HIV -1 Infection, Mental Health Issue
Conditions
Keywords
Youth, Adolescents, Tanzania, Cognitive behavioral therapy
Brief 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. 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.
Interventions
BEHAVIORALiSYV (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.
OTHERmHealth
A gamified version of iSYV that can be played via SMS or Whatsapp messaging.
OTHEReSOC
mental health screening and referral within the standard of care for moderate to severe symptoms
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Trial statisticians
Eligibility
Sex/Gender
ALL
Age
15 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
1. youth living with HIV (YLWH) 15-24 years; 2. have understanding of their HIV status; 3. able to attend iSYV sessions if site is randomized to the intervention.
Exclusion criteria
1. inability to provide informed consent/assent or participate meaningfully in the intervention due to cognitive impairment, psychosis, or other disability; 2. enrollment in any other MH, stigma-related, or adherence intervention research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| viral load | at 6-months | HIV RNA \<50 copies/mL considered suppression (per National guidelines) |
| retention in care | at 6-months | clinical follow up as prescribed within 30 days of scheduled 6-month appointment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in self-reported antiretroviral therapy (ART) regarding adherence | 6-months, 12-months, 18-months | Self-reported adherence on a 3 question survey (Wilson) 0-100 range, higher scores indicate greater adherence |
| change in self-reported mental health difficulties related to depression | 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 |
| change in self-reported mental health difficulties related to anxiety | 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 |
| 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 | 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 |
| viral load | 12-months, 18-months as drawn per standard of care | HIV RNA |
| retention in care | 12-months and 18-months | follow up in routine HIV care within 30 days of scheduled 12-month and 18-month appointments |
| change in coping and self efficacy on the Coping and Self-Efficacy Scale (CSES) | 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 |
| change in resilience on People Living with HIV (PLHIV) Resilience Scale | 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 |
| SYV risk behaviors scale | 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. |
| interpersonal violence on the World Health Organization intimate partner violence (WHO IPV) scale | 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. |
Countries
Tanzania
Contacts
CONTACTStuart T Carr, BA
CONTACTSandy Askew, MPh
PRINCIPAL_INVESTIGATORDorothy Dow, MD, MSc
Duke Universtiy
Outcome results
None listed