The effect of group support psychotherapy on adherence to anti-retroviral therapy and viral suppression among HIV positive young people: Study protocol for a pilot randomized controlled trial.

Background: Several studies have demonstrated an association between psychological risk factors and HIV disease progression. However, there is limited information on the use of psychological interventions to improve HIV treatment outcomes in young people living with HIV. Objective: This pilot trial aims to evaluate the feasibility, acceptability and preliminary effectiveness of group support psychotherapy in improving adherence to anti-retroviral therapy and viral suppression in young people living with HIV in Uganda. Methods: We recruited 120 young people with HIV, aged 10-18 years, who had non-viral suppression 6 months after initiating first-line anti-retroviral therapy (ART) from community based HIV clinics in Kitgum district, northern Uganda. Participants were randomly assigned to receive GSP plus IAC (N = 60) or IAC alone (N = 60). Primary outcomes will be indicators of feasibility and acceptability as well as preliminary effectiveness of GSP in improving ART adherence and viral suppression analysed by intention to treat using cluster-adjusted t tests and permutation tests. Secondary outcomes will be measures of depression, anxiety and cost-effectiveness. Results: The trial has been approved by the Makerere College of Health Sciences School of Health Sciences Research Ethics Committee, and the Uganda National Council of Science and Technology. Recruitment began in June 2021 and 120 young people living with HIV with their adult caregivers have been recruited to the trial. An analysis of baseline and 6-month data is in progress. The results of this trial will not only be presented at national and international conferences but also submitted for publication in peer-reviewed journals and as a report to the funding agencies. Conclusions: This pilot trial will provide critical evidence to support the ongoing mental health integration into routine HIV care in Uganda. Trial Registration: Pan African Clinical Trials Registry (PACTR): 202006601935462.

Long-Term Effect of Group Support Psychotherapy on Depression and HIV Treatment Outcomes: Secondary Analysis of a Cluster Randomized Trial in Uganda.

OBJECTIVE: We aimed to determine the effect of group support psychotherapy (GSP) compared with group HIV education (GHE) on depression and HIV treatment outcomes 24 months after treatment. We further aimed to investigate the mediating role of depression and antiretroviral therapy (ART) adherence in the relationship between GSP and viral load suppression. METHODS: Thirty HIV clinics across three districts were randomly assigned to deliver either GSP or GHE for depression. Depression and optimal (≥95%) ART adherence was assessed at baseline and 6, 12, 18, and 24 months after treatment. Viral load was drawn from the medical charts at baseline and 12 and 24 months after treatment. Multilevel mixed-effects regression models and generalized structural equation modeling were used to estimate 24-month outcomes and mediation effects. RESULTS: Participants ( N = 1140) were enrolled from HIV clinics offering either GSP ( n = 578 [51%]) or GHE ( n = 562 [49%]). Fewer GSP than GHE participants met the criteria for depression at 24 months after treatment (1% versus 25%; adjusted odds ratio [aOR] = 0.002, 95% confidence interval [CI] = 0.0002-0.018). More GSP than GHE participants reported optimal (≥95%) ART adherence (96% versus 88%; aOR = 20.88, 95% CI = 5.78-75.33) and improved viral suppression (96% versus 88%; aOR = 3.38, 95% CI = 1.02-11.02). The indirect effects of GSP through sequential reduction in depression and improvement in ART adherence at 12 months may partially explain the higher viral suppression rates at 24 months in GSP than GHE groups. CONCLUSION: In settings where the HIV epidemic persists, depression treatment with GSP may be critical for optimal HIV treatment outcomes.Trial Registration: The Pan African Clinical Trials Registry, number PACTR201608001738234.

Effectiveness and cost-effectiveness of group support psychotherapy delivered by trained lay health workers for depression treatment among people with HIV in Uganda: a cluster-randomised trial.

BACKGROUND: WHO recommends the use of psychological interventions as first-line treatment for depression in low-income and middle-income countries. However, evaluations of the effectiveness and cost-effectiveness of such interventions among people with HIV are scarce. Our aim was to establish the effectiveness of group support psychotherapy (GSP) delivered by lay health workers for depression treatment among people living with HIV in a rural area of Uganda on a large scale. METHODS: In this cluster-randomised trial, we included 30 health centres offering HIV care. These were randomly assigned to deliver either GSP or group HIV education (GHE). Randomisation, in a ratio of 1:1, was achieved by health centre managers separately picking a paper containing the intervention allocation from a basket. Participants were people living with HIV, aged 19 years and older, with mild to moderate major depression assessed with the Mini International Neuropsychiatric Interview depression module, taking antiretroviral therapy, and antidepressant-naive. Group sessions were led by trained lay health workers once a week for 8 weeks. The primary outcomes were the proportion of participants with major depression and function scores at 6 months post-treatment, analysed by intention to treat by means of multilevel random effect regression analyses adjusting for clustering in health centres. This trial is registered with the Pan African Clinical Trials Registry, PACTR201608001738234. FINDINGS: Between Sept 13 and Dec 15, 2016, we assessed 1473 individuals, of whom 1140 were recruited from health centres offering GSP (n=578 [51%]) or GHE (n=562 [49%]). Two (<1%) participants in the GSP group were diagnosed with major depression 6 months post-treatment compared with 160 (28%) in the GHE group (adjusted odds ratio=0·01, 95% CI 0·003-0·012, p<0·0001). The mean function scores 6 months post-treatment were 9·85 (SD 0·76) in the GSP group and 6·83 (2·85) in the GHE group (ß=4·12; 95% CI 3·75-4·49, p<0·0001). 36 individuals had 63 serious adverse events, which included 25 suicide attempts and 22 hospital admissions for medical complications. The outcomes of these serious adverse events included 16 deaths, 4 of which were completed suicides (GSP=2; GHE=2), and 12 of which were HIV-related medical complications (GSP=8; GHE=4). Cost-effectiveness estimates showed an incremental cost-effectiveness ratio of US$13·0 per disability-adjusted life-year averted, which can be considered very cost-effective in Uganda. INTERPRETATION: Integration of cost-effective psychological treatments such as group support psychotherapy into existing HIV interventions might improve the mental health of people living with HIV. FUNDING: MQ Transforming Mental Health and Grand Challenges Canada.

Recruitment and Baseline Characteristics of Participants in the Social, Emotional, and Economic Empowerment Through Knowledge of Group Support Psychotherapy Study (SEEK-GSP): Cluster Randomized Controlled Trial.

BACKGROUND: Psychosocial characteristics, including self-esteem, perceived social support, coping skills, stigma, discrimination, and poverty, are strongly correlated with depression symptoms. However, data on the extent of these correlations among persons living with HIV and the associations between psychosocial characteristics and HIV treatment outcomes are limited in sub-Saharan Africa. OBJECTIVE: This paper aims to describe the recruitment process and baseline characteristics associated with depression in a sample of HIV-positive people in a cluster randomized trial of group support psychotherapy (GSP) for depression delivered by trained lay health workers (LHWs). METHODS: Thirty eligible primary care health centers across three districts in Uganda were randomly allocated to have their LHWs trained to deliver GSP (intervention arm) or group HIV education and treatment as usual (control arm) to persons living with HIV comorbid with depression. Baseline demographic, socioeconomic, and psychosocial characteristics were collected via interviewer-administered questionnaires. Among eligible participants, differences between those enrolled versus those who refused enrollment were assessed using chi square for categorical variables and t tests for continuous variables. Spearman rank order correlation analyses were conducted to determine associations between baseline depression symptoms and adherence to antiretroviral therapy (ART), viral load suppression, and other psychosocial variables. RESULTS: The study screened 1473 people and 1140 were found to be eligible and enrolled over 14 weeks. Participants recruited comprised 95% of the target sample size of 1200. The sample's mean age was 38.5 (SD 10.9) years and both genders were well represented (males: 46.32%, 528/1140). Most participants met the diagnostic criteria for major depressive disorder (96.92%, 1105/1140), had significant posttraumatic stress symptoms (72.46%, 826/1140), reported moderate suicide risk (52.54%, 599/1140), had primary or no formal education (86.22%, 983/1140), and reported no income-generating activity (72.63%, 828/1140) and no food insecurity (81.67%, 931/1140). Among eligible participants, 48 of 1140 (4.21%) refused to participate in the interventions; these participants were more likely to be males (χ21=4.0, P=.045) and have significantly lower depression symptoms scores (t2=2.36, P=.01) than those who participated in the interventions. There was a significant positive correlation between viral load and number of traumatic experiences (ρ=.12, P=.05). Adherence to ART was positively correlated with perceived social support (ρ=.15, P<.001), but negatively correlated with depression symptoms (ρ=-.11, P=.05) and stigma (ρ=-.14, P<.001). CONCLUSIONS: Men and women with HIV and depression experience multiple social and economic vulnerabilities and disadvantages. Culturally tailored psychological interventions aimed at these individuals should address these socioeconomic disadvantages in addition to addressing their mental health care needs. TRIAL REGISTRATION: Pan African Clinical Trials Registry PACTR201608001738234; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1738 (Archived by WebCite at http://www.webcitation.org/74NtMphom).

The Effect of Group Support Psychotherapy Delivered by Trained Lay Health Workers for Depression Treatment Among People with HIV in Uganda: Protocol of a Pragmatic, Cluster Randomized Trial.

BACKGROUND: There is limited information on the effectiveness of task shifting of mental health services in populations with HIV. OBJECTIVE: This trial aims to evaluate the effectiveness of group support psychotherapy delivered by trained lay health workers to persons living with HIV (PLWH) with depression in primary care. METHODS: Thirty eligible primary care health centers across three districts were randomly allocated to have their lay health workers trained to deliver group support psychotherapy (intervention arm) or group HIV education and treatment as usual (control arm) to PLWH with depression. Treated PLWH will be evaluated at baseline, after the end of treatment, and at 6-month intervals thereafter for 2 years. Primary outcomes will be the difference in follow-up proportions of participants with Mini International Neuropsychiatric Interview criteria for major depression and difference in follow-up function scores of participants in the intervention and control arms 6 months after the end of treatment. Secondary outcomes will include measures of self-esteem, posttraumatic stress symptoms, social support, stigma, adherence to antiretroviral therapy, viral load, and number of disability days, asset possession indices, and cost-effectiveness data. Primary and secondary outcomes as well as subgroup analyses will be conducted at the individual level using multilevel random effects regression analyses adjusting for clustering in health centers. A process evaluation using mixed methods to assess acceptability, feasibility, fidelity, causal mediating processes, and contextual influences in the trial will be conducted. RESULTS: The trial has been approved by the Makerere College of Health Sciences School of Health Sciences Research Ethics Committee, the AIDS Support Organization, and the Uganda National Council of Science and Technology. A data and safety monitoring board has been put in place to monitor trial progress. A total of 1140 persons living with HIV have been recruited to the trial. An analysis of baseline and 6-month data is in progress. The results of this trial will not only be presented at national and international conferences but also submitted for publication in peer-reviewed journals and as a report to the funding agencies. CONCLUSIONS: This cluster randomized trial will provide critical evidence to support culturally sensitive group-based psychotherapy for depression treatment in sub-Saharan Africa. Process evaluation outcomes will provide contextual information that health care and public health stakeholders can use to guide implementation decisions for their particular setting. TRIAL REGISTRATION: Pan African Clinical Trials Registry (PACTR): 201608001738234; http://www.pactr.org/ATMWeb/ appmanager/atm/atmregistry?dar=true&tNo=PACTR201608001738234 (Archived by WebCite at http://www.webcitation.org/ 6vUAgAQlj).

Process Evaluation of a Randomized Controlled Trial of Group Support Psychotherapy for Depression Treatment Among People with HIV/AIDS in Northern Uganda.

We describe the process evaluation for a randomized controlled trial that compared group support psychotherapy (GSP) with group HIV education for treatment of depression among people with HIV. Process data were obtained using mixed methods. Variables evaluated were indicators of feasibility and acceptability; causal mediating processes and contextual influences. GSP was feasible and acceptable. Potential mediating variables between GSP and reduction of depression were improved emotional and social support, better coping strategies, and pursuit of livelihoods. Culturally sensitive intervention content facilitated intervention delivery. These data complement the trial outcomes, and may provide a contextualized description of how GSP treats depression.

Group support psychotherapy for depression treatment in people with HIV/AIDS in northern Uganda: a single-centre randomised controlled trial.

BACKGROUND: Group support psychotherapy (GSP) is a culturally sensitive intervention that aims to treat depression by enhancing social support, teaching coping skills, and income-generating skills. We compared GSP with group HIV education (GHE) for treatment of depression in people with HIV in Uganda. METHODS: In this open-label randomised controlled trial, we included men and women with HIV, aged 19 years or older, who met the Mini International Neuropsychiatric Interview criteria for major depression from an urban HIV care centre in Kitgum district, northern Uganda. Participants were randomly assigned to receive eight weekly sessions of either GSP or GHE. Randomisation was achieved by urn (men and women separately picked a paper containing the intervention allocation from a basket; ratio 1:1), and the intervention sessions were given to gender-specific groups. Participants were followed up immediately after the intervention and 6 months after the end of treatment. The primary outcomes were change in depressive symptom scores (measured with the Self-Reporting Questionnaire) and in function scores (measured with a locally developed method), analysed by intention to treat using cluster-adjusted t tests and permutation tests. This trial is registered with The Pan African Clinical Trials Registry, number PACTR201402000742370. FINDINGS: Between Jan 6, and Jan 20, 2014, we assessed 150 individuals, of whom 109 were randomly assigned to receive eight weekly sessions of either GSP (n=57) or GHE (n=52). Change in mean depression scores immediately after intervention did not differ between groups (mean difference -0·19, 95% CI -1·77 to 1·39, p=0·78). Mean function scores did not differ between groups either (0·24, -0·41 to 0·88; p=0·41). At 6 months after end of treatment, participants in the GSP group had lower mean depression scores than did those in the GHE group (-2·50, -3·98 to 1·02, p value=0·005), and higher function scores (0·74, -0·17 to 1·65, p=0·09) than did participants in the GHE group. No adverse events were reported. INTERPRETATION: The benefits of existing HIV educational interventions in HIV care services could be improved by the addition of GSP content. Potential benefits of the integration of GSP into existing HIV interventions, such as adherence counselling or group HIV educational programmes, should be addressed in future studies. FUNDING: Grand Challenges Canada.

Outcomes, feasibility and acceptability of a group support psychotherapeutic intervention for depressed HIV-affected Ugandan adults: a pilot study.

BACKGROUND: Psychotherapy is the recommended first line treatment for mild to moderate depression. However, its availability in low resource settings is limited. We developed a manualized culturally sensitive group support psychotherapeutic intervention for depressed HIV affected Ugandan adults. In this study, we aimed to assess its feasibility, acceptability and impact on depression, functioning, social support and self-esteem. METHODS: A total of 77 depressed individuals were assigned to the group intervention (n=48) and a wait-list control group (n=29), and assessed before, during and at the end of the intervention. The self-reporting questionnaire, a locally relevant function assessment instrument, the Rosenberg self-esteem scale, and the multiple dimensions perceived social support scale were administered to assess depression symptoms, functioning, self-esteem and social support at three assessment periods. Multivariate longitudinal regression models were used to determine change in outcomes over time between the two groups. Participants were asked to evaluate the intervention. RESULTS: Post -intervention assessments indicate that, in comparison to the wait-list control group, the intervention group had a faster reduction in depression symptom scores [OR=0.00,95% CI, 0.00-0.003] and faster increase in functioning scores [OR=4.82, 95% CI, 2.39 to 9.75], social support scores [OR=2.68, 95% CI, 1.50-4.78] and self-esteem [OR=1.90, 95% CI 1.48-2.44]. Sixty-three percent of participants strongly agreed that the intervention had reduced their depression and would recommend it to other depressed individuals. LIMITATIONS: Inadequate study power due to small sample sizes may result in imprecise confidence intervals even when there are significant differences. The use of non-random samples could have resulted in selection bias. CONCLUSIONS: This intervention appears feasible, acceptable and promising in treating depression and restoring function, enhancing social support and self-esteem. Larger and randomized evaluations are warranted.

Developing a culturally sensitive group support intervention for depression among HIV infected and non-infected Ugandan adults: a qualitative study.

BACKGROUND: Depression is ranked first among neuropsychiatric diseases that contribute to the burden of disease in low- and middle-income countries. However, access to antidepressants is limited and there is a dearth of locally developed psychotherapeutic interventions targeted to treat depression. AIM: We aimed to obtain information on the cultural understanding of depression symptoms, complications and treatment methods used in post-conflict communities in northern Uganda in order to inform the development of an indigenous group support intervention to treat depression. METHODS: Focus group discussions (FGDs) were conducted with a total of 110 men and women aged 19-68 years. FDGs took place in a private space, lasted about 2-3h and were conducted in the local language for patients and their caregivers and in English for health workers. Interview transcripts from the FGDs were reviewed for accuracy, translated into English and transcribed. QRS Nvivo 10 qualitative data analysis software was used for coding and thematic analysis. RESULTS: Our study revealed community misperceptions about etiology, presentation and treatment of depression. Regardless of HIV status, most FGD participants who were not health workers linked depression symptoms to HIV infection. Although there were concerns about confidentiality of issues disclosed, many FGD participants were supportive of a group support intervention, tailored to their gender and age, that would not only focus on treating depression but also provided them with skills to improve their livelihoods. Simple CBT techniques were deemed culturally appropriate and acceptable. LIMITATION: Generalizability of study findings may be limited given that the sample was primarily of Luo ethnicity yet there are different ethnic populations in the region. CONCLUSION: Local communities can directly inform intervention content. The participants׳ preferences confirmed the need for a gender-specific intervention for depression that extends beyond medications and empowers them emotionally, socially and economically.