Although there is overrepresentation of African Americans among patients with major risk factors for NASH, individuals of primarily African American descent are infrequently represented among our patients with NASH or cryptogenic cirrhosis. This could result from underrecognition, underreferral, or a true lower prevalence of these disorders among African Americans.

mHealth has been proposed to address inefficiencies in the current South African healthcare system, including home-based HIV testing and counseling (HTC) programs. Yet wide-scale adoption of mHealth has not occurred. Even as infrastructure barriers decrease, a need to better understand perceived adoption barriers by stakeholders remains. We conducted focus group discussions (FGD) in South Africa in 2016 with 10 home-based HTC field staff, 12 community health workers (CHWs) and 10 persons living with HIV (PLH). Key informant (KI) interviews were conducted with five health officials. Perceptions about current home-based HTC practices, future mHealth systems and the use of biometrics for patient identification were discussed, recorded and transcribed for qualitative analysis. Themes were based on a conceptual model for perceived mHealth service quality. Stakeholders brought up a lack of communication in sharing patient health information between clinics, between clinics and CHWs, and between clinics and patients as major barriers to care that mHealth can address. CHWs need better patient information from clinics in terms of physical location and health status to plan visitation routes and address patient needs. CHWs perceive that communication barriers create distrust towards them by clinic staff. PLH want automated appointment and medication reminders. KI see mHealth as a way to improve health information transfer to government officials to better allocate healthcare resources. Stakeholders are also optimistic about the ability for biometrics to improve patient identification but disagreed as to which biometrics would be acceptable, especially in older patients. All stakeholders provided useful information towards the development of mHealth systems. Hospitals are adopting patient-centered approaches that solicit feedback from patients and incorporate them into decision-making processes. A similar approach is needed in the development of mHealth systems. Further, such systems are critical to the successful extension of the health system from health facilities into people’s homes.

BackgroundAmong youth living with HIV (YLH) aged 12-24 years who have health care in the United States, only 30% to 40% are virally suppressed. YLH must achieve viral suppression in order to reduce the probability of infecting others as well as increasing the length and quality of their own life.ObjectiveThis randomized controlled trial aimed to evaluate the efficacy of an Enhanced Standard Care condition (n=110) compared to an Enhanced Stepped Care intervention condition (n=110) to increase viral suppression among YLH aged 12-24 years with established infection (not acutely infected).MethodsYLH (N=220) who are not virally suppressed will be identified at homeless shelters, health clinics, and gay-identified community-based organizations in Los Angeles, CA, and New Orleans, LA. Informed consent will be obtained from all participants. YLH will be randomly assigned to one of two study conditions: Enhanced Standard Care, which includes standard clinical care plus an automated messaging and monitoring intervention (AMMI), or an Enhanced Stepped Care, which includes three levels of intervention (AMMI, Peer Support via social media plus AMMI, or Coaching plus Peer Support and AMMI). The primary outcome is viral suppression of HIV, and YLH will be assessed at 4-month intervals for 24 months. For the Enhanced Stepped Care intervention group, those who do not achieve viral suppression (via blood draw, viral load<200 copies/mL) at any 4-month assessment will “step up” to the next level of intervention. Secondary outcomes will be retention in care, antiretroviral therapy adherence, alcohol use, substance use, sexual behavior, and mental health symptoms.ResultsRecruitment for this study began in June 2017 and is ongoing. We estimate data collection to be completed by the end of 2020.ConclusionsThis is the first known application of an Enhanced Stepped Care intervention model for YLH. By providing the lowest level of intervention needed to achieve viral suppression, this model has the potential to be a cost-effective method of helping YLH achieve viral suppression and improve their quality of life.Trial RegistrationClinicalTrials.gov NCT03109431; https://clinicaltrials.gov/ct2/show/NCT03109431International Registered Report Identifier (IRRID)DERR1-10.2196/10791

Background America’s increasing HIV epidemic among youth suggests the need to identify novel strategies to leverage services and settings where youth at high risk (YAHR) for HIV can be engaged in prevention. Scalable, efficacious, and cost-effective strategies are needed, which support youth during developmental transitions when risks arise. Evidence-based behavioral interventions (EBIs) have typically relied on time-limited, scripted, and manualized protocols that were often delivered with low fidelity and lacked evidence for effectiveness. Objective This study aims to examine efficacy, implementation, and cost-effectiveness of easily mountable and adaptable, technology-based behavioral interventions in the context of an enhanced standard of care and study assessments that implement the guidelines of Centers for Disease Control and Prevention (CDC) for routine, repeat HIV, and sexually transmitted infection (STI) testing for high-risk youth. Methods Youth aged between 12 and 24 years (n=1500) are being recruited from community-based organizations and clinics serving gay, bisexual, and transgender youth, homeless youth, and postincarcerated youth, with eligibility algorithms weighting African American and Latino youth to reflect disparities in HIV incidence. At baseline and 4-month intervals over 24 months (12 months for lower-risk youth), interviewers monitor uptake of HIV prevention continuum steps (linkage to health care, use of pre- or postexposure prophylaxis, condoms, and prevention services) and secondary outcomes of substance use, mental health, and housing security. Assessments include rapid diagnostic tests for HIV, STIs, drugs, and alcohol. The study is powered to detect modest intervention effects among gay or bisexual male and transgender youth with 70% retention. Results The project was funded in September 2016 and enrollment began in May 2017. Enrollment will be completed between June and August 2019. Data analysis is currently underway, and the first results are expected to be submitted for publication in 2019. Conclusions This hybrid implementation-effectiveness study examines alternative models for implementing the CDC guidelines for routine HIV/STI testing for YAHR of acquiring HIV and for delivering evidence-based behavioral intervention content in modular elements instead of scripted manuals and available over 24 months of follow-up, while also monitoring implementation, costs, and effectiveness. The greatest impacts are expected for coaching, whereas online group peer support is expected to have lower impact but may be more cost-effective. Trial Registration ClinicalTrials.gov NCT03134833; https://clinicaltrials.gov/ct2/show/NCT03134833 (Archived by WebCite at http://www.webcitation.org/76el0Viw9) International Registered Report Identifier (IRRID) DERR1-10.2196/11165

Introduction Strategies are needed to improve the efficacy of paraprofessional home visitors for pregnant women in the United States. This study evaluates the maternal and child outcomes when evidence-based practices (EBP) are replicated with flexibility, rather than fidelity to a manualized intervention. Methods Pregnant mothers (N = 203) in five clinics were recruited in the waiting rooms and randomized to standard clinic care as the control condition (n = 104) or standard care plus home visiting (n = 99). Home visitors (n = 9) were selected, trained in foundational skills common to EBP and four problem domains (weight control, breastfeeding, daily habits, and depression). Independent interviewers assessed targeted outcomes at birth (82%) and 6 months later (83%). Results: Home visitors, called Mentor Mothers [MM], made an average of 14.9 home visits or telephone contacts (SD = 9; total contacts = 1491) addressing maternal daily habits, breastfeeding, and depression. Intervention and control mothers were similar in weight, Body Mass Index (BMI), depression and social support at baseline and 6 months later. The percentage of low birth weight babies was similar; intervention infants’ growth (weight/height Z score) tended to be significantly better compared to the control condition. Discussion: There are many explanations for the failure to find significant benefits: insufficient statistical power; the benefits of repeated assessments by warm, supportive peers to improve outcomes; or the failure of EBP and the need to maintain replication with fidelity. All study mothers had better outcomes than documented among comparable published samples of low-income, Latina and Korean–American mothers in Los Angeles, CA. ClinicalTrials.gov registration NCT01687634.

BackgroundYoung men in South Africa face concurrent epidemics of HIV, drug and alcohol abuse, and unemployment. Standard HIV prevention programs, located in healthcare settings and/or using counseling models, fail to engage men. Soccer and vocational training are examined as contexts to deliver male-specific, HIV prevention programs.MethodsYoung men (n = 1200) are randomly assigned by neighborhood to one of three conditions: 1) soccer league (n = 400; eight neighborhoods); 2) soccer league plus vocational training (n = 400; eight neighborhoods); or 3) a control condition (n = 400; eight neighborhoods). Soccer practices and games occur three times per week and vocational training is delivered by Silulo Ulutho Technologies and Zenzele Training and Development. At baseline, 6 months, 12 months, and 24 months, the relative efficacy of these strategies to increase the number of significant outcomes (NSO) among 15 outcomes which occur (1) or not (0) are summed and compared using binomial logistic regressions. The summary primary outcome reflects recent HIV testing, substance abuse, employment, sexual risk, violence, arrests, and mental health status.DiscussionThe failure of men to utilize HIV prevention programs highlights the need for gender-specific intervention strategies. However, men in groups can provoke and encourage greater risk-taking among themselves. The current protocol evaluates a male-specific strategy to influence men’s risk for HIV, as well as to improve their ability to contribute to family income and daily routines. Both interventions are expected to significantly benefit men compared with the control condition.Trial registrationClinicalTrials.gov registration, NCT02358226. Registered 24 November 2014.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2804-3) contains supplementary material, which is available to authorized users.

Background Mothers Living with HIV (MLH) and their children are typically studied to ensure that perinatal HIV transmission is blocked. Yet, HIV impacts MLH and their children lifelong. We examine child outcomes from pregnancy to three years post-birth among a peri-urban population of pregnant MLH and Mothers without HIV (MWOH). Methods Almost all pregnant women in 12 neighborhoods (98%; N=584) in Cape Town, South Africa were recruited and repeatedly assessed within two weeks of birth (92%), at 6 months (88%), 18 months (84%), and three years post-birth (86%). There were 186 MLH and 398 MWOH. Controlling for neighborhood and repeated measures, child and maternal outcomes were contrasted over time using longitudinal random effects regression analyses. For measures collected only at three years, outcomes were analyzed using multiple regressions. Results Compared to MWOH, MLH had less income, more informal housing and food insecurity, used alcohol more often during pregnancy, and were more depressed during pregnancy and over time. Only 4.8% of MLH's children were seropositive; seropositive children were excluded from additional analyses. Children of MLH tended to have significantly lower weights (p<.10) over time (i.e., lower weight-for-age Z-scores) and were also hospitalized significantly more often than children of MWOH (p<.01). Children of MLH and MWOH died at similar rates (8.5%) and were similar in social and behavioral adjustment, vocabulary, and executive functioning at three years post-birth. Conclusions Despite living in households with fewer resources and having more depressed mothers, only the physical health of children of MLH is compromised, compared to children of MWOH. In township neighborhoods with extreme poverty, social, behavioral, language, and cognitive functioning appear similar over the first three years of life between children of MLH and MWOH.

Background: The rate of HIV has doubled in the last 15 years among young people to 22% of HIV cases. Scientific advances in biomedical HIV prevention strategies have not been utilized by youth. Methods/Design: Young people aged 12 -24 years old (n= 1500) are being recruited from community-based organizations (CBO) and clinics serving gay, bisexual, and transgender youth, homeless youth, youth on probation or released from incarceration, and youth in other high-risk venues (e.g., bars and clubs). Youth are randomized in a factorial design to: 1) an automated messaging and monitoring intervention (AMMI) using text messages (n = 900); 2) AMMI plus peer support via private social media (n = 200); 3) AMMI plus strengths-based coaching (n = 200); and 4) AMMI, peer support, and coaching (n = 200). At four-month intervals over 24 months, interviewers monitor: uptake of the steps in the HIV Prevention Continuum (linkage to health care and adherence to pre-or post-exposure prophylaxis or 100% condom use), and conduct repeat rapid diagnostic tests for HIV, sexually transmitted infections (STI), drugs and alcohol use. Weekly automated monitoring via text (or email) in AMMI includes questions on acute HIV and STI symptoms for immediate follow-up by interviewers to provide HIV and STI testing, STI treatment, and partner therapy. Discussion: The greatest impacts are expected among youth receiving the most intensive intervention (i.e., AMMI, peer support, and coach). However, the youth's concurrent mental health, substance abuse, and housing and food security are expected to be significant covariates that influence the uptake of the HIV Prevention Continuum. This study operationalizes the guidelines of the Centers of Disease Control and Prevention (CDC) regarding the prevention of HIV among the highest risk youth, using community-based point of care diagnostics supported by scalable technology-mediated interventions. Similarly, over 90% of adolescents under age 18 go online daily, more than half several times a day which is facilitated by access to smartphones among 75% of youth of each ethnicity, crossing the digital divide [28]. Much of this online activity is driven by social media use, particularly via smartphones -for example, over 70% of adolescents under 18 years use Facebook, while about half also use Instagram and Snapchat [28]. The interventions in this study use text messaging and social media to engage "youth where they are" in the digital environment. This approach has resulted in four intervention arms which vary in intensity and costs. In order of increasing intensity and costs, the interventions are: 1) automated text-messaging and weekly monitoring probes; 2) peer support via social media; 3) paraprofessional coaching; and 4) all three combined. This study's automated and interpersonally-mediated technology-based interventions will be based on the shared features of existing EBI -we will not create a new app nor an EBI with a manual to be replicated with 6 fidelity [14,33,34]. In the last 25 years, over...