regarding HIVST kit use, Arm 1 \& 2 participants will be followed up one month after T3 to request to purchase unused kits back. Participants will not be informed of this as an option prior to this time.
Measured: Time 3 (month 12)
Secondary outcomes (5)
Changes in HIV stigma
HIV stigma outcomes will be assessed using Steward et al.'s 10 item perceived HIV stigma sbuscale. Higher scores indicate higher stigma.
Measured: Time 1 (month 0), Time 2 (month 9), Time 3 (month 12)
Changes in Safer Sex Self-Efficacy.
Safer sex efficacy will be assessed using the Safer Sex Self-Efficacy Scale. Higher scores mean a better outcome. Range 5-20.
Measured: Time 1 (month 0), Time 2 (month 9), Time 3 (month 12)
Changes in Consistent Condom Use Frequency.
Frequency of self-reported consistent condom use frequency (always vs. not always) will be assessed.
Measured: Time 1 (month 0), Time 2 (month 9), Time 3 (month 12)
Changes in Sexual Relationship Power
Sexual relationship power will be assessed using the 15-item Relationship Control Sub-scale from the Sexual \& Relationship Power Scale (SRPS). Scores range from 15-60. Higher scores mean a worse outcome.
Measured: Time 1 (month 0), Time 2 (month 9), Time 3 (month 12)
Changes in adolescent sexual and reproductive health stigma.
Adolescent sexual and reproductive health (SRH) stigma will be assessed using the Adolescent SRH Stigma scale, sub-scale of sexual activity and pregnancy (7 items). Higher scores indicate higher stigma.
Measured: Time 1 (month 0), Time 2 (month 9), Time 3 (month 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start13 Nov 2019
- Primary completion20 Aug 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This cluster randomized controlled trial (cRCT) will evaluate the effectivness of HIVST delivery approaches on HIV testing uptake among refugee youth in Kampala. Clusters include 3 sites, informal settlements. Sites will be randomized in a 1:1:1 method to one of 3 study arms: Arm 1-HIVST, Arm 2- HIVST+ m-health, and Arm 3-standard of care (control). We propose a cRCT design of randomizing by slums to reduce the possibility of experimental contamination due to the shared social and physical environment in slums. Data collectors will administer tablet-based surveys (baseline, t1: 8 months, t2: 12 months). Arms 1 \& 2 will receive HIVST kits at each time-point.
- Masking
- None (open label)
- Enrolment
- 454 participants (actual)
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
- Investigators
- Carmen Logie, PhD, Principal investigator, University of Toronto, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504097
- Sponsor's protocol ID
- CIHR389142
- Acronym
- Tushirikiane
- Status last verified
- Dec 2021
- First submitted
- 30 Jul 2020
- Last updated
- 28 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final dataset will consist of self-reported demographic and social-ecological data from interviews with the participants and laboratory data from HIV confirmatory tests for HIV positive individuals. Even though the final dataset will be de-identified before release for sharing, it may be possible to deductively disclose subjects using a combination of common characteristics. Therefore, to access our data, users need to meet our data-sharing agreement that provides for: (1) ability to secure ethics approval from both the user's institution and the University of Toronto research ethics board (2) a commitment to using the data solely for research purposes and not to identify any individual participant; (3) a dedication to securing the data using appropriate computer technology such as encryption; and (4) a commitment to destroying or returning the data after analyses are completed.
Publications
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.
PubMed 37850816Logie 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.
PubMed 33528378
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tushirikiane (Supporting Each Other): Development, Implementation and Evaluation of Novel HIV Self-Testing Delivery Approaches With Urban Displaced and Refugee Adolescents and Youth in Uganda
- ClinicalTrials.gov ID
- NCT04504097
- Acronym / sponsor ID
- Tushirikiane / CIHR389142
- Conditions
- HIV/AIDS, HIV Infections, Knowledge, Attitudes, Practice
- Keywords
- HIV self testing, Forcibly displaced youth, mhealth, HIV prevention, Uganda, informal settlements, linkage to confirmatory testing, routine HIV testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 454 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 7 Aug 2020 (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.
HIV is the leading cause of death for adolescents and young people (AYP) in sub-Saharan Africa (SSA). Uganda hosts 1.3 million refugees/displaced persons, and more than 80,000 live in Kampala, most in slums, yet little is known of HIV testing and prevention needs with displaced/refugee AYP living in Kampala's slums. This study aims to develop, implement and evaluate an oral HIV-self testing (HIVST) intervention with displaced/refugee AYP aged 16- 24 in Kampala. HIVST is acceptable and properly used with AYP in other SSA regions, yet there are knowledge gaps regarding the best way to link HIVST to HIV care. This study aims to explore how m-health (healthcare delivered on mobile-phones), congruent with how AYP learn and socialize, can improve linkage to care with HIVST. This trial focuses on implementing a cluster randomized trial with displaced/refugee AYP aged 16-24 living in informal settlements in Kampala (Arm1: HIVST; Arm 2: HIVST + m-health; Arm 3: standard of care). The study will assess changes in HIV testing practices, HIV status knowledge, and linkage to HIV prevention and care between the 3 arms.
Detailed description
The proposed study will take place in Kampala, Uganda, hosting over 80,000 refugees. This research will be conducted in 5 informal settlements ('slums') grouped into 3 clusters based on proximity (1: Kabalanga and Kasanga, 2: Katwe and Nsambya, 3: Rubaga) where most displaced/refugee persons in Kampala live.
The proposed intervention involves a cluster randomized controlled trial (cRCT) to evaluate the effectivness of HIVST delivery approaches on HIV testing uptake among refugee youth aged 16-24 in Kampala. Clusters include 3 sites, slums of: Kabalanga/kasanga, Katwe/Nsambya and Rubaga. Sites will be randomized in a 1:1:1 method to one of 3 study arms:
Arms 1 \& 2: HIVST Interventions: At the first visit study participants are provided with a HIVST kit (Oraquick: approved and used in Uganda by the Ministry of Health) that is an oral swab test stick and tube solutions, and a written detailed step by step description of how to correctly use the HIVST kits, pictorial and written guide for HIVST kits, condoms and lubricant, information booklets on HIV and testing, referral cards with addresses and phone numbers to MARPI clinics for confirmatory testing. The cards will also have a peer navigator (PN)'s phone numbers for participants to text message (SMS) if they need additional information on how to use the kits, or support to go to confirmatory tests at the MARPI clinics. Instructions for the kits are in French, Swahili, Luganda and English and reflect the context of the urban displaced adolescent and young people. There is a 24-hour contact number for participants to text if/when they have questions. These texts will be managed through WelTel system that will flag these messages in real-time. The Research Coordinator and PN team will rotate being on-call to respond to these issues by text and will offer to phone, text, or WhatsApp support the participant and offer to make an appointment to see them and/or support them to attend MARPI or collaborating agency for further support. At follow-up visits PN will check in with participants about the HIVST kits, distribute another HIVST kit and condoms/lubricant, and screen for adverse events (e.g. negative HIVST related experiences).
Arm 2: HIVST + m-Health: Participants will receive weekly text messages via WelTel that check in with their wellbeing. Arm 2 PNs will discuss the weekly two-ways messages with participants, and request participants to respond to the message (detailed above) within 2 days.
Arm 3: Standard of Care: PNs will provide information about HIV testing, care and support services at MARPI clinics and provide a pamphlet of information about HIV \& HIV prevention strategies (written in French, English, Luganda and Swahili).
Participant retention: Community collaborators will facilitate recruitment and retention; PNs will use multiple study reminder strategies (e.g. social media, texts) to maintain engagement, and we will utilize existing outreach and services by MARPI, YARID, Interaid Uganda, Tomorrow Vijana and community partners.
Research Team Training: This research involves collaborations with the Ministry of Health's Most At Risk Population Initiative (MARPI) clinics, YARID's women empowerment centre, Tomorrow Vijana's and Interaid Uganda's urban outreach programs in Kampala. MARPI clinic staff will provide technical assistance for HIVST and train PN and the research team in: a) using HIV rapid test kits (Alere Determine HIV-1/2); b) using OraQuick, a rapid oral HIVST used in Uganda; c) pre/post HIV test counseling; and d) linkages to confirmatory testing and HIV care.
m-Health training: This research involves a collaboration with WelTel's non-profit agency for the supportive SMS intervention (Arm 2). WelTel staff will conduct SMS training with: Research Coordinator, Logie, Okumu, and the research team, including the PN. The WelTel system will manage the SMS intervention on their structured mobile-phone platform (all SMS interactions are logged). Weekly 2-way supportive messages (how are you? In Swahili: Habari Yako?) will automatically be sent on the same weekday with WelTel software to Arm 2 participants. PN ask Arm 2 participants to respond within 48 hours if they are well (Mzuri sana) or have a problem (Nina shida), and will follow-up with non-responders. The Arm 2 PN and Research Coordinator will access the server every 24-48 hours to triage and respond to participants who express a problem or need.
Linkage to testing and care: Participants across all study arms will meet with PN at 3 time points (t0: baseline, t1: 8 months, t2: 12 months) to complete surveys. Each participant will have a study identification (ID) number printed on 'movie coupons'; they can bring these coupons to MARPI for HIV testing, confirmatory testing, linkage to HIV care, SRH services. The survey ID will be linked to resources accessed. Persons who test positive will be linked with the collaborator Uganda Network of Young People Living with HIV \& AIDS (UNYPA)'s support groups and services.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This cluster randomized controlled trial (cRCT) will evaluate the effectivness of HIVST delivery approaches on HIV testing uptake among refugee youth in Kampala. Clusters include 3 sites, informal settlements. Sites will be randomized in a 1:1:1 method to one of 3 study arms: Arm 1-HIVST, Arm 2- HIVST+ m-health, and Arm 3-standard of care (control). We propose a cRCT design of randomizing by slums to reduce the possibility of experimental contamination due to the shared social and physical environment in slums. Data collectors will administer tablet-based surveys (baseline, t1: 8 months, t2: 12 months). Arms 1 \& 2 will receive HIVST kits at each time-point.
| Arm | Type | Receives |
|---|---|---|
| HIV self-testing + m-Health | Experimental | Behavioral: m-Health, Diagnostic Test: HIV self-testingAt the first visit participants will receive a HIVST kit and a detailed description of how to use the HIVST kits, pictorial and written guide for HIVST kits, condoms and lubricant, in addition to contact information for confirmatory testing and linkage to care at MARPI clinics. We will provide a 24-hour contact number to text, managed through WelTel system that will flag these messages in real-time. Participants will also receive a weekly bidirectional SMS hosted by WelTel to check how they are. |
| HIV self-testing | Active comparator | Diagnostic Test: HIV self-testingAt the first visit participants will receive a HIVST kit and a detailed description of how to use the HIVST kits, pictorial and written guide for HIVST kits, condoms and lubricant, in addition to contact information for confirmatory testing and linkage to care at MARPI clinics |
| Standard of Care | No intervention | –Participants will receive information about HIV testing, care and support services at MARPI clinics and provide a pamphlet of information about HIV \& HIV prevention strategies. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- live in one of the 5 slum/informal settlement sites (Kabalanga, Kasanga, Katwe, Nsambya Rubaga)
- identify as a refugee/displaced person or have refugee parents
- aged 16-24
- report HIV negative status at baseline
- own or have access to a mobile phone for the study.
Key exclusion criteria (2 listed)
- report HIV-positive status at baseline
- do not identify as refugee or do not have refugee parents have no mobile phone do not live in the 5 selected slums
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 |
|---|---|---|
| m-HealthParticipants receive a weekly bidirectional text message (SMS) asking how they are doing. They are requested to reply fine, or not fine, in which case they will be contacted with support by a peer navigator. If they do not reply to the message within the specified timeframe a peer navigator will follow up with them. | Behavioural | HIV self-testing + m-Health |
| HIV self-testingParticipants will receive HIVST kits so that they can perform their HIV testing. | Diagnostic test | HIV self-testing, HIV self-testing + m-Health |
Primary outcome
Changes in HIV testing Frequency
Time frame: Time 1 (month 0), Time 2 (month 9), Time 3 (month 12)
To assess changes in past 3 month HIV testing frequencies, participants are asked to self-report when their last HIV test was and where their last HIV test was (if they used the HIVST, clinic, or point-of-care testing).
Change in Knowledge of HIV status
Time frame: Time 1 (month 0), Time 2 (month 9), Time 3 (month 12)
To address social desirability bias challenges regarding self-reported HIV serostatus there are multiple steps employed. First, at Time 1 and Time 2 participants are asked their current HIV status. Second, participants are offered a completely voluntary rapid HIV test (Alere). Knowledge of HIV status will be assessed as correct for persons who agree to take the rapid test and correctly report their HIV status.
Changes in Linkage to confirmatory HIV testing
Time frame: Time 2 (month 9), Time 3 (month 12)
For arms 1 \& 2 participants at Time 2 and Time 3 are asked if they used their HIVST kit; for those who respond affirmatively they will be asked the result, and those who report a positive result will be asked if and where they received confirmatory testing.
Changes in Linkage to HIV care
Time frame: Time 2 (month 9), Time 3 (month 12)
Participants who seroconvert during the study are asked the frequency of accessing HIV care services.
HIVST kit use
Time frame: Time 3 (month 12)
To understand the frequency of kit use by m-health arm, and to reduce social desirability bias regarding HIVST kit use, Arm 1 \& 2 participants will be followed up one month after T3 to request to purchase unused kits back. Participants will not be informed of this as an option prior to this time.
5 secondary outcomes
Changes in HIV stigma
Time frame: Time 1 (month 0), Time 2 (month 9), Time 3 (month 12)
Changes in Safer Sex Self-Efficacy.
Time frame: Time 1 (month 0), Time 2 (month 9), Time 3 (month 12)
Changes in Consistent Condom Use Frequency.
Time frame: Time 1 (month 0), Time 2 (month 9), Time 3 (month 12)
Changes in Sexual Relationship Power
Time frame: Time 1 (month 0), Time 2 (month 9), Time 3 (month 12)
Changes in adolescent sexual and reproductive health stigma.
Time frame: Time 1 (month 0), Time 2 (month 9), Time 3 (month 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Derived from this study: PubMed 37850816Logie 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.
- Derived from this study: PubMed 33528378Logie 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.
- Individual participant dataSharing planned: Yes. The final dataset will consist of self-reported demographic and social-ecological data from interviews with the participants and laboratory data from HIV confirmatory tests for HIV positive individuals. Even though the final dataset will be de-identified before release for sharing, it may be possible to deductively disclose subjects using a combination of common characteristics. Therefore, to access our data, users need to meet our data-sharing agreement that provides for: (1) ability to secure ethics approval from both the user's institution and the University of Toronto research ethics board (2) a commitment to using the data solely for research purposes and not to identify any individual participant; (3) a dedication to securing the data using appropriate computer technology such as encryption; and (4) a commitment to destroying or returning the data after analyses are completed.
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HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Carmen Logie, PhD principal investigator
University of Toronto, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing m-Health and HIV self-testing in people with HIV/AIDS and HIV Infections, run by University of Toronto at 1 site in Canada.
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 2 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: finished, as of the sponsor's last update on 28 Dec 2021. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in HIV testing Frequency (time frame: Time 1 (month 0), Time 2 (month 9), Time 3 (month 12)). The study lists 5 primary outcomes in all. 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 NCT04504097, which also lists 2 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 28 Dec 2021.