The lived experiences and treatment needs of women with opioid use disorder and posttraumatic stress symptoms: A mixed methods study.

INTRODUCTION: Women show a gender-specific risk for co-occurring opioid use disorder (OUD) and posttraumatic stress disorder (PTSD). Expert groups have called for the development of integrated treatments for women with OUD/PTSD, but there remains limited information on such interventions. METHODS: This mixed-methods study interviewed and surveyed 10 women with current or past OUD and co-occurring posttraumatic stress symptoms (PTSS) and 16 providers who work with these women. Interviews and surveys queried patient participants' and providers' experiences of OUD/PTSS and how to best design an integrated, trauma-focused treatment for OUD/PTSD. RESULTS: Patient participants (90 % white, 90 % mothers, Mage = 45.70) met criteria for severe, lifetime OUD and 40 % met a provisional diagnosis for PTSD. Four themes emerged for participants' experiences of OUD/PTSS: 1) numerous stressors; 2) shame; 3) multiple motivations to use opioids; and 4) a cycle of trauma and opioid use. Four themes emerged regarding patient participants' perceptions on the development of an OUD/PTSD treatment: 1) mixed attitudes towards medications for OUD; 2) barriers to treatment (e.g., insufficient treatments and contextual factors); 3) treatment facilitators (e.g., social support); and 4) preferences in treatment (e.g., trauma-focused, gender-focused, family content, ambivalence around group therapy). Providers (Mage = 38.94) were primarily white women (76.5 %). Two themes emerged from their experiences working with women with OUD/PTSS: 1) perceiving women to use opioids to regulate emotions and 2) gender differences in trauma types. Three themes emerged for providers' perceptions on the development of an OUD/PTSD treatment: 1) barriers to treatment (e.g., chaotic lives, contextual factors, family); 2) treatment facilitators (e.g., trust and external motivations); and 3) desired treatment modifications (e.g., stabilization, early skills in therapy, flexibility in therapy, social supports, safety guidelines, and assistance in identifying an index trauma). Most participants (90.0 %) and providers (93.5 %) preferred working on OUD/PTSD symptoms simultaneously rather than separately. CONCLUSIONS: Findings demonstrate the need to modify integrated treatments to meet the preferences of providers and women with OUD/PTSS and OUD/PTSD. Treatments should consider therapeutic content, structure, contextual factors, social support, and PTSD severity to enhance uptake and reach.

Understanding and maximising the community impact of seasonal malaria chemoprevention in Burkina Faso (INDIE-SMC): study protocol for a cluster randomised evaluation trial.

INTRODUCTION: Seasonal malaria chemoprevention (SMC) involves repeated administrations of sulfadoxine-pyrimethamine plus amodiaquine to children below the age of 5 years during the peak transmission season in areas of seasonal malaria transmission. While highly impactful in reducing Plasmodium falciparum malaria burden in controlled research settings, the impact of SMC on infection prevalence is moderate in real-life settings. It remains unclear what drives this efficacy decay. Recently, the WHO widened the scope for SMC to target all vulnerable populations. The Ministry of Health (MoH) in Burkina Faso is considering extending SMC to children below 10 years old. We aim to assess the impact of SMC on clinical incidence and parasite prevalence and quantify the human infectious reservoir for malaria in this population. METHODS AND ANALYSIS: We will perform a cluster randomised trial in Saponé Health District, Burkina Faso, with three study arms comprising 62 clusters of three compounds: arm 1 (control): SMC in under 5-year-old children, implemented by the MoH without directly observed treatment (DOT) for the full course of SMC; arm 2 (intervention): SMC in under 5-year-old children, with DOT for the full course of SMC; arm 3 (intervention): SMC in under 10-year-old children, with DOT for the full course of SMC. The primary endpoint is parasite prevalence at the end of the malaria transmission season. Secondary endpoints include the impact of SMC on clinical incidence. Factors affecting SMC uptake, treatment adherence, drug concentrations, parasite resistance markers and transmission of parasites will be determined. ETHICS AND DISSEMINATION: The London School of Hygiene & Tropical Medicine's Ethics Committee (29193) and the Burkina Faso National Medical Ethics Committee (Deliberation No 2023-05-104) approved this study. The findings will be presented to the community; disease occurrence data and study outcomes will also be shared with the Burkina Faso MoH. Findings will be published irrespective of their results. TRIAL REGISTRATION NUMBER: NCT05878366.

Historical trauma and polysubstance use in Black young adults: The role of contemporary racism.

OBJECTIVES: The legacy of slavery renders Black individuals vulnerable to the harmful effects of historical trauma which may interact with contemporary racism-related experiences to increase substance use. We examined the associations between historical and contemporary racism-related experiences (i.e., historical loss thinking, major racial discrimination events, racial microaggressions, and internalized racism) and polysubstance use in a group of Black young adults. METHOD: Black young adults (N = 163; 60% female) aged 18-35 years (M = 25.7, SD = 3.27) completed surveys online. RESULTS: Historical loss thinking (b = 0.03, 95% CI [0.01, 0.05], p = .003), racial microaggressions (b = 0.03, 95% CI [0.02, 0.04], p < .001), major racial discrimination events (b = 0.42, 95% CI [0.30, 0.53], p < .001), and internalized racism (b = 0.49, 95% CI [0.33, 0.65], p < .001) were independently associated with past 12-month polysubstance use. Major racial discrimination events showed the largest association with polysubstance use (ß = 0.26, 95% CI [0.08, 0.45], p = .006). No significant interactions between historical loss thinking and contemporary racism-related experiences were observed. CONCLUSIONS: Findings suggest an association between substance use and historical and contemporary-related experiences among Black young adults. This may suggest that experiences with racism contextualized within historical and contemporary manifestations may impact risk for polysubstance use among Black young adults. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Cannabis use and trauma-focused treatment for co-occurring posttraumatic stress disorder and substance use disorders: A meta-analysis of individual patient data.

High rates of cannabis use among people with posttraumatic stress disorder (PTSD) have raised questions about the efficacy of evidence-based PTSD treatments for individuals reporting cannabis use, particularly those with co-occurring alcohol or other substance use disorders (SUDs). Using a subset of four randomized clinical trials (RCTs) included in Project Harmony, an individual patient meta-analysis of 36 RCTs (total N = 4046) of treatments for co-occurring PTSD+SUD, we examined differences in trauma-focused (TF) and non-trauma-focused (non-TF) treatment outcomes for individuals who did and did not endorse baseline cannabis use (N = 410; 70% male; 33.2% endorsed cannabis use). Propensity score-weighted mixed effects modeling evaluated main and interactive effects of treatment assignment (TF versus non-TF) and baseline cannabis use (yes/no) on attendance rates and within-treatment changes in PTSD, alcohol, and non-cannabis drug use severity. Results revealed significant improvements across outcomes among participants in all conditions, with larger PTSD symptom reductions but lower attendance among individuals receiving TF versus non-TF treatment in both cannabis groups. Participants achieved similar reductions in alcohol and drug use across all conditions. TF outperformed non-TF treatments regardless of recent cannabis use, underscoring the importance of reducing barriers to accessing TF treatments for individuals reporting cannabis use.

Safety and immunogenicity of BK-SE36/CpG malaria vaccine in healthy Burkinabe adults and children: a phase 1b randomised, controlled, double-blinded, age de-escalation trial.

Background: BK-SE36/CpG is a recombinant blood-stage malaria vaccine candidate based on the N-terminal Plasmodium falciparum serine repeat antigen5 (SE36), adsorbed to aluminium hydroxide gel and reconstituted, prior to administration, with synthetic oligodeoxynucleotides bearing CpG motifs. In healthy Japanese adult males, BK-SE36/CpG was well tolerated. This study assessed its safety and immunogenicity in healthy malaria-exposed African adults and children. Methods: A double-blind, randomised, controlled, age de-escalating clinical trial was conducted in an urban area of Ouagadougou, Burkina Faso. Healthy participants (n=135) aged 21-45 years (Cohort 1), 5-10 years (Cohort 2) and 12-24 months (Cohort 3) were randomised to receive three vaccine doses (Day 0, 28 and 112) of BK-SE36/CpG or rabies vaccine by intramuscular injection. Results: One hundred thirty-four of 135 (99.2%) subjects received all three scheduled vaccine doses. Vaccinations were well tolerated with no related Grade 3 (severe) adverse events (AEs). Pain/limitation of limb movement, headache in adults and fever in younger children (all mild to moderate in intensity) were the most frequently observed local and systemic AEs. Eighty-three of BK-SE36/CpG (91%) recipients and 37 of control subjects (84%) had Grade 1/2 events within 28 days post vaccination. Events considered by the investigator to be vaccine related were experienced by 38% and 14% of subjects in BK-SE36/CpG and control arms, respectively. Throughout the trial, six Grade 3 events (in 4 subjects), not related to vaccination, were recorded in the BK-SE36/CpG arm: 5 events (in 3 subjects) within 28 days of vaccination. All serious adverse events (SAEs) (n=5) were due to severe malaria (52-226 days post vaccination) and not related to vaccination. In all cohorts, BK-SE36/CpG arm had higher antibody titres after Dose 3 than after Dose 2. Younger cohorts had stronger immune responses (12-24-month-old > 5-10 years-old > 21-45 years-old). Sera predominantly reacted to peptides that lie in intrinsically unstructured regions of SE36. In the control arm, there were no marked fold changes in antibody titres and participants' sera reacted poorly to all peptides spanning SE36. Conclusion: BK-SE36/CpG was well-tolerated and immunogenic. These results pave the way for further proof-of-concept studies to demonstrate vaccine efficacy. Clinical trial registration: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1921, PACTR201701001921166.

Project harmony: A systematic review and network meta-analysis of psychotherapy and pharmacologic trials for comorbid posttraumatic stress, alcohol, and other drug use disorders.

We conducted a systematic review and network meta-analyses (NMA) of psychotherapy and pharmacologic treatments for individuals with co-occurring posttraumatic stress disorder (PTSD) and alcohol or other drug use disorder (AOD). A comprehensive search spanning 1995-2019 yielded a pool of 39 studies for systematic review, including 24 randomized controlled trials for the NMA. Study interventions were grouped by target of treatment (PTSD + AOD, PTSD-only, and AOD-only) and approach (psychotherapy or medication). Standardized mean differences (SMD) from the NMA yielded evidence that at the end of treatment, integrated, trauma-focused therapy for PTSD + AOD was more effective at reducing PTSD symptoms than integrated, non-trauma-focused therapy (SMD = -0.30), AOD-focused psychotherapy (SMD = -0.29), and other control psychotherapies (SMD = -0.43). End-of-treatment alcohol use severity was less for AOD medication compared to placebo medication (SMD = -0.36) and trauma-focused therapy for PTSD + placebo medication (SMD = -0.67), and less for trauma-focused psychotherapy + AOD medication compared to PTSD medication (SMD = -0.53), placebo medication (SMD = -0.50), and trauma-focused psychotherapy + placebo medication (SMD = -0.81). Key limitations include the small number of studies in the NMA for pharmacologic treatments and the lack of demographic diversity apparent in the existing literature. Findings suggest room for new studies that can address limitations in study sample composition, sample sizes, retention, and apply new techniques for conducting comparative effectiveness in PTSD + AOD treatment. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Malariometric Indices in the Context of Seasonal Malaria Chemoprevention in Children Aged 1.5 to 12 Years during the Period of High Malaria Transmission in the Suburban Area of Banfora, Burkina Faso.

Continuous monitoring of malaria epidemiology is needed in malaria-endemic settings to inform malaria control and elimination strategies. This study aimed to compare the malariometric indices between the under-fives and school-age children. We surveyed children aged 1.5 to 12 years for plasmodia carriage with the aim of including them in a longitudinal follow-up cohort. The survey took place from 7-11 September 2020 in a southwest area of Burkina Faso. Clinical and demographic data including malaria control measures were collected. A finger prick blood sample was taken for haemoglobin testing, and blood smears and dried blood spot preparation. The malariometric indices were calculated and compared between school-age children and those under the age of five. Multiple logistic regression was fitted to assess the association between malaria parasite carriage and age categories. Based on the PCR results, the parasite prevalence was 21.4% in the under-fives versus 44.2% in school-age children (p-value < 0.0001), with a pooled prevalence of 32.7% (CI = [28.8, 36.8]). The gametocyte prevalence was also significantly higher in school-age children (11.9%) compared to the under-fives (3.7%). Adjusted for covariates, school-age children were 2.9 times (IC = [2.0, 4.2]) more likely to carry the asexual parasite, compared to the under-fives. Malaria was moderate and stable endemic in this area and school-age children play a key role in the spread of the disease. The WHO conditional recommendation for intermittent preventive treatment of malaria in school-aged children living in malaria-endemic settings with moderate to high perennial or seasonal transmission should be implemented.

Alcohol, cannabis, and nicotine use have distinct associations with COVID-19 pandemic-related experiences: An exploratory Bayesian network analysis across two timepoints.

BACKGROUND: Substance use trends during the COVID-19 pandemic have been extensively documented. However, relatively less is known about the associations between pandemic-related experiences and substance use. METHOD: In July 2020 and January 2021, a broad U.S. community sample (N = 1123) completed online assessments of past month alcohol, cannabis, and nicotine use and the 92-item Epidemic-Pandemic Impacts Inventory, a multidimensional measure of pandemic-related experiences. We examined links between substance use frequency, and pandemic impact on emotional, physical, economic, and other key domains, using Bayesian Gaussian graphical networks in which edges represent significant associations between variables (referred to as nodes). Bayesian network comparison approaches were used to assess the evidence of stability (or change) in associations between the two timepoints. RESULTS: After controlling for all other nodes in the network, multiple significant edges connecting substance use nodes and pandemic-experience nodes were observed across both time points, including positive- (r range 0.07-0.23) and negative-associations (r range -0.25 to -0.11). Alcohol was positively associated with social and emotional pandemic impacts and negatively associated with economic impacts. Nicotine was positively associated with economic impact and negatively associated with social impact. Cannabis was positively associated with emotional impact. Network comparison suggested these associations were stable across the two timepoints. CONCLUSION: Alcohol, nicotine, and cannabis use had unique associations to a few specific domains among a broad range of pandemic-related experiences. Given the cross-sectional nature of these analyses with observational data, further investigation is needed to identify potential causal links.

Feasibility and Acceptability of a Strategy Deploying Multiple First-Line Artemisinin-Based Combination Therapies for Uncomplicated Malaria in the Health District of Kaya, Burkina Faso.

(1) Background: Effective malaria case management relies on World Health Organization (WHO) recommended artemisinin-based combination therapies (ACTs), but partial resistance to artemisinin has emerged and is spreading, threatening malaria control and elimination efforts. The strategy of deploying multiple first-line therapies (MFT) may help mitigate this threat and extend the therapeutic life of current ACTs. (2) Methods: A district-wide pilot quasi-experimental study was conducted, deploying three different ACTs at the public health facility (PHF) level for uncomplicated malaria treatment from December 2019 to December 2020 in the health district (HD) of Kaya, Burkina Faso. Mixed methods, including household and health facility-based quantitative and qualitative surveys, were used to evaluate the pilot programme. (3) Results: A total of 2008 suspected malaria patients were surveyed at PHFs, of which 79.1% were tested by rapid diagnostic test (RDT) with 65.5% positivity rate. In total, 86.1% of the confirmed cases received the appropriate ACT according to the MFT strategy. The adherence level did not differ by study segment (p = 0.19). Overall, the compliance level of health workers (HWs) with MFT strategy was 72.7% (95% CI: 69.7-75.5). The odds of using PHF as the first source of care increased after the intervention (aOR = 1.6; 95% CI, 1.3-1.9), and the reported adherence to the 3-day treatment regimen was 82.1%; (95% CI: 79.6-84.3). Qualitative results showed a high acceptance of the MFT strategy with positive opinions from all stakeholders. (4) Conclusions: Implementing an MFT strategy is operationally feasible and acceptable by stakeholders in the health systems in Burkina Faso. This study provides evidence to support the simultaneous use of multiple first-line artemisinin combination therapies in malaria-endemic countries such as Burkina Faso.

Differential symptom weighting in estimating empirical thresholds for underlying PTSD severity: Toward a "platinum" standard for diagnosis?

OBJECTIVE: Symptom counts as the basis for Post-Traumatic Stress Disorder (PTSD) diagnoses in the DSM presume each symptom is equally reflective of underlying disorder severity. However, the "equal weight" assumption fails to fit PTSD symptom data when tested. The present study developed an enhanced PTSD diagnosis based on (a) a conventional PTSD diagnosis from a clinical interview and (b) an empirical classification of full PTSD that reflected the relative clinical weights of each symptom. METHOD: Baseline structured interview data from Project Harmony (N = 2658) was used. An enhanced diagnosis for full PTSD was estimated using an empirical threshold from moderated nonlinear factor analysis (MNLFA) latent PTSD scale scores, in combination with a full conventional PTSD diagnosis based on interview data. RESULTS: One in 4 patients in the sample had a PTSD diagnosis that was inconsistent with their empirical PTSD grouping, such that the enhanced diagnostic standard reduced the diagnostic discrepancy rate by 20%. Veterans, and in particular female Veterans, were at greatest odds for discrepancy between their underlying PTSD severity and DSM diagnosis. CONCLUSION: Psychometric methodologies that differentially weight symptoms can complement DSM criteria and may serve as a platform for symptom prioritization for diagnoses in future editions of DSM.

Posttraumatic stress disorder symptom trajectories in a 16-month COVID-19 pandemic period.

COVID-19 pandemic presents an unheralded opportunity to better understand trajectories of posttraumatic stress disorder (PTSD) symptoms across a prolonged period of social disruption and stress. We tracked PTSD symptoms among trauma-exposed individuals in the United States and sought to identify population-based variability in PTSD symptom trajectories and understand what, if any, early pandemic experiences predicted membership in one trajectory versus others. As part of a longitudinal study of U.S. residents during the pandemic, participants who reported at least one potentially traumatic experience in their lifetime (N = 1,206) at Wave 1 (April 2020) were included in the current study. PTSD symptoms were assessed using the PCL-5 at four time points extending to July 2021. Latent growth mixture modeling was used to identify heterogeneous symptom trajectories. Trajectory membership was regressed on experiences from the early stage of the pandemic as measured using the Epidemic-Pandemic Impacts Inventory in a model that controlled for variables with documented associations to PTSD trajectories, including age, sex, income, and trauma history. Four trajectories were identified, categorized as resilient (73.0%), recurring (13.3%), recovering (8.3%), and chronic (5.5%). Emotional and physical health problems and positive changes associated with the early phase of the pandemic were each significant predictors of trajectory membership over and above all other variables in the model. Predictors primarily differentiated the resilient trajectory from each of the other three trajectories. Distinct PTSD symptom trajectories during the COVID-19 pandemic suggest a need for targeted efforts to help individuals at most risk for ongoing distress.

Project Harmony: A Meta-Analysis With Individual Patient Data on Behavioral and Pharmacologic Trials for Comorbid Posttraumatic Stress and Alcohol or Other Drug Use Disorders.

OBJECTIVE: Treatment efficacy for co-occurring posttraumatic stress disorder (PTSD) and substance use disorders is well established, yet direct evidence for comparative effectiveness across treatments is lacking. The present study compared the effectiveness of several behavioral and pharmacological therapies for adults with co-occurring PTSD and alcohol or other drug use disorders. METHODS: A systematic search of PsycINFO, MEDLINE, and ClinicalTrials.gov was conducted through December 2020 for trials targeting PTSD, alcohol or other drug use disorders, or both disorders (36 studies, N=4,046). Primary outcomes were severity scores for PTSD, alcohol use, and drug use, estimated via moderated nonlinear factor analysis. Propensity score weight-adjusted multilevel models were used. Model-predicted effect sizes were estimated for each treatment, and comparative effect sizes for each active arm against treatment as usual, at end of treatment and at 12-month follow-up. RESULTS: Compared with treatment as usual, combining trauma-focused therapy and pharmacotherapy for substance use disorders showed the largest comparative effect sizes for PTSD severity (d=-0.92, 95% CI=-1.57, -0.30) and alcohol use severity (d=-1.10, 95% CI=-1.54, -0.68) at end of treatment. Other treatments with large comparative effect sizes included pharmacotherapies for alcohol or other drug use disorders, trauma-focused integrated therapies, and trauma-focused nonintegrated therapies. Reductions in outcomes for PTSD symptoms and alcohol use were observed for nearly all treatments. CONCLUSIONS: The findings provide support for treating comorbid PTSD and substance use disorders using a variety of approaches, with alcohol-targeted pharmacotherapies and trauma-focused behavioral therapies as a combination of treatments that lead to early and sustained improvements in PTSD and alcohol use severity. Further treatment development is indicated for combining behavioral and pharmacological treatments for synergized impact and understanding the mechanisms of action and conditions under which each treatment type is optimized.

Cognitive Processing Therapy or Relapse Prevention for comorbid Posttraumatic Stress Disorder and Alcohol Use Disorder: A randomized clinical trial.

OBJECTIVE: To compare a Posttraumatic Stress Disorder (PTSD) treatment (Cognitive Processing Therapy; CPT), an Alcohol Use Disorder (AUD) treatment (Relapse Prevention; RP), and assessment-only (AO) for those meeting diagnostic criteria for both PTSD and AUD. METHOD: Participants with current PTSD/AUD (N = 101; mean age = 42.10; 56% female) were initially randomized to CPT, RP, or AO and assessed post-treatment or 6-weeks post-randomization (AO). AO participants were then re-randomized to CPT or RP. Follow-ups were at immediate post-treatment, 3-, and 12-months. Mixed effects intent-to-treat models compared conditions on changes in PTSD symptom severity, drinking days, and heavy drinking days. RESULTS: At post-treatment, participants assigned to CPT showed significantly greater improvement than those in AO on PTSD symptom severity (b = -9.72, 95% CI [-16.20, -3.23], d = 1.22); the RP and AO groups did not differ significantly on PTSD. Both active treatment conditions significantly decreased heavy drinking days relative to AO (CPT vs. AO: Count Ratio [CR] = 0.51, 95% CI [0.30, 0.88]; RP vs. AO: CR = 0.34, 95% CI [0.19, 0.59]). After re-randomization both treatment conditions showed substantial improvements in PTSD symptoms and drinking between pre-treatment and post-treatment over the 12-month follow-up period, with RP showing an advantage on heavy drinking days. CONCLUSION: Treatments targeting one or the other aspects of the PTSD/AUD comorbidity may have salutary effects on both PTSD and drinking outcomes. These preliminary results suggest that people with this comorbidity may have viable treatment options whether they present for mental health or addiction care. TRIAL REGISTRATION: The trial is registered at clinicaltrials.gov (NCT01663337).

Measurement Error-Corrected Estimation of Clinically Significant Change Trajectories for Interventions Targeting Comorbid PTSD and Substance Use Disorders in OEF/OIF Veterans.

In randomized control trials (RCTs), a focus on average differences between treatment arms often limits our understanding of whether individuals show clinically significant improvement or deterioration. The present study examined differences in individual-level clinical significance trajectories between Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE) and Relapse Prevention (RP). Eighty-one treatment-seeking veterans with a comorbid PTSD/SUD diagnosis were randomized to COPE or RP; data from an additional n = 48 patients who did not meet criteria for both disorders was used to establish a normative threshold. A newly developed, modernized approach to the Jacobson and Truax (1991) clinically significant change framework, using (a) moderated nonlinear factor analysis (MNLFA) scale scoring and (b) measurement error-corrected multilevel modeling (MEC-MLM) was used; this approach was compared to other approaches using conventional total scores and/or assuming no measurement error. Using a conventional approach to estimating the Reliable Change Index (RCI) yielded no differences between COPE and RP in the percentage of patients achieving statistically significant improvement (SSI; 88.9% for both groups). However, under MNLFA/MEC-MLM, higher percentages of patients receiving COPE (75.0%) achieved SSI compared to RP (40.7%). Findings suggest that, even though COPE and RP appear to reduce the same number of PTSD symptoms, MNLFA scoring of outcome measures gives greater weight to interventions that target and reduce "hallmark" PTSD symptoms.

Stakeholder perceptions on the deployment of multiple first-line therapies for uncomplicated malaria: a qualitative study in the health district of Kaya, Burkina Faso.

BACKGROUND: In Burkina Faso, malaria remains the first cause of medical consultation and hospitalization in health centres. First-line case management of malaria in the country's health facilities is based on the use of artemisinin-based combination therapy (ACT). To optimize the use of these anti-malarial drugs in the perspective of mitigating the emergence of artemisinin resistance, which is a serious threat to malaria control and elimination, a pilot programme using multiple first-line therapies (MFTs) [three artemisinin-based combinations-pyronaridine-artesunate, dihydroartemisinin-piperaquine and artemether-lumefantrine] has been designed for implementation. As the success of this MFT pilot programme depends on the perceptions of key stakeholders in the health system and community members, the study aimed to assess their perceptions on the implementation of this strategy. METHODS: Semi-structured interviews, including 27 individual in-depth interviews and 41 focus groups discussions, were conducted with key stakeholders including malaria control policymakers and implementers, health system managers, health workers and community members. Volunteers from targets stakeholder groups were randomly selected. All interviews were recorded, transcribed and translated. Content analysis was performed using the qualitative software programme QDA Miner. RESULTS: The interviews revealed a positive perception of stakeholders on the implementation of the planned MFT programme. They saw the strategy as an opportunity to strengthen the supply of anti-malarial drugs and improve the management of fever and malaria. However, due to lack of experience with the products, health workers and care givers expressed some reservations about the effectiveness and side-effect profiles of the two anti-malarial drugs included as first-line therapy in the MFT programme (pyronaridine-artesunate, dihydroartemisinin-piperaquine). Questions were raised about the appropriateness of segmenting the population into three groups and assigning a specific drug to each group. CONCLUSION: The adherence of both populations and key stakeholders to the MFT implementation strategy will likely depend on the efficacy of the proposed drugs, the absence of, or low frequency of, side-effects, the cost of drugs and availability of the different combinations.

Attitudes, practices, and determinants of community care-seeking behaviours for fever/malaria episodes in the context of the implementation of multiple first-line therapies for uncomplicated malaria in the health district of Kaya, Burkina Faso.

BACKGROUND: Malaria case management relies on World Health Organization (WHO)-recommended artemisinin-based combination therapy (ACT), and a continuous understanding of local community knowledge, attitudes, and practices may be a great support for the success of malaria disease control efforts. In this context, this study aimed to identify potential facilitators or barriers at the community level to inform a health district-wide implementation of multiple first-line therapies (MFT) as a new strategy for uncomplicated malaria case management. METHODS: A community-based cross-sectional study using a mixed-method design was carried out from November 2018 to February 2019, in the health district (HD) of Kaya in Burkina Faso. Quantitative data were collected using a standardized questionnaire from 1394 individuals who had fever/malaria episodes four weeks prior to the survey. In addition, 23 focus group discussions (FGDs) were conducted targeting various segments of the community. Logistic regression models were used to assess the predictors of community care-seeking behaviours. RESULTS: Overall, 98% (1366/1394) of study participants sought advice or treatment, and 66.5% did so within 24 h of fever onset. 76.4% of participants preferred to seek treatment from health centres as the first recourse to care, 5.8% were treated at home with remaining drug stock, and 2.3% preferred traditional healers. Artemether-lumefantrine (AL) was by far the most used anti-malarial drug (98.2%); reported adherence to the 3-day treatment regimen was 84.3%. Multivariate analysis identified less than 5 km distance travelled for care (AOR = 2.7; 95% CI 2.1-3.7) and education/schooling (AOR = 1.8; 95% CI 1.3-2.5) as determinants of prompt care-seeking for fever. Geographical proximity (AOR = 1.5, 95% CI 1.2-2.1), having a child under five (AOR = 4.6, 95% CI 3.2-6.7), being pregnant (AOR = 6.5, 95% CI 1.9-22.5), and living in an urban area (AOR = 2.8, 95% CI 1.8-4.2) were significant predictors for visiting health centres. The FGDs showed that participants had good knowledge about malaria symptoms, prevention tools, and effective treatment. Behaviour change regarding malaria treatment and free medication for children under five were the main reasons for participants to seek care at health centres. CONCLUSIONS: The study showed appropriate knowledge about malaria and positive community care-seeking behaviour at health centres for fever/malaria episodes. This could potentially facilitate the implementation of a MFT pilot programme in the district. CLINICALTRIALS: gov Identifier: NCT04265573.

Predictors of therapeutic alliance, treatment feedback, and clinical outcomes among African American women in treatment for co-occurring PTSD and SUD.

INTRODUCTION: Black women are at heightened risk for trauma exposure, post-traumatic stress disorder (PTSD), and substance use disorders (SUDs), compared to White women and the general population. However, disparities in treatment engagement and retention persist, particularly for Black women with co-occurring PTSD+SUD. Although therapeutic alliance is an important predictor and mediator of treatment retention and outcomes, we know little about predictors of alliance and the mediating role of alliance for PTSD+SUD outcomes among Black women. METHODS: This study utilized data previously collected for the National Drug Abuse Treatment Clinical Trials Network (CTN) Women and Trauma Study. Participants were 88 Black/African American women (Mage = 41.90, SD = 7.72) participating in a clinical trial comparing Seeking Safety (a cognitive-behavioral intervention for PTSD+SUD) to Women's Health Education (control). This study includes participants from both arms. Measures included the Helping Alliance Questionnaire, Addiction Severity Index-Lite, and Clinician Administered PTSD Scale. Women in the intervention arm also completed the Seeking Safety Feedback Questionnaire. RESULTS: Stepwise, hierarchical linear regressions indicated that years of education and previous alcohol/drug treatment attempts significantly predicted early alliance in the second week of therapy (ß = 0.411, p = .021 and ß = 0.383, p = .011, respectively), but not late alliance in the last week of therapy (ps > .794). Greater education and more treatment attempts were associated with higher early alliance. Alliance did not mediate relationships between these significant predictors and treatment outcomes (e.g., attendance, post-treatment PTSD and SUD symptoms) or treatment feedback in the Seeking Safety group. CONCLUSIONS: Education and prior treatment attempts predicted early alliance among Black/African American women in PTSD+SUD group treatment, and higher education level was associated with poorer Seeking Safety feedback topic ratings. Educational level and treatment history should be considered during alliance building in therapeutic interventions with Black women. Clinicians may consider the integration of pre-treatment alliance-building strategies with Black female patients who have lower levels of education. This study provides insight into the relative impact of several important factors that influence early alliance among Black women with co-occurring PTSD+SUD.

Estimating posttraumatic stress disorder severity in the presence of differential item functioning across populations, comorbidities, and interview measures: Introduction to Project Harmony.

Multiple factor analytic and item response theory studies have shown that items/symptoms vary in their relative clinical weights in structured interview measures for posttraumatic stress disorder (PTSD). Despite these findings, the use of total scores, which treat symptoms as though they are equally weighted, predominates in practice, with the consequence of undermining the precision of clinical decision-making. We conducted an integrative data analysis (IDA) study to harmonize PTSD structured interview data (i.e., recoding of items to a common symptom metric) from 25 studies (total N = 2,568). We aimed to identify (a) measurement noninvariance/differential item functioning (MNI/DIF) across multiple populations, psychiatric comorbidities, and interview measures simultaneously and (b) differences in inferences regarding underlying PTSD severity between scale scores estimated using moderated nonlinear factor analysis (MNLFA) and a total score analog model (TSA). Several predictors of MNI/DIF impacted effect size differences in underlying severity across scale scoring methods. Notably, we observed MNI/DIF substantial enough to bias inferences on underlying PTSD severity for two groups: African Americans and incarcerated women. The findings highlight two issues raised elsewhere in the PTSD psychometrics literature: (a) bias in characterizing underlying PTSD severity and individual-level treatment outcomes when the psychometric model underlying total scores fails to fit the data and (b) higher latent severity scores, on average, when using DSM-5 (net of MNI/DIF) criteria, by which multiple factors (e.g., Criterion A discordance across DSM editions, changes to the number/type of symptom clusters, changes to the symptoms themselves) may have impacted severity scoring for some patients.

Frontal Alpha Asymmetry in Children with Trauma Exposure.

The purpose of the current study was to investigate differences in frontal alpha asymmetry (FAA) between children (5-17 years) with or without histories of trauma exposure. EEG data were obtained from 165 children who participated in the Healthy Brain Network Initiative during rest with eyes open and closed. FAA during resting-state electroencephalography was significantly more negative in the trauma-exposed group, suggesting greater left lateralized FAA and avoidance-oriented motivation. Moreover, alpha suppression (difference in alpha amplitude between eyes open and eyes closed conditions) was marginally greater in the trauma-exposed group. The results suggest that early exposure to trauma may be associated with trait-level avoidance of environmental stimuli, which ultimately may be predictive of psychopathology, including posttraumatic stress disorder (PTSD). Study findings thus provide preliminary evidence of brain-based mechanisms that may confer risk for PTSD in the wake of early trauma exposure.

What's in a name? A data-driven method to identify optimal psychotherapy classifications to advance treatment research on co-occurring PTSD and substance use disorders.

Background/Objective: The present study leveraged the expertise of an international group of posttraumatic stress and substance use disorder (PTSD+SUD) intervention researchers to identify which methods of categorizing interventions which target SUD, PTSD, or PTSD+SUD for populations with both PTSD+SUD may be optimal for advancing future systematic reviews, meta-analyses, and comparative effectiveness studies which strive to compare effects across a broad variety of psychotherapy types. Method: A two-step process was used to evaluate the categorization terminology. First, we searched the literature for pre-existing categories of PTSD+SUD interventions from PTSD+SUD clinical trials, systematic and literature reviews. Then, we surveyed international trauma and substance use subject matter experts about their opinions on pre-existing intervention categorization and ideal categorization nomenclature. Results: Mixed method analyses revealed that a proliferation of PTSD+SUD treatment research over the last twenty years brought with it an abundance of ways to characterize the treatments that have been evaluated. Results from our survey of experts (N = 27) revealed that interventions for PTSD+SUD can be classified in many ways that appear to overlap highly with one another. Many experts (11/27; 41%) selected the categories of 'trauma-focused and non-trauma focused' as an optimal way to distinguish treatment types. Although several experts reinforced this point during the subsequent meeting, it became clear that no method of categorizing treatments is without flaws. Conclusion: One possible categorization (trauma-focused/non-trauma focused) was identified. Revised language and nomenclature for classification of PTSD+SUD treatments are needed in order to accommodate the needs of this advancing field.

Antecedentes/Objetivo: El presente estudio aprovechó la experticia de un grupo internacional de investigadores de intervención en trastorno de estrés postraumático y trastorno por uso de sustancias (TEPT+TUS) para identificar qué métodos de categorización de las intervenciones con foco en TUS, TEPT y TEPT+TUS para poblaciones con ambos TEPT+TUS serían óptimos para avanzar en futuras revisiones sistemáticas, meta-análisis y estudios comparativos de efectividad que busquen comparar efectos en una amplia variedad de tipos de psicoterapia.Método: Se utilizó un proceso de dos etapas para evaluar la terminología de categorización. Primero, buscamos en la literatura categorías pre-existentes de intervenciones para TEPT+TUS en ensayos clínicos de TEPT+TUS, revisiones sistemáticas y de la literatura. Después, entrevistamos a expertos internacionales en la materia de trauma y uso de sustancias sobre su opinión de la categorización pre-existente de las intervenciones y la nomenclatura ideal de categorización.Resultados: Métodos de análisis mixtos revelaron que una proliferación de investigación de tratamientos para TEPT+TUS en los últimos veinte años trajo consigo una abundancia de formas de categorizar los tratamientos que han sido evaluados. Los resultados de nuestra encuesta de expertos (N = 27) revelaron que las intervenciones para TEPT+TUS pueden ser clasificadas en muchas formas que parecen sobreponerse altamente entre sí. Muchos expertos (11/27; 41%) seleccionaron las categorías de 'centrados en el trauma y no centrados en el trauma' como una forma óptima de distinguir los tipos de tratamiento. Aunque varios expertos reforzaron este punto en la reunión subsecuente, quedó claro que ningún método de categorización de los tratamientos está libre de defectos.Conclusión: Se identificó una posible categorización (centrado en el trauma/No centrado en el trauma). Se necesita lenguaje y nomenclatura revisada para la clasificación de tratamientos de TEPT+TUS a fin de acomodar las necesidades de este campo en desarrollo.