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Abstract Background Despite the significant burden of alcohol use disorders (AUD), there is a large treatment gap, especially in settings and populations affected by armed conflict. A key barrier to care is the lack of contextually relevant interventions and adequately skilled human resources to deliver them. This paper describes the systematic development of the CHANGE intervention, a potentially scalable psychological intervention for people with co-existing AUD and psychological distress in conflict-affected populations, delivered by non-specialist workers (NSWs). Methods CHANGE was developed in sequential steps: (1) identifying potential treatment strategies through a meta-review and Delphi survey with international experts; (2) in-depth interviews (IDIs) with key stakeholders from the study settings in Uganda and Ukraine; and (3) three consultative workshops with international experts and experts from Uganda and Ukraine to develop a theoretical framework for the intervention informed by outputs of the Delphi and IDIs. Results In the Delphi survey, experts reached agreement on the acceptability, feasibility and potential effectiveness of the following components: identify high-risk situations, problem solving skills, assessment, handling drinking urges, communication skills, pros and cons of drinking, and identifying high-risk situations. From the IDIs we identified (a) causal attributions for using alcohol e.g., psychosocial stressors; (b) cultural norms related to alcohol consumption such as patriarchal stereotypes; and (c) coping strategies to deal with drinking problems such as distraction. The CHANGE intervention developed through the consultative workshops can be delivered in three sequential phases focussed on assessment, feedback, and information (Phase 1); providing the client with need-based skills for dealing with high-risk situations related to alcohol use (Phase 2), and relapse prevention and management (Phase 3). Conclusions CHANGE is a contextually relevant and potentially scalable treatment for co-existing AUD and psychological distress to be delivered by NSWs to conflict-affected populations. Effectiveness and cost-effectiveness of CHANGE will be tested in Uganda and Ukraine.

Background: Alcohol misuse is a significant health problem among forcibly displaced populations including male South Sudanese refugees in northern Uganda, yet interventions are sorely lacking. Developing an explanatory model of alcohol misuse in this population is the first step to designing appropriate and effective interventions. The aim of the current study was to examine alcohol misuse in this setting and to conceptualize an explanatory model of alcohol misuse. Method: A total of 57 interviews were conducted with male refugees (18+ years) with alcohol misuse (n = 17), their family members (n = 15), community and religious leaders (n = 15), and mental health and psychosocial support providers (n = 10) in Rhino Camp settlement in northern Uganda. A thematic analysis approach was used to inductively analyze the data. Results: Alcohol misuse was identified as a significant psychosocial problem among men in this setting. The adversity (e.g. trauma, loss, poverty), psychological distress (e.g. demoralization), perpetuators (e.g. ease of availability of alcohol, family conflict), and consequences of alcohol use (e.g. interpartner violence, exacerbated poverty) were identified. An explanatory model emerged from the data showing a reinforcing relationship in which adversity causes psychological distress, which leads to increased alcohol use via a number of personal, interpersonal, community and societal perpetuators, and over time increased alcohol use amplifies psychological distress which further increases alcohol misuse. Conclusions: Given the need to address alcohol misuse in this population, this explanatory model of alcohol misuse can be used to inform prevention and treatment interventions for alcohol misuse. These interventions should endeavor to address the identified determinants of alcohol misuse while being cognizant of the social and cultural considerations specific to males in this population.

In conflict-affected settings, prevalence of alcohol use disorders (AUDs) can be high. However, limited practical information exists on AUD management in low-income settings. Using a theory of change (ToC) approach, we aimed to identify pathways influencing the implementation and maintenance of a new transdiagnostic psychological intervention (“CHANGE”), targeting both psychological distress and AUDs in humanitarian settings. Three half-day workshops in Uganda engaged 41 stakeholders to develop a ToC map. ToC is a participatory program theory approach aiming to create a visual representation of how and why an intervention leads to specific outcomes. Additionally, five semi-structured interviews were conducted to explore experiences of stakeholders that participated in the ToC workshops. Two necessary pathways influencing the implementation and maintenance of CHANGE were identified: policy impact, and mental health service delivery. Barriers identified included policy gaps, limited recognition of social determinants and the need for integrated follow-up care. Interviewed participants valued ToC’s participatory approach and expressed concerns about its adaptability in continuously changing contexts (e.g., humanitarian settings). Our study underscores ToC’s value in delineating context-specific outcomes and identifies areas requiring further attention. It emphasizes the importance of early planning and stakeholder engagement for sustainable implementation of psychological interventions in humanitarian settings.

As evidence supporting the effectiveness of mental health and psychosocial interventions grows, more research is needed to understand optimal strategies for improving their implementation in diverse contexts. We conducted a qualitative process evaluation of a multicomponent psychosocial intervention intended to promote well-being among refugee, migrant and host community women in three diverse contexts in Ecuador and Panamá. The objective of this study is to describe the relationships among implementation determinants, strategies and outcomes of this community-based psychosocial intervention. The five implementation strategies used in this study included stakeholder engagement, promoting intervention adaptability, group and community-based delivery format, task sharing and providing incentives. We identified 10 adaptations to the intervention and its implementation, most of which were made during pre-implementation. Participants (n = 77) and facilitators (n = 30) who completed qualitative interviews reported that these strategies largely improved the implementation of the intervention across key outcomes and aligned with the study’s intervention and implementation theory of change models. Participants and facilitators also proposed additional strategies for improving reach, implementation and maintenance of this community-based psychosocial intervention.

Women with HIV (WWH) may be more vulnerable to cognitive impairment than men with HIV (MWH), which may be explained by the direct effects of HIV or by sociodemographic and psychiatric characteristics. We recruited 105 people with HIV (PWH; 76 women) with incomplete antiretroviral therapy adherence, comorbid major depressive disorder, and socioeconomically disadvantaged backgrounds. Participants completed neuropsychological testing and measures gathering sociodemographic, medical, and psychiatric information. We compared WWH and MWH cognitive performance using unadjusted and adjusted regressions, and within each respective group, we explored predictors of cognitive performance. Results showed no significant between-sex differences in cognitive performance, both globally and within domains. Fewer years of education ( β = 0.94), illiteracy ( β = 4.55), and greater food insecurity ( β = −0.28) predicted lower cognitive performance in WWH but not MWH. We conclude that sex differences in PWH are likely due to sample characteristics representing broader inequalities, rather than true biological differences.

Abstract Background Community- and strengths-based psychosocial interventions are central to mental health and psychosocial support guidelines, but rigorous evidence regarding the effectiveness of these interventions is limited. The complexity and variability that is inherent to many community-based psychosocial interventions requires innovative strategies in order to facilitate the comparability and synthesis across research studies without compromising the fit and appropriateness of interventions to specific study populations and context. Entre Nosotras is a community-based psychosocial intervention developed for migrant and host community women that is designed to be flexible enough to enable integration of external intervention components and adaptable to diverse study contexts and populations. This protocol describes a study that aims to evaluate the appropriateness, acceptability, and feasibility of integrating a standardized stress management intervention into Entre Nosotras. Methods This study will evaluate the appropriateness, acceptability, feasibility, and safety of intervention and research procedures for a cluster randomized comparative effectiveness trial conducted in Ecuador and Panamá with migrant and host community women. In this feasibility trial, we will allocate communities nested within the three study sites to the integrated Entre Nosotras + stress management intervention versus Entre Nosotras alone through stratified randomization. Migrant and host community women residing in these study communities who report low to moderate levels of distress will be allocated to the intervention condition that their community is assigned (n = 220 total). We will collect quantitative measures of psychosocial wellbeing, psychological distress, coping, social support, and functioning from study participants. We will collect quantitative measures of fidelity and facilitator competencies through observation and facilitator self-assessment. Data on appropriateness, acceptability, feasibility, and safety will be gathered from participants and facilitators through quantitative assessments at 0, 5, and 10 weeks post-enrollment and qualitative interviews conducted with all facilitators and a subset of 70 study participants during the post-intervention follow-up period. Discussion Results from this feasibility trial will determine whether a multi-site cluster randomized comparative effectiveness trial of an adaptable community-based psychosocial intervention for migrant and host community women is relevant, acceptable, and feasible. Trial registration ClinicalTrials.gov identifier: NCT05130944 . Registered November 23, 2021—retrospectively registered.

Abstract Background Despite a high prevalence of problematic substance use among people living with HIV in South Africa, there remains limited access to substance use services within the HIV care system. To address this gap, our team previously developed and adapted a six-session, peer-delivered problem-solving and behavioral activation-based intervention (Khanya) to improve HIV medication adherence and reduce substance use in Cape Town. This study evaluated patient and provider perspectives on the intervention to inform implementation and future adaptation. Methods Following intervention completion, we conducted semi-structured individual interviews with patients (n = 23) and providers (n = 9) to understand perspectives on the feasibility, acceptability, and appropriateness of Khanya and its implementation by a peer. Patients also quantitatively ranked the usefulness of individual intervention components (problem solving for medication adherence ‘Life-Steps’, behavioral activation, mindfulness training, and relapse prevention) at post-treatment and six months follow-up, which we triangulated with qualitative feedback to examine convergence and divergence across methods. Results Patients and providers reported high overall acceptability, feasibility, and appropriateness of Khanya, although there were several feasibility challenges. Mindfulness and Life-Steps were identified as particularly acceptable, feasible, and appropriate components by patients across methods, whereas relapse prevention strategies were less salient. Behavioral activation results were less consistent across methods. Conclusions Findings underscore the importance of examining patients’ perspectives on specific intervention components within intervention packages. While mindfulness training and peer delivery models were positively perceived by consumers, they are rarely used within task-shared behavioral interventions in low- and middle-income countries.

Community-based psychosocial interventions are key elements of mental health and psychosocial support; yet evidence regarding their effectiveness and implementation in humanitarian settings is limited. This study aimed to assess the appropriateness, acceptability, feasibility and safety of conducting a cluster randomized trial evaluating two versions of a group psychosocial intervention. Nine community clusters in Ecuador and Panamá were randomized to receive the standard version of the Entre Nosotras intervention, a community-based group psychosocial intervention co-designed with community members, or an enhanced version of Entre Nosotras that integrated a stress management component. In a sample of 225 refugees, migrants and host community women, we found that both versions were safe, acceptable and appropriate. Training lay facilitators to deliver the intervention was feasible. Challenges included slow recruitment related to delays caused by the COVID-19 pandemic, high attrition due to population mobility and other competing priorities, and mixed psychometric performance of psychosocial outcome measures. Although the intervention appeared promising, a definitive cluster randomized comparative effectiveness trial requires further adaptations to the research protocol. Within this pilot study we identified strategies to overcome these challenges that may inform adaptations. This comparative effectiveness design may be a model for identifying effective components of psychosocial interventions.

There is increasing evidence supporting the effectiveness of scalable mental health and psychosocial support (MHPSS) interventions delivered by non-specialists for improving wellbeing among migrant populations in humanitarian settings. Balancing fidelity in the implementation of evidence-based MHPSS interventions with their fit to the needs and preferences of new populations and contexts remains a challenge when introducing MHPSS interventions in new settings. This paper describes a community-based participatory approach to MHPSS intervention design incorporating processes to promote local adaptability and fit while maintaining standardized elements of existing MHPSS interventions. We conducted a mixed-methods study to design a community-based MHPSS intervention that fit the mental health and psychosocial needs of migrant women in three sites in Ecuador and Panama. Drawing from a set of community-based participatory research methods, we identified the priority mental health and psychosocial needs among migrant women, co-developed intervention mechanisms that aligned with those needs, matched mechanisms to existing psychosocial intervention components, and iteratively piloted and refined the intervention with community stakeholders. The resulting intervention was a five-session, lay facilitator-delivered group intervention titled, Entre Nosotras (‘among/between us’). The intervention combined elements of individual and community problem solving, psychoeducation, stress management, and social support mobilization to address prioritized problems including psychological distress, safety, community connectedness, xenophobia and discrimination, and social support. This research outlines an emphasis on the social dimension of psychosocial support, as well as a process for balancing fit and fidelity in intervention design and implementation.

Abstract Background Substance use is prevalent in South Africa and associated with poor HIV treatment outcomes, yet, it is largely unaddressed in HIV care. Implementing an evidence-based, task-shared intervention for antiretroviral therapy (ART) adherence and substance use integrated into HIV care may be a feasible and effective way to improve HIV treatment outcomes and reduce substance use in this population. Methods Guided by the RE-AIM framework, a randomized, hybrid type 1 effectiveness-implementation trial (n = 60) is being used to evaluate a peer-delivered intervention that integrates evidence-based intervention components, including Life-Steps (problem solving and motivational skills for HIV medication adherence), behavioral activation to increase alternative, substance-free rewarding activities in one’s environment, and relapse prevention skills, including mindfulness. The comparison condition is enhanced standard of care, which includes facilitating a referral to a local substance use treatment clinic (Matrix). Participants are followed for a period of 6 months. Implementation outcomes are defined by Proctor’s model for implementation and include mixed methods evaluations of feasibility, acceptability, and fidelity, and barriers and facilitators to implementation. Primary patient-level effectiveness outcomes are ART adherence (Wisepill) and substance use (WHO-ASSIST and urinalysis); viral load is an exploratory outcome. Discussion Results of this trial will provide important evidence as to whether peer delivery of an integrated intervention for ART adherence and substance use is feasible, acceptable, and effective. Implementation outcomes will provide important insight into using peers as an implementation strategy to extend task sharing models for behavioral health in resource-limited settings globally. Trial registration ClinicalTrials.gov identifier: NCT03529409 . Trial registered on May 18, 2018.

Introduction: Despite efforts to detect and treat problematic substance use (SU) among people living with HIV (PLWH) in South Africa, integration of HIV and SU services is limited. We sought to understand whether PLWH and problematic SU were: (a) routinely referred to SU treatment, a co-located Matrix clinic, (b) used SU treatment services when referred, and (c) the individual amount spent on SU. Methods: Guided by the RE-AIM implementation science framework, we examined patient-level quantitative screening and baseline data from a pilot clinical trial for medication adherence and problematic SU. Qualitative data came from semi-structured interviews with HIV care providers (N = 8), supplemented by patient interviews (N = 15). Results: None of the screened patient participants (N = 121) who were seeking HIV care and had problematic SU were engaged in SU treatment, despite the freely available co-located SU treatment program. Only 1.5% of the enrolled patient study sample (N = 66) reported lifetime referral to SU treatment. On average, patients with untreated SU spent 33.3% (SD=34.5%) of their monthly household income on substances. HIV care providers reported a lack of clarity about the SU referral process and a lack of direct communication with patients about patients’ needs or interest in receiving an SU referral. Discussion: SU treatment referrals and uptake were rare among PLWH reporting problematic SU, despite the high proportion of individual resources allocated to substances and the co-located Matrix site. A standardized referral policy between the HIV and Matrix sites may improve communication and uptake of SU referrals.