Trauma-informed Collaborative Care for African American Primary Care Patients in Federally Qualified Health Centers: A Pilot Randomized Trial.

BACKGROUND: African Americans have nearly double the rate of posttraumatic stress disorder (PTSD) compared with other racial/ethnic groups. OBJECTIVE: To understand whether trauma-informed collaborative care (TICC) is effective for improving PTSD among African Americans in New Orleans who receive their care in Federally Qualified Health Centers (FQHCs). DESIGN AND METHOD: In this pilot randomized controlled trial, we assigned patients within a single site to either TICC or to enhanced usual care (EUC). We performed intent to treat analysis by nonparametric exact tests for small sample sizes. PARTICIPANTS: We enrolled 42 patients from October 12, 2018, through July 2, 2019. Patients were eligible if they considered the clinic their usual source of care, had no obvious physical or cognitive obstacles that would prevent participation, were age 18 or over, self-identified as African American, and had a provisional diagnosis of PTSD. MEASURES: Our primary outcome measures were PTSD measured as both a symptom score and a provisional diagnosis based on the PTSD Checklist for DSM-5 (PCL-5). KEY RESULTS: Nine months following baseline, both PTSD symptom scores and provisional PTSD diagnosis rates decreased substantially more for patients in TICC than in EUC. The decreases were by 26 points in EUC and 36 points in TICC for symptoms (P=0.08) and 33% in EUC and 57% in TICC for diagnosis rates (P=0.27). We found no effects for mediator variables. CONCLUSIONS: TICC shows promise for addressing PTSD in this population. A larger-scale trial is needed to fully assess the effectiveness of this approach in these settings.

Stepped care for depression at integrated chronic care centers (IC3) in Malawi: study protocol for a stepped-wedge cluster randomized controlled trial.

BACKGROUND: Malawi is a low-income country in sub-Saharan Africa that has limited resources to address a significant burden of disease-including HIV/AIDS. Additionally, depression is a leading cause of disability in the country but largely remains undiagnosed and untreated. The lack of cost-effective, scalable solutions is a fundamental barrier to expanding depression treatment. Against this backdrop, one major success has been the scale-up of a network of more than 700 HIV clinics, with over half a million patients enrolled in antiretroviral therapy (ART). As a chronic care system with dedicated human resources and infrastructure, this presents a strategic platform for integrating depression care and responds to a robust evidence base outlining the bi-directionality of depression and HIV outcomes. METHODS: We will evaluate a stepped model of depression care that combines group-based Problem Management Plus (group PM+) with antidepressant therapy (ADT) for 420 adults with moderate/severe depression in Neno District, Malawi, as measured by the Patient Health Questionnaire-9 (PHQ-9) and Mini-International Neuropsychiatric Interview (MINI). Roll-out will follow a stepped-wedge cluster randomized design in which 14 health facilities are randomized to implement the model in five steps over a 15-month period. Primary outcomes (depression symptoms, functional impairment, and overall health) and secondary outcomes (e.g., HIV: viral load, ART adherence; diabetes: A1C levels, treatment adherence; hypertension: systolic blood pressure, treatment adherence) will be measured every 3 months through 12-month follow-up. We will also evaluate the model's cost-effectiveness, quantified as an incremental cost-effectiveness ratio (ICER) compared to baseline chronic care services in the absence of the intervention model. DISCUSSION: This study will conduct a stepped-wedge cluster randomized trial to compare the effects of an evidence-based depression care model versus usual care on depression symptom remediation as well as physical health outcomes for chronic care conditions. If determined to be cost-effective, this study will provide a model for integrating depression care into HIV clinics in additional districts of Malawi and other low-resource settings with high HIV prevalence. TRIAL REGISTRATION: ClinicalTrials.gov NCT04777006 . Registered on 1 March, 2021.

"Our Choice" improves use of safer conception methods among HIV serodiscordant couples in Uganda: a cluster randomized controlled trial evaluating two implementation approaches.

BACKGROUND: Safer conception counseling (SCC) to promote the use of safer conception methods (SCM) is not yet part of routine family planning or HIV care. Guidelines for the use of SCM have been published, but to date there are no published controlled evaluations of SCC. Furthermore, it is unknown whether standard methods commonly used in resource constrained settings to integrate new services would be sufficient, or if enhanced training and supervision would result in a more efficacious approach to implementing SCC. METHODS: In a hybrid, cluster randomized controlled trial, six HIV clinics were randomly assigned to implement the SCC intervention Our Choice using either a high (SCC1) or low intensity (SCC2) approach (differentiated by amount of training and supervision), or existing family planning services (usual care). Three hundred eighty-nine HIV clients considering childbearing with an HIV-negative partner enrolled. The primary outcome was self-reported use of appropriate reproductive method (SCM if trying to conceive; modern contraceptives if not) over 12 months or until pregnancy. RESULTS: The combined intervention groups used appropriate reproductive methods more than usual care [20.8% vs. 6.9%; adjusted OR (95% CI)=10.63 (2.79, 40.49)], and SCC1 reported a higher rate than SCC2 [27.1% vs. 14.6%; OR (95% CI)=4.50 (1.44, 14.01)]. Among those trying to conceive, the intervention arms reported greater accurate use of SCM compared to usual care [24.1% vs. 0%; OR (95% CI)=91.84 (4.94, 1709.0)], and SCC1 performed better than SCC2 [34.6% vs. 11.5%; OR (95% CI)=6.43 (1.90, 21.73)]. The arms did not vary on modern contraception use among those not trying to conceive. A cost of $631 per person was estimated to obtain accurate use of SCM in SCC1, compared to $1014 in SCC2. CONCLUSIONS: More intensive provider training and more frequent supervision leads to greater adoption of complex SCM behaviors and is more cost-effective than the standard low intensity implementation approach. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03167879 ; date registered May 23, 2017.

Reproductive intentions and corresponding use of safer conception methods and contraception among Ugandan HIV clients in serodiscordant relationships.

CONTEXT: Among people living with HIV in Uganda, desires to have a child and unplanned pregnancies are both common, while utilization of safer conception methods (SCM) and modern contraceptives are low. METHODS: Three hundred eighty-nine HIV clients who reported considering childbearing with their uninfected partner enrolled in a safer conception counseling intervention trial in Uganda. Multiple regression analysis and baseline data were used to examine correlates of reproductive intentions and behaviors, including use of safer conception methods and contraception. RESULTS: Most (n = 313; 80.5%) reported that both they and their partner wanted to have a child now, which was associated with being married, in a longer relationship, not having a child with partner, greater SCM knowledge, lower internalized childbearing stigma, and higher perceived community stigma of childbearing. However, just 117 reported trying to conceive in the prior 6 months, which was associated with being female, not having a child with their partner, less decision-making control within the relationship, and greater perceived cultural acceptability of SCM. Among those who had tried to conceive in the past 6 months, 14 (11.9%) used SCM, which was associated with greater control in decision making. Of the 268 who were not trying to conceive, 69 (25.7%) were using a modern contraceptive, which was associated with being in a shorter relationship, less control over decision-making, more positive attitudes towards contraception and lower depression. CONCLUSION: Methods to promote reproductive goals are underused by HIV serodiscordant couples, and relationships characteristics and childbearing-related stigma appear to be most influential and thus targets for intervention. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03167879 ; date registered May 23, 2017.

Association Between State Medicaid Eligibility Thresholds and Deaths Due to Substance Use Disorders.

Importance: The United States is currently facing an epidemic of deaths related to substance use disorder (SUD), with totals exceeding those due to motor vehicle crashes and gun violence. The epidemic has led to decreased life expectancy in some populations. In recent years, Medicaid eligibility has expanded in some states, and the association of this expansion with SUD-related deaths is yet to be examined. Objective: To examine the association between eligibility thresholds for state Medicaid coverage and SUD-related deaths. Design, Setting, and Participants: Economic evaluation study using a retrospective analysis of state-level data between 2002 and 2015 to determine the association between the Medicaid eligibility threshold and SUD-related deaths, controlling for other relevant policies, state socioeconomic characteristics, fixed effects, and a time trend. Policy variables were lagged by 1 year to allow time for associations to materialize. Data were collected and analyzed from 2016 to 2017. Exposures: The policy of interest was the state Medicaid eligibility threshold, ie, the highest allowed income that qualifies a person for Medicaid, expressed as a percentage of the federal poverty level. State policies related to mental health, overdose treatment, and law enforcement of drug crimes were included as controls. Main Outcomes and Measures: The primary outcome was number of SUD-related deaths, obtained from data provided by the Centers for Disease Control and Prevention. Results: Across 700 state-year observations, the mean (SD) number of SUD-related deaths was 21.15 (6.05) per 100 000 population. Between 2002 and 2015, the national SUD-related death rate increased from 16.0 to 27.5 per 100 000, while the average Medicaid eligibility threshold increased from 87.2% to 97.1% of the federal poverty level. Over this period, every 100-percentage point increase in the Medicaid eligibility threshold (eg, from 50% to 150% of the federal poverty level) was associated with 1.373 (95% CI, -2.732 to -0.014) fewer SUD-related deaths per 100 000 residents, a reduction of 6.50%. In the 22 states with net contractions in eligibility thresholds between 2005 and 2015, an estimated increase of 570 SUD-related deaths (95% CI, -143 to 1283) occurred. In the 28 states that increased eligibility thresholds, an estimated 1045 SUD-related deaths (95% CI, -209 to 2299) may have been prevented. Conclusions and Relevance: These findings suggest that the overall increase in SUD-related deaths between 2002 and 2015 may have been greater had the average eligibility threshold for Medicaid not increased over this period. Broader eligibility for Medicaid coverage may be one tool to help reduce SUD-related deaths.

The financial burden and health care utilization patterns associated with amnestic mild cognitive impairment.

INTRODUCTION: Individuals with amnestic mild cognitive impairment (aMCI) are at elevated risk of developing Alzheimer's disease (AD) dementia. METHODS: With data from the Aging, Demographics, and Memory Study, we used the Clinical Dementia Rating Sum of Boxes classifications to conduct a cross-sectional analysis assessing the relationship between cognitive state and various direct and indirect costs and health care utilization patterns. RESULTS: Patients with aMCI had less medical expenditures than patients with moderate and severe AD dementia (P < .001) and were also significantly less likely to have been hospitalized (P = .04) and admitted to nursing home (P < .001). Compared to individuals with normal cognition, patients with aMCI had significantly less household income (P = .018). DISCUSSION: Patients with aMCI had lower medical expenditures than patients with AD dementia. Poor cognitive status was linearly associated with lower household income, higher medical expenditures, higher likelihood of nursing and home care services, and lower likelihood of outpatient visits.