A Pilot Randomized Control Trial of the Striving Towards EmPowerment and Medication Adherence (STEP-AD) Intervention for Black Women Living with HIV.

Black women living with HIV (BWLWH) face adversities associated with lower HIV medication adherence, viral non-suppression, and mental health symptoms (e.g., post-traumatic stress disorder) such as trauma/violence, racism, HIV-related discrimination/stigma, and gender-related stressors. We developed the first intervention based in cognitive behavioral therapy and culturally congruent coping for BWLWH to increase medication adherence and decrease PTSD symptoms by enhancing resilience, self-care, engagement in care, and coping for trauma, racism, HIV-related discrimination/stigma, and gender-related stressors. A pilot randomized control trial was conducted with BWLWH and histories of trauma who were at risk for their HIV viral load remaining or becoming detectable (i.e., below 80% medication adherence, detectable viral load in the past year, and/or missed HIV-related appointments). 119 BWLWH were assessed at baseline and 70 met inclusion criteria, completed one session of Life-Steps adherence counseling, and were randomized to either nine sessions of STEP-AD (Striving Towards EmPowerment and Medication Adherence) or ETAU (enhanced treatment as usual consisting of biweekly check-ins). Women completed a post intervention follow up assessment (3 months post baseline) and 3-month post intervention follow-up (6 months post baseline). Via STATA the difference-in-difference methodology with mixed models compared STEP-AD to ETAU on changes in outcomes over time. BWLWH in STEP-AD compared to E-TAU had significantly higher ART adherence (estimate = 9.36 p = 0.045) and lower likelihood of being clinically diagnosed with PTSD (OR = .07, estimate = - 2.66, p = 0.03) as well as borderline significance on higher CD4 count (estimate = 161.26, p = 0.05). Our findings suggest preliminary efficacy of STEP-AD in improving ART adherence, mental health, and immune function.

Gendered Racial Microaggressions, Self-silencing, Substance Use, and HIV Outcomes Among Black Women Living with HIV: A Structural Equation Modeling Approach.

To better understand factors that may contribute to HIV outcomes experienced by Black women living with HIV (BWLWH), the present study examined the relationships among gendered racial microaggressions (GRM; subtle daily insults due to racism and sexism), self-silencing, substance use, antiretroviral therapy (ART) medication adherence, and viral suppression using structural equation modeling and path analysis. Self-silencing and substance use were examined as potential mediators. Participants were 119 BWLWH residing in South Florida. Results of this study showed that GRM was directly and positively associated with self-silencing and indirectly and negatively associated with medication adherence via self-silencing. GRM was directly related to higher alcohol use disorder severity. Self-silencing was directly and negatively associated with medication adherence. Medication adherence was directly and negatively related to viral suppression. The model fit the data well. Identifying the negative consequences of GRM in conjunction with self-silencing and substance use may help inform prevention and intervention strategies to improve mental health and HIV-related outcomes among BWLWH.

RESUMEN: Para comprender mejor los factores que pueden contribuir a los resultados del VIH experimentados por las mujeres negras que viven con el VIH (BWLWH), el presente estudio examinó las relaciones entre las microagresiones raciales de género (GRM; sutiles insultos diarios debido al racismo y el sexismo), el auto silenciamiento, el uso de sustancias, la adherencia a la medicación de la terapia antirretroviral (ART) y la supresión viral utilizando modelos de ecuaciones estructurales y análisis de ruta. El autosilenciamiento y el consumo de sustancias se examinaron como mediadores potenciales. Los participantes fueron 119 BWLWH que residían en el sur de Florida. Los resultados de este estudio mostraron que GRM se asoció directa y positivamente con el autosilenciamiento e indirecta y negativamente se asoció con la adherencia a la medicación a través del autosilenciamiento. GRM se relacionó directamente con una mayor gravedad del trastorno por consumo de alcohol. El autosilenciamiento se asoció directa y negativamente con la adherencia a la medicación. La adherencia a la medicación se relacionó directa y negativamente con la supresión viral. El modelo se ajusta bien a los datos. Identificar las consecuencias negativas de GRM junto con el auto silenciamiento y el uso de sustancias puede ayudar a informar estrategias de prevención e intervención para mejorar la salud mental y los resultados relacionados con el VIH entre BWLWH.

Proactively Offered Text Messages and Mailed Nicotine Replacement Therapy for Smokers in Primary Care Practices: A Pilot Randomized Trial.

INTRODUCTION: Proactive, population health cessation programs can guide efforts to reach smokers outside of the clinic to encourage quit attempts and treatment use. AIMS AND METHODS: This study aimed to measure trial feasibility and preliminary effects of a proactive intervention offering text messages (TM) and/or mailed nicotine replacement therapy (NRT) to smokers in primary care clinics. From 2017 to 2019 we performed a pilot randomized trial comparing brief telephone advice (control: BA), TM, 2 weeks of mailed NRT, or both interventions (TM + NRT). Patients were identified using electronic health records and contacted proactively by telephone to assess interest in the study. We compared quit attempts, treatment use, and cessation in the intervention arms with BA. RESULTS: Of 986 patients contacted, 153 (16%) enrolled (mean age 53 years, 57% female, 76% white, 11% black, 8% Hispanic, 52% insured by Medicaid) and 144 (94%) completed the 12-week assessment. On average, patients in the TM arms received 159 messages (99.4% sent, 0.6% failed), sent 19 messages, and stayed in the program for 61 days. In all groups, a majority of patients reported quit attempts (BA 67% vs. TM 86% [p = .07], NRT 81% [p = .18], TM + NRT 79% [p = .21]) and NRT use (BA 51% vs. NRT 83% [p = .007], TM 65% [p = .25], TM + NRT 76% [p = .03]). Effect estimates for reported 7-day abstinence were BA 10% versus TM 26% (p = .09), NRT 28% (p = .06), and TM + NRT 23% (p = .14). CONCLUSIONS: Proactively offering TM or mailed nicotine medications was feasible among primary care smokers and a promising approach to promote quit attempts and short-term abstinence. IMPLICATIONS: Proactive intervention programs to promote quit attempts outside of office visits among smokers enrolled in primary care practices are needed. TM have potential to engage smokers not planning to quit or to support smokers to make a planned quit attempt. This pilot study demonstrates the feasibility of testing a proactive treatment model including TM and/or mailed NRT to promote quit attempts, treatment use, and cessation among nontreatment-seeking smokers in primary care. CLINICALTRIALS.GOV IDENTIFIER: NCT03174158.

"I was able to eat what I am supposed to eat"-- patient reflections on a medically-tailored meal intervention: a qualitative analysis.

BACKGROUND: Medically-tailored meal programs that provide home-delivered medically-appropriate food are an emerging intervention when type 2 diabetes co-occurs with food insecurity (limited or uncertain access to nutritious food owing to cost). We sought to understand the experiences of medically-tailored meal program participants. METHODS: We conducted semi-structured interviews with participants in a randomized trial of medically-tailored meals (NCT02426138) until reaching content saturation. Participants were adults (age > 20 years) with type 2 diabetes in eastern Massachusetts, and the interviews were conducted from April to July 2017. Interviews were transcribed verbatim and coded by two independent reviewers. We determined emergent themes using content analysis. RESULTS: Twenty individuals were interviewed. Their mean age was 58 (SD: 13) years, 60.0% were women, 20.0% were non-Hispanic black, and 15.0% were Hispanic. Key themes were 1) satisfaction and experience with medically-tailored meals 2) food preferences and cultural appropriateness, 3) diabetes management and awareness, and 4) suggestions for improvement and co-interventions. Within these themes, participants were generally satisfied with medically-tailored meals and emphasized the importance of receiving culturally appropriate food. Participants reported several positive effects of medically-tailored meals, including improved quality of life and ability to manage diabetes, and stress reduction. Participants suggested combining medically-tailored meals with diabetes self-management education or lifestyle interventions. CONCLUSIONS: Individuals with diabetes and food insecurity expressed satisfaction with the medically-tailored meal program, and reported that participation reduced stress and the burden of diabetes management. Suggestions to help ensure the success of medically-tailored meal programs included a strong emphasis on culturally acceptability and accommodating taste preferences for provided foods, and combining medically-tailored meals with diabetes education or lifestyle intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT02426138.

Health Center-Based Community-Supported Agriculture: An RCT.

INTRODUCTION: Socioeconomically vulnerable individuals often face poor access to nutritious food and bear a disproportionate burden of diet-related chronic illness. This study tested whether a subsidized community-supported agriculture intervention could improve diet quality. STUDY DESIGN: An RCT was conducted from May 2017 to December 2018 (data analyzed in 2019). SETTING/PARTICIPANTS: Adults with a BMI >25 kg/m2 seen at a community health center in central Massachusetts, or who lived in the surrounding county, were eligible. INTERVENTION: Individuals were randomized to receive either subsidized community-supported agriculture membership (which provided a weekly farm produce pickup from June to November) or healthy eating information (control group). For equity, the control group received financial incentives similar to the intervention group. MAIN OUTCOME MEASURES: The primary outcome was the Healthy Eating Index 2010 total score (range, 0-100; higher indicates better diet quality; minimum clinically meaningful difference, 3). Healthy Eating Index was assessed using 3 24-hour recalls per participant collected each growing season. Intention-to-treat analyses compared Healthy Eating Index scores between the intervention and control group, accounting for repeated measures with generalized estimating equations. RESULTS: There were 128 participants enrolled and 122 participants for analysis. The participants' mean age was 50.3 (SD=13.6) years; 82% were women; and 88% were white, non-Hispanic, with a similar distribution of baseline characteristics comparing the intervention and control groups. Baseline Healthy Eating Index total score was 53.9 (SD=15.3) in the control group and 55.1 (SD=15.2) in the intervention group (p=0.68). The intervention increased the mean Healthy Eating Index total score relative to the control group (4.3 points higher, 95% CI=0.5, 8.1, p=0.03). Food insecurity was lower in the intervention group (RR=0.68, 95% CI=0.48, 0.96). CONCLUSIONS: A community-supported agriculture intervention resulted in clinically meaningful improvements in diet quality. Subsidized community-supported agriculture may be an important intervention for vulnerable individuals. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT03231592. SUPPLEMENT INFORMATION: This article is part of a supplement entitled Identifying and Intervening on Social Needs in Clinical Settings: Evidence and Evidence Gaps, which is sponsored by the Agency for Healthcare Research and Quality of the U.S. Department of Health and Human Services, Kaiser Permanente, and the Robert Wood Johnson Foundation.

Combining Real-Time Ratings With Qualitative Interviews to Develop a Smoking Cessation Text Messaging Program for Primary Care Patients.

BACKGROUND: Text messaging (short message service, SMS) interventions show promise as a way to help cigarette smokers quit. Few studies have examined the effectiveness of text messaging (SMS) programs targeting smokers associated with primary care or hospital settings. OBJECTIVE: This study aimed to develop a text messaging (SMS) program targeting primary care smokers. METHODS: Adult smokers in primary care were recruited from February 2017 to April 2017. We sent patients 10 to 11 draft text messages (SMS) over 2 days and asked them to rate each message in real time. Patients were interviewed daily by telephone to discuss ratings, message preferences, and previous experiences with nicotine replacement therapy (NRT). Content analysis of interviews was directed by a step-wise text messaging (SMS) intervention development process and the Information-Motivation-Behavioral Skills model of medication adherence. RESULTS: We sent 149 text messages (SMS) to 15 patients. They replied with ratings for 93% (139/149) of the messages: 134 (96%, 134/139) were rated as clear or useful and 5 (4%, 5/139) as unclear or not useful. Patients' preferences included the addition of graphics, electronic cigarette (e-cigarette) content, and use of first names. Regarding NRT, patients identified informational gaps around safety and effectiveness, preferred positively framed motivational messages, and needed behavioral skills to dose and dispose of NRT. CONCLUSIONS: Patients recommended text message (SMS) personalization, inclusion of e-cigarette information and graphics, and identified barriers to NRT use. Combining real-time ratings with telephone interviews is a feasible method for incorporating primary care patients' preferences into a behavioral text messaging (SMS) program.

Medically Tailored Meal Delivery for Diabetes Patients with Food Insecurity: a Randomized Cross-over Trial.

BACKGROUND: Food insecurity, defined as inconsistent food access owing to cost, leads to poor health. OBJECTIVE: To test whether a medically tailored meal delivery program improved dietary quality in individuals with type 2 diabetes and food insecurity. DESIGN: Randomized cross-over clinical trial. PARTICIPANTS: Forty-four adults with diabetes, hemoglobin A1c > 8.0%, and food insecurity (defined as at least one positive item on the two-item "Hunger Vital Sign"). INTERVENTION: In the Community Servings: Food as Medicine for Diabetes cross-over clinical trial (NCT02426138), conducted from June 2015 to July 2017, we randomly assigned the order of "on-meals" (home delivery of 10 meals/week for 12 weeks delivered by Community Servings, a non-profit organization) and "off-meals" (12 weeks usual care and a Choose MyPlate healthy eating brochure) periods. MAIN MEASURES: The primary outcome was Healthy Eating Index 2010 score (HEI), assessed by three 24-h food recalls in both periods. Higher HEI score (range 0-100; clinically significant difference 5) represents better dietary quality. Secondary outcomes included food insecurity and self-reported hypoglycemia. KEY RESULTS: Mean "on-meal" HEI score was 71.3 (SD 7.5) while mean "off-meal" HEI score was 39.9 (SD 7.8) (difference 31.4 points, p < 0.0001). Participants experienced improvements in almost all sub-categories of HEI score, with increased consumption of vegetables, fruits, and whole grains and decreased solid fats, alcohol, and added sugar consumption. Participants also reported lower food insecurity (42% "on-meal" vs. 62% "off-meal," p = 0.047), less hypoglycemia (47% "on-meal" vs. 64% "off-meal," p = 0.03), and fewer days where mental health interfered with quality of life (5.65 vs. 9.59 days out of 30, p = 0.03). CONCLUSIONS: For food-insecure individuals with diabetes, medically tailored meals improved dietary quality and food insecurity and reduced hypoglycemia. Longer-term studies should evaluate effects on diabetes control (e.g., hemoglobin A1c) and patient-reported outcomes (e.g., well-being).

Food Insecurity and Diabetes in Developed Societies.

Food insecurity is an important issue in public health even in developed societies, particularly for vulnerable populations. Food insecurity refers to the uncertain or limited access to adequate and safe foods. Emerging evidence shows an association between food insecurity, type 2 diabetes risk factors, and management of type 1 and type 2 diabetes. A review of the current literature describing the association between food insecurity and diabetes reveals possible mechanisms and pathophysiologic pathways. There is less evidence for effective interventions, and much of the current literature is limited to cross-sectional studies. Future work should evaluate longitudinal associations and ways to help vulnerable patients with diabetes access adequate food for effective diabetes management.