DepressionNCT05965245
Suubi-Mhealth: A Mobile Health Intervention to Address Depression Among Youth
A study testing Suubi-Mhealth in people with Depression and HIV Infection, run by Washington University School of Medicine at 2 sites in 2 countries.
Trial summary
The overall goal of this study is to develop an mHealth intervention (Suubi-Mhealth) for use among Ugandan youth (14-17 years) with comorbid HIV and depression, taking into account their unique contextual, cultural, and developmental needs. Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Depression, HIV Infection
- What is being tested?
- Suubi-Mhealth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 23 Nov 2022to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 14-17 years
- HIV positive and aware of their status i.e., disclosed to
- Prescribed antiretroviral therapy
- Living within a family, including with extended family members (not in institutions)
- Health care providers who work with youth at participating clinics who agree to participate in the study.
Who cannot join
- A significant cognitive impairment that interferes with the participant's understanding of the informed consent process, or inability/unwillingness to commit to completing the study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63130
Uganda1 site
International Center for Child Health and Development (ICHAD)
Masaka
About this study
Official title: Suubi-Mhealth: A Mobile Health Intervention to Address Depression and Improve ART Adherence Among Youth Living With HIV (YLHIV) in Uganda
The overall goal of this study is to develop an mHealth intervention (Suubi-Mhealth) for use among Ugandan youth (14-17 years) with comorbid HIV and depression, taking into account their unique contextual, cultural, and developmental needs. This digital therapy intervention delivered via a mobile application, will utilize the core tenets of cognitive-behavioral therapy (CBT) found to improve depression and ART adherence.
Read the detailed description
Approximately 1.7 million children under 15 years old were living with HIV in 2020; and most new HIV infections (85%) occurred in Sub-Saharan Africa (SSA). People living with HIV (PLHIV) often struggle with mental health comorbidities that lower their antiretroviral therapy (ART) adherence. However, 76% to 85% of PLHIV in SSA receive no treatment for serious mental health disorders, especially depression. Depression reduces ART adherence, which negatively impacts health and increases HIV transmission risks. Older adolescents (≥14 years) living with HIV are particularly vulnerable to these risks as caregivers withdraw or lessen their support during their transition to young adulthood. Moreover, older adolescents are also moving into larger and less accommodating adult HIV clinic settings and are at risk for dropping out of ART programs. Given that mental health services are severely under equipped in SSA, including in Uganda, and are inaccessible by many YLHIV, new solutions to increase access to mental health care and close the treatment gap are urgently needed. The overall goal of this study is to develop an mHealth intervention (Suubi-mhealth) for use among Ugandan youth (14-17 years) with comorbid HIV and depression, taking into account their unique contextual, cultural, and developmental needs. This digital therapy intervention delivered via a mobile application, will utilize the core tenets of cognitive-behavioral therapy (CBT) found to improve depression and ART adherence. The study will specifically: Phase 1. R21 Aim 1: Develop and iteratively refine an intervention protocol for Suubi-Mhealth based on formative work to understand needs of youth living with HIV (YLHIV). Four focus groups with youth and two focus groups with health care providers (6-8 youth each) will be conducted for feedback on intervention content and methods to increase participation and retention. R21 Aim 2: Based on results of Aim 1, explore the feasibility and acceptability of Suubi-Mhealth on a small scale (N=30), to inform subsequent refinement for the larger R33 phase. Phase 2. R33 Aim 1: Test the preliminary impact of Suubi-Mhealth versus a waitlist control group (N=200), on youth outcomes (depression, ART adherence, mental health functioning, quality of life, stigma). R33 Aim 2: Examine barriers and facilitators for integrating Suubi-Mhealth into health care settings for YLHIV. The study will be conducted in 10 health clinics in the greater Masaka region in Southern Uganda. Suubi-Mhealth is expected to be an acceptable and feasible mHealth tool to reduce depression, improve ART adherence and overall mental health functioning among YLHIV. If the results of this pilot are promising, then the next step is an R01 to rigorously test Suubi-Mhealth in a larger trial, spanning multiple sites across Uganda.
- Conditions
- Depression, HIV Infection
- Being tested
- Suubi-Mhealth
- Medical subject headings
- Depression, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suubi-MhealthBehavioural
Suubi-Mhealth is a theoretically-based digital therapeutics tool that aims to provide educational content on depression while considering the unique needs of SSA youth living with HIV. This educational content will be aligned with scientific recommendations for cognitive-behavioral therapy for adherence and depression as applied to HIV medication adherence. Core instruction will include psychoeducation on the interplay between HIV and depression; minimizing cognitive distortions related to ART adherence and stigma, as well as depression; challenging negative automatic thoughts; analysis and development of behavioral skills; reducing environmental stressors. Suubi-Mhealth will also have a social networking center in which patients can contact the research team, peers who are also taking part in this intervention, and other trusted individuals such as loved ones. Other features include tools for setting and monitoring goals, and a clinical management dashboard for the research team.
| Study group | Role | What they receive |
|---|---|---|
| Suubi-Mhealth | Experimental | Participants in this condition will receive the Suubi-Mhealth intervention delivered via a smart phone app. Receives: Behavioral: Suubi-Mhealth |
| Waitlist Control | Other | Participants in this condition will receive the Suubi-Mhealth intervention after the active treatment group. They will also receive a smart phone without the Suubi-Mhealth app at the same time as the intervention group. Receives: Behavioral: Suubi-Mhealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire (PHQ-9) Health Questionnaire (PHQ-9)
Depression will be assessed using the Patient Health Questionnaire (PHQ-9). Change in the mean score on the PHQ-9 over time will be assessed. The total score ranges between 0-27, with higher scores indicating higher levels of depressive symptoms.
Measured: Baseline, 1 month, 2 months, 6 months
Secondary outcomes (8)
ART Treatment Adherence
Change in ART adherence over time will be assessed by three items that have been:1) number of days that participants report taking their medication in the past month relative to the total number of days they were prescribed the medication; 2) frequency of taking the medicine in the way they were supposed to in the past month; and 3) how good a job they did at taking the medicine in the way they were supposed to in the past month. Responses from each item will be linearized into a continuous scale ranging from 0-100, with low scores representing poor adherence and 100 representing perfect adherence.
Measured: Baseline, 1 month, 2 months, 6 months
Brief Symptoms Index (BSI)
Psychological distress will be measured using the Brief Symptoms Index, which has been used globally and validated for use among adolescents. Change in mean score on the BSI over time will be assessed. The total score ranges between 53-212, with higher score indicating higher levels of psychological distress.
Measured: Baseline, 1 month, 2 months, 6 months
Pediatric Quality of Life Inventory (PedsQL)
Quality of Life will be measured by the Pediatric Quality of Life Inventory which includes items assessing general well-being, stress levels, functioning impairment, and cognitive functioning. Change in mean score on the PedsQL over time will be assessed. The total score ranges between 43-132, with higher scores indicating poor quality of life.
Measured: Baseline, 1 month, 2 months, 6 months
Medical Outcomes Study HIV Health Survey (MOSHIV)
Medical Outcomes Study HIV Health Survey (MOSHIV) will be used to assess physical health and HIV symptom impact. Change in symptoms and physical health over time will be measured.
Measured: Baseline, 1 month, 2 months, 6 months
HIV/AIDS Stigma and Discrimination Scale
HIV Stigma will be measured using the HIV/AIDS Stigma and Discrimination Scale. Change in the mean score over time will be assessed. The total score ranges between 22-88, with higher score indicating higher levels of HIV stigma.
Measured: Baseline, 1 month, 2 months, 6 months
Shame Questionnaire
Shame related to living with HIV will be measured using the Shame Questionnaire. Change in the mean score over time will be assessed. The total score range between 0 and 16 with a higher score indicating higher levels of HIV-associated shame.
Measured: Baseline, 1 month, 2 months, 6 months
Multidimensional Scale of Perceived Social Support
Multidimensional social support from friends, family members and community members will be measured using the Multidimensional Scale of Perceived Social Support. Change in the mean score on the MSPSS over time will be assessed. The total score ranges between 40-240, with higher score indicating higher levels of Multidimensional social support.
Measured: Baseline, 1 month, 2 months, 6 months
Social Support Behavioral Scale (SS-B)
Additional social support from family members and friends will be measured using the Social Support Behaviors Scale (SSBS). Change in the mean score on the SSBS over time will be assessed. The total score ranges between 45-225, with higher score indicating higher levels of social support.
Measured: Baseline, 1 month, 2 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start23 Nov 2022
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Proscovia Nabunya, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965245
- Sponsor's protocol ID
- R21MH131044 - 202209115
- Other IDs
- R21MH131044
- Status last verified
- May 2026
- First submitted
- 12 Jul 2023
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once all of the data has been de-identified, cleaned, and validated, and main findings have been published, the Investigators expect to share data with the scientific community. The research team will make datasets available to any individual who makes a direct request to the PI and indicates the data will be used for the purposes of research (per Code of Federal Regulations Title 45 Part 46: "Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."). In sharing participant data, the team will follow Washington University in St. Louis' Office of Sponsored Projects' data sharing agreement.
Publications
Nabunya P, Cavazos-Rehg P, Mugisha J, Kasson E, Namuyaba OI, Najjuuko C, Nsubuga E, Filiatreau LM, Mwebembezi A, Ssewamala FM. An mHealth Intervention to Address Depression and Improve Antiretroviral Therapy Adherence Among Youths Living With HIV in Uganda: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2024 Mar 8;13:e54635. doi: 10.2196/54635.
PubMed 38457202
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suubi-Mhealth: A Mobile Health Intervention to Address Depression and Improve ART Adherence Among Youth Living With HIV (YLHIV) in Uganda
- ClinicalTrials.gov ID
- NCT05965245
- Acronym / sponsor ID
- R21MH131044 - 202209115
- Conditions
- Depression, HIV Infection
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 28 Jul 2023 (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.
The overall goal of this study is to develop an mHealth intervention (Suubi-Mhealth) for use among Ugandan youth (14-17 years) with comorbid HIV and depression, taking into account their unique contextual, cultural, and developmental needs. This digital therapy intervention delivered via a mobile application, will utilize the core tenets of cognitive-behavioral therapy (CBT) found to improve depression and ART adherence.
Detailed description
Approximately 1.7 million children under 15 years old were living with HIV in 2020; and most new HIV infections (85%) occurred in Sub-Saharan Africa (SSA). People living with HIV (PLHIV) often struggle with mental health comorbidities that lower their antiretroviral therapy (ART) adherence. However, 76% to 85% of PLHIV in SSA receive no treatment for serious mental health disorders, especially depression. Depression reduces ART adherence, which negatively impacts health and increases HIV transmission risks. Older adolescents (≥14 years) living with HIV are particularly vulnerable to these risks as caregivers withdraw or lessen their support during their transition to young adulthood. Moreover, older adolescents are also moving into larger and less accommodating adult HIV clinic settings and are at risk for dropping out of ART programs. Given that mental health services are severely under equipped in SSA, including in Uganda, and are inaccessible by many YLHIV, new solutions to increase access to mental health care and close the treatment gap are urgently needed. The overall goal of this study is to develop an mHealth intervention (Suubi-mhealth) for use among Ugandan youth (14-17 years) with comorbid HIV and depression, taking into account their unique contextual, cultural, and developmental needs. This digital therapy intervention delivered via a mobile application, will utilize the core tenets of cognitive-behavioral therapy (CBT) found to improve depression and ART adherence. The study will specifically: Phase 1. R21 Aim 1: Develop and iteratively refine an intervention protocol for Suubi-Mhealth based on formative work to understand needs of youth living with HIV (YLHIV). Four focus groups with youth and two focus groups with health care providers (6-8 youth each) will be conducted for feedback on intervention content and methods to increase participation and retention. R21 Aim 2: Based on results of Aim 1, explore the feasibility and acceptability of Suubi-Mhealth on a small scale (N=30), to inform subsequent refinement for the larger R33 phase. Phase 2. R33 Aim 1: Test the preliminary impact of Suubi-Mhealth versus a waitlist control group (N=200), on youth outcomes (depression, ART adherence, mental health functioning, quality of life, stigma). R33 Aim 2: Examine barriers and facilitators for integrating Suubi-Mhealth into health care settings for YLHIV. The study will be conducted in 10 health clinics in the greater Masaka region in Southern Uganda. Suubi-Mhealth is expected to be an acceptable and feasible mHealth tool to reduce depression, improve ART adherence and overall mental health functioning among YLHIV. If the results of this pilot are promising, then the next step is an R01 to rigorously test Suubi-Mhealth in a larger trial, spanning multiple sites across Uganda.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suubi-Mhealth | Experimental | Behavioral: Suubi-MhealthParticipants in this condition will receive the Suubi-Mhealth intervention delivered via a smart phone app. |
| Waitlist Control | Other | Behavioral: Suubi-MhealthParticipants in this condition will receive the Suubi-Mhealth intervention after the active treatment group. They will also receive a smart phone without the Suubi-Mhealth app at the same time as the intervention group. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Ages 14-17 years
- HIV positive and aware of their status i.e., disclosed to
- Prescribed antiretroviral therapy
- Living within a family, including with extended family members (not in institutions)
- Health care providers who work with youth at participating clinics who agree to participate in the study.
Key exclusion criteria (1 listed)
- A significant cognitive impairment that interferes with the participant's understanding of the informed consent process, or inability/unwillingness to commit to completing the study
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 |
|---|---|---|
| Suubi-MhealthSuubi-Mhealth is a theoretically-based digital therapeutics tool that aims to provide educational content on depression while considering the unique needs of SSA youth living with HIV. This educational content will be aligned with scientific recommendations for cognitive-behavioral therapy for adherence and depression as applied to HIV medication adherence. Core instruction will include psychoeducation on the interplay between HIV and depression; minimizing cognitive distortions related to ART adherence and stigma, as well as depression; challenging negative automatic thoughts; analysis and development of behavioral skills; reducing environmental stressors. Suubi-Mhealth will also have a social networking center in which patients can contact the research team, peers who are also taking part in this intervention, and other trusted individuals such as loved ones. Other features include tools for setting and monitoring goals, and a clinical management dashboard for the research team. | Behavioural | Suubi-Mhealth, Waitlist Control |
Primary outcome
Patient Health Questionnaire (PHQ-9) Health Questionnaire (PHQ-9)
Time frame: Baseline, 1 month, 2 months, 6 months
Depression will be assessed using the Patient Health Questionnaire (PHQ-9). Change in the mean score on the PHQ-9 over time will be assessed. The total score ranges between 0-27, with higher scores indicating higher levels of depressive symptoms.
8 secondary outcomes
ART Treatment Adherence
Time frame: Baseline, 1 month, 2 months, 6 months
Brief Symptoms Index (BSI)
Time frame: Baseline, 1 month, 2 months, 6 months
Pediatric Quality of Life Inventory (PedsQL)
Time frame: Baseline, 1 month, 2 months, 6 months
Medical Outcomes Study HIV Health Survey (MOSHIV)
Time frame: Baseline, 1 month, 2 months, 6 months
HIV/AIDS Stigma and Discrimination Scale
Time frame: Baseline, 1 month, 2 months, 6 months
Shame Questionnaire
Time frame: Baseline, 1 month, 2 months, 6 months
Multidimensional Scale of Perceived Social Support
Time frame: Baseline, 1 month, 2 months, 6 months
Social Support Behavioral Scale (SS-B)
Time frame: Baseline, 1 month, 2 months, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Derived from this study: PubMed 38457202Nabunya P, Cavazos-Rehg P, Mugisha J, Kasson E, Namuyaba OI, Najjuuko C, Nsubuga E, Filiatreau LM, Mwebembezi A, Ssewamala FM. An mHealth Intervention to Address Depression and Improve Antiretroviral Therapy Adherence Among Youths Living With HIV in Uganda: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2024 Mar 8;13:e54635. doi: 10.2196/54635.
- Individual participant dataSharing planned: Yes. Once all of the data has been de-identified, cleaned, and validated, and main findings have been published, the Investigators expect to share data with the scientific community. The research team will make datasets available to any individual who makes a direct request to the PI and indicates the data will be used for the purposes of research (per Code of Federal Regulations Title 45 Part 46: "Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."). In sharing participant data, the team will follow Washington University in St. Louis' Office of Sponsored Projects' data sharing agreement.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suubi-Mhealth in people with Depression and HIV Infection, run by Washington University School of Medicine at 2 sites in 2 countries.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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?
This study is still under way. Results are not available in the source record yet.
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?
Patient Health Questionnaire (PHQ-9) Health Questionnaire (PHQ-9) (time frame: Baseline, 1 month, 2 months, 6 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 NCT05965245, which also lists 1 linked publication.
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 12 May 2026.