Evaluation of implementation outcomes of an integrated group postpartum and well-child care model at clinics in Malawi.

BACKGROUND: Persistently elevated rates of maternal and infant mortality and morbidities in Malawi indicate the need for increased quality of maternal and well-child care services. The first-year postpartum sets the stage for long-term health for the childbearing parent and infant. Integrated group postpartum and well-child care may improve maternal and infant health outcomes. The purpose of this study was to examine implementation outcomes for this model of care. METHODS: We used mixed methods to examine implementation outcomes of integrated group postpartum and well-child care. We piloted sessions at three clinics in Blantyre District, Malawi. During each session we evaluated fidelity using a structured observation checklist. At the end of each session, we administered three surveys to health care workers and women participants, the Acceptability of Intervention Measure, the Intervention Appropriateness Measure, and the Feasibility of Intervention Measure. Focus groups were conducted to gain greater understanding of people's experience with and evaluation of the model. RESULTS: Forty-one women with their infants participated in group sessions. Nineteen health care workers across the three clinics co-facilitated group sessions, 9 midwives and 10 health surveillance assistants. Each of the 6 sessions was tested once at each clinic for a total of 18 pilot sessions. Both women and health care workers reported group postpartum and well-child care was highly acceptable, appropriate, and feasible across clinics. Fidelity to the group care model was high. During each session as part of structured observation the research team noted common health issues, the most common one among women was high blood pressure and among infants was flu-like symptoms. The most common services received within the group space was family planning and infant vaccinations. Women reported gaining knowledge from health promotion group discussions and activities. There were some challenges implementing group sessions. CONCLUSION: We found that clinics in Blantyre District, Malawi were able to implement group postpartum and well-child care with fidelity and that it was highly acceptable, appropriate, and feasible to women and health care workers. Due to these promising results, we recommend future research examine the effectiveness of the model on maternal and child health outcomes.

Needs and unmet needs for support services for recently pregnant intimate partner violence survivors in Ethiopia during the COVID-19 pandemic.

BACKGROUND: Globally, 2-14% of women experience intimate partner violence (IPV) during pregnancy. Timely response to IPV is critical to mitigate related adverse health outcomes. Barriers to accessing limited IPV support services are pervasive in low- and middle-income countries (LMICs), such as Ethiopia; key barriers include mistrust, stigmatization, and self-blame, and discourage women from disclosing their experiences. Infection control measures for COVID-19 have the potential to further disrupt access to IPV services. METHODS: In-depth qualitative interviews were undertaken from October-November 2020 with 24 women who experienced IPV during recent pregnancy to understand the needs and unmet needs of IPV survivors in Ethiopia amid the COVID-19 pandemic. Trained qualitative interviewers used a structured note-taking tool to allow probing of experiences, while permitting rapid analysis for timely results. Inductive thematic analysis identified emergent themes, which were organized into matrices for synthesis. RESULTS: Qualitative themes center around knowledge of IPV services; experiences of women in seeking services; challenges in accessing services; the impact of COVID-19 on resource access; and persistent unmet needs of IPV survivors. Notably, few women discussed the violence they experienced as unique to pregnancy, with most referring to IPV over an extended period, both prior to and during COVID-19 restrictions. The majority of IPV survivors in our study heavily relied on their informal network of family and friends for protection and assistance in resolving the violence. Though formal IPV services remained open throughout the pandemic, restrictions resulted in the perception that services were not available, and this perception discouraged survivors from seeking help. Survivors further identified lack of integrated and tailored services as enduring unmet needs. CONCLUSIONS: Results reveal a persistent low awareness and utilization of formal IPV support and urge future policy efforts to address unmet needs through expansion of services by reducing socio-cultural barriers. COVID-19 impacted access to both formal and informal support systems, highlighting needs for adaptable, remote service delivery and upstream violence prevention. Public health interventions must strengthen linkages between formal and informal resources to fill the unmet needs of IPV survivors in receiving medical, psychosocial, and legal support in their home communities.

Concerned friends of intimate partner violence survivors: results from the myPlan randomized controlled trial on college campuses.

BACKGROUND: Nearly half of intimate partner violence (IPV) survivors experience their first abusive relationship at college age (18-24 years). Most often they disclose the violence to friends. Existing college campus "bystander" interventions training peers to safely intervene have been effective in sexual assault prevention; similar interventions have rarely been tested for IPV. Therefore, we evaluated the effectiveness of an interactive, personalized safety decision and planning tool, myPlan app, on decisional conflict, decisional preparedness, confidence in intervening, supportive safety behaviors, and IPV attitudes with concerned friends of abused college women. METHODS: We recruited college students (age 18-24, N = 293) of any gender who had a female-identified friend who had recently experienced IPV ("concerned friends") from 41 Oregon and Maryland colleges/universities. Participants were randomized to myPlan (n = 147) or control (usual web-based resources; n = 146). Outcomes included decisional conflict, decisional preparedness, confidence to intervene, safety/support behaviors, and IPV attitudes. RESULTS: At baseline, concerned friends described the abused person as a close/best friend (79.1%); 93.7% had tried at least one strategy to help. Most (89.2%) reported concerns their friend would be seriously hurt by the abuser; 22.7% reported extreme concern. Intervention participants had greater improvements in decisional conflict (specifically, understanding of their own values around the decision to intervene and help a friend) and decisional preparedness immediately after their first use of myPlan, and a significantly greater increase in confidence to talk with someone about their own relationship concerns at 12 months. At 12-month follow-up, both intervention and control groups reported increased confidence to intervene, and did not differ significantly in terms of percentage of safety/support strategies used, whether strategies were helpful, or IPV attitudes. CONCLUSIONS: A technology-based intervention, myPlan, was effective in reducing one aspect of decisional conflict (improving clarity of values to intervene) and increasing decisional preparedness to support a friend in an unsafe relationship. Information on IPV and related safety strategies delivered through the myPlan app or usual web-based resources both increased confidence to intervene with a friend. College students in the myPlan group were more likely to talk with someone about concerns about their own relationship, demonstrating potential for IPV prevention or early intervention. TRIAL REGISTRATION: Clinicaltrials.gov ID: NCT02236663, registration date 10/09/2014.

Adapting group care to the postpartum period using a human-centered design approach in Malawi.

BACKGROUND: Responsive and resilient strategies to reduce high rates of maternal and infant mortality and clinician shortages are needed in low- and middle-income countries (LMICs). Malawi has some of the highest maternal and infant mortality rates globally. Group healthcare is a service delivery model that integrates these strategies. Although primarily implemented during the prenatal period, its potential for improving both maternal and infant health outcomes during the postpartum period has not been realized. The purpose of this study was to adapt and co-design the prototype for an evidence-based group care model for the postpartum period using a human-centered design approach with key stakeholders in Malawi. METHODS: We completed steps of a framework guiding the use of human-centered design: 1) define the problem and assemble a team; 2) gather information through evidence and inspiration; 3) synthesize; and 4) intervention design: guiding principles and ideation. Qualitative methods were used to complete steps 2-4. In-depth interviews (n = 24), and incubator sessions (n = 6) that employed free listing, pile sorting and ranking were completed with key stakeholders. Data analysis consisted of content analysis of interviews and framework analysis for incubator sessions to produce the integrated group postpartum and well-child care model prototype. The fifth step is detailed in a separate paper. RESULTS: All stakeholders reported a desire to participate in and offer group care in the postpartum period. Stakeholders worked collaboratively to co-create the prototype that included a curriculum of health promotion topics and interactive activities and the service delivery structure. Health promotion topic priorities were hygiene, breastfeeding, family planning, nutrition, and mental health. The recommended schedule included 6 sessions corresponding with the child vaccination schedule over the 12-month postpartum period. CONCLUSIONS: Using a human-centered design approach to adapt an evidence-based group care model in an LMIC, specifically Malawi, is feasible and acceptable to key stakeholders and resulted in a prototype curriculum and practical strategies for clinic implementation.

A Conceptual Framework for Group Well-Child Care: A Tool to Guide Implementation, Evaluation, and Research.

OBJECTIVE: To use scoping review methods to construct a conceptual framework based on current evidence of group well-child care to guide future practice and research. METHODS: We conducted a scoping review using Arksey and O'Malley's (2005) six stages. We used constructs from the Consolidated Framework for Implementation Research and the quadruple aim of health care improvement to guide the construction of the conceptual framework. RESULTS: The resulting conceptual framework is a synthesis of the key concepts of group well-child care, beginning with a call for a system redesign of well-child care to improve outcomes while acknowledging the theoretical antecedents structuring the rationale that supports the model. Inputs of group well-child care include health systems contexts; administration/logistics; clinical setting; group care clinic team; community/patient population; and curriculum development and training. The core components of group well-child care included structure (e.g., group size, facilitators), content (e.g., health assessments, service linkages). and process (e.g., interactive learning and community building). We found clinical outcomes in all four dimensions of the quadruple aim of healthcare. CONCLUSION: Our conceptual framework can guide model implementation and identifies several outcomes that can be used to harmonize model evaluation and research. Future research and practice can use the conceptual framework as a tool to standardize model implementation and evaluation and generate evidence to inform future healthcare policy and practice.

Experiences of pregnant women exposed to Hurricanes Irma and Maria in the US Virgin Islands: a qualitative study.

INTRODUCTION: Hurricanes Irma and Maria made landfall in the US Virgin Islands (USVI) in 2017. To date, there is no published literature available on the experiences of pregnant women in the USVI exposed to these hurricanes. Understanding how hurricanes affect pregnant women is key to developing and executing targeted hurricane preparedness and response policies. The purpose of this study was to explore the experiences of pregnancy and birth among women in the USVI exposed to Hurricanes Irma and Maria. METHODS: We employed a qualitative descriptive methodology to guide sampling, data collection, and analysis. Semi-structured interviews of 30-60 min in length were conducted with a purposive sample of women (N = 18) in the USVI who were pregnant during or became pregnant within two months after the hurricanes. Interviews were transcribed verbatim and data managed in MAXQDA. Team members developed a codebook, applied codes for content, and reconciled discrepancies. We thematically categorized text according to a socioecological conceptual framework of risk and resilience for maternal-neonatal health following hurricane exposure. RESULTS: Women's experiences were organized into two main categories (risk and resilience). We identified the following themes related to risk at 3 socioecological levels including: (1) individual: changes in food access (We had to go without) and stress (I was supposed to be relaxing); (2) household/community: diminished psychosocial support (Everyone was dealing with their own things) and the presence of physical/environmental hazards (I was really scared); and (3) maternity system: compromised care capacity (The hospital was condemned). The themes related to resilience included: (1) individual: personal coping strategies (Being calm); (2) household/community: mutual psychosocial and tangible support (We shared our resources); and (3) the maternity system: continuity of high-quality care (On top of their game). CONCLUSIONS: A socioecological approach provides a useful framework to understand how risk and resilience influence the experience of maternal hurricane exposure. As the frequency of the most intense hurricanes is expected to increase, clinicians, governments, and health systems should work collaboratively to implement hurricane preparedness and response plans that address pregnant women's unique needs and promote optimal maternal-infant health.

Assessing the reliability and validity of attitudes and confidence scales for the care of women and girls affected by female genital mutilation/cutting.

BACKGROUND: Approximately 545,000 women and girls in the USA have undergone Female Genital Mutilation/ Cutting (FGM/C) or have mothers from a country where FGM/C is practiced. Women and girls living with FGM/C in the USA may experience stigma and bias due to their FGM/C, immigration, racial, and language status. Health care provider attitudes toward FGM/C and confidence for related clinical care may affect the quality of care, yet there are no validated instruments to measure these constructs. METHODS: We developed the instruments via review of the FGM/C literature, the development of scale items, expert review, and pre-testing. We validated the instruments using a convenience sample of providers in Arizona and Maryland. We used exploratory factor analysis (EFA) to confirm factor structures, and compared scores between known groups to assess validity. RESULTS: The EFA revealed a two-factor solution for attitudes, including subscales for Negative Attitudes and Empathetic Attitudes toward FGM/C and those who practice with Cronbach's alphas of 0.814 and 0.628 respectively. The EFA for confidence revealed a two-factor solution including Confidence in Clinical FGM/C Care and Confidence in Critical Communication Skills for FGM/C Care with Cronbach's alphas of 0.857 and 0.694 respectively. CONCLUSIONS: Health care provider attitudes and confidence toward FGM/C care may affect quality of care and health outcomes for women and girls. Our study describes the rigorous psychometric analysis to create reliable and valid instruments to assess health care provider attitudes and confidence for the care of women and girls who have experienced FGM/C. TRIAL REGISTRATION: ClinicalTrials.gov , NCT03249649 . Registered on 15 August 2017. Retrospectively registered.

A technology-based intervention to improve safety, mental health and empowerment outcomes for immigrant women with intimate partner violence experiences: it's weWomen plus sequential multiple assignment randomized trial (SMART) protocol.

BACKGROUND: Intimate partner violence (IPV) disproportionately affects immigrant women, an understudied and underserved population in need for evidence-based rigorously evaluated culturally competent interventions that can effectively address their health and safety needs. METHODS: This study uses a sequential, multiple assignment, randomized trial (SMART) design to rigorously evaluate an adaptive, trauma-informed, culturally tailored technology-delivered intervention tailored to the needs of immigrant women who have experienced IPV. In the first stage randomization, participants are randomly assigned to an online safety decision and planning or a usual care control arm and safety, mental health and empowerment outcomes are assessed at 3-, 6- and 12-months post-baseline. For the second stage randomization, women who do not report significant improvements in safety (i.e., reduction in IPV) and empowerment from baseline to 3 months follow up (i.e., non-responders) are re- randomized to safety and empowerment strategies delivered via text only or a combination of text and phone calls with trained advocates. Data on outcomes (safety, mental health, and empowerment) for early non-responders is assessed at 6 and 12 months post re-randomization. DISCUSSION: The study's SMART design provides an opportunity to implement and evaluate an individualized intervention protocol for immigrant women based on their response to type or intensity of intervention. The findings will be useful for identifying what works for whom and characteristics of participants needing a particular type or intensity level of intervention for improved outcomes. If found to be effective, the study will result in an evidence-based trauma-informed culturally tailored technology-based safety decision and planning intervention for immigrant survivors of IPV that can be implemented by practitioners serving immigrant women in diverse settings. TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov as NCT04098276 on September 13, 2019.

Challenging the status quo of scientific presentations.

Scientific presentations, usually given with slide presentation software such as PowerPoint™, are the most common method for disseminating knowledge to students and peers. Unfortunately, many are boring, text-heavy, and bullet point-riddled data dumps, with animations or cartoons that obscure or distract rather than clarify the message. These presentations, which we have all sat through and/or delivered, are often so dull that they are referred to as "death by PowerPoint™." In this paper, the authors intend to impart basic techniques for organizing and communicating information in the most effective, engaging, and actionable ways possible. We focus on three processes: generating ideas and outlining a talk, creating visually appealing uncluttered slides, and delivering an inspiring, practice-changing presentation. We also discuss considerations for a virtual presentation. We believe that even experienced speakers could benefit from reflecting on these recommendations and editing their slide presentations for clarity and simplicity.

Effectiveness of the Common Elements Treatment Approach (CETA) in reducing intimate partner violence and hazardous alcohol use in Zambia (VATU): A randomized controlled trial.

BACKGROUND: Both intimate partner violence (IPV) and alcohol misuse are highly prevalent, and partner alcohol misuse is a significant contributor to women's risk for IPV. There are few evidence-based interventions to address these problems in low- and middle-income countries (LMICs). We evaluated the effectiveness of an evidence-based, multi-problem, flexible, transdiagnostic intervention, the Common Elements Treatment Approach (CETA) in reducing (a) women's experience of IPV and (b) their male partner's alcohol misuse among couples in urban Zambia. METHODS AND FINDINGS: This was a single-blind, parallel-assignment randomized controlled trial in Lusaka, Zambia. Women who reported moderate or higher levels of IPV and their male partners with hazardous alcohol use were enrolled as a couple and randomized to CETA or treatment as usual plus safety checks (TAU-Plus). The primary outcome, IPV, was assessed by the Severity of Violence Against Women Scale (SVAWS) physical/sexual violence subscale, and the secondary outcome, male alcohol misuse, by the Alcohol Use Disorders Identification Test (AUDIT). Assessors were blinded. Analyses were intent-to-treat. Primary outcome assessments were planned at post-treatment, 12 months post-baseline, and 24 months post-baseline. Enrollment was conducted between May 23, 2016, and December 17, 2016. In total, 123 couples were randomized to CETA, 125 to TAU-Plus. The majority of female (66%) and a plurality of male (48%) participants were between 18 and 35 years of age. Mean reduction in IPV (via SVAWS subscale score) at 12 months post-baseline was statistically significantly greater among women who received CETA compared to women who received TAU-Plus (-8.2, 95% CI -14.9 to -1.5, p = 0.02, Cohen's d effect size = 0.49). Similarly, mean reduction in AUDIT score at 12 months post-baseline was statistically significantly greater among men who received CETA compared to men who received TAU (-4.5, 95% CI -6.9 to -2.2, p < 0.001, Cohen's d effect size = 0.43). The Data and Safety Monitoring Board recommended the trial be stopped early due to treatment effectiveness following the 12-month post-baseline assessment, and CETA was offered to control participants. Limitations of the trial included the lack of a true control condition (i.e., that received no intervention), self-reported outcomes that may be subject to social desirability bias, and low statistical power for secondary IPV outcomes. CONCLUSIONS: Results showed that CETA was more effective than TAU-Plus in reducing IPV and hazardous alcohol use among high-risk couples in Zambia. Future research and programming should include tertiary prevention approaches to IPV, such as CETA, rather than offering only community mobilization and primary prevention. TRIAL REGISTRATION: The trial was registered on ClinicalTrials.gov (NCT02790827).

Microenterprise Intervention to Reduce Sexual Risk Behaviors and Increase Employment and HIV Preventive Practices Among Economically-Vulnerable African-American Young Adults (EMERGE): A Feasibility Randomized Clinical Trial.

Economic vulnerability, such as homelessness and unemployment, contributes to HIV risk among U.S. racial minorities. Yet, few economic-strengthening interventions have been adapted for HIV prevention in this population. This study assessed the feasibility of conducting a randomized clinical trial of a 20-week microenterprise intervention for economically-vulnerable African-American young adults. Engaging MicroenterprisE for Resource Generation and Health Empowerment (EMERGE) aimed to reduce sexual risk behaviors and increase employment and uptake of HIV preventive behaviors. The experimental group received text messages on job openings plus educational sessions, mentoring, a start-up grant, and business and HIV prevention text messages. The comparison group received text messages on job openings only. Primary feasibility objectives assessed recruitment, randomization, participation, and retention. Secondary objectives examined employment, sexual risk behaviors, and HIV preventive behaviors. Outcome assessments used an in-person pre- and post-intervention interview and a weekly text message survey. Several progression criteria for a definitive trial were met. Thirty-eight participants were randomized to experimental (n = 19) or comparison group (n = 19) of which 95% were retained. The comparison intervention enhanced willingness to be randomized and reduced non-participation. Mean age of participants was 21.0 years; 35% were male; 81% were unemployed. Fifty-eight percent (58%) of experimental participants completed ≥ 70% of intervention activities, and 74% completed ≥ 50% of intervention activities. Participation in intervention activities and outcome assessments was highest in the first half (~ 10 weeks) of the study. Seventy-one percent (71%) of weekly text message surveys received a response through week 14, but responsiveness declined to 37% of participants responding to ≥ 70% of weekly text message surveys at the end of the study. The experimental group reported higher employment (from 32% at baseline to 83% at week 26) and lower unprotected sex (79% to 58%) over time compared to reported changes in employment (37% to 47%) and unprotected sex (63% to 53%) over time in the comparison group. Conducting this feasibility trial was a critical step in the process of designing and testing a behavioral intervention. Development of a fully-powered effectiveness trial should take into account lessons learned regarding intervention duration, screening, and measurement.Trial Registration ClinicalTrials.gov. NCT03766165. Registered 04 December 2018. https://clinicaltrials.gov/ct2/show/NCT03766165.

Reproductive Coercion among Intimate Partner Violence Survivors in Nairobi.

Reproductive coercion (RC), or partner interference in reproductive decisions, limits women's autonomy. Little is known about RC behaviors and measurement in low- and middle-income countries (LMICs). In this mixed-methods study, we examined the transferability of the US-developed RC Scale to the Kenyan context. Through community-based sampling, recent intimate partner violence (IPV) survivors were recruited from Nairobi's informal settlements. We conducted quantitative analyses (n = 327) to assess the transferability of RC measures via exploratory factor analysis and used descriptive statistics to examine prevalence and continuous metrics. We conducted in-depth interviews (IDIs; n = 30) to contextualize results. Psychometric analyses indicated a two-factor solution comprising pregnancy coercion and condom manipulation (alpha = 0.86). Eighty-two percent of IPV survivors reported experiencing RC (pregnancy coercion = 76.6 percent; condom manipulation = 59.5 percent). IDIs highlighted women's multiple, severe RC experiences; experiences described in IDIs were largely consistent with quantitative findings. We found the RC Scale was transferable to this LMIC context, where IPV survivors face prevalent, severe RC and would benefit from linkage to woman-centered support services.

Longitudinal impacts of an online safety and health intervention for women experiencing intimate partner violence: randomized controlled trial.

BACKGROUND: Responding to intimate partner violence (IPV) and its consequences is made complex by women's diverse needs, priorities and contexts. Tailored online IPV interventions that account for differences among women have potential to reduce barriers to support and improve key outcomes. METHODS: Double blind randomized controlled trial of 462 Canadian adult women who experienced recent IPV randomly were assigned to receive either a tailored, interactive online safety and health intervention (iCAN Plan 4 Safety) or a static, non-tailored version of this tool. Primary (depressive symptoms, PTSD symptoms) and secondary (helpfulness of safety actions, confidence in safety planning, mastery, social support, experiences of coercive control, and decisional conflict) outcomes were measured at baseline and 3, 6, and 12 months later via online surveys. Generalized Estimating Equations were used to test for differences in outcomes by study arm. Differential effects of the tailored intervention for 4 strata of women were examined using effect sizes. Exit survey process evaluation data were analyzed using descriptive statistics, t-tests and conventional content analysis. RESULTS: Women in both tailored and non-tailored groups improved over time on primary outcomes of depression (p < .001) and PTSD (p < .001) and on all secondary outcomes. Changes over time did not differ by study arm. Women in both groups reported high levels of benefit, safety and accessibility of the online interventions, with low risk of harm, although those completing the tailored intervention were more positive about fit and helpfulness. Importantly, the tailored intervention had greater positive effects for 4 groups of women, those: with children under 18 living at home; reporting more severe violence; living in medium-sized and large urban centers; and not living with a partner. CONCLUSION: This trial extends evidence about the effectiveness of online safety and health interventions for women experiencing IPV to Canadian women and provides a contextualized understanding about intervention processes and effects useful for future refinement and scale up. The differential effects of the tailored intervention found for specific subgroups support the importance of attending to diverse contexts and needs. iCAN is a promising intervention that can complement resources available to Canadian women experiencing IPV. TRIAL REGISTRATION: Clinicaltrials.gov ID NCT02258841 (Prospectively Registered on Oct 2, 2014).

Comparative effectiveness of an economic empowerment program on adolescent economic assets, education and health in a humanitarian setting.

BACKGROUND: Adolescence is a critical period of human development, however, limited research on programs to improve health and well-being among younger adolescents living in conflict-affected and humanitarian settings exists. The purpose of this study was to assess the comparative effectiveness of an economic empowerment program on young adolescent outcomes in a complex humanitarian setting. METHODS: This longitudinal, mixed methods study examined the relative effectiveness of an integrated parent (Pigs for Peace, PFP) and young adolescent (Rabbits for Resilience, RFR) animal microfinance/asset transfer program (RFR + PFP) on adolescent outcomes of asset building, school attendance, mental health, experienced stigma, and food security compared to RFR only and PFP only over 24 months. A sub-sample of young adolescents completed in-depth qualitative interviews on the benefits and challenges of participating in RFR. RESULTS: Five hundred forty-two young adolescents (10-15 years) participated in three groups: RFR + PFP (N = 178), RFR only (N = 187), PFP only (N = 177). 501 (92.4%) completed baseline surveys, with 81.7% (n = 442) retention at endline. The group by time interaction (24 months) was significant for adolescent asset building (X2 = 16.54, p = .002), school attendance (X2 = 12.33, p = .015), and prosocial behavior (X2 = 10.56, p = .032). RFR + PFP (ES = 0.31, ES = 0.38) and RFR only (ES-0.39, ES = 0.14) adolescents had greater improvement in asset building and prosocial behavior compared to PFP only, respectively. The odds of missing two or more days of school in the past month were 78.4% lower in RFR only and 45.1% lower in RFR + PFP compared to PFP only. No differences between groups in change over time were found for internalizing behaviors, experienced stigma, or food security. Differences by age and gender were observed in asset building, prosocial behavior, school attendance, experienced stigma, and food security. The voices of young adolescents identified the benefits of the RFR program through their ability to pay for school fees, help their families meet basic needs, and the respect they gained from family and community. Challenges included death of rabbits and potential conflict within the household on how to use the rabbit asset. CONCLUSION: These findings underscore the potential for integrating economic empowerment programs with both parents and young adolescents to improve economic, educational, and health outcomes for young adolescents growing up in rural and complex humanitarian settings. TRIAL REGISTRATION: NCT02008695. Retrospectively registered 11 December 2013.

Acceptability of a feasibility randomized clinical trial of a microenterprise intervention to reduce sexual risk behaviors and increase employment and HIV preventive practices (EMERGE) in young adults: a mixed methods assessment.

BACKGROUND: Acceptability is a critical requisite in establishing feasibility when planning a larger effectiveness trial. This study assessed the acceptability of conducting a feasibility randomized clinical trial of a 20-week microenterprise intervention for economically-vulnerable African-American young adults, aged 18 to 24, in Baltimore, Maryland. Engaging MicroenterprisE for Resource Generation and Health Empowerment (EMERGE) aimed to reduce sexual risk behaviors and increase employment and uptake of HIV preventive behaviors. METHODS: Thirty-eight participants were randomized to experimental (n = 19) or comparison group (n = 19). The experimental group received text messages on job openings plus educational sessions, mentoring, a start-up grant, and business and HIV prevention text messages. The comparison group received text messages on job openings only. Qualitative and quantitative post-intervention, in-person interviews were used in addition to process documentation of study methods. RESULTS: Our results found that the study design and interventions showed promise for being acceptable to economically-vulnerable African-American young adults. The largely positive endorsement suggested that factors contributing to acceptability included perceived economic potential, sexual health education, convenience, incentives, and encouraging, personalized feedback to participants. Barriers to acceptability for some participants included low cell phone connectivity, perceived payment delays, small cohort size, and disappointment with one's randomization assignment to comparison group. Use of peer referral, network, or wait-list designs, in addition to online options may enhance acceptability in a future definitive trial. Expanding administrative and mentoring support may improve overall experience. CONCLUSION: Microenterprise interventions are acceptable ways of providing young adults with important financial and sexual health content to address HIV risks associated with economic vulnerability. TRIAL REGISTRATION: ClinicalTrials.gov. NCT03766165 . Registered 04 December 2018.

Adapting the myPlan safety app to respond to intimate partner violence for women in low and middle income country settings: app tailoring and randomized controlled trial protocol.

BACKGROUND: Intimate partner violence (IPV) is a leading threat to women's health and safety globally. Women in abusive relationships make critical decisions about safety and harm reduction while weighing multiple competing priorities, such as safety of children, housing and employment. In many low- and middle-income countries (LMIC), IPV prevention and response services are limited and women lack access to safety planning resources. In high-resource settings, an interactive safety decision aid app (myPlan) has been found valuable in reducing decisional conflict and empowering women to take action in accordance with their safety priorities. This paper describes 1) the community-participatory formative process used to adapt the myPlan app content, interface, and implementation for the Kenya context, and 2) the randomized clinical trial study protocol for efficacy evaluation of myPlan Kenya. METHODS: A community-participatory formative process engaged service providers and stakeholders, as well as IPV survivors for adaptation, followed by an in-depth pilot and final refinements. A randomized clinical trial design will then be used to determine efficacy of the myPlan Kenya app compared to standard care among women reporting IPV or fear of partner and living in an urban settlement. myPlan Kenya app provides and solicits information on a) relationship health; b) safety priorities; and c) severity of relationship violence. Based on the woman's inputs, the evidence-based algorithm developed for myPlan Kenya generates a tailored safety plan. Outcome measures are assessed at baseline, immediate post-intervention, and 3-month post-baseline. Difference-in-differences analysis compares primary (e.g. safety preparedness, safety behavior, IPV), and secondary outcomes (e.g. resilience, mental health, service utilization, self-blame) across timepoints by group. DISCUSSION: Formative phase revealed high feasibility and acceptability of a technology-based intervention for safety planning in this LMIC setting. This phase generated essential refinements to myPlan Kenya app readability, content and implementation, including increased visualization of messaging, and implementation via community health volunteers (CHVs). The resulting trial will be the first to evaluate efficacy of a community-partnered technology-based IPV intervention in a LMIC. Our adaptation process and trial results will inform researchers and interventionists to integrate multiple data sources to adapt IPV intervention content and interface in settings where technology-based interventions for IPV are novel and literacy is limited. TRIAL REGISTRATION: Pan African Clinical Trial Registry approval received 25 April 2018 (PACTR201804003321122); retrospectively registered.

Effect of COVID-19 pandemic on women's health and safety: A study of immigrant survivors of intimate partner violence.

Intimate partner violence (IPV) is a significant national and global public health concern, with COVID-19 pandemic increasing IPV and associated health issues. Immigrant women may be disproportionately vulnerable to IPV-related health risks during the pandemic. Using qualitative in-depth interviews, we explored the perspectives of service providers (n = 17) and immigrant survivors of IPV(n = 45) on the impact of COVID-19 on immigrant women, existing services for survivors and strategies needed needed to enhance women's health and safety. Participants reported issues such as increased IPV and suggested strategies (e.g. strengthening virtual platforms). The findings could be informative for providers in national and international settings.

Impact of intimate partner violence on clinic attendance, viral suppression and CD4 cell count of women living with HIV in an urban clinic setting.

The substance abuse, violence and HIV/AIDS (SAVA) syndemic represents a complex set of social determinants of health that impacts the lives of women. Specifically, there is growing evidence that intimate partner violence (IPV) places women at risk for both HIV acquisition and poorer HIV-related outcomes. This study assessed prevalence of IPV in an HIV clinic setting, as well as the associations between IPV, symptoms of depression and PTSD on three HIV-related outcomes-CD4 count, viral load, and missed clinic visits. In total, 239 adult women attending an HIV-specialty clinic were included. Fifty-one percent (95% CI: 45%-58%) reported past year psychological, physical, or sexual intimate partner abuse. In unadjusted models, IPV was associated with having a CD4 count <200 (OR: 3.284, 95% CI: 1.251-8.619, p = 0.016) and having a detectable viral load (OR: 1.842, 95% CI: 1.006-3.371, p = 0.048). IPV was not associated with missing >33% of past year all type clinic visits (OR: 1.535, 95% CI: 0.920-2.560, p = 0.101) or HIV specialty clinic visits (OR: 1.251, 95% CI: 0.732-2.140). In multivariable regression, controlling for substance use, mental health symptoms and demographic covariates, IPV remained associated with CD4 count <200 (OR: 3.536, 95% CI: 1.114-11.224, p = 0.032), but not viral suppression. The association between IPV and lower CD4 counts, but not adherence markers such as viral suppression and missed visits, indicates a need to examine potential physiologic impacts of trauma that may alter the immune functioning of women living with HIV. Incorporating trauma-informed approaches into current HIV care settings is one opportunity that begins to address IPV in this patient population.

Efficacy of a Web-Based Safety Decision Aid for Women Experiencing Intimate Partner Violence: Randomized Controlled Trial.

BACKGROUND: Intimate partner violence (IPV) is a human rights violation and leading health burden for women. Safety planning is a hallmark of specialist family violence intervention, yet only a small proportion of women access formal services. A Web-based safety decision aid may reach a wide audience of women experiencing IPV and offer the opportunity to prioritize and plan for safety for themselves and their families. OBJECTIVE: The aim of this study was to test the efficacy of a Web-based safety decision aid (isafe) for women experiencing IPV. METHODS: We conducted a fully automated Web-based two-arm parallel randomized controlled trial (RCT) in a general population of New Zealand women who had experienced IPV in the past 6 months. Computer-generated randomization was based on a minimization scheme with stratification by severity of violence and children. Women were randomly assigned to the password-protected intervention website (safety priority setting, danger assessment, and tailored action plan components) or control website (standard, nonindividualized information). Primary endpoints were self-reported mental health (Center for Epidemiologic Studies Depression Scale-Revised, CESD-R) and IPV exposure (Severity of Violence Against Women Scale, SVAWS) at 12-month follow-up. Analyses were by intention to treat. RESULTS: Women were recruited from September 2012 to September 2014. Participants were aged between 16 and 60 years, 27% (111/412) self-identified as Maori (indigenous New Zealand), and 51% (210/412) reported at baseline that they were unsure of their future plans for their partner relationship. Among the 412 women recruited, retention at 12 months was 87%. The adjusted estimated intervention effect for SVAWS was -12.44 (95% CI -23.35 to -1.54) for Maori and 0.76 (95% CI -5.57 to 7.09) for non-Maori. The adjusted intervention effect for CESD-R was -7.75 (95% CI -15.57 to 0.07) for Maori and 1.36 (-3.16 to 5.88) for non-Maori. No study-related adverse events were reported. CONCLUSIONS: The interactive, individualized Web-based isafe decision aid was effective in reducing IPV exposure limited to indigenous Maori women. Discovery of a treatment effect in a population group that experiences significant health disparities is a welcome, important finding. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12612000708853; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612000708853 (Archived by Webcite at http://www.webcitation/61MGuVXdK).