HIV -1 InfectionNCT07621510
Integrating iSYV Within HIV Clinical Care for Youth Living With HIV in Tanzania
A study testing iSYV (integrated Sauti ya Vijana; The Voice of Youth), mHealth and eSOC in people with HIV -1 Infection and Mental Health Issue, run by Duke University at 1 site in Tanzania.
Trial summary
Youth living with HIV (YLWH) experience mental health (MH) challenges that compromise their HIV care. Though the MH gap is well described, MH service delivery to YLWH is rare, especially in low resource settings. MH professionals are few and interventions tailored to the needs of this population are scarce. Read more about this study
- Who is it for?
- Ages 15 to 24 years
- Conditions the study is for
- HIV -1 Infection, Mental Health Issue
- What is being tested?
- iSYV (integrated Sauti ya Vijana; The Voice of Youth), mHealth and eSOC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteTanzania
- Study dates
- 10 Jan 2027to 30 Sep 2030
- 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 15 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- youth living with HIV (YLWH) 15-24 years;
- have understanding of their HIV status;
- able to attend iSYV sessions if site is randomized to the intervention.
Who cannot join
- inability to provide informed consent/assent or participate meaningfully in the intervention due to cognitive impairment, psychosis, or other disability;
- enrollment in any other MH, stigma-related, or adherence intervention research study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sandy Askew, MPh contact
Tanzania1 site
Elizabeth Glaser Pediatric AIDS Foundation implementing partner sites in Tanzania
Moshi
Akwila Temu, MD, MMED
About this study
Youth living with HIV (YLWH) experience mental health (MH) challenges that compromise their HIV care. Though the MH gap is well described, MH service delivery to YLWH is rare, especially in low resource settings. MH professionals are few and interventions tailored to the needs of this population are scarce. This project proposes a way to bridge the gap by streamlining the Sauti ya Vijana (SYV, The Voice of Youth) intervention redesigned to integrate into the differentiated HIV clinical care model in Tanzania. SYV is a peer-led, group-based treatment designed with and for YLWH to address their self-reported MH challenges and stressors living with HIV.
Read the detailed description
SYV incorporates components of existing evidence-based models: Trauma Focused-Cognitive Behavioral Therapy, Interpersonal Psychotherapy, and Motivational Interviewing to address the needs youth described in formative interviews. Preliminary data indicates implementation success with estimated effects towards improved MH, antiretroviral therapy adherence, and a 10% greater increase in viral suppression in the intervention arm compared to standard of care. The central hypothesis here is that the new integrated "i" SYV will be acceptable, feasible, and effective to improve virologic suppression and improve retention in care. The mechanism of change is that improved MH leads to better medication adherence, viral suppression, and care engagement. The rationale is twofold: 1) Tanzania is planning to initiate MH screening in HIV clinical visits, but the MH treatment gap persists; 2) the iSYV stepped-care package could be an effective approach to support integrated MH care for YLWH. The central hypothesis will be tested in a hybrid type-2 effectiveness-implementation trial. The first aim will leverage the Fit to Context Framework, using an iterative Designing for Dissemination and Sustainability approach. Current SYV peer-group leaders with extensive experience delivering SYV will co-design the new iSYV package. The iSYV in-person sessions will be delivered by trained peer youth leaders and be aligned to the Tanzanian differentiated care model: stable youth (those fully suppressed) attend clinic every 6 months; and unstable youth (those with HIV RNA > 50 copies/mL) attend enhanced adherence counseling monthly. Youth with symptoms of MH difficulties on screening (PHQ9-depression, GAD7-anxiety, Trauma-related stress) will join the unstable group. To support engagement between visits, iSYV will explore use of a mHealth gamification strategy. The second aim includes a pilot and a four-arm cluster randomized trial. Two large implementing partners of PEPFAR clinics will support testing of the iSYV care package. The primary outcome is powered to show an increase in viral suppression (HIV RNA <50 copies/mL) in the unstable group and improved retention in care among the stable group. Change in MH is measured as a secondary outcome. The third aim will evaluate implementation determinants and outcomes, including acceptability, feasibility, fidelity, and cost informed by the Consolidated Framework for Implementation Research. The proposal is significant because it is expected to help address the MH gap for YLWH with implications for HIV care in Tanzania and other low income areas.
- Conditions
- HIV -1 Infection, Mental Health Issue
- Being tested
- iSYV (integrated Sauti ya Vijana; The Voice of Youth), mHealth, eSOC
- Keywords
- Youth, Adolescents, Tanzania, Cognitive behavioral therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iSYV (integrated Sauti ya Vijana; The Voice of Youth)Behavioural
Integrated "i"SYV is a streamlined version of the original intervention SYV that is adapted for integration into routine clinical care. The original SYV intervention included 10 group weekly sessions (2 incorporating caregivers) and 2 individual sessions with adaptation to fit without routine adolescent HIV care based on Tanzanian National HIV Guidelines for HIV care follow up visits.
mHealthOther
A gamified version of iSYV that can be played via SMS or Whatsapp messaging.
eSOCOther
mental health screening and referral within the standard of care for moderate to severe symptoms
| Study group | Role | What they receive |
|---|---|---|
| eSOC (enhanced Standard of Care) | Active comparator | Currently mental health screening is not part of routine care. Youth at all trial clinics who report moderate to severe symptoms will be referred for care within the local standard. Receives: Other: eSOC |
| eSOC (enhanced Standard of Care) + iSYV (integrated Sauti ya Vijana or The voice of youth) | Experimental | iSYV is an intervention that will be peer-led and group based in six monthly sessions. Receives: Behavioral: iSYV (integrated Sauti ya Vijana; The Voice of Youth); Other: eSOC |
| eSOC (enhanced Standard of Care) + iSYV + mHealth (mobile Health) | Experimental | mHealth will be an additional experimental intervention exploring the boosting effect of gamification of intervention content to boost participant knowledge and understanding of iSYV content Receives: Behavioral: iSYV (integrated Sauti ya Vijana; The Voice of Youth); Other: mHealth; Other: eSOC |
| eSOC (enhanced Standard of Care) + mHealth (mobile Health) | Experimental | mHealth is evaluated as a stand alone experimental intervention in this arm to evaluate if mHealth alone (without in person iSYV content) can improve mental health and/or HIV RNA outcomes. Receives: Other: mHealth; Other: eSOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
viral load
HIV RNA <50 copies/mL considered suppression (per National guidelines)
Measured: at 6-months
retention in care
clinical follow up as prescribed within 30 days of scheduled 6-month appointment
Measured: at 6-months
Secondary outcomes (10)
changes in self-reported antiretroviral therapy (ART) regarding adherence
Self-reported adherence on a 3 question survey (Wilson) 0-100 range, higher scores indicate greater adherence
Measured: 6-months, 12-months, 18-months
change in self-reported mental health difficulties related to depression
self-report of the Patient Health Questionnaire-9 (PHQ-9 ) range is 0-27, higher scores indicate greater depression
Measured: 6-months, 12-months, 18-months
change in self-reported mental health difficulties related to anxiety
self-report on the Generalized Anxiety Disorder-7 (GAD-7) range 0-21 with higher scores indicating greater anxiety
Measured: 6-months, 12-months, 18-months
change in HIV knowledge in the SOC+iSYV intervention arm compared to SOC arm at 6 month follow-up and at all timepoints in the intervention arm compared to SOC arm
self reported knowledge on the HIV-KQ18 (HIV Knowledge questionnaire 18) range 0-18. higher score indicates more HIV knowledge
Measured: 6-months, 12-months, 18-months
viral load
HIV RNA
Measured: 12-months, 18-months as drawn per standard of care
retention in care
follow up in routine HIV care within 30 days of scheduled 12-month and 18-month appointments
Measured: 12-months and 18-months
change in coping and self efficacy on the Coping and Self-Efficacy Scale (CSES)
self-reported, 13 questions with scale of 0 to 2 (range 0 to 26), where a higher number is a better outcome, more coping and self-efficacy
Measured: 6-months, 12-months, 18-months
change in resilience on People Living with HIV (PLHIV) Resilience Scale
10 items, scale 0 to 2 (range 0 to 20), higher number means more resilience and a better outcome
Measured: 6-months, 12-months, 18-months
SYV risk behaviors scale
5 items assessing sexual activity, number of sexual partners, condom use, consumption of alcohol, cocaine, heroin, or other substances. These are yes/no response with clarification of rate/amount. Higher numbers is higher risk.
Measured: 6-months, 12-months, 18-months
interpersonal violence on the World Health Organization intimate partner violence (WHO IPV) scale
self report, 15 items with 0=no and 1-yes. More yes (higher scale) means more experience with IPV.
Measured: 6-months, 12-months, 18-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start10 Jan 2027 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV -1 InfectionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dorothy Dow, MD, MSc, Principal investigator, Duke Universtiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621510
- Sponsor's protocol ID
- Pro00119752
- Status last verified
- Mar 2026
- First submitted
- 13 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: de-identified data
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating iSYV Within HIV Clinical Care for Youth Living With HIV in Tanzania
- ClinicalTrials.gov ID
- NCT07621510
- Acronym / sponsor ID
- Pro00119752
- Conditions
- HIV -1 Infection, Mental Health Issue
- Keywords
- Youth, Adolescents, Tanzania, Cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 10 Jan 2027 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 2 Jun 2026 (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.
Youth living with HIV (YLWH) experience mental health (MH) challenges that compromise their HIV care. Though the MH gap is well described, MH service delivery to YLWH is rare, especially in low resource settings. MH professionals are few and interventions tailored to the needs of this population are scarce. This project proposes a way to bridge the gap by streamlining the Sauti ya Vijana (SYV, The Voice of Youth) intervention redesigned to integrate into the differentiated HIV clinical care model in Tanzania. SYV is a peer-led, group-based treatment designed with and for YLWH to address their self-reported MH challenges and stressors living with HIV.
Detailed description
SYV incorporates components of existing evidence-based models: Trauma Focused-Cognitive Behavioral Therapy, Interpersonal Psychotherapy, and Motivational Interviewing to address the needs youth described in formative interviews. Preliminary data indicates implementation success with estimated effects towards improved MH, antiretroviral therapy adherence, and a 10% greater increase in viral suppression in the intervention arm compared to standard of care. The central hypothesis here is that the new integrated "i" SYV will be acceptable, feasible, and effective to improve virologic suppression and improve retention in care. The mechanism of change is that improved MH leads to better medication adherence, viral suppression, and care engagement. The rationale is twofold: 1) Tanzania is planning to initiate MH screening in HIV clinical visits, but the MH treatment gap persists; 2) the iSYV stepped-care package could be an effective approach to support integrated MH care for YLWH. The central hypothesis will be tested in a hybrid type-2 effectiveness-implementation trial. The first aim will leverage the Fit to Context Framework, using an iterative Designing for Dissemination and Sustainability approach. Current SYV peer-group leaders with extensive experience delivering SYV will co-design the new iSYV package. The iSYV in-person sessions will be delivered by trained peer youth leaders and be aligned to the Tanzanian differentiated care model: stable youth (those fully suppressed) attend clinic every 6 months; and unstable youth (those with HIV RNA > 50 copies/mL) attend enhanced adherence counseling monthly. Youth with symptoms of MH difficulties on screening (PHQ9-depression, GAD7-anxiety, Trauma-related stress) will join the unstable group. To support engagement between visits, iSYV will explore use of a mHealth gamification strategy. The second aim includes a pilot and a four-arm cluster randomized trial. Two large implementing partners of PEPFAR clinics will support testing of the iSYV care package. The primary outcome is powered to show an increase in viral suppression (HIV RNA <50 copies/mL) in the unstable group and improved retention in care among the stable group. Change in MH is measured as a secondary outcome. The third aim will evaluate implementation determinants and outcomes, including acceptability, feasibility, fidelity, and cost informed by the Consolidated Framework for Implementation Research. The proposal is significant because it is expected to help address the MH gap for YLWH with implications for HIV care in Tanzania and other low income areas.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| eSOC (enhanced Standard of Care) | Active comparator | Other: eSOCCurrently mental health screening is not part of routine care. Youth at all trial clinics who report moderate to severe symptoms will be referred for care within the local standard. |
| eSOC (enhanced Standard of Care) + iSYV (integrated Sauti ya Vijana or The voice of youth) | Experimental | Behavioral: iSYV (integrated Sauti ya Vijana; The Voice of Youth), Other: eSOCiSYV is an intervention that will be peer-led and group based in six monthly sessions. |
| eSOC (enhanced Standard of Care) + iSYV + mHealth (mobile Health) | Experimental | Behavioral: iSYV (integrated Sauti ya Vijana; The Voice of Youth), Other: mHealth, Other: eSOCmHealth will be an additional experimental intervention exploring the boosting effect of gamification of intervention content to boost participant knowledge and understanding of iSYV content |
| eSOC (enhanced Standard of Care) + mHealth (mobile Health) | Experimental | Other: mHealth, Other: eSOCmHealth is evaluated as a stand alone experimental intervention in this arm to evaluate if mHealth alone (without in person iSYV content) can improve mental health and/or HIV RNA outcomes. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- youth living with HIV (YLWH) 15-24 years;
- have understanding of their HIV status;
- able to attend iSYV sessions if site is randomized to the intervention.
Key exclusion criteria (2 listed)
- inability to provide informed consent/assent or participate meaningfully in the intervention due to cognitive impairment, psychosis, or other disability;
- enrollment in any other MH, stigma-related, or adherence intervention research 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 |
|---|---|---|
| iSYV (integrated Sauti ya Vijana; The Voice of Youth)Integrated "i"SYV is a streamlined version of the original intervention SYV that is adapted for integration into routine clinical care. The original SYV intervention included 10 group weekly sessions (2 incorporating caregivers) and 2 individual sessions with adaptation to fit without routine adolescent HIV care based on Tanzanian National HIV Guidelines for HIV care follow up visits. | Behavioural | eSOC (enhanced Standard of Care) + iSYV (integrated Sauti ya Vijana or The voice of youth), eSOC (enhanced Standard of Care) + iSYV + mHealth (mobile Health) |
| mHealthA gamified version of iSYV that can be played via SMS or Whatsapp messaging. | Other | eSOC (enhanced Standard of Care) + iSYV + mHealth (mobile Health), eSOC (enhanced Standard of Care) + mHealth (mobile Health) |
| eSOCmental health screening and referral within the standard of care for moderate to severe symptoms | Other | eSOC (enhanced Standard of Care), eSOC (enhanced Standard of Care) + iSYV (integrated Sauti ya Vijana or The voice of youth), eSOC (enhanced Standard of Care) + iSYV + mHealth (mobile Health), eSOC (enhanced Standard of Care) + mHealth (mobile Health) |
Primary outcome
viral load
Time frame: at 6-months
HIV RNA <50 copies/mL considered suppression (per National guidelines)
retention in care
Time frame: at 6-months
clinical follow up as prescribed within 30 days of scheduled 6-month appointment
10 secondary outcomes
changes in self-reported antiretroviral therapy (ART) regarding adherence
Time frame: 6-months, 12-months, 18-months
change in self-reported mental health difficulties related to depression
Time frame: 6-months, 12-months, 18-months
change in self-reported mental health difficulties related to anxiety
Time frame: 6-months, 12-months, 18-months
change in HIV knowledge in the SOC+iSYV intervention arm compared to SOC arm at 6 month follow-up and at all timepoints in the intervention arm compared to SOC arm
Time frame: 6-months, 12-months, 18-months
viral load
Time frame: 12-months, 18-months as drawn per standard of care
retention in care
Time frame: 12-months and 18-months
change in coping and self efficacy on the Coping and Self-Efficacy Scale (CSES)
Time frame: 6-months, 12-months, 18-months
change in resilience on People Living with HIV (PLHIV) Resilience Scale
Time frame: 6-months, 12-months, 18-months
SYV risk behaviors scale
Time frame: 6-months, 12-months, 18-months
interpersonal violence on the World Health Organization intimate partner violence (WHO IPV) scale
Time frame: 6-months, 12-months, 18-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 2 Jun 2026.
- Individual participant dataSharing planned: Yes. de-identified data
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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.
Sandy Askew, MPh contact
Dorothy Dow, MD, MSc principal investigator
Duke Universtiy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iSYV (integrated Sauti ya Vijana; The Voice of Youth), mHealth and eSOC in people with HIV -1 Infection and Mental Health Issue, run by Duke University at 1 site in Tanzania.
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 3 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: opening soon, as of the sponsor's last update on 2 Jun 2026. 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 Tanzania. 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?
Contact Stuart T Carr, BA ((919) 668-4849, stuart.carr@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
viral load (time frame: at 6-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2026.