The impact of Dual Eligible Special Need Plan regulations on healthcare utilization.

BACKGROUND: To determine if requiring Dual Eligible Special Need Plans (D-SNPs) to receive approval from the National Committee of Quality Assurance and contract with state Medicaid agencies impacts healthcare utilization. METHODS: We use a Multiple Interrupted Time Series to examine the association of D-SNP regulations with dichotomized measures of emergency room (ER) and hospital utilization. Our treatment group is elderly D-SNP enrollees. Our comparison group is near-elderly (ages 60-64) beneficiaries enrolled in Medicaid Managed Care plans (N = 360,405). We use segmented regression models to estimate changes in the time-trend and slope of the outcomes associated with D-SNP regulations, during the post-implementation (2012-2015) period, relative to the pre-implementation (2010-2011) period. Models include a treatment-status indicator, a monthly time-trend, indicators and splines for the post-period and the interactions between these variables. We conduct the following sensitivity analyses: (1) Re-estimating models stratified by state (2) Estimating models including interactions of D-SNP implementation variables with comorbidity count to assess for differential D-SNP regulation effects across comorbidity level. (3) Re-estimating the models stratifying by race/ethnicity and (4) Including a transition period (2012-2013) in the model. RESULTS: We do not find any statistically significant changes in ER or hospital utilization associated with D-SNP regulation implementation in the broad D-SNP population or among specific racial/ethnic groups; however, we do find a reduction in hospitalizations associated with D-SNP regulations in New Jersey (DD level = - 3.37%; p = 0.02)/(DD slope = - 0.23%; p = 0.01) and among individuals with higher, relative to lower levels of co-morbidity (DDD slope = - 0.06%; p = 0.01). CONCLUSIONS: These findings suggest that the impact of D-SNP regulations varies by state. Additionally, D-SNP regulations may be particularly effective in reducing hospital utilization among beneficiaries with high levels of co-morbidity.

Evaluation of a National Care Coordination Program to Reduce Utilization Among High-cost, High-need Medicaid Beneficiaries With Diabetes.

BACKGROUND: Medical, behavioral, and social determinants of health are each associated with high levels of emergency department (ED) visits and hospitalizations. OBJECTIVE: The objective of this study was to evaluate a care coordination program designed to provide combined "whole-person care," integrating medical, behavioral, and social support for high-cost, high-need Medicaid beneficiaries by targeting access barriers and social determinants. RESEARCH DESIGN: Individual-level interrupted time series with a comparator group, using person-month as the unit of analysis. SUBJECTS: A total of 42,214 UnitedHealthcare Medicaid beneficiaries (194,834 person-months) age 21 years or above with diabetes, with Temporary Assistance to Needy Families, Medicaid expansion, Supplemental Security Income without Medicare, or dual Medicaid/Medicare. MEASURES: Our outcome measures were any hospitalizations and any ED visits in a given month. Covariates of interest included an indicator for intervention versus comparator group and indicator and spline variables measuring changes in an outcome's time trend after program enrollment. RESULTS: Overall, 6 of the 8 examined comparisons were not statistically significant. Among Supplemental Security Income beneficiaries, we observed a larger projected decrease in ED visit risk among the intervention sample versus the comparator sample at 12 months postenrollment (difference-in-difference: -6.6%; 95% confidence interval: -11.2%, -2.1%). Among expansion beneficiaries, we observed a greater decrease in hospitalization risk among the intervention sample versus the comparator sample at 12 months postenrollment (difference-in-difference: -5.8%; 95% confidence interval: -11.4%, -0.2%). CONCLUSION: A care coordination program designed to reduce utilization among high-cost, high-need Medicaid beneficiaries was associated with fewer ED visits and hospitalizations for patients with diabetes in selected Medicaid programs but not others.

Trends in Costs of Care and Utilization for Medicaid Patients With Diabetes in Accountable Care Communities.

BACKGROUND/OBJECTIVES: Medicaid beneficiaries with diabetes have complex care needs. The Accountable Care Communities (ACC) Program is a practice-level intervention implemented by UnitedHealthcare to improve care for Medicaid beneficiaries. We examined changes in costs and utilization for Medicaid beneficiaries with diabetes assigned to ACC versus usual care practices. RESEARCH DESIGN: Interrupted time series with concurrent control group analysis, at the person-month level. The ACC was implemented in 14 states, and we selected comparison non-ACC practices from those states to control for state-level variation in Medicaid program. We adjusted the models for age, sex, race/ethnicity, comorbidities, seasonality, and state-by-year fixed effects. We examined the difference between ACC and non-ACC practices in changes in the time trends of expenditures and hospital and emergency room utilization, for the 4 largest categories of Medicaid eligibility [Temporary Assistance to Needy Families, Supplemental Security Income (without Medicare), Expansion, Dual-Eligible]. SUBJECTS/MEASURES: Eligibility and claims data from Medicaid adults with diabetes from 14 states between 2010 and 2016, before and after ACC implementation. RESULTS: Analyses included 1,200,460 person-months from 66,450 Medicaid patients with diabetes. ACC implementation was not associated with significant changes in outcome time trends, relative to comparators, for all Medicaid categories. CONCLUSIONS: Medicaid patients assigned to ACC practices had no changes in cost or utilization over 3 years of follow-up, compared with patients assigned to non-ACC practices. The ACC program may not reduce costs or utilization for Medicaid patients with diabetes.

The Effects of Three Kinds of Insurance Benefit Design Features on Specialty Mental Health Care Use in Managed Care.

BACKGROUND: Insurance benefit features play a role in determining access to specialty mental health care. Previous research, primarily examining the effects of copayments, coinsurance, and deductibles in a fee-for-service setting, has concluded that specialty mental health use is highly sensitive to changes in financial requirements. Less is known about the effects of other benefit features and the effects of all of these features in a managed care environment. AIMS OF THE STUDY: Determine whether increased generosity of three types of benefit features was associated with increases in specialty mental health use and expenditures in a managed care setting. Secondary analyses investigated whether these associations varied by income level. METHODS: A first-differences design used linked claims, enrollment, and benefit data for 1,242,949 non-elderly adults (aged 18-64) with employer-sponsored insurance, before (2009) and after (2011) national behavioral health parity implementation. The data were provided by a large national managed behavioral health organization. Benefit design features included combined cost sharing from copayment and coinsurance, deductibles, the presence of annual use limits, cost sharing penalties associated with services used without getting required prior-authorization, and provider network. Outcomes included visits/days, total expenditures and patient out-of-pocket expenditures for individual psychotherapy and inpatient use, with separate values for in-network and out-of-network (OON) service use. Ordinary least squares regression was performed on change scores (2011 minus 2009 values) of all outcomes to implement the first-differences study design and normalize distributions of otherwise heavily skewed (towards zero) variables. Regressions stratified by higher income (>=USD75,000) and net worth (>=USD100,000) and lower income/net worth were also conducted. RESULTS: For in-network individual psychotherapy, larger increases in cost sharing from copayment and coinsurance were modestly associated with larger decreases in use and total expenditures (beta_visits=--0.00008, p-value=0.030; beta_total expenditures=USD--0.00629, p-value=0.011), and elimination of treatment limits was associated with larger increases in use (beta=0.09637, p-value=0.002) and total expenditures (beta=USD6.57506, p-value=0.001). These results were observed among all enrollees of plans that covered in-network and out-of-network plans and among a sub-set of these enrollees who did not change plans between 2009 and 2011. Benefit features had fewer associations with inpatient care and OON services. DISCUSSION: Elimination of limits was associated with small average increases in in-network individual psychotherapy utilization and expenditures. Cost sharing sensitivities of individual psychotherapy visits to financial requirements reported here were small, and resembled previous findings based in a managed care setting, which were smaller than findings based on the fee-for-service settings. Cost sharing may not pose a practical barrier to specialty behavioral health for non-elderly adults with employer-sponsored managed care plans. However, the influence of cost sharing may vary by specific healthcare needs, something that should be explored in further research.

The Mental Health Parity and Addiction Equity Act Evaluation Study: Impact on Nonquantitative Treatment Limits for Specialty Behavioral Health Care.

OBJECTIVE: To assess frequency, type, and extent of behavioral health (BH) nonquantitative treatment limits (NQTLs) before and after implementation of the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA). DATA SOURCES: Secondary administrative data for Optum carve-out and carve-in plans. STUDY DESIGN: Cross-tabulations and "two-part" regression models were estimated to assess associations of parity period with NQTLs. DATA COLLECTION/EXTRACTION METHODS: Optum provided four proprietary BH databases, including 2008-2013 data for 40 carve-out and 385 carve-in employers from Optum's claims processing databases and 2010 data from interviews conducted by Optum's parity compliance team with 49 carve-out employers. PRINCIPAL FINDINGS: Preparity, carve-out plans required preauthorization for in-network inpatient/intermediate care; otherwise coverage was denied. Postparity, 73 percent would review later by request and half charged no penalty for late authorization. Outpatient visit authorization requirements virtually disappeared. For carve-out out-of-network inpatient/intermediate care, and for carve-ins, plans changed penalties to match medical service policies, but this did not necessarily lead to fewer requirements or lower penalties. CONCLUSION: After 2011, MHPAEA was associated with the transformation of BH care management, including much less restrictive preauthorization requirements, especially for in-network care provided by carve-out plans.

The Mental Health Parity and Addiction Equity Act Evaluation Study: Impact on Mental Health Financial Requirements among Commercial "Carve-In" Plans.

OBJECTIVE: Did mental health cost-sharing decrease following implementation of the Mental Health Parity and Addiction Equity Act (MHPAEA)? DATA SOURCE: Specialty mental health copayments, coinsurance, and deductibles, 2008-2013, were obtained from benefits databases for "carve-in" plans from a national commercial managed behavioral health organization. STUDY DESIGN: Bivariate and regression-adjusted analyses compare the probability of use and (conditional) level of cost-sharing pre- and postparity. An interaction term is added to compare differential levels of pre- and postparity cost-sharing changes for plans that were and were not already at parity pre-MHPAEA. FINDINGS: Controlling for employer/plan characteristics, MHPAEA is associated with higher intermediate care copayments ($15.9) but lower outpatient ($2.6) copayments among in-network-only plans. Among plans with in- and out-of-network benefits, MHPAEA is associated with lower inpatient ($23.2) and outpatient ($2.5) copayments, but increases in inpatient and intermediate in-network and out-of-network coinsurance (about 1 percentage point). Among the few plans not at parity pre-MHPAEA, changes in use and level of cost-sharing associated with MHPAEA were more dramatic. CONCLUSION: Mixed evidence that MHPAEA led to more generous mental health benefits may stem from the finding that many plans were already at parity pre-MHPAEA. Future policy focus in mental health may shift to slowing growth in cost-sharing for all health services.

The Mental Health Parity and Addiction Equity Act evaluation study: Impact on specialty behavioral healthcare utilization and spending among enrollees with substance use disorders.

BACKGROUND: The federal Mental Health Parity and Addiction Equity Act (MHPAEA) sought to eliminate historical disparities between behavioral health and medical health insurance benefits among the commercially insured. This study determines whether MHPAEA was associated with increased BH expenditures and utilization among a population with substance use disorder (SUD) diagnoses. METHODS: Claims and eligibility data from 5,987,776 enrollees, 2008-2013, were obtained from a national, commercial, managed behavioral health organization. An interrupted time series study design with segmented regression analysis estimated time trends of per-member-per-month (PMPM) spending and use before (2008-2009), during (2010), and after (2011-2013) MHPAEA compliance. The study sample contained individuals with drug or alcohol use disorder diagnosis during study period (N=2,716,473 member-month observations). Outcomes included: total, plan, patient out-of-pocket spending; outpatient utilization (assessment/diagnostic evaluation visits; medication management; individual, group and family psychotherapy, and structured outpatient care); intermediate care utilization (day treatment; recovery home and residential); and inpatient utilization. RESULTS: Starting at the beginning of the post-parity period, MHPAEA was associated with increased levels of PMPM total and plan spending ($25.80 [p=0.01]; $28.33 [p=0.00], respectively), as well as the number of PMPM assessment/evaluation, individual psychotherapy, and group psychotherapy visits, and inpatient days (0.01 visits [p=0.01]; 0.02 visits [p=0.01]; 0.01 visits [p=0.03]; 0.01days [p=0.01], respectively). Following these initial level changes, MHPAEA was also associated with monthly increases in PMPM total, plan, and patent out-of-pocket spending ($2.56/month [p=0.00]; $2.25/month [p=0.00]; $0.27 [p=0.03], respectively), as well as structured outpatient visits and inpatient days (0.0012 visits/month [p=0.01]; 0.0012days/month [p=0.00]). CONCLUSION: MHPAEA was associated with modest increases in total, plan, and patient out-of-pocket spending and outpatient and inpatient utilization. These increases, while modest in magnitude, are larger in magnitude than increases detected among a sample of all enrollees (i.e. not only those with SUD diagnoses).

Beyond the Primary Endpoint Paradigm: A Test of Intervention Effect in HIV Behavioral Intervention Trials with Numerous Correlated Outcomes.

Behavioral interventions are increasingly based on holistic approaches to health with an understanding that health-related behaviors are linked. A motivating example is provided by the Philani study, an intervention trial conducted to improve the health of South African mothers and their children. Inter-related health problems around maternal alcohol use, malnutrition, and HIV were addressed; multiple endpoints were targeted. The traditional hypothesis testing paradigm that tests significance on one primary outcome did not suffice. Past multiple endpoint studies have utilized a sign test on the number of estimated differences between treatment and control that favor the intervention. However, in order to preserve type 1 error, one must account for correlations among the outcomes. We propose an alternative approach that counts the number of significant treatment-control differences. Monte Carlo simulation is used to adjust for correlation, providing updated critical values and p values. Our method is implemented through an R package and applied to the Philani data to test the intervention's overall effect.

The Mental Health Parity and Addiction Equity Act (MHPAEA) Evaluation Study: Impact on Quantitative Treatment Limits.

OBJECTIVE: The Mental Health Parity and Addiction Equity Act (MHPAEA) significantly changed regulations governing behavioral health benefits for large, commercially insured employers. Pre-MHPAEA, many plans covered only a specific number of behavioral health treatment days or visits; post-MHPAEA, such quantitative treatment limits (QTLs) were allowed only if they were "at parity" with medical-surgical limits. This study assessed MHPAEA's effect on the prevalence of behavioral health QTLs. METHODS: Analyses used 2008-2013 specialty behavioral health benefit design data for Optum large-group plans, both carve-outs (N=2,257 plan-years, corresponding to 1,527 plans and 40 employers) and carve-ins (N=11,644 plan-years, 3,569 plans, and 340 employers). Descriptive statistics were calculated for limits existing at parity implementation, distinguished by accumulation period (annual or lifetime), level of care (inpatient, intermediate, or outpatient), unit (days, visits, or courses), condition, and network level. Proportions of plans using specific limits during the preparity (2008-2009), transition (2010), and postparity (2011-2013) periods were compared with Fisher's exact tests. RESULTS: Preparity, the most common QTLs were annual visit or day limits. Accounting for overlap in limit types, 89% of regular carve-out plans, 90% of in-network-only carve-outs, and 77% of carve-in plans limited outpatient visits; 66% of regular carve-out plans, 74% of in-network-only carve-outs, and 73% of carve-ins limited inpatient or intermediate days. Postparity, QTLs almost entirely disappeared (p<.001). CONCLUSIONS: Before MHPAEA, QTLs were common. Postimplementation, virtually all plans dropped such limits, suggesting that MHPAEA was effective at eliminating QTLs. However, increasing access to behavioral health care will mean going beyond such QTL changes and looking at other areas of benefit management.

The Mental Health Parity and Addiction Equity Act Evaluation Study: Impact on Specialty Behavioral Health Care Utilization and Spending Among Carve-In Enrollees.

OBJECTIVE: The federal Mental Health Parity and Addiction Equity Act (MHPAEA) sought to eliminate historical disparities between insurance coverage for behavioral health (BH) treatment and coverage for medical treatment. Our objective was to evaluate MHPAEA's impact on BH expenditures and utilization among "carve-in" enrollees. METHODS: We received specialty BH insurance claims and eligibility data from Optum, sampling 5,987,776 adults enrolled in self-insured plans from large employers. An interrupted time series study design with segmented regression analysis estimated monthly time trends of per-member spending and use before (2008-2009), during (2010), and after (2011-2013) MHPAEA compliance (N=179,506,951 member-month observations). Outcomes included: total, plan, patient out-of-pocket spending; outpatient utilization (assessment/diagnostic evaluation visits, medication management, individual and family psychotherapy); intermediate care utilization (structured outpatient, day treatment, residential); and inpatient utilization. RESULTS: MHPAEA was associated with increases in monthly per-member total spending, plan spending, assessment/diagnostic evaluation visits [respective immediate increases of: $1.05 (P=0.02); $0.88 (P=0.04); 0.00045 visits (P=0.00)], and individual psychotherapy visits [immediate increase of 0.00578 visits (P=0.00) and additional increases of 0.00017 visits/mo (P=0.03)]. CONCLUSIONS: MHPAEA was associated with modest increases in total and plan spending and outpatient utilization; for example, in July 2012 predicted per-enrollee plan spending was $4.92 without MHPAEA and $6.14 with MHPAEA. Efforts should focus on understanding how other barriers to BH care unaddressed by MHPAEA may affect access/utilization. Future research should evaluate effects produced by the Affordable Care Act's inclusion of BH care as an essential health benefit and expansion of MHPAEA protections to the individual and small group markets.

The Mental Health Parity and Addiction Equity Act evaluation study: Impact on specialty behavioral health utilization and expenditures among "carve-out" enrollees.

Interrupted time series with and without controls was used to evaluate whether the federal Mental Health Parity and Addiction Equity Act (MHPAEA) and its Interim Final Rule increased the probability of specialty behavioral health treatment and levels of utilization and expenditures among patients receiving treatment. Linked insurance claims, eligibility, plan and employer data from 2008 to 2013 were used to estimate segmented regression analyses, allowing for level and slope changes during the transition (2010) and post-MHPAEA (2011-2013) periods. The sample included 1,812,541 individuals ages 27-64 (49,968,367 person-months) in 10,010 Optum "carve-out" plans. Two-part regression models with Generalized Estimating Equations were used to estimate expenditures by payer and outpatient, intermediate and inpatient service use. We found little evidence that MHPAEA increased utilization significantly, but somewhat more robust evidence that costs shifted from patients to plans. Thus the primary impact of MHPAEA among carve-out enrollees may have been a reduction in patient financial burden.

Community health workers can improve child growth of antenatally-depressed, South African mothers: a cluster randomized controlled trial.

BACKGROUND: Maternal antenatal depression has long-term consequences for children's health. We examined if home visits by community health workers (CHW) can improve growth outcomes for children of mothers who are antenatally depressed. METHODS: A cluster randomized controlled trial of all pregnant, neighbourhood women in Cape Town, South Africa. Almost all pregnant women (98 %, N = 1238) were recruited and assessed during pregnancy, two weeks post-birth (92 %) and 6 months post-birth (88 %). Pregnant women were randomized to either: 1) Standard Care (SC), which provided routine antenatal care; or 2) an intervention, The Philani Intervention Program (PIP), which included SC and home visits by CHW trained as generalists (M = 11 visits). Child standardized weight, length, and weight by length over 6 months based on maternal antenatal depression and intervention condition. RESULTS: Depressed mood was similar across the PIP and SC conditions both antenatally (16.5 % rate) and at 6 months (16.7 %). The infants of depressed pregnant women in the PIP group were similar in height (height-for-age Z scores) to the children of non-depressed mothers in both the PIP and the SC conditions, but significantly taller at 6 months of age than the infants of pregnant depressed mothers in the SC condition. The intervention did not moderate children's growth. Depressed SC mothers tended to have infants less than two standard deviations in height on the World Health Organization's norms at two weeks post-birth compared to infants of depressed PIP mothers and non-depressed mothers in both conditions. CONCLUSIONS: A generalist, CHW-delivered home visiting program improved infant growth, even when mothers' depression was not reduced. Focusing on maternal caretaking of infants, even when mothers are depressed, is critical in future interventions. TRIAL REGISTRATION: ClinicalTrials.gov registration # NCT00996528 . October 15, 2009.

A cluster randomised controlled effectiveness trial evaluating perinatal home visiting among South African mothers/infants.

BACKGROUND: Interventions are needed to reduce poor perinatal health. We trained community health workers (CHWs) as home visitors to address maternal/infant risks. METHODS: In a cluster randomised controlled trial in Cape Town townships, neighbourhoods were randomised within matched pairs to 1) the control, healthcare at clinics (n = 12 neighbourhoods; n = 594 women), or 2) a home visiting intervention by CBW trained in cognitive-behavioural strategies to address health risks (by the Philani Maternal, Child Health and Nutrition Programme), in addition to clinic care (n = 12 neighbourhoods; n = 644 women). Participants were assessed during pregnancy (2% refusal) and 92% were reassessed at two weeks post-birth, 88% at six months and 84% at 18 months later. We analysed 32 measures of maternal/infant well-being over the 18 month follow-up period using longitudinal random effects regressions. A binomial test for correlated outcomes evaluated overall effectiveness over time. The 18 month post-birth assessment outcomes also were examined alone and as a function of the number of home visits received. RESULTS: Benefits were found on 7 of 32 measures of outcomes, resulting in significant overall benefits for the intervention compared to the control when using the binomial test (p = 0.008); nevertheless, no effects were observed when only the 18 month outcomes were analyzed. Benefits on individual outcomes were related to the number of home visits received. Among women living with HIV, intervention mothers were more likely to implement the PMTCT regimens, use condoms during all sexual episodes (OR = 1.25; p = 0.014), have infants with healthy weight-for-age measurements (OR = 1.42; p = 0.045), height-for-age measurements (OR = 1.13, p<0.001), breastfeed exclusively for six months (OR = 3.59; p<0.001), and breastfeed longer (OR = 3.08; p<0.001). Number of visits was positively associated with infant birth weight ≥2500 grams (OR = 1.07; p = 0.012), healthy head-circumference-for-age measurements at 6 months (OR = 1.09, p = 0.017), and improved cognitive development at 18 months (OR = 1.02, p = 0.048). CONCLUSIONS: Home visits to neighbourhood mothers by CHWs may be a feasible strategy for enhancing maternal/child outcomes. However, visits likely must extend over several years for persistent benefits. TRIAL REGISTRATION: ClinicalTrials.gov NCT00996528.

Depression and Health Risk Behaviors: Towards Optimizing Primary Care Service Strategies for Addressing Risk.

PURPOSE: Depression and health risk behaviors in adolescents are leading causes of preventable morbidity and mortality. Primary care visits provide prime opportunities to screen and provide preventive services addressing risk behaviors/conditions. This study evaluated the co-occurrence of depression and health risk behaviors (focusing on smoking, drug and alcohol misuse, risky sexual behavior, and obesity-risk) with the goal of informing preventive service strategies. METHODS: Consecutive primary care patients (n=217), ages 13 to 18 years, selected to over-sample for depression, completed a Health Risk Behavior Survey and the Diagnostic Interview Schedule for Children and Adolescents (DISC) depression module. RESULTS: Youths with DISC-defined past-year depression were significantly more likely to report risk across multiple risk-areas, Wald X2(1)=14.39, p<.001, and to have significantly higher rates of past-month smoking, X2(1)=5.86, p=.02, substance misuse, X2(1)=15.12, p<.001, risky sex, X2 (1) =5.04, p=.03, but not obesity-risk, X2 (1) =0.19, p=.66. Cross-sectional predictors of risk behaviors across risk areas were similar. Statistically significant predictors across all risk domains included: youths' expectancies about future risk behavior; attitudes regarding the risk behavior; and risk behaviors in peers/others in their environments. CONCLUSIONS: Depression in adolescents is associated with a cluster of health risk behaviors that likely contribute to the high morbidity and mortality associated with both depression and health risk behaviors. Consistent with the United States National Prevention Strategy (2011) and the focus on integrated behavioral and medical health care, results suggest the value of screening and preventive services using combination strategies that target depression and multiple areas of associated health risk.

Antenatal depression case finding by community health workers in South Africa: feasibility of a mobile phone application.

Randomized controlled trials conducted in resource-limited settings have shown that once women with depressed mood are evaluated by specialists and referred for treatment, lay health workers can be trained to effectively administer psychological treatments. We sought to determine the extent to which community health workers could also be trained to conduct case finding using short and ultrashort screening instruments programmed into mobile phones. Pregnant, Xhosa-speaking women were recruited independently in two cross-sectional studies (N = 1,144 and N = 361) conducted in Khayelitsha, South Africa and assessed for antenatal depression. In the smaller study, community health workers with no training in human subject research were trained to administer the Edinburgh Postnatal Depression Scale (EPDS) during the routine course of their community-based outreach. We compared the operating characteristics of four short and ultrashort versions of the EPDS with the criterion standard of probable depression, defined as an EPDS-10 ≥ 13. The prevalence of probable depression (475/1144 [42 %] and 165/361 [46 %]) was consistent across both samples. The 2-item subscale demonstrated poor internal consistency (Cronbach's α ranged from 0.55 to 0.58). All four subscales demonstrated excellent discrimination, with area under the receiver operating characteristic curve (AUC) values ranging from 0.91 to 0.99. Maximal discrimination was observed for the 7-item depressive symptoms subscale: at the conventional screening threshold of ≥10, it had 0.97 sensitivity and 0.76 specificity for detecting probable antenatal depression. The comparability of the findings across the two studies suggests that it is feasible to use community health workers to conduct case finding for antenatal depression.

Pregnant women living with HIV (WLH) supported at clinics by peer WLH: a cluster randomized controlled trial.

Throughout Africa, Peer Mentors who are women living with HIV (WLH) are supporting pregnant WLH at antenatal and primary healthcare clinics (McColl in BMJ 344:e1590, 2012). We evaluate a program using this intervention strategy at 1.5 months post-birth. In a cluster randomized controlled trial in KwaZulu-Natal, South Africa, eight clinics were randomized for their WLH to receive either: standard care (SC), based on national guidelines to prevent mother-to-child transmission (4 clinics; n = 656 WLH); or an enhanced intervention (EI; 4 clinics; n = 544 WLH). The EI consisted of four antenatal and four postnatal small group sessions led by Peer Mentors, in addition to SC. WLH were recruited during pregnancy and 70 % were reassessed at 1.5 months post-birth. EI's effect was ascertained on 16 measures of maternal and infant well-being using random effects regressions to control for clinic clustering. A binomial test for correlated outcomes evaluated EI's overall effectiveness. Among EI WLH reassessed, 87 % attended at least one intervention session (mean 4.1, SD 2.0). Significant overall benefits were found in EI compared to SC using the binomial test. However, it is important to note that EI WLH were significantly less likely to adhere to ARV during pregnancy compared to SC. Secondarily, compared to SC, EI WLH were more likely to ask partners to test for HIV, better protected their infants from HIV transmission, and were less likely to have depressed mood and stunted infants. Adherence to clinic intervention groups was low, yet, there were benefits for maternal and infant health at 1.5 months post-birth.

A cluster randomized controlled trial evaluating the efficacy of peer mentors to support South African women living with HIV and their infants.

OBJECTIVE: We evaluate the effect of clinic-based support by HIV-positive Peer Mentors, in addition to standard clinic care, on maternal and infant well-being among Women Living with HIV (WLH) from pregnancy through the infant's first year of life. METHODS: In a cluster randomized controlled trial in KwaZulu-Natal, South Africa, eight clinics were randomized for pregnant WLH to receive either: a Standard Care condition (SC; 4 clinics; n = 656 WLH); or an Enhanced Intervention (EI; 4 clinics; n = 544 WLH). WLH in the EI were invited to attend four antenatal and four postnatal meetings led by HIV-positive Peer Mentors, in addition to SC. WLH were recruited during pregnancy, and at least two post-birth assessment interviews were completed by 57% of WLH at 1.5, 6 or 12 months. EI's effect was ascertained on 19 measures of maternal and infant well-being using random effects regressions to control for clinic clustering. A binomial test for correlated outcomes evaluated EI's overall efficacy. FINDINGS: WLH attended an average of 4.1 sessions (SD = 2.0); 13% did not attend any sessions. Significant overall benefits were found in EI compared to SC using the binomial test. Secondarily, over time, WLH in the EI reported significantly fewer depressive symptoms and fewer underweight infants than WLH in the SC condition. EI WLH were significantly more likely to use one feeding method for six months and exclusively breastfeed their infants for at least 6 months. CONCLUSIONS: WLH benefit by support from HIV-positive Peer Mentors, even though EI participation was partial, with incomplete follow-up rates from 6-12 months. TRIAL REGISTRATION: ClinicalTrials.gov NCT00972699.

Multiple risk factors during pregnancy in South Africa: the need for a horizontal approach to perinatal care.

South African children's long-term health and well-being is jeopardized during their mothers' pregnancies by the intersecting epidemics of HIV, alcohol use, low birth weight (LBW; <2,500 g) related to poor nutrition, and depressed mood. This research examines these overlapping risk factors among 1,145 pregnant Xhosa women living in 24 township neighborhoods in Cape Town, South Africa. Results revealed that 66 % of pregnant women experienced at least one risk factor. In descending order of prevalence, 37 % reported depressed mood, 29 % were HIV+, 25 % used alcohol prior to knowing that they were pregnant, and 15 % had a previous childbirth with a LBW infant. Approximately 27 % of women had more than one risk factor: depressed mood was significantly associated with alcohol use and LBW, with a trend to significance with HIV+. In addition, alcohol use was significantly related to HIV+. These results suggest the importance of intervening across multiple risks to maternal and child health, and particularly with depression and alcohol use, to positively impact multiple maternal and infant outcomes.

Outcomes of home visits for pregnant mothers and their infants: a cluster randomized controlled trial.

OBJECTIVE: To evaluate the effect of home visits by community health workers (CHWs) on maternal and infant well being from pregnancy through the first 6 months of life for women living with HIV (WLH) and all neighborhood mothers. DESIGN AND METHODS: In a cluster randomized controlled trial in Cape Town townships, neighborhoods were randomized within matched pairs to either standard care, comprehensive healthcare at clinics (n=12 neighborhoods; n=169 WLH; n=594 total mothers); or Philani Intervention Program, home visits by CHWs in addition to standard care (PIP; n=12 neighborhoods; n=185 WLH; n=644 total mothers). Participants were assessed during pregnancy (2% refusal) and reassessed at 1 week (92%) and 6 months (88%) postbirth. We analyzed PIP's effect on 28 measures of maternal and infant well being among WLH and among all mothers using random effects regression models. For each group, PIP's overall effectiveness was evaluated using a binomial test for correlated outcomes. RESULTS: Significant overall benefits were found in PIP compared to standard care among WLH and among all participants. Secondarily, compared to standard care, PIP WLH were more likely to complete tasks to prevent vertical transmission, use one feeding method for 6 months, avoid birth-related medical complications, and have infants with healthy height-for-age measurements. Among all mothers, compared to standard care, PIP mothers were more likely to use condoms consistently, breastfeed exclusively for 6 months, and have infants with healthy height-for-age measurements. CONCLUSION: PIP is a model for countries facing significant reductions in HIV funding whose families face multiple health risks.

Plastids contain a second sec translocase system with essential functions.

Proteins that are synthesized on cytoplasmic ribosomes but function within plastids must be imported and then targeted to one of six plastid locations. Although multiple systems that target proteins to the thylakoid membranes or thylakoid lumen have been identified, a system that can direct the integration of inner envelope membrane proteins from the stroma has not been previously described. Genetics and localization studies were used to show that plastids contain two different Sec systems with distinct functions. Loss-of-function mutations in components of the previously described thylakoid-localized Sec system, designated as SCY1 (At2g18710), SECA1 (At4g01800), and SECE1 (At4g14870) in Arabidopsis (Arabidopsis thaliana), result in albino seedlings and sucrose-dependent heterotrophic growth. Loss-of-function mutations in components of the second Sec system, designated as SCY2 (At2g31530) and SECA2 (At1g21650) in Arabidopsis, result in arrest at the globular stage and embryo lethality. Promoter-swap experiments provided evidence that SCY1 and SCY2 are functionally nonredundant and perform different roles in the cell. Finally, chloroplast import and fractionation assays and immunogold localization of SCY2-green fluorescent protein fusion proteins in root tissues indicated that SCY2 is part of an envelope-localized Sec system. Our data suggest that SCY2 and SECA2 function in Sec-mediated integration and translocation processes at the inner envelope membrane.