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Abstract Background Poor person-centered maternal care (PCMC) contributes to high maternal mortality and morbidity, directly and indirectly, through lack of, delayed, inadequate, unnecessary, or harmful care. While evidence on poor PCMC prevalence, as well as inequities, expanded in the last decade, there is still a significant gap in evidence-based interventions to address PCMC. We describe the protocol for a trial to test the effectiveness of the “Caring for Providers to Improve Patient Experience” (CPIPE) intervention, which includes five strategies, targeting provider stress and bias as intermediate factors to improve PCMC and address inequities. Methods The trial will assess the effect of CPIPE on PCMC, as well as on intermediate and distal outcomes, using a two-arm cluster randomized controlled trial in 40 health facilities in Migori and Homa Bay Counties in Kenya and Upper East and Northeast Regions in Ghana. Twenty facilities in each country will be randomized to 10 intervention and 10 control sites. The primary intervention targets are all healthcare workers who provide maternal health services. The intervention impact will be assessed among healthcare workers in the study health facilities and among women who give birth in the study health facilities. The primary outcome is PCMC measured with the PCMC scale, via multiple cross-sectional surveys of mothers who gave birth in the preceding 12 weeks in study facilities at baseline (prior to the intervention), midline (6 months after intervention start), and endline (12 months post-baseline) (N = 2000 across both countries at each time point). Additionally, 400 providers in the study facilities across both countries will be followed longitudinally at baseline, midline, and endline, to assess intermediate outcomes. The trial incorporates a mixed-methods design; survey data alongside in-depth interviews (IDIs) with healthcare facility leaders, providers, and mothers to qualitatively explore factors influencing the outcomes. Finally, we will collect process and cost data to assess intervention fidelity and cost-effectiveness. Discussion This trial will be the first to rigorously assess an intervention to improve PCMC that addresses both provider stress and bias and will advance the evidence base for interventions to improve PCMC and contribute to equity in maternal and neonatal health. Trial registration ClinicalTrials.gov: NCT06085105. Protocol version and date: v2-11-07-23

Abstract Background People living with HIV (PLWH) are at increased risk of cardiometabolic disorders (CMD). Adequate access to care for both HIV and CMD is crucial to improving health outcomes; however, there is limited research that have examined couples’ experiences accessing such care in resource-constrained settings. We aimed to identify barriers to accessing CMD care among PLWH in Malawi and the role of partners in mitigating these barriers. Methods We conducted a qualitative investigation of barriers to CMD care among 25 couples in Malawi. Couples were eligible if at least one partner was living with HIV and had hypertension or diabetes (i.e., the index patient). Index patients were recruited from HIV care clinics in the Zomba district, and their partners were enrolled thereafter. Interviews were conducted separately with both partners to determine barriers to CMD care access and how partners were involved in care. Results Participants framed their experiences with CMD care by making comparisons to HIV treatment, which was free and consistently available. The main barriers to accessing CMD care included shortage of medications, cost of tests and treatments, high cost of transportation to health facilities, lengthy wait times at health facilities, faulty or unavailable medical equipment and supplies, inadequate monitoring of patients’ health conditions, some cultural beliefs about causes of illness, use of herbal therapies as an alternative to prescribed medicine, and inadequate knowledge about CMD treatments. Partners provided support through decision-making on accessing medical care, assisting partners in navigating the healthcare system, and providing financial assistance with transportation and treatment expenses. Partners also helped manage care for CMD, including communicating health information to their partners, providing appointment reminders, supporting medication adherence, and supporting recommended lifestyle behaviors. Conclusions Couples identified many barriers to CMD care access, which were perceived as greater challenges than HIV care. Partners provided critical forms of support in navigating these barriers. With the rise of CMD among PLWH, improving access to CMD care should be prioritized, using lessons learned from HIV and integrated care approaches. Partner involvement in CMD care may help mitigate most barriers to CMD care.

Abstract Background Transgender women are disproportionately affected by both HIV and gender-based violence (GBV), defined as physical, sexual, or emotional violence perpetrated against an individual based on their gender identity/expression. While a growing body of evidence demonstrates that GBV leads to poor HIV care and treatment outcomes among cisgender women, less research has examined this association among transgender women. We assessed the impact of lifetime experiences of GBV on subsequent retention in HIV care and laboratory confirmed viral suppression among a sample of transgender women living with HIV (TWH) in Brazil. Methods A pilot trial of a peer navigation intervention to improve HIV care and treatment among TWH was conducted in São Paulo, Brazil between 2018 and 2019. TWH were recruited and randomized into the intervention or control arm and participated in a baseline and 9-month follow-up survey and ongoing extraction of clinical visit, prescribing, and laboratory data. Generalized linear model regressions with a Poisson distribution estimated the relative risk (RR) for the association of lifetime physical and sexual violence reported at baseline with treatment outcomes (retention in HIV care and viral suppression) at follow-up, adjusting for baseline sociodemographic characteristics. Results A total of 113 TWH participated in the study. At baseline, median age was 30 years, and the prevalence of lifetime physical and sexual violence was 62% and 45%, respectively. At follow-up, 58% (n = 66/113) were retained in care and 35% (n = 40/113) had evidence of viral suppression. In adjusted models, lifetime physical violence was non-significantly associated with a 10% reduction in retention in care (aRR: 0.90, 95% CI: 0.67, 1.22) and a 31% reduction in viral suppression (aRR: 0.69; 95% CI: 0.43, 1.11). Lifetime sexual violence was non-significantly associated with a 28% reduction in retention in HIV care (aRR: 0.72, 95% CI: 0.52, 1.00) and significantly associated with a 56% reduction in viral suppression (aRR: 0.44; 95% CI: 0.24, 0.79). Conclusion Our findings are among the first to demonstrate that lifetime experiences with physical and sexual violence are associated with poor HIV outcomes over time among transgender women. Interventions seeking to improve HIV treatment outcomes should assess and address experiences of GBV among this population. Trial registration ClinicalTrials.gov Identifier: NCT03525340.

Abstract Introduction HIV stigma can impact couple relationships through stress or bring partners closer through shared experiences. Conversely, couple relationships may protect against the harms of stigma, including anticipated stigma on negative health outcomes. Yet few studies have assessed the potential link between HIV stigma, relationship dynamics, and antiretroviral therapy (ART) adherence. Using dyadic data from a cross-sectional study of Malawian couples living with HIV, we tested associations between anticipated stigma and: 1) relationship dynamics (e.g., trust, sexual satisfaction, communication) and partner support; and 2) self-reported ART adherence. Methods Heterosexual couples (211 couples, 422 individuals) with at least one partner on ART were recruited from clinics in Zomba, Malawi. Partners completed separate surveys on anticipated stigma, relationship dynamics, and ART adherence. Linear mixed models evaluated associations between anticipated stigma and relationship dynamics, and whether associations varied by gender. Generalized estimating equation models tested for associations between anticipated stigma and high ART adherence (90–100% vs.

Abstract Background Suubi is an evidenced based multi-component intervention that targets psychosocial and economic hardships to improve ART adherence, viral suppression, mental health, family financial stability, and family cohesion for adolescents living with HIV (ALHIV) in Uganda. Suubi was originally tested as a combined package of four components: 1) Financial Literacy Training; 2) incentivized matched Youth Savings Accounts with income-generating activities; 3) a manualized and visual-based intervention for ART adherence and stigma reduction; and 4) engagement with HIV treatment-experienced role models. However, it is unknown if each component in Suubi had a positive effect, how the components interacted, or if fewer components could have produced equivalent effects. Hence, the overall goal of this new study is to identify the most impactful and sustainable economic and psychosocial components across 48 health clinics in Uganda. Methods A total of 576 ALHIV (aged 11–17 years at enrollment) will be recruited from 48 clinics and each clinic will be randomized to one of 16 study conditions. Each condition represents every possible combination of the 4 components noted above. Assessments will be conducted at baseline, 12, 24, 36 and 48- months post-intervention initiation. Using the multi-phase optimization strategy (MOST), we will identify the optimal combination of components and associated costs for viral suppression, as well as test key mediators and moderators of the component-viral suppression relationship. Discussion The study is a shift in the paradigm of research to use new thinking to build/un-pack highly efficacious interventions that lead to new scientific knowledge in terms of understanding what drives an intervention’s success and how to iterate on them in ways that are more efficient, affordable and scalable. The study advances intervention science for HIV care outcomes globally. Trial Registration This project was registered at clinicaltrials.gov (NCT05600621) on October, 31, 2022. https://clinicaltrials.gov/ct2/show/NCT05600621

Abstract Background People who inject drugs living with HIV (PWIDLH) suffer the lowest rates of HIV viral suppression due to episodic injection drug use and poor mental health coupled with poor retention in HIV care. Approximately 44% of PWIDLH along the US-Mexico border are retained in care and only 24% are virally suppressed. This underserved region faces a potential explosion of transmission of HIV due to highly prevalent injection drug use. This protocol describes an optimization trial to promote sustained viral suppression among Spanish-speaking Latinx PWIDLH. Methods The multiphase optimization strategy (MOST) is an engineering-inspired framework for designing and building optimized interventions and guides this intervention. The primary aim is to conduct a 24 factorial experiment in which participants are randomized to one of 16 intervention conditions, with each condition comprising a different combination of four behavioral intervention components. The components are peer support for methadone uptake and persistence; behavioral activation therapy for depression; Life-Steps medication adherence counseling; and patient navigation for HIV care. Participants will complete a baseline survey, undergo intervention, and then return for 3-,6-,9-, and 12-month follow-up assessments. The primary outcome is sustained viral suppression, defined as viral loads of

ABSTRACT: Objectives: We examined sex-specific associations of partner age disparity and relationship concurrency with Neisseria gonorrhoeae and/or Chlamydia trachomatis (NG/CT) infection, higher-risk relationships, and condom use as proxies for HIV risk. Methods: Data were collected in 2016 from 2179 adults in 12 communities in Uganda and Kenya. Logistic regression models examined associations of age disparity and relationship concurrency with NG/CT infection, condom use, and higher-risk (commercial sex and other higher-risk) relationships in the past 6 months, controlling for covariates. Results: Partner age and relationship concurrency were associated with NG/CT infection in women but not men. Relative to women in age-disparate relationships, women in both age-disparate and age-homogeneous relationships had higher odds of NG/CT infection (adjusted odds ratio [aOR]=3.82, 95% confidence interval [CI]: 1.46–9.98). Among men and women, partnership concurrency was associated with higher-risk partnerships. In addition, relative to those with a single age-homogeneous partner, those with concurrent age-homogeneous partners had higher odds of condom use (men: aOR=2.85, 95% CI: 1.89–4.31; women: aOR=2.99, 95% CI: 1.52–5.89). Concurrent age-disparate partnerships were associated with condom use among men only (aOR=4.02, 95% CI: 2.54–6.37). Conclusion: Findings underscore the importance of targeted HIV prevention efforts for couples in age-disparate and concurrent relationships.

Abstract Background Sub-Saharan Africa (SSA) is heavily burdened by HIV, with 85% of the global new infections among adolescents happening in the region. With advances in medication and national policies promoting antiretroviral therapy (ART), children < 15 years living with HIV (CLWH) continue to grow with a chronic, highly stigmatized disease. Unfortunately, the stigma they experience results in much lower quality of life, including poor mental health and treatment outcomes. Family members also experience stigma and shame by virtue of their association with an HIV-infected family member. Yet, stigma-reduction interventions targeting CLWH and their families are very limited. The goal of this study is to address HIV-associated stigma among CLWH and their caregivers in Uganda. Methods This three-arm cluster randomized control trial, known as Suubi4Stigma, will evaluate the feasibility, acceptability, and preliminary impact of two evidence-based interventions: (1) group cognitive behavioral therapy (G-CBT) focused on cognitive restructuring and strengthening coping skills at the individual level and (2) a multiple family group (MFG) intervention that strengthens family relationships to address stigma among CLWH (N = 90, 10–14 years) and their families (dyads) in Uganda. Nine clinics will be randomized to one of three study arms (n = 3 clinics, 30 child-caregiver dyads each): (1) usual care; (2) G-CBT + usual care; and (3) MFG + usual care. Both treatment and control conditions will be delivered over a 3-month period. Data will be collected at baseline (pre-intervention) and at 3 months and 6 months post-intervention initiation. Conclusion The primary aim of the proposed project is to address the urgent need for theoretically and empirically informed interventions that seek to reduce HIV-associated stigma and its negative impact on adolescent health and psychosocial well-being. As several countries in SSA grapple with care and support for CLWH, this study will lay the foundation for a larger intervention study investigating how HIV-associated stigma can be reduced to foster healthy child development—especially for CLWH as they transition through adolescence. Trial registration ClinicalTrials.gov: NCT04528732 ; Registered August 27, 2020

Abstract Background Food insecurity is an important underlying driver of HIV risk and vulnerability among adolescents in sub-Saharan Africa. In this region, adolescents account for 80% of all new HIV infections. The primary purpose of this analysis is to understand perceived mechanisms for how a multisectoral agricultural intervention influenced sexual risk taking among HIV-affected adolescents in southwestern Kenya. Methods We conducted semi-structured, individual interviews with 34 adolescent-caregiver dyads who were participants in Adolescent Shamba Maisha (NCT03741634), a sub-study of adolescent girls and caregivers with a household member participating in the Shamba Maisha trial (NCT01548599), a multi-sectoral agricultural and microfinance intervention. Interviews were audiotaped, transcribed, translated, and analyzed using framework and interpretive description analysis methods. Results Adolescents receiving the Shamba Maisha intervention described no longer needing to engage in transactional sex or have multiple concurrent sexual partners as a way to meet their basic needs, including food. Key mechanisms for these effects include greater sexual agency among adolescent girls, and increased confidence and self-efficacy in overcoming existing reciprocity norms and sexual relationship power inequity; as well as staying in school. The intervention also increased caregiver confidence in talking about adolescent sexual reproductive health issues. In contrast, driven primarily by the need for food and basic needs, girls in the control arms described engaging in transactional sex, having multiple sexual partners, being unable to focus in school, getting pregnant or becoming HIV infected. Conclusion These findings emphasize the need to address food insecurity as a part of structural interventions targeting adolescent HIV risk in low-resource countries. We recommend that future interventions build upon the Shamba Maisha model by combining sustainable agricultural production, with household level interventions that deliberately target gender norms that contribute to unequal power dynamics.

Introduction: The minority stress model is the primary explanatory model for disparities in substance use and other mental health problems among sexual minority men (SMM) compared to heterosexual men. This pilot randomized controlled trial tested the feasibility of AWARENESS, a novel 9-session cognitive-behavioral psychotherapeutic intervention that targets intersectional minority stress and stigma, among sexual minority men living with HIV who use substances. Methods: Feasibility was determined by the number of participants screened to obtain the target sample size, the percentage of eligible participants randomized, percentage of study intervention and assessment visits attended, time to complete study procedures, and percentage of data completeness of intervention assessments. Forty-two sexual minority men living with HIV with any illicit substance use or who reported at least one occasion of consuming five or more drinks in one setting in the last three months were randomized to AWARENESS (n = 22) or an attention control condition (n = 20). Results: Feasibility of the trial was supported, with adequate completion of study procedures and visits (73% completed all intervention sessions, 71% completed all study assessment sessions). This trial also demonstrated the feasibility of using AWARENESS skills and strategies in relation to multiple intersecting identities, with participants discussing an average of 5.7 identities (e.g., sexual orientation) or individual characteristics (e.g., socioeconomic status) in relation to intervention content. Conclusion: Our results support the feasibility of an AWARENESS trial to reduce intersectional minority stress related to multiple identities and characteristics among sexual minority men living with HIV who use substances.

Abstract Background In this paper, we argue for Gender as a Sociocultural Variable (GASV) as a complement to Sex as a Biological Variable (SABV). Sex (biology) and gender (sociocultural behaviors and attitudes) interact to influence health and disease processes across the lifespan—which is currently playing out in the COVID-19 pandemic. This study develops a gender assessment tool—the Stanford Gender-Related Variables for Health Research—for use in clinical and population research, including large-scale health surveys involving diverse Western populations. While analyzing sex as a biological variable is widely mandated, gender as a sociocultural variable is not, largely because the field lacks quantitative tools for analyzing the influence of gender on health outcomes. Methods We conducted a comprehensive review of English-language measures of gender from 1975 to 2015 to identify variables across three domains: gender norms, gender-related traits, and gender relations. This yielded 11 variables tested with 44 items in three US cross-sectional survey populations: two internet-based (N = 2051; N = 2135) and a patient-research registry (N = 489), conducted between May 2017 and January 2018. Results Exploratory and confirmatory factor analyses reduced 11 constructs to 7 gender-related variables: caregiver strain, work strain, independence, risk-taking, emotional intelligence, social support, and discrimination. Regression analyses, adjusted for age, ethnicity, income, education, sex assigned at birth, and self-reported gender identity, identified associations between these gender-related variables and self-rated general health, physical and mental health, and health-risk behaviors. Conclusion Our new instrument represents an important step toward developing more comprehensive and precise survey-based measures of gender in relation to health. Our questionnaire is designed to shed light on how specific gender-related behaviors and attitudes contribute to health and disease processes, irrespective of—or in addition to—biological sex and self-reported gender identity. Use of these gender-related variables in experimental studies, such as clinical trials, may also help us understand if gender factors play an important role as treatment-effect modifiers and would thus need to be further considered in treatment decision-making.

Background: Substance use and mental health are two barriers to engagement in care and antiretroviral therapy (ART) adherence among youth and young adults living with HIV (YLWH). The consequences of suboptimal adherence in YLWH are increased risk of HIV transmission and a future generation of immunodeficient adults with drug-resistant virus. Methods: The Youth to Telehealth and Texting for Engagement in Care (Y2TEC) study was a pilot randomized crossover trial that examined the feasibility and acceptability of a novel video-counseling series and accompanying text messages aimed at mental health, substance use, and HIV care engagement for YLWH. The intervention consisted of twelve 20?30-min weekly video-counseling sessions focused on identifying and addressing barriers to HIV care, mental health, and substance use challenges. Participants completed quantitative surveys at baseline, 4 months, and 8 months. Feasibility and acceptability were evaluated using prespecified benchmarks. Results: Fifty YLWH aged 18?29 years living in the San Francisco Bay Area were enrolled. Eighty-six percent and 75% of participants were retained at 4 and 8 months, respectively. A total of 455 (76%) video-counseling sessions were completed. In 82% of sessions, participants responded that they strongly agreed/agreed with this statement: ?I felt heard, understood, and respected by the counselor.? In 81% of sessions, participants responded that they strongly agreed/agreed with this statement: ?Overall, today's session was right for me.? At baseline, among participants reporting mental health challenges, only 10% noted having ever received mental health services, and among those who reported substance use challenges, ?19% reported ever receiving substance use services. After 4 months of the Y2TEC intervention, participants reported slightly higher ART adherence and HIV knowledge, decreased depression and anxiety, and reduced stigma related to mental health and substance use. Conclusions: The Y2TEC intervention using video-counseling and text messaging was feasible and acceptable for YLWH. ClinicalTrials.gov ID: NCT03681145

Abstract Background HIV-related maternal deaths and HIV infection among infants remain unacceptably high across sub-Saharan Africa despite increased antenatal care attendance and provision of antiretroviral therapy to pregnant women. In the Jamii Bora (“Better Family” in Swahili) Study, we seek to test the efficacy of an interdependence theory-based couple intervention. The intervention reaches pregnant women and male partners through home visits by male-female pairs of lay health workers. The aim is to increase access to home-based couples’ HIV testing and counseling services to improve family health. Methods This is a three-arm randomized control trial among 1080 pregnant women 15 years of age or older, living with their male partners, and who have not undergone couples’ HIV testing and counseling in Kisumu and Migori Counties in Kenya. Couples will be randomized into three groups: home-based couple visits, HIV self-testing kits for couple use, or standard care (male partner clinic invitation letters). Participants will be followed up to 18 months postpartum. The study has three aims: in aim 1, we will determine the effects of the intervention on our primary outcome of couple HIV testing, compared to HIV self-testing kits and standard care; in aim 2, we will examine the intervention impact on HIV prevention behaviors, facility delivery, and postnatal healthcare utilization, as well as secondary health outcomes of maternal viral suppression and HIV-free child survival up to 18 months for couples living with HIV; and in aim 3, we will compare the cost-effectiveness of the home-based couple intervention to the less resource-intensive strategies used in the other two study arms. Assessments with couples are conducted at baseline, late pregnancy, and at months 3, 6, 12, and 18 after birth. Discussion The results from this study will inform decision-makers about the cost-effective strategies to engage pregnant couples in the prevention of mother-to-child transmission and family health, with important downstream benefits for maternal, paternal, and infant health. Trial registration ClinicalTrials.gov NCT03547739 . Registered on May 9, 2018

Abstract Background Youth living with HIV (YLHIV) in Sub-Saharan African (SSA) are less likely to adhere to antiretroviral therapy (ART) and other health-related regimens. As a consequence, YLHIV are not only at risk for health problems and mental health comorbidities, but are also at risk for cognitive deficits, including in areas of memory and executive functioning. The Suubi+Adherence study followed 702 adolescents (10-16 years of age) receiving bolstered standard of care and a family economic empowerment intervention comprising an incentivized youth financial savings account (YSA) augmented with financial literacy training (FLT) and peer mentorship. The study findings pointed to superior short-term viral suppression and positive adolescent health and mental health functioning among participants receiving the intervention. The original group of adolescents who received Suubi+Adherence are now transitioning into young adulthood. This paper presents a protocol for the follow-up phase titled Suubi+Adherence Round 2. Methods The original cohort in Suubi+Adherence will be tracked for an additional five years (2020-2025). Specifically, the long term follow-up will allow to: 1) ascertain the extent to which the short term outcomes identified in the first 6 years of the intervention are maintained as the same group transitions through young adulthood; and 2) address new scientific questions regarding ART adherence; HIV care engagement; protective health behaviors; and the potential of FEE to mitigate the development of HIV-associated neurocognitive disorders in YLHIV. Additionally, the team examines the potential mechanisms through which the observed long-term outcomes happen. Moreover, the Suubi+Adherence-Round 2 adds a qualitative component and extends the cost effectiveness component. Discussion Guided by asset and human development theories, Suubi+Adherence-R2 will build on the recently concluded Suubi+Adherence study to conduct one of the largest and longest running studies of YLHIV in SSA as they transition into young adulthood. The study will address new scientific questions regarding long-term ART adherence, HIV care engagement, protective health behaviors, and the potential of FEE to mitigate the development of HIV-associated neurocognitive disorders in YLHIV. The findings may inform efforts to improve HIV care among Uganda’s YLHIV, with potential replicability in other low-resource countries. Trial registration ClinicalTrials.gov , ID: NCT01790373

Abstract Background The International Labor Organization (ILO) estimates that 11% of children (ages 5 to 17) worldwide are child laborers. ILO recently drew attention to migrant child laborers as an underreported, but more vulnerable group to adverse outcomes relative to children working locally. Sub-Saharan Africa (SSA) continues to be the continent with the highest rates of child labor, with Ghana registering one of the highest incidence rates at 22%, including unaccompanied child migrants engaged in labor. Adolescent girls make up the majority of unaccompanied rural-to-urban migrants in search of better economic opportunities. Studies document the myriad of serious threats to health and emotional well-being experienced by adolescent girls who migrate to engage in child labor. These threats underline the urgent need for theoretically informed preventive interventions, specifically tailored to address the root causes of female child migrant labor and the needs of girls from economically insecure families and communities. Methods A two-arm cluster randomized control trial will be conducted to assess the feasibility, acceptability, and preliminary impact of ANZANSI (family economic empowerment + multiple family groups) among 100 adolescent girls and their caregivers in the Northern Region of Ghana. Ten schools will be randomly selected from a list of eligible schools, and randomized to one of two study arms: (1) control arm (n = 5 schools, n = 50 adolescent-caregiver dyads); (2) treatment arm (n = 5 schools, n = 50 adolescent-caregiver dyads) receiving ANZANSI over a 9-month period. Adolescents (ages 11 to 14) in the same school will be assigned to the same study condition to avoid contamination. Discussion The primary aim of the study is to address the urgent need for theoretically and empirically informed interventions that prevent adolescent girls’ unaccompanied rural-to-urban migration for child labor. Existing programs are not preventive and primarily target children who already migrated to the city and are living and working on the streets. This study is one of the first studies to pilot test a combination intervention, integrating family economic empowerment targeting household poverty with multiple family groups addressing family cohesion and perceptions on gender norms, child education/labor, all of which are factors, when combined, force girls to drop out of school and migrate. Trial registration ClinicalTrials.gov ; NCT04231669 ; Registered January 18, 2020;

Background The bidirectional associations between negative self-conscious emotions such as shame and guilt and substance use are poorly understood. Longitudinal research is needed to examine the causes, consequences, and moderators of negative self-conscious emotions in people who use substances. Methods Using parallel process latent growth curve modeling, we assessed bidirectional associations between shame and guilt and substance use (i.e., number of days in the past 30 used stimulants, alcohol to intoxication, other substances, or injected drugs) as well as the moderating role of positive emotion. Emotions were assessed using the Differential Emotions Scale. The sample included 110 sexual minority cisgender men with biologically confirmed recent methamphetamine use, enrolled in a randomized controlled trial in San Francisco, CA. Participants self-reported emotions and recent substance use behaviors over six time points across 15 months. Results Higher initial levels of shame were associated with slower decreases in stimulant use over time (b = 0.23, p = .041) and guilt was positively associated with stimulant use over time (β = 0.85, p < .0001). Initial levels of guilt and alcohol use were positively related (b = 0.29, p = .040), but over time, they had a negative relationship (β = -0.99, p < .0001). Additionally, higher initial levels of other drug use were associated with slower decreases in shame over time (b = 0.02, p = .041). All results were independent of depression, highlighting the specific role of self-conscious emotions. Conclusions Shame and guilt are barriers to reducing stimulant use, and expanded efforts are needed to mitigate the deleterious effects of these self-conscious emotions in recovery from a stimulant use disorder.

Introduction: Transgender women (assigned “male” at birth but who do not identify as male) are disproportionately impacted by HIV and experience unique barriers and facilitators to HIV care engagement. In formative work, we identified culturally specific and modifiable barriers to HIV treatment engagement among transgender women living with HIV (TWH), including prioritizing transition-related healthcare over HIV treatment, avoiding HIV care settings due to gender-related and HIV stigma, concerns about potential drug interactions with hormones, and inadequate social support. Grounded in the investigators' Models of Gender Affirmation and Health Care Empowerment, we developed the Healthy Divas intervention to optimize engagement in HIV care among TWH at risk for treatment failure and consequential morbidity, mortality, and onward transmission of HIV.Methods and Analysis: We conducted a 2-arm randomized controlled trial (RCT) of the intervention's efficacy in Los Angeles and San Francisco to improve engagement in care among TWH (N = 278). The primary outcome was virologic control indicated by undetectable HIV-1 level (undetectability = < 20 copies/mL), at baseline and follow-up assessment for 12 months at 3-month intervals.Ethics and Dissemination: This study was approved by University of California, San Francisco Institutional Review Board (15-17910) and Western Institutional Review Board (20181370). Participants provided informed consent before enrolment in the study. We are committed to collaboration with National Institutes of Health officials, other researchers, and health and social services communities for rapid dissemination of data and sharing of materials. The results will be published in peer-reviewed academic journals and scientific presentations. We will make our results available to researchers interested in transgender health to avoid unintentional duplication of research, as well as to others in health and social services communities, including HIV clinics, LGBT community-based organizations, and AIDS service organizations.Clinical Trial Registration:Clinicaltrials.gov, identifier NCT03081559.

Major depression is a prevalent psychiatric disorder among people living with HIV (PWH). Major depression symptoms, including suicidal ideation, can hinder clinical care engagement and anti-retroviral treatment adherence. Research suggests that inquiry about major depression symptomatology and suicidal ideation should be standard practice when offering primary care services to PWH. However, studies examining depression and suicidal ideation inquiry are scarce. This study’s aim was to describe medical students’ clinical skills for dealing with major depression symptomatology and suicidal ideation among PWH in Puerto Rico. A total of 100 4th year medical students participated in a Standardized Patient simulation with a trained actor posing as a PWH and with a previous major depression diagnosis. One-way frequency tables were used to characterize the sample and the percentage of each observed clinical skill. Two key findings stem from these results only 10% of the participants referred the patient to psychological/psychiatric treatment, and only 32% inquired about suicidal ideation. Our findings highlight the need for enhancing medical students’ competencies regarding mental health issues, particularly when providing services to at risk populations such as PWH within primary care settings.

Background: Globally, 1.8 million children

Abstract Background Asset-based economic empowerment interventions, which take an integrated approach to building human, social, and economic capital, have shown promise in their ability to reduce HIV risk for young people, including adolescent girls, in sub-Saharan Africa. Similarly, community and family strengthening interventions have proven beneficial in addressing mental health and behavioral challenges of adolescents transitioning to adulthood. Yet, few programs aimed at addressing sexual risk have applied combination interventions to address economic stability and mental health within the traditional framework of health education and HIV counseling/testing. This paper describes a study protocol for a 5-year, NIMH-funded, cluster randomized-controlled trial to evaluate a combination intervention aimed at reducing HIV risk among adolescent girls in Uganda. The intervention, titled Suubi4Her, combines savings-led economic empowerment through youth development accounts (YDA) with an innovative family strengthening component delivered via Multiple Family Groups (MFG). Methods Suubi4Her will be evaluated via a three-arm cluster randomized-controlled trial design (YDA only, YDA + MFG, Usual Care) in 42 secondary schools in the Central region of Uganda, targeting a total of 1260 girls (ages 15–17 at enrollment). Assessments will occur at baseline, 12, 24, and 36 months. This study addresses two primary outcomes: 1) change in HIV risk behavior and 2) change in mental health functioning. Secondary exploratory outcomes include HIV and STI incidence, pregnancy, educational attainment, financial savings behavior, gender attitudes, and self-esteem. For potential scale-up, cost effectiveness analysis will be employed to compare the relative costs and outcomes associated with each study arm. Conclusions Suubi4Her will be one of the first prospective studies to examine the impact and cost of a combination intervention integrating economic and social components to reduce known HIV risk factors and improve mental health functioning among adolescent girls, while concurrently exploring mental health as a mediator in HIV risk reduction. The findings will illuminate the pathways that connect economic needs, mental health, family support, and HIV risk. If successful, the results will promote holistic HIV prevention strategies to reduce risk among adolescent girls in Uganda and potentially the broader sub-Saharan Africa region. Trial registration Clinical Trials NCT03307226 (Registered: 10/11/17).

Abstract Background Obstetric fistula is a debilitating and traumatic birth injury affecting 2–3 million women globally, mostly in sub-Saharan Africa and Asia. Affected women suffer physically, psychologically and socioeconomically. International efforts have increased access to surgical treatment, yet attention to a holistic outcome of post-surgical rehabilitation is nascent. We sought to develop and pilot test a measurement instrument to assess post-surgical family and community reintegration. Methods We conducted an exploratory sequential mixed-methods study, beginning with 16 in-depth interviews and four focus group discussions with 17 women who underwent fistula surgery within two previous years to inform measure development. The draft instrument was validated in a longitudinal cohort of 60 women recovering from fistula surgery. Qualitative data were analyzed through thematic analysis. Socio-demographic characteristics were described using one-way frequency tables. We used exploratory factor analysis to determine the latent structure of the scale, then tested the fit of a single higher-order latent factor. We evaluated internal consistency and temporal stability reliability through Raykov’s ρ and Pearson’s correlation coefficient, respectively. We estimated a series of linear regression models to explore associations between the standardized reintegration measure and validated scales representing theoretically related constructs. Results Themes central to women’s experiences following surgery included resuming mobility, increasing social interaction, improved self-esteem, reduction of internalized stigma, resuming work, meeting their own needs and the needs of dependents, meeting other expected and desired roles, and negotiating larger life issues. We expanded the Return to Normal Living Index to reflect these themes. Exploratory factor analysis suggested a four-factor structure, titled ‘Mobility and social engagement’, ‘Meeting family needs’, ‘Comfort with relationships’, and ‘General life satisfaction’, and goodness of fit statistics supported a higher-order latent variable of ‘Reintegration.’ Reintegration score correlated significantly with quality of life, depression, self-esteem, stigma, and social support in theoretically expected directions. Conclusion As more women undergo surgical treatment for obstetric fistula, attention to the post-repair period is imperative. This preliminary validation of a reintegration instrument represents a first step toward improving measurement of post-surgical reintegration and has important implications for the evidence base of post-surgical reintegration epidemiology and the development and evaluation of fistula programming.

Abstract Background The global response to HIV has started over 18 million persons on life-saving antiretroviral therapy (ART)—the vast majority in low- and middle-income countries (LMIC)—yet substantial gaps remain: up to 40% of persons living with HIV (PLHIV) know their status, while another 30% of those who enter care are inadequately retained after starting treatment. Identifying strategies to enhance use of treatment is urgently needed, but the conceptualization and specification of implementation interventions is not always complete. We sought to assess the completeness of intervention reporting in research to advance uptake of treatment for HIV globally. Methods We carried out a systematic review to identify interventions targeting the adult HIV care cascade in LMIC dating from 1990 to 2017. We identified components of each intervention as “intervention types” to decompose interventions into common components. We grouped “intervention types” into a smaller number of more general “implementation approaches” to aid summarization. We assessed the reporting of six intervention characteristics adapted from the implementation science literature: the actor, action, action dose, action temporality, action target, and behavioral target in each study. Findings In 157 unique studies, we identified 34 intervention “types,” which were empirically grouped into six generally understandable “approaches.” Overall, 42% of interventions defined the actor, 64% reported the action, 41% specified the intervention “dose,” 43% reported action temporality, 61% defined the action target, and 69% reported a target behavior. Average completeness of reporting varied across approaches from a low of 50% to a high of 72%. Dimensions that involved conceptualization of the practices themselves (e.g., actor, dose, temporality) were in general less well specified than consequences (e.g., action target and behavioral target). Implications The conceptualization and Reporting of implementation interventions to advance treatment for HIV in LMIC is not always complete. Dissemination of standards for reporting intervention characteristics can potentially promote transparency, reproducibility, and scientific accumulation in the area of implementation science to address HIV in low- and middle-income countries.

The purpose of this study was to better understand the relation between psychological distress and alcohol and substance related sexual risk in Latino migrant day laborers (LMDLs). In addition to examining the roles of depression and anxiety, it was also necessary to examine the role of desesperación, a popular Latino idiom of distress frequently expressed by LMDLs in response to the thwarting of major migration related life goals such as traveling to the U.S. in search of work to support families, projects and purchases in country of origin. Given the structural vulnerability of LMDLs to under-employment and frequent unemployment, LMDLs also refer to desesperación as a prelude to problem drinking, substance use, and sexual risk taking. Hence we developed and validated a scale of desesperación for LMDLs to explore this culturally relevant construct of psychological distress in this unique population of Latinos. Based on a cross sectional survey of 344 LMDLs, this study found that the dissatisfaction subscale of desesperación predicted alcohol-related sexual risk taking, while depression predicted substance-related sexual risk taking. These findings are discussed including implications of preventing alcohol and substance related sexual risk taking in LMDLs. Keywords: Latinos, Desesperación, Depression, Anxiety, Alcohol, Substance, Sexual risk

We conducted a cross-sectional analysis of baseline data from the Adolescent Trials Network for HIV/AIDS Interventions to examine the association between the use of social media sites to find sex partners and recent diagnosis of sexually transmitted infections (STIs) among 13- to 24-year-old men who have sex with men and transgender women living with HIV. We used linear regression to determine the relationship between the number of STIs and the number of social media sites used to find sex partners with each type of sex act included in the analysis. Secondary analyses substituted frequency of social media site use for number of social media sites. Among 741 participants, for every 1 social media account used to find sex partners, there was a 2.53% (95% confidence interval: 0.28-5.54) increase in STIs. This association was mediated through condomless receptive anal intercourse or condomless insertive anal intercourse but not barrierless oral intercourse. Similar but attenuated associations were found when frequency of social media site use was substituted for number of social media sites. Future research should examine innovative interventions on these social media sites with respect for its users.

Abstract Background Contingency management (CM) is an evidence-based intervention providing tangible rewards as positive reinforcement for abstinence from stimulants such as methamphetamine. Integrative approaches targeting affect regulation could boost the effectiveness of CM in community-based settings and optimize HIV/AIDS prevention efforts. Methods/Design This randomized controlled trial with HIV-positive, methamphetamine-using men who have sex with men (MSM) is examining the efficacy of a 5-session, individually delivered positive affect regulation intervention – Affect Regulation Treatment to Enhance Methamphetamine Intervention Success (ARTEMIS). ARTEMIS is designed to sensitize individuals to non-drug-related sources of reward as well as assist with managing depression and other symptoms of stimulant withdrawal during CM. HIV-positive, methamphetamine-using MSM who are enrolled in a community-based, 12-week CM program are randomized to receive ARTEMIS or an attention-matched control condition. Follow-up assessments are conducted at 3, 6, 12, and 15 months after enrollment in CM. Four peripheral venous blood samples are collected over the 15-month follow-up with specimen banking for planned biomarker sub-studies. The primary outcome is mean HIV viral load. Secondary outcomes include: sustained HIV viral suppression, T-helper cell count, psychological adjustment, stimulant use, and potentially amplified transmission risk behavior. Discussion Implementation of this randomized controlled trial highlights the importance of delineating boundaries between research activities and community-based service provision. It also provides insights into best practices for integrating the distinct agendas of academic and community partners in clinical research. This trial is currently enrolling and data collection is anticipated to be completed in September of 2018. Trial registration This trial was registered on clinicaltrials.gov ( NCT01926184 ) on August 16, 2013.

Scale development and validation are critical to much of the work in the health, social, and behavioral sciences. However, the constellation of techniques required for scale development and evaluation can be onerous, jargon-filled, unfamiliar, and resource-intensive. Further, it is often not a part of graduate training. Therefore, our goal was to concisely review the process of scale development in as straightforward a manner as possible, both to facilitate the development of new, valid, and reliable scales, and to help improve existing ones. To do this, we have created a primer for best practices for scale development in measuring complex phenomena. This is not a systematic review, but rather the amalgamation of technical literature and lessons learned from our experiences spent creating or adapting a number of scales over the past several decades. We identified three phases that span nine steps. In the first phase, items are generated and the validity of their content is assessed. In the second phase, the scale is constructed. Steps in scale construction include pre-testing the questions, administering the survey, reducing the number of items, and understanding how many factors the scale captures. In the third phase, scale evaluation, the number of dimensions is tested, reliability is tested, and validity is assessed. We have also added examples of best practices to each step. In sum, this primer will equip both scientists and practitioners to understand the ontology and methodology of scale development and validation, thereby facilitating the advancement of our understanding of a range of health, social, and behavioral outcomes.

Sleep problems are common for young children especially if they live in adverse home environments. Some studies investigate if young children may also be at a higher risk of sleep problems if they have a specific biological sensitivity to adversity. This paper addresses the research question, does the relations between children’s exposure to family adversities and their sleep problems differ depending on their autonomic nervous system’s sensitivity to challenges? As part of a larger cohort study of Latino, low-income families, we assessed the cross-sectional relations among family demographics (education, marital status), adversities [routines, major life events (MLE)], and biological sensitivity as measured by autonomic nervous system (ANS) reactivity associated with parent-rated sleep problems when the children were 5 years old. Mothers were interviewed in English or Spanish and completed demographic, family, and child measures. The children completed a 15-min standardized protocol while continuous cardiac measures of the ANS [respiratory sinus arrhythmia (RSA), preejection period (PEP)] were collected during resting and four challenge conditions. Reactivity was defined as the mean of the responses to the four challenge conditions minus the first resting condition. Four ANS profiles, co-activation, co-inhibition, reciprocal low RSA and PEP reactivity, and reciprocal high RSA and PEP reactivity, were created by dichotomizing the reactivity scores as high or low reactivity. Logistic regression models showed there were significant main effects for children living in families with fewer daily routines having more sleep problems than for children living in families with daily routines. There were significant interactions for children with low PEP reactivity and for children with the reciprocal, low reactivity profiles who experienced major family life events in predicting children’s sleep problems. Children who had a reciprocal, low reactivity ANS profile had more sleep problems if they also experienced MLE than children who experienced fewer MLE. These findings suggest that children who experience family adversities have different risks for developing sleep problems depending on their biological sensitivity. Interventions are needed for young Latino children that support family routines and reduce the impact of family adversities to help them develop healthy sleep practices.

Despite numerous potential health outcomes of dog guardianship, their value has not been examined in the HIV-positive population. The study objective was to examine the relationship between dog guardianship and HIV clinical outcomes (antiretroviral adherence [≥95% versus

HIV/AIDS stigma continues to be a challenge for HIV prevention and treatment. When health professionals manifest stigma it can limit access to quality treatment. With an ever-growing epidemic among Latinos, including Puerto Ricans living on the Caribbean Island, the social and structural factors that foster HIV/AIDS stigma need to be understood. In this study, we documented the association of religion with HIV/AIDS stigma in a sample of medical students in Puerto Rico. Findings suggest that importance placed on religion, and participation in religious activities, is associated with HIV/AIDS stigma for this population.