Study protocol for Sauti ya Vijana (The Voice of Youth): A hybrid-type 1 randomized trial to evaluate effectiveness and implementation of a mental health and life skills intervention to improve health outcomes for Tanzanian youth living with HIV

Abstract

Objective: Young people living with HIV (YPLWH) experience increased morbidity and mortality compared to all other age groups. Adolescence brings unique challenges related to sexual reproductive health, the elevated importance of peer groups, and often, emerging symptoms of emotional distress. Failure to address this unique life stage for YPLWH can lead to worse HIV and mental health outcomes. Herein lies the protocol for a hybrid-type-1 effectiveness-implementation trial designed to evaluate a mental health and life skills intervention that aims to address these needs for YPLWH in Tanzania.

Methods: This is an individually randomized group-treatment trial designed to evaluate the effectiveness of Sauti ya Vijana (SYV: The Voice of Youth) toward improving viral suppression (HIV RNA <400 copies/mL) and mental health outcomes and to assess implementation including acceptability, feasibility, fidelity, and cost-effectiveness of the manualized intervention. The trial is being conducted across four geographically distinct regions of Tanzania. Peer group leaders (PGL) with lived HIV experience deliver the 10-session group-based intervention and two individual sessions during which participants describe their disclosure narrative (when they learned they live with HIV) and value-based goal setting. Caregiver or chosen supportive adults are encouraged to attend two specific group sessions with their youth. Participants are 10-24 years of age, prescribed antiretroviral therapy for at least 6 months, fully aware of their HIV status, able to commit to session attendance, and able to understand and meaningfully contribute to group sessions. Participant study visits occur at 5 time points for evaluation: baseline, 4-, 6-, 12-, and 18-months post baseline. A single booster session is conducted before the 12-month visit. Study visits evaluate mental health, adverse childhood events, interpersonal violence, resilience, stigma, HIV knowledge, substance use, sexual relationships, ART adherence, and HIV RNA. Implementation outcomes evaluate feasibility and acceptability through attendance, intervention session notes, focus discussion groups and qualitative interviews. Fidelity to the intervention is measured using fidelity checklists by a PGL observer at each group session. Cost effectiveness is calculated using an incremental cost-effectiveness ratio that utilizes a patient cost questionnaire and financial records of study costs.

Significance: Few mental health interventions for YPLWH have demonstrated effectiveness. Results from this study will provide information about effectiveness and implementation of a peer-led intervention for delivering a mental health and life skills intervention in low-income settings.

Trial identifier: This trial is registered at clinicaltrials.gov NCT05374109.

Fig 1. Spirit schedule.

Fig 2. Tanzanian map reflecting distances for each study site location.

Fig 3. Consort diagram flow.

Fig 4. Sauti ya Vijana (SYV) applied to the modified social action theory framework³⁵.

Abbreviations: Psychotherapeutic strategies informed by 1) CBT: Cognitive Behavioral Therapy; 2) IPT: Interpersonal Psychotherapy: 3) MI: Motivational Interviewing; ART: antiretroviral therapy; PHQ: Patient Health Questionnaire; SDQ: Strengths and Difficulties Questionnaire; QOL: quality of life *Two sessions (one and six) are joint with caregivers; Not shown are two individual sessions (after session 4 and after session 10). Republished from Sauti ya Vijana (https://sites.duke.edu/sautiyavijana/about-syv/) under a CC BY license, with permission from Dorothy Dow, original copyright 2020.

Fig 5. SYV training and supervision.

Fig 6. Study timeline.

Effectiveness Aim 1: SYV: Sauti ya Vijana (Voice of Youth) Intervention delivery occurs over 12 weeks. T₀ is enrollment study visit; T₁ is 4-month; T₂ is 6-month and the study primary endpoint; T₃*includes a one-session booster before the 12-month visit; T₄ is 18-month study visit. Qualitative Aim 3: IDI: in-depth-interview; FDG: Focus Discussion Group; Inner Setting, Outer Setting, Individuals involved.

Fig 7. Simplified SYV intervention proposed mechanism of change.