Dataset Information

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

ABSTRACT: 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

SUBMITTER: Dow DE

PROVIDER: S-EPMC7487650 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Dow Dorothy E DE Mmbaga Blandina T BT Gallis John A JA Turner Elizabeth L EL Gandhi Monica M Cunningham Coleen K CK O'Donnell Karen E KE

BMC public health 20200904 1

<h4>Background</h4>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.<h4>Methods</h4>This pilot group treatment trial individually randomized YPLWH from two clinical sites in Tanzania, evaluated acceptability, feasibility, and preliminary effectiveness of a m ...[more]

PMID: 32887558

Similar Datasets

Project description:ObjectivesPilot feasibility randomised controlled trial (RCT) for the singing groups for people with aphasia (SPA) intervention to assess: (1) the acceptability and feasibility of participant recruitment, randomisation and allocation concealment; (2) retention rates; (3) variance of continuous outcome measures; (4) outcome measure completion and participant burden; (5) fidelity of intervention delivery; (6) SPA intervention costs; (7) acceptability and feasibility of trial and intervention to participants and others involved.DesignA two-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed methods process evaluation and economic evaluation.SettingThree community-based cohorts in the South-West of England.ParticipantsEligible participants with post-stroke aphasia were randomised 1:1 to SPA or control.InterventionThe manualised SPA intervention was delivered over 10 weekly singing group sessions, led by a music facilitator and assisted by an individual with post-stroke aphasia. The intervention was developed using the Information-Motivation-Behavioural skills model of behaviour change and targeted psychosocial outcomes. Control and intervention participants all received an aphasia information resource pack.Outcome measuresCollected at baseline, 3 and 6 months post-randomisation, candidate primary outcomes were measured (well-being, quality of life and social participation) as well as additional clinical outcomes. Feasibility, acceptability and process outcomes included recruitment and retention rates, and measurement burden; and trial experiences were explored in qualitative interviews.ResultsOf 87 individuals screened, 42 participants were recruited and 41 randomised (SPA=20, control=21); 36 participants (SPA=17, control=19) completed 3-month follow-up, 34 (SPA=18, control=16) completed 6-month follow-up. Recruitment and retention (83%) were acceptable for a definitive RCT, and participants did not find the study requirements burdensome. High fidelity of the intervention delivery was shown by high attendance rates and facilitator adherence to the manual, and participants found SPA acceptable. Sample size estimates for a definitive RCT and primary/secondary outcomes were identified.ConclusionsThe SPA pilot RCT fulfilled its objectives, and demonstrated that a definitive RCT of the intervention would be both feasible and acceptable.Trial registration numberNCT03076736.

Project description:BackgroundYouth homelessness is a substantial issue, and many youths experiencing homelessness have mental health issues as both a cause and consequence of homelessness. These youths face many barriers to receiving traditional mental health services, and as a result, only a few youths experiencing homelessness receive any form of mental health care.ObjectiveThis project aimed to develop and determine the feasibility and acceptability of engaging young adults (ie, individuals aged 18-24 years) experiencing homelessness in a remotely delivered mental health intervention. This intervention provided brief emotional support and coping skills, drawing from cognitive behavioral principles as an introduction into psychosocial support. The intervention was piloted in a homeless shelter network.MethodsA total of 35 young adults experiencing homelessness participated in a single-arm feasibility pilot trial. Participants received a mobile phone, a service and data plan, and 1 month of support from a coach consisting of up to 3 brief phone sessions, text messaging, and mobile mental health apps. We evaluated feasibility by looking at completion of sessions as well as the overall program and acceptability with satisfaction ratings. We also collected clinical symptoms at baseline and the end of the 1-month support period. We used validity items to identify participants who might be responding inappropriately and thus only report satisfaction ratings and clinical outcomes from valid responses.ResultsMost participants (20/35, 57%) completed all 3 of their phone sessions, with an average of 2.09 sessions (SD 1.22) completed by each participant. Participants sent an average of 15.06 text messages (SD 12.62) and received an average of 19.34 messages (SD 12.70). We found higher rates of satisfaction among the participants with valid responses, with 100% (23/23) of such participants indicating that they would recommend participation to someone else and 52% (12/23) reporting that they were very or extremely satisfied with their participation. We found very little change from pre- to posttreatment on measures of depression (d=0.27), post-traumatic stress disorder (d=0.17), and emotion regulation (d=0.10).ConclusionsThis study demonstrated that it was feasible to engage homeless young adults in mental health services in this technology-based intervention with high rates of satisfaction. We did not find changes in clinical outcomes; however, we had a small sample size and a brief intervention. Technology might be an important avenue to reach young adults experiencing homelessness, but additional work could explore proper interventions to deliver with such a platform.Trial registrationClinicalTrials.gov NCT03620682; https://clinicaltrials.gov/ct2/show/NCT03620682.

Project description:BackgroundLongitudinal studies examining the life trajectories of young people after they have exited homelessness have identified concerns with persistent social and economic exclusion, struggles to shake off identities of homelessness, and housing instability. This pilot study sought to explore the feasibility of improving socioeconomic inclusion outcomes by bolstering identity capital (sense of purpose and control, self-efficacy and self-esteem) among young people who had experienced homelessness.MethodsNineteen individuals (aged 18-26) who had transitioned out of homelessness within the past three years participated in a six-week, six-session program focused on building identity capital. The study employed a mixed method prospective cohort hybrid design with an intervention group (Group One) and a delayed intervention comparison group (Group Two). Participants were interviewed every three months until nine months post-intervention.ResultsNone of the youth who began the intervention dropped out of the program, with the exception of one participant who moved across the country and was unable to continue. Immediately after participating in the intervention, Group One had statistically significant improvements (p < .05) and large to very large effect sizes in self-esteem (d = 1.16) and physical community integration (d = 1.79) compared to changes in Group Two over the same period, which had not yet begun the intervention. In the pooled analysis, small to moderate effect sizes in hopelessness, physical community integration, and self-esteem were observed at all post-intervention time points. Notably, at six- and nine-months post-intervention, statistically significant improvements (p < .05) and moderate effect sizes in hopelessness (d = -0.73 and d = -0.60 respectively) and self-esteem (d = 0.71 and d = 0.53 respectively) were observed. Youth shared they appreciated the normalizing (vs. pathologizing) of strategies they needed to learn and spoke of the importance of framing new skills as something one needs "to have a better life" vs. "to get better."ConclusionsThese early findings signal that targeting identity capital is feasible and may be a promising approach to incorporate into a more complex intervention that includes housing, education, and employment supports to help youth transition out of homelessness. Future research could build on these findings through a sufficiently powered randomized controlled trial.

Project description:Background: Substance use and mental health are two barriers to engagement in care and antiretroviral therapy (ART) adherence among youth and young adults living with HIV (YLWH). The consequences of suboptimal adherence in YLWH are increased risk of HIV transmission and a future generation of immunodeficient adults with drug-resistant virus. Methods: The Youth to Telehealth and Texting for Engagement in Care (Y2TEC) study was a pilot randomized crossover trial that examined the feasibility and acceptability of a novel video-counseling series and accompanying text messages aimed at mental health, substance use, and HIV care engagement for YLWH. The intervention consisted of twelve 20-30-min weekly video-counseling sessions focused on identifying and addressing barriers to HIV care, mental health, and substance use challenges. Participants completed quantitative surveys at baseline, 4 months, and 8 months. Feasibility and acceptability were evaluated using prespecified benchmarks. Results: Fifty YLWH aged 18-29 years living in the San Francisco Bay Area were enrolled. Eighty-six percent and 75% of participants were retained at 4 and 8 months, respectively. A total of 455 (76%) video-counseling sessions were completed. In 82% of sessions, participants responded that they strongly agreed/agreed with this statement: "I felt heard, understood, and respected by the counselor." In 81% of sessions, participants responded that they strongly agreed/agreed with this statement: "Overall, today's session was right for me." At baseline, among participants reporting mental health challenges, only 10% noted having ever received mental health services, and among those who reported substance use challenges, ?19% reported ever receiving substance use services. After 4 months of the Y2TEC intervention, participants reported slightly higher ART adherence and HIV knowledge, decreased depression and anxiety, and reduced stigma related to mental health and substance use. Conclusions: The Y2TEC intervention using video-counseling and text messaging was feasible and acceptable for YLWH. ClinicalTrials.gov ID: NCT03681145.

Project description:BACKGROUND:Cash and in-kind incentives can improve health outcomes in various settings; however, there is concern that incentives may 'crowd out' intrinsic motivation to engage in beneficial behaviors. We examined this hypothesis in a randomized trial of food and cash incentives for people living with HIV infection in Tanzania. METHODS:We analyzed data from 469 individuals randomized to one of three study arms: standard of care, short-term cash transfers, or short-term food assistance. Eligible participants were: 1) ?18 years old; 2) HIV-infected; 3) food insecure; and 4) initiated antiretroviral therapy (ART) ?90 days before the study. Food or cash transfers, valued at ~$11 per month and conditional on attending clinic visits, were provided for ?6 months. Intrinsic motivation was measured at baseline, 6, and 12 months using the autonomous motivation section of the Treatment Self-Regulation Questionnaire (TSRQ). We compared the change in TSRQ score from baseline to 6 and 12 months and the change within study arms. RESULTS:The mean intrinsic motivation score was 2.79 at baseline (range: 1-3), 2.91 at 6 months (range: 1-3), and 2.95 at 12 months (range: 2-3), which was 6 months after the incentives had ended. Among all patients, the intrinsic motivation score increased by 0.13 points at 6 months (95% CI (0.09, 0.17), Cohen's d = 0.29) and 0.19 points at 12 months (95% CI (0.14, 0.24), Cohen's d = 0.49). Intrinsic motivation also increased within each study group at 6 months: 0.15 points in the food arm (95% CI (0.09, 0.21), Cohen's d = 0.37), 0.11 points in the cash arm (95% CI (0.05, 0.18), Cohen's d = 0.25), and 0.08 points in the comparison arm (95% CI (-0.03, 0.19), Cohen's d = 0.21); findings were similar at 12 months. Increases in motivation were statistically similar between arms at 6 and 12 months. CONCLUSION:Intrinsic motivation for ART adherence increased significantly both overall and within the food and cash incentive arms, even after the incentive period was over. Increases in motivation did not differ by study group. These results suggest that incentive interventions for treatment adherence should not be withheld due to concerns of crowding out intrinsic motivation.

Project description:Background:Young adults have elevated rates of mental health disorders, yet they often do not receive consistent care. The challenge of continuing to engage young adults has been pervasive worldwide. Few engagement interventions have been designed for young adults with serious mental illness. Just Do You is a theoretically guided engagement intervention. It uses innovative modalities (i.e., technology, expressive arts activities, narrative expression, mentoring) to engage participants in conversations about services and how they work, while simultaneously orienting them to treatment. Methods/design:This pilot and feasibility study utilizes a hybrid research design, examining feasibility, acceptability, and preliminary impact, alongside implementation. The study combines qualitative methods, a small pilot randomized trial, and a small cost-benefit analysis. Respondents are clinic staff and young adults who have made initial contact with the Personalized Recovery Oriented Services (PROS) program. Quantitative survey data are collected at baseline, 2?weeks (post-intervention), 1?month, and 3?months. The assessments focus on measuring feasibility, acceptability, engagement, and mental health outcomes. Medical record extraction will be used to triangulate self-report data. We will conduct single degree of freedom contrasts to examine whether Just Do You leads to improved outcomes relative to Treatment-As-Usual using robust regression for each outcome measure. We will examine whether changes in the proposed mediating variables occur across groups using a similar contrast strategy. In addition, we will use structural equation modeling to examine the contribution of mediators to ultimate outcomes. Finally, we will use constant comparison coding techniques for qualitative analyses. Discussion:The aim of this study is to examine the feasibility of a young adult engagement meta-intervention through an intensive preliminary pilot trial, learning through collaboration with stakeholders. Just Do You has the potential to fill a gap in the service system for young adults with serious mental illnesses, improving the seemingly intractable problem of disengagement. The program uses culturally responsive strategies, is recovery-oriented, and builds upon the best evidence to date. Our efforts align with local and national health care reform efforts embedding people with lived experience. Trial registration:This trial was registered with ClinicalTrials.gov (Identifier: NCT03423212) on April 18, 2018, as Protocol Record R34 MH111861-01, New York University, as the Just Do You Program for Young Adults with Serious Mental Illness.

Dataset Information

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

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure