Jessica M. Harwood

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 PIPs effect on 28 measures of maternal and infant well being among WLH and among all mothers using random effects regression models. For each group, PIPs 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.

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 infants 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. EIs 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 EIs 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

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

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:

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

1.05 (P=0.02);

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

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

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

4.92 without MHPAEA and

Multiple Risk Factors During Pregnancy in South Africa: The Need for a Horizontal Approach to Perinatal Care

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.

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

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 evaluation study: Impact on specialty behavioral health utilization and expenditures among “carve-out” enrollees

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 (