Sauti ya Vijana (SYV; The Voice of Youth): Longitudinal Outcomes of an Individually Randomized Group Treatment Pilot Trial for Young People Living with HIV in Tanzania.

Sauti ya Vijana is a mental health and life skills intervention delivered by young adult group leaders for the improvement of HIV outcomes in young people living with HIV in Tanzania. This pilot randomized controlled trial estimated exploratory intervention effectiveness compared to standard of care. YPLWH (N = 105) were randomized to receive intervention or SOC. The mean age of participants was 18.1 years and 53% were female. Mean scores on mental health measures (Patient Health Questionnaire [PHQ-9], Strengths and Difficulties Questionnaire [SDQ], UCLA Trauma) were asymptomatic to mild in both study arms through 30-month follow-up with a non-significant fluctuation of 1-2 points. The mean self-reported adherence was higher in the intervention arm across all time points (but the confidence interval contained the null at all time points except 6 months). Risk ratio of virologic suppression (HIV RNA < 400 copies/mL) in the intervention arm compared to SOC was 1.15 [95% CI = 0.95, 1.39]) at 6-months, 1.17 [95% CI: 0.92, 1.48] at 12-months, and 0.99 [95% CI 0.76, 1.31] at 18-months. Though these findings were not powered for statistical significance, the trends in HIV outcomes suggest that SYV holds promise for improving antiretroviral therapy (ART) adherence and virologic suppression in YPLWH.

A group-based mental health intervention for young people living with HIV in Tanzania: results of a pilot individually randomized group treatment trial.

BACKGROUND: Increasing numbers of young people living with HIV (YPLWH) have unaddressed mental health challenges. Such challenges are associated with poor antiretroviral therapy (ART) adherence and high mortality. Few evidence-based mental health interventions exist to improve HIV outcomes among YPLWH. METHODS: This pilot group treatment trial individually randomized YPLWH from two clinical sites in Tanzania, evaluated acceptability, feasibility, and preliminary effectiveness of a mental health intervention, Sauti ya Vijana (SYV; The Voice of Youth), was compared to the local standard-of-care (SOC) for improving ART adherence and virologic suppression. Enrolled YPLWH were 12-24 years of age and responded to mental health and stigma questionnaires, self-reported adherence, objective adherence measures (ART concentration in hair), and HIV RNA at baseline and 6-months (post-intervention). Feasibility and acceptability were evaluated, and potential effectiveness was assessed by comparing outcomes between arms using mixed effects modeling. RESULTS: Between June 2016 and July 2017, 128 YPLWH enrolled; 105 were randomized and 93 (55 in SYV) followed-up at 6-months and were thereby included in this analysis. Mean age was 18.1 years; 51% were female; and 84% were HIV-infected perinatally. Attendance to intervention sessions was 86%; 6-month follow-up was 88%, and fidelity to the protocol approached 100%. Exploratory analyses of effectiveness demonstrated self-reported adherence improved by 7.3 percentage points (95% CI: 2.2, 12.3); and the pooled standard deviation for all ART concentration values increased by 0.17 units (95% CI: - 0.52, 0.85) in the SYV arm compared to SOC. Virologic suppression rates (HIV RNA < 400 copies/mL) at baseline were 65% in both arms but increased to 75% in the SYV arm while staying the same in the SOC arm (RR 1.13; 95% CI: 0.94, 1.36). CONCLUSIONS: YPLWH often have poor HIV outcomes, making interventions to improve outcomes in this population critical. This pilot trial of the Tanzania-based SYV intervention demonstrated trends towards improvement in ART adherence and virologic outcomes among YPLWH, supporting efforts to scale the intervention into a fully-powered effectiveness trial. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02888288 . Registered August 9, 2016. Retrospectively registered as first participant enrolled June 16, 2016.

Building resilience: a mental health intervention for Tanzanian youth living with HIV.

Despite a growing population of youth living with HIV, few interventions have been developed to address their unique mental health needs and to promote resilience. Based on our prior needs assessment, a mental health intervention, Sauti ya Vijana ( The Voice of Youth), was developed to address identified mental health needs and promote resilience. The intervention emphasized resilience strategies for identifying and coping with stressful events, supporting strong familial and social relationships, and planning for a safe and healthy living environment through stigma reduction, planning for disclosure, and instilling hope for the future. Ten group sessions (two of which were joint youth/caregiver sessions) and two individual sessions were developed around these three resilience domains. Youth living with HIV (average age 17.4 years), who were receiving antiretroviral therapy and attending HIV adolescent clinic in Tanzania were randomized to intervention or treatment as usual. Trained group leaders led the intervention sessions. Near perfect program fidelity by the group leaders and unanimous acceptance of the intervention by the youth was documented. SYV successfully promoted youth resilience as measured by youth-reported utilization of new coping skills, improved peer and caregiver relationships, reduced stigma, and improved confidence to live positively according to their personal values.

A group-based mental health intervention for Tanzanian youth living with HIV: Secondary analysis of a pilot trial.

BACKGROUND: Youth living with human immunodeficiency virus (YLWH) are vulnerable to incomplete adherence to antiretroviral therapy in the context of stigma, decreased hope for future, and mental health challenges. Despite these challenges, few mental health interventions have been developed to support YLWH. Previous randomized results from the Sauti ya Vijana (SYV; "The Voice of Youth") mental health intervention were indicative of the intervention's benefits in promoting virologic suppression. METHODS: SYV is a group-based mental health and life skills intervention (pilot, individually randomized group treatment trial) developed alongside YLWH. SYV was comprised of 10, 90-minute sessions based on evidence-based treatment models designed to improve coping, social support, and hope for future as a pathway to improved adherence and virologic suppression. At baseline, YLWH 12 to 24 years of age were randomized to SYV or standard of care. Participants included in this secondary analysis were enrolled in SYV's crossover waves due to either being randomized to standard of care or inability to attend an earlier group, and therefore delayed intervention exposure. Measured outcomes included self-reported mental health measures, self-reported human immunodeficiency virus measures (stigma and adherence), and human immunodeficiency virus ribonucleic acid. Data was collected at baseline, preintervention, and postintervention timepoints. Participants were included if they attended a crossover wave and had data at all 3 timepoints. RESULTS: Twenty-one crossover participants met inclusion criteria. Mean scores of self-reported mental health questionnaires were in an asymptomatic range both pre- and postintervention. Viral suppression was N = 15 (71%) preintervention compared to N = 17 (81%) postintervention. The participants who became virologically suppressed had no change in antiretroviral therapy. CONCLUSIONS: Despite the small sample size, findings from this study demonstrate that mental wellbeing may be an important pathway to improved HIV outcomes for YLWH. The same trend toward virologic suppression pre- to postintervention was demonstrated in the randomized pilot trial and suggests that SYV holds promise to improve HIV outcomes. Data from this analysis support the fully powered trial that is now underway.