Dataset Information

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.

ABSTRACT: 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.

SUBMITTER: Dow DE

PROVIDER: S-EPMC8784208 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

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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.

Dow Dorothy E DE O'Donnell Karen E KE Mkumba Laura L Gallis John A JA Turner Elizabeth L EL Boshe Judith J Shayo Aisa M AM Cunningham Coleen K CK Mmbaga Blandina T BT

AIDS and behavior 20220124 6

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 [ ...[more]

PMID: 35067831

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Project description:BackgroundIncreasing 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.MethodsThis 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.ResultsBetween 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).ConclusionsYPLWH 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 registrationClinicalTrials.gov Identifier: NCT02888288 . Registered August 9, 2016. Retrospectively registered as first participant enrolled June 16, 2016.

Project description:ObjectiveYoung 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.MethodsThis 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.SignificanceFew 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 identifierThis trial is registered at clinicaltrials.gov NCT05374109.

Project description:High adherence to antiretroviral therapy (ART) is essential for achieving viral suppression and preventing HIV transmission. Yet adherence is suboptimal among adolescents who face unique adherence challenges. Little is known about the role of conditional economic incentives (CEIs) for increasing ART adherence in this population. During 2017-2019, we conducted a mixed-methods discrete choice experiment in Cape Town, South Africa to inform the optimal design of a CEI intervention for ART adherence among youth. In-depth interviews were conducted with n = 35 adolescents (10-19 years old) living with HIV and prescribed ART, to identify attributes of a youth-centered CEI intervention for ART adherence. A discrete choice experiment was subsequently conducted with N = 168 adolescents to elicit preferences for intervention components. A rank-ordered mixed logit model was used for main results; marginal willingness-to-accept (mWTA) was then estimated. Five attributes emerged from the qualitative research as important for a CEI-based intervention for youth ART adherence: (1) incentive amount, (2) incentive format, (3) incentive recipient, (4) delivery mode, and (5) program participants. Youth had a high probability of acceptance of any incentives program (88-100%), yet they did not have a strong preference of a quarterly over a monthly program. From a maximum incentive amount of R1920 (~US$115), youth were willing to forgo up to R126 per year (~US$9) if the incentive was given in cash (versus fashion vouchers); R274 (~US$19.6) if it was open to both previously adherent and non-adherent youth (instead of non-adherent only); and up to R91 (~US$6.5) to receive incentives at a clinic setting (instead of electronically). The use of incentives over the short term during the critical age- and developmental-transition, when adolescents begin to take sole responsibility for their medication-taking behaviors, holds great promise for habituating adherence into adulthood.

Dataset Information

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.

Publications

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.

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