- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07621510
Integrating iSYV Within HIV Clinical Care for Youth Living With HIV in Tanzania
27 mei 2026 bijgewerkt door: Duke University
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.
Studie Overzicht
Toestand
Nog niet aan het werven
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
5000
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Stuart T Carr, BA
- Telefoonnummer: (919) 668-4849
- E-mail: stuart.carr@duke.edu
Studie Contact Back-up
- Naam: Sandy Askew, MPh
- E-mail: sandy.askew@duke.edu
Studie Locaties
-
-
-
Moshi, Tanzania
- Elizabeth Glaser Pediatric AIDS Foundation implementing partner sites in Tanzania
-
Hoofdonderzoeker:
- Akwila Temu, MD, MMED
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: eSOC (enhanced Standard of Care)
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.
|
mental health screening and referral within the standard of care for moderate to severe symptoms
|
|
Experimenteel: eSOC (enhanced Standard of Care) + iSYV (integrated Sauti ya Vijana or The voice of youth)
iSYV is an intervention that will be peer-led and group based in six monthly sessions.
|
mental health screening and referral within the standard of care for moderate to severe symptoms
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.
|
|
Experimenteel: eSOC (enhanced Standard of Care) + iSYV + mHealth (mobile Health)
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
|
mental health screening and referral within the standard of care for moderate to severe symptoms
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.
A gamified version of iSYV that can be played via SMS or Whatsapp messaging.
|
|
Experimenteel: eSOC (enhanced Standard of Care) + mHealth (mobile Health)
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.
|
mental health screening and referral within the standard of care for moderate to severe symptoms
A gamified version of iSYV that can be played via SMS or Whatsapp messaging.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
viral load
Tijdsspanne: at 6-months
|
HIV RNA <50 copies/mL considered suppression (per National guidelines)
|
at 6-months
|
|
retention in care
Tijdsspanne: at 6-months
|
clinical follow up as prescribed within 30 days of scheduled 6-month appointment
|
at 6-months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
changes in self-reported antiretroviral therapy (ART) regarding adherence
Tijdsspanne: 6-months, 12-months, 18-months
|
Self-reported adherence on a 3 question survey (Wilson) 0-100 range, higher scores indicate greater adherence
|
6-months, 12-months, 18-months
|
|
change in self-reported mental health difficulties related to depression
Tijdsspanne: 6-months, 12-months, 18-months
|
self-report of the Patient Health Questionnaire-9 (PHQ-9 ) range is 0-27, higher scores indicate greater depression
|
6-months, 12-months, 18-months
|
|
change in self-reported mental health difficulties related to anxiety
Tijdsspanne: 6-months, 12-months, 18-months
|
self-report on the Generalized Anxiety Disorder-7 (GAD-7) range 0-21 with higher scores indicating greater anxiety
|
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
Tijdsspanne: 6-months, 12-months, 18-months
|
self reported knowledge on the HIV-KQ18 (HIV Knowledge questionnaire 18) range 0-18.
higher score indicates more HIV knowledge
|
6-months, 12-months, 18-months
|
|
viral load
Tijdsspanne: 12-months, 18-months as drawn per standard of care
|
HIV RNA
|
12-months, 18-months as drawn per standard of care
|
|
retention in care
Tijdsspanne: 12-months and 18-months
|
follow up in routine HIV care within 30 days of scheduled 12-month and 18-month appointments
|
12-months and 18-months
|
|
change in coping and self efficacy on the Coping and Self-Efficacy Scale (CSES)
Tijdsspanne: 6-months, 12-months, 18-months
|
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
|
6-months, 12-months, 18-months
|
|
change in resilience on People Living with HIV (PLHIV) Resilience Scale
Tijdsspanne: 6-months, 12-months, 18-months
|
10 items, scale 0 to 2 (range 0 to 20), higher number means more resilience and a better outcome
|
6-months, 12-months, 18-months
|
|
SYV risk behaviors scale
Tijdsspanne: 6-months, 12-months, 18-months
|
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.
|
6-months, 12-months, 18-months
|
|
interpersonal violence on the World Health Organization intimate partner violence (WHO IPV) scale
Tijdsspanne: 6-months, 12-months, 18-months
|
self report, 15 items with 0=no and 1-yes.
More yes (higher scale) means more experience with IPV.
|
6-months, 12-months, 18-months
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Dorothy Dow, MD, MSc, Duke Universtiy
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
10 januari 2027
Primaire voltooiing (Geschat)
31 maart 2029
Studie voltooiing (Geschat)
30 september 2030
Studieregistratiedata
Eerst ingediend
13 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
27 mei 2026
Eerst geplaatst (Werkelijk)
2 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
2 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
27 mei 2026
Laatst geverifieerd
1 maart 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Pro00119752
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
de-identified data
IPD-tijdsbestek voor delen
at the conclusion of trial analysis
IPD-toegangscriteria voor delen
Data sharing is critical to confirm findings, discover important new associations, and to test new ideas that impact health.
Our core quantitative dataset will be archived in the National Institute of Mental Health (NIMH) Data Archive (NDA).
To achieve this we will harmonize our data to NDA common data elements (CDE) as much as possible prior to data collection.
We will follow the standard practices of the NDA for data uploads, submitting data biannually beginning in the second submission cycle following the Notice of Award.
Data will be made publicly available in the data archive at the time of publication.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ANALYTIC_CODE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .