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Integrating iSYV Within HIV Clinical Care for Youth Living With HIV in Tanzania

ConditionsHIV -1 InfectionMental Health Issue
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-24
SponsorDuke University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • iSYV (integrated Sauti ya Vijana; The Voice of Youth)

    Behavioral

    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.

  • mHealth

    Other intervention

    A gamified version of iSYV that can be played via SMS or Whatsapp messaging.

  • eSOC

    Other intervention

    mental health screening and referral within the standard of care for moderate to severe symptoms

Treatment groups

5,000 Participants
are divided into 4 treatment groups
Group A: eSOC (enhanced Standard of Care)Active comparator 1 intervention
Group B: eSOC (enhanced Standard of Care) + iSYV (integrated Sauti ya Vijana or The voice of youth)Experimental treatment 2 interventions
Group C: eSOC (enhanced Standard of Care) + iSYV + mHealth (mobile Health)Experimental treatment 3 interventions
Group D: eSOC (enhanced Standard of Care) + mHealth (mobile Health)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

viral load

HIV RNA \<50 copies/mL considered suppression (per National guidelines)

Time frame
at 6-months
2

retention in care

clinical follow up as prescribed within 30 days of scheduled 6-month appointment

Time frame
at 6-months

Secondary outcomes

1

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

Time frame
6-months, 12-months, 18-months
2

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

Time frame
6-months, 12-months, 18-months
3

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

Time frame
6-months, 12-months, 18-months
4

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

Time frame
6-months, 12-months, 18-months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: