Prevention of postpartum methamphetamine use with micronized progesterone trial (PROMPT): A pilot randomized controlled trial protocol.

Background: While most pregnant individuals with methamphetamine use disorder (MUD) achieve abstinence, the postpartum period remains a vulnerable time for return to methamphetamine use (MU). Promising data from human and animal models, including three randomized controlled trials, suggest that micronized progesterone may prevent postpartum return to cocaine and nicotine use by reducing cravings. The primary objective of this study is to assess feasibility of enrollment and randomization of postpartum individuals with MUD to micronized progesterone to prevent return to MU. The secondary objectives are to evaluate safety, establish a preliminary estimate of efficacy, and characterize the association between allopregnanolone levels and methamphetamine cravings. Methods: This is a pilot double-blind placebo randomized controlled trial. We plan to enroll 40 postpartum individuals with MUD over 24-months. Individuals, stratified by opioid use disorder (OUD), are randomized 1:1-400 mg oral micronized progesterone daily or placebo and attend weekly study sessions for 12 weeks. Feasibility is measured by achieving 80 % of enrollment goal. Safety is evaluated by side effect frequency, mental health status changes, lactation and medical complications. Efficacy is assessed by comparing proportion of participants with return to MU and time to return to MU based on self-report or urine testing between treatment and control groups. Salivary allopregnanolone levels and methamphetamine cravings are compared between the groups. Conclusion: Study results will provide a first critical step towards potential intervention for prevention of return to MU among postpartum individuals. Completion of this trial will set the stage for a large-scale efficacy trial.

Evaluating analytic models for individually randomized group treatment trials with complex clustering in nested and crossed designs.

Many individually randomized group treatment (IRGT) trials randomly assign individuals to study arms but deliver treatments via shared agents, such as therapists, surgeons, or trainers. Post-randomization interactions induce correlations in outcome measures between participants sharing the same agent. Agents can be nested in or crossed with trial arm, and participants may interact with a single agent or with multiple agents. These complications have led to ambiguity in choice of models but there have been no systematic efforts to identify appropriate analytic models for these study designs. To address this gap, we undertook a simulation study to examine the performance of candidate analytic models in the presence of complex clustering arising from multiple membership, single membership, and single agent settings, in both nested and crossed designs and for a continuous outcome. With nested designs, substantial type I error rate inflation was observed when analytic models did not account for multiple membership and when analytic model weights characterizing the association with multiple agents did not match the data generating mechanism. Conversely, analytic models for crossed designs generally maintained nominal type I error rates unless there was notable imbalance in the number of participants that interact with each agent.

Study protocol for Sauti ya Vijana (The Voice of Youth): A hybrid-type 1 randomized trial to evaluate effectiveness and implementation of a mental health and life skills intervention to improve health outcomes for Tanzanian youth living with HIV.

OBJECTIVE: Young people living with HIV (YPLWH) experience increased morbidity and mortality compared to all other age groups. Adolescence brings unique challenges related to sexual reproductive health, the elevated importance of peer groups, and often, emerging symptoms of emotional distress. Failure to address this unique life stage for YPLWH can lead to worse HIV and mental health outcomes. Herein lies the protocol for a hybrid-type-1 effectiveness-implementation trial designed to evaluate a mental health and life skills intervention that aims to address these needs for YPLWH in Tanzania. METHODS: This is an individually randomized group-treatment trial designed to evaluate the effectiveness of Sauti ya Vijana (SYV: The Voice of Youth) toward improving viral suppression (HIV RNA <400 copies/mL) and mental health outcomes and to assess implementation including acceptability, feasibility, fidelity, and cost-effectiveness of the manualized intervention. The trial is being conducted across four geographically distinct regions of Tanzania. Peer group leaders (PGL) with lived HIV experience deliver the 10-session group-based intervention and two individual sessions during which participants describe their disclosure narrative (when they learned they live with HIV) and value-based goal setting. Caregiver or chosen supportive adults are encouraged to attend two specific group sessions with their youth. Participants are 10-24 years of age, prescribed antiretroviral therapy for at least 6 months, fully aware of their HIV status, able to commit to session attendance, and able to understand and meaningfully contribute to group sessions. Participant study visits occur at 5 time points for evaluation: baseline, 4-, 6-, 12-, and 18-months post baseline. A single booster session is conducted before the 12-month visit. Study visits evaluate mental health, adverse childhood events, interpersonal violence, resilience, stigma, HIV knowledge, substance use, sexual relationships, ART adherence, and HIV RNA. Implementation outcomes evaluate feasibility and acceptability through attendance, intervention session notes, focus discussion groups and qualitative interviews. Fidelity to the intervention is measured using fidelity checklists by a PGL observer at each group session. Cost effectiveness is calculated using an incremental cost-effectiveness ratio that utilizes a patient cost questionnaire and financial records of study costs. SIGNIFICANCE: Few mental health interventions for YPLWH have demonstrated effectiveness. Results from this study will provide information about effectiveness and implementation of a peer-led intervention for delivering a mental health and life skills intervention in low-income settings. TRIAL IDENTIFIER: This trial is registered at clinicaltrials.gov NCT05374109.

A cluster-randomized trial of client and provider directed financial interventions to align incentives with appropriate case management in private medicine retailers: Results of the TESTsmART trial in Lagos, Nigeria.

Malaria remains a major health priority in Nigeria. Among children with fever who seek care, less than a quarter gets tested for malaria, leading to inappropriate use of the recommended treatment for malaria; Artemisinin-based Combination Therapy (ACT). Here we test an innovative strategy to target ACT subsidies to clients seeking care in Nigeria's private retail health sector who have a confirmed malaria diagnosis. We supported point-of-care malaria testing (mRDTs) in 48 Private Medicine Retailers (PMRs) in the city of Lagos, Nigeria and randomized them to two study arms; a control arm offering subsidized mRDT testing for USD $0.66, and an intervention arm where, in addition to access to subsidized testing as in the control arm, clients who received a positive mRDT at the PMR were eligible for a free (fully subsidized) first-line ACT and PMRs received USD $0.2 for every mRDT performed. Our primary outcome was the proportion of ACTs dispensed to individuals with a positive diagnostic test. Secondary outcomes included proportion of clients who were tested at the PMR and adherence to diagnostic test results. Overall, 23% of clients chose to test at the PMR. Test results seemed to inform treatment decisions and resulted in enhanced targeting of ACTs to confirmed malaria cases with only 26% of test-negative clients purchasing an ACT compared to 58% of untested clients. However, the intervention did not offer further improvements, compared to the control arm, in testing rates or dispensing of ACTs to test-positive clients. We found that ACT subsidies were not passed on to clients testing positive in the intervention arm. We conclude that mRDTs could reduce ACT overconsumption in Nigeria's private retail health sector, but PMR-oriented incentive structures are difficult to implement and may need to be complemented with interventions targeting clients of PMRs to increase test uptake and adherence. Trials registration: Clinical Trials Registration Number: NCT04428307. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7816435/ Correction: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9476591/.

Recommendations for postpartum athletes returning to sport: the past, present, and future.

INTRODUCTION: There is a growing percentage of elite female athletes who choose to start a family during their athletic careers. Current guidelines to manage postpartum elite athletes returning to sport are weakly rooted in athlete-centered evidence and/or are restricted by small sample sizes. The purpose of this review was to collect and compare existing protocols and guidelines for elite athletes returning to sport following childbirth and to highlight the current culture surrounding postpartum athletes. METHODS: Online databases including PubMed and BioMed Central were searched from September 2023 to May 2024. Studies of any design were included if they contained information on pregnancy and postpartum. Peer-reviewed research studies, systematic reviews, case reports, and data from organizational websites (American College of Obstetricians and Gynecologists, the World Health Organization, and the Official Olympics) were included. RESULTS: Athlete-mothers face numerous challenges in their transition back to competitive sport following childbirth, including the societal expectations of a 'good' mother, potential loss of financial sponsorships, and limited guidance on postpartum training. Additionally, the healthcare community historically managed postpartum athletes in a reactionary manner by treating symptoms from pregnancy and childbirth as they arise. Recent literature is pointing toward adopting a preventive and proactive model of care to optimize an athlete's health prior to pregnancy and therefore support their safe return to sport postpartum. CONCLUSION: Increased support for female participation in sports must also be met by increased support for pregnant and postpartum athletes. There is a continued need for research regarding return-to-sport guidelines for postpartum athletes, and their proper implementation.

How should a cluster randomized trial be analyzed?

In cluster randomized trials, individuals from the same cluster tend to have more similar outcomes than individuals from different clusters. This correlation must be taken into account in the analysis of every cluster trial to avoid incorrect inferences. In this paper, we describe the principles guiding the analysis of cluster trials including how to correctly account for intra-cluster correlations as well as how to analyze more advanced designs such as stepped-wedge and cluster cross-over trials. We then describe how to handle specific issues such as small sample sizes and missing data.

A cluster-randomized trial of client and provider-directed financial interventions to align incentives with appropriate case management in retail medicine outlets: Results of the TESTsmART Trial in western Kenya.

ACTs are responsible for a substantial proportion of the global reduction in malaria mortality over the last ten years, made possible by publicly-funded subsidies making these drugs accessible and affordable in the private sector. However, inexpensive ACTs available in retail outlets have contributed substantially to overconsumption. We test an innovative, scalable strategy to target ACT-subsidies to clients with a confirmatory diagnosis. We supported malaria testing(mRDTs) in 39 medicine outlets in western Kenya, randomized to three study arms; control arm offering subsidized mRDT testing (0.4USD), client-directed intervention where all clients who received a positive RDT at the outlet were eligible for a free (fully-subsidized) ACT, and a combined client and provider directed intervention where clients with a positive RDT were eligible for free ACT and outlets received 0.1USD for every RDT performed. Our primary outcome was the proportion of ACT dispensed to individuals with a positive diagnostic test. Secondary outcomes included proportion of clients tested at the outlet and adherence to diagnostic test results. 43% of clients chose to test at the outlet. Test results informed treatment decisions, resulting in targeting of ACTs to confirmed malaria cases- 25.3% of test-negative clients purchased an ACT compared to 75% of untested clients. Client-directed and client+provider-directed interventions did not offer further improvements, compared to the control arm, in testing rates(RD = 0.09, 95%CI:-0.08,0.26) or dispensing of ACTs to test-positive clients(RD = 0.01,95% CI:-0.14, 0.16). Clients were often unaware of the price they paid for the ACT leading to uncertainty in whether the ACT subsidy was passed on to the client. This uncertainty undermines our ability to definitively conclude that client-directed subsidies are not effective for improving testing and appropriate treatment. We conclude that mRDTs could reduce ACT overconsumption in the private retail sector, but incentive structures are difficult to scale and their value to private providers is uncertain. Trial registration: ClinicalTrials.gov NCT04428307.

Longitudinal pathways between maternal depression, parenting behaviors, and early childhood development: a mediation analysis.

Maternal depression is a global public health concern with far-reaching impacts on child development, yet our understanding of mechanisms remains incomplete. This study examined whether parenting mediates the association between maternal depression and child outcomes. Participants included 841 rural Pakistani mother-child dyads (50% female). Maternal depression was measured at 12 months postpartum, parenting behaviors (warmth, stimulation, and harsh parenting) were measured at 24 months, and child outcomes (mental health, socioemotional development, and cognitive skills) were measured at 36 months. Maternal depression predicted increased harsh parenting, child mental health difficulties, and child socioemotional concerns; however, there was little evidence for parenting as a mediator between maternal depression and child outcomes. Sex-stratified results are discussed, and findings are situated in context.

Autism Caregiver Coaching in Africa (ACACIA): Protocol for a type 1-hybrid effectiveness-implementation trial.

BACKGROUND: While early autism intervention can significantly improve outcomes, gaps in implementation exist globally. These gaps are clearest in Africa, where forty percent of the world's children will live by 2050. Task-sharing early intervention to non-specialists is a key implementation strategy, given the lack of specialists in Africa. Naturalistic Developmental Behavioral Interventions (NDBI) are a class of early autism intervention that can be delivered by caregivers. As a foundational step to address the early autism intervention gap, we adapted a non-specialist delivered caregiver coaching NDBI for the South African context, and pre-piloted this cascaded task-sharing approach in an existing system of care. OBJECTIVES: First, we will test the effectiveness of the caregiver coaching NDBI compared to usual care. Second, we will describe coaching implementation factors within the Western Cape Department of Education in South Africa. METHODS: This is a type 1 effectiveness-implementation hybrid design; assessor-blinded, group randomized controlled trial. Participants include 150 autistic children (18-72 months) and their caregivers who live in Cape Town, South Africa, and those involved in intervention implementation. Early Childhood Development practitioners, employed by the Department of Education, will deliver 12, one hour, coaching sessions to the intervention group. The control group will receive usual care. Distal co-primary outcomes include the Communication Domain Standard Score (Vineland Adaptive Behavior Scales, Third Edition) and the Language and Communication Developmental Quotient (Griffiths Scales of Child Development, Third Edition). Proximal secondary outcome include caregiver strategies measured by the sum of five items from the Joint Engagement Rating Inventory. We will describe key implementation determinants. RESULTS: Participant enrolment started in April 2023. Estimated primary completion date is March 2027. CONCLUSION: The ACACIA trial will determine whether a cascaded task-sharing intervention delivered in an educational setting leads to meaningful improvements in communication abilities of autistic children, and identify implementation barriers and facilitators. TRIAL REGISTRATION: NCT05551728 in Clinical Trial Registry (https://clinicaltrials.gov).

Dietary intervention in gestational diabetes: a qualitative study of the acceptability and feasibility of a novel whole-diet intervention in healthcare professionals.

Gestational diabetes is treated with medical nutrition therapy, delivered by healthcare professionals; however, the optimal diet for affected women is unknown. Randomised controlled trials, such as the DiGest (Dietary Intervention in Gestational Diabetes) trial, will address this knowledge gap, but the acceptability of whole-diet interventions in pregnancy is unclear. Whole-diet approaches reduce bias but require high levels of participant commitment and long intervention periods to generate meaningful clinical outcomes. We aimed to assess healthcare professionals' views on the acceptability of the DiGest dietbox intervention for women with gestational diabetes and to identify any barriers to adherence which could be addressed to support good recruitment and retention to the DiGest trial. Female healthcare professionals (n 16) were randomly allocated to receive a DiGest dietbox containing 1200 or 2000 kcal/d including at least one weeks' food. A semi-structured interview was conducted to explore participants' experience of the intervention. Interviews were audio-recorded, transcribed verbatim and analysed thematically using NVivo software. Based on the findings of qualitative interviews, modifications were made to the dietboxes. Participants found the dietboxes convenient and enjoyed the variety and taste of the meals. Factors which facilitated adherence included participants having a good understanding of study aims and sufficient organisational skills to facilitate weekly meal planning in advance. Barriers to adherence included peer pressure during social occasions and feelings of deprivation or hunger (affecting both standard and reduced calorie groups). Healthcare professionals considered random allocation to a whole-diet replacement intervention to be acceptable and feasible in a clinical environment and offered benefits to participants including convenience.

The Use and Perceptions of the Defense and Veterans Pain Rating Scale by Nursing Personnel.

BACKGROUND: In 2010, the Office of the US Army Surgeon General recommended the Veterans Administration (VA) assess pain using the Defense and Veterans Pain Rating Scale (DVPRS). One item in the DVPRS is for measuring pain intensity. This item contains a combination of five response metrics: categories, faces, colors, numbers, and functional descriptors. A few studies have supported patients' and health care providers' preferences for the DVPRS and its psychometric properties. However, they also left uncertainties about its usability and validity. AIMS: To advance our understanding of the DVPRS, this study examined the use and perceptions of the DVPRS' pain intensity item by nursing personnel during multi-modal care. DESIGN: A cross-sectional survey design was used. SETTING: VA Community Living Center. PARTICIPANTS: Nursing personnel. METHODS: Nursing personnel answered closed- and open-ended survey questions during a single session. RESULTS: Nursing personnel reported sufficient training before implementing the measure and that patients primarily used the numeric metric. When patients used a non-numeric metric, the nursing personnel responded in variable ways. In addition, the nursing personnel interpreted the functional descriptors differently. The nursing personnel also noted the need to supplement the pain intensity item with patients' pain duration and pain location. CONCLUSIONS: Results from this study inform the nursing community about the DVPRS' pain intensity item, which combines multiple response metrics. The results support the need for nursing units to generate and standardize procedures for using the item to measure multi-site pain and for interpreting and documenting patients' non-numeric responses. The effects of such procedures on the measure's usability and psychometric properties warrants additional investigation.

Designing individually randomized group treatment trials with repeated outcome measurements using generalized estimating equations.

Individually randomized group treatment (IRGT) trials, in which the clustering of outcome is induced by group-based treatment delivery, are increasingly popular in public health research. IRGT trials frequently incorporate longitudinal measurements, of which the proper sample size calculations should account for correlation structures reflecting both the treatment-induced clustering and repeated outcome measurements. Given the relatively sparse literature on designing longitudinal IRGT trials, we propose sample size procedures for continuous and binary outcomes based on the generalized estimating equations approach, employing the block exchangeable correlation structures with different correlation parameters for the treatment arm and for the control arm, and surveying five marginal mean models with different assumptions of time effect: no-time constant treatment effect, linear-time constant treatment effect, categorical-time constant treatment effect, linear time by treatment interaction, and categorical time by treatment interaction. Closed-form sample size formulas are derived for continuous outcomes, which depends on the eigenvalues of the correlation matrices; detailed numerical sample size procedures are proposed for binary outcomes. Through simulations, we demonstrate that the empirical power agrees well with the predicted power, for as few as eight groups formed in the treatment arm, when data are analyzed using the matrix-adjusted estimating equations for the correlation parameters with a bias-corrected sandwich variance estimator.

The Patient Experience After Spontaneous Coronary Artery Dissection.

OBJECTIVE: There is considerable burden of anxiety, depression, and post-traumatic stress disorder in patients with spontaneous coronary artery dissection (SCAD), yet research is limited on the experience and impact of SCAD from the patient perspective. This literature review sought to describe the current state of the literature on the patient experience of SCAD and consequences for patients following a SCAD event from the patient perspective. To better understand how people's experiences of SCAD affect their wellbeing, quality of life, lifestyles, and identity, and what would be useful from the patient perspective, an integrative review was performed. METHODS: An integrative literature review was conducted to understand the experience of SCAD and the post-event implications. Five databases were searched. Search terms included 'spontaneous coronary artery dissection', 'SCAD', 'patient', 'experience', 'perspective', and 'opinion'. English-language, peer-reviewed primary research in people with a diagnosis of SCAD that reflected the patient experience was included. Data indicating the SCAD experience including distress prevalence were extracted into an Excel spreadsheet, and narrative synthesis of included studies followed. FINDINGS: From 325 identified studies, five were included for review, yielding a combined sample of 447 participants. Patients with SCAD reported a lack of information about SCAD and the recovery process, and use of the internet for obtaining information. Patients with SCAD reported challenges in recovery including anxiety associated with fear of recurrence and uncertainty, and a need for greater support. A wide range of negative emotions was reported during and after the SCAD event. Participants reported participating in support groups, with mixed reviews of their appropriateness and effectiveness.

Towards Novel Nutritional Strategies in Gestational Diabetes: Eating Behaviour and Obesity in Women with Gestational Diabetes Compared with Non-Pregnant Adults.

BACKGROUND: Gestational diabetes is associated with increased risk of obesity, type 2 diabetes and cardiovascular disease. Effective nutritional strategies are needed to reduce BMI and improve long-term maternal cardiometabolic health, but the relative contribution of maternal eating behaviour, a potential barrier to dietary change, has not been explored. We compared eating behaviour in women with gestational diabetes with that of men and non-pregnant women with comparable risk factors, and tested associations between eating behaviour traits and BMI in women with gestational diabetes. We hypothesized that eating behaviour would be unfavourable in gestational diabetes and would be associated with BMI. METHODS: Participants (n = 417) including 53 men, 164 non-pregnant women and 200 women with gestational diabetes (singleton pregnancy; 29 weeks' gestation) were recruited into three prospective studies assessing weight loss interventions, with similar entry criteria. The three-factor eating questionnaire (TFEQ-R18) assessed uncontrolled eating, emotional eating and cognitive restraint at study enrolment. Associations between BMI at study enrolment and TFEQ-R18 (% maximum score) were assessed using linear regression. RESULTS: Women with gestational diabetes had significantly lower uncontrolled eating scores vs. men (53% vs. 65%; p < 0.001) and non-pregnant women (53% vs. 66%; p < 0.001), lower emotional eating scores vs. non-pregnant women (60% vs. 71%; p < 0.001) and higher cognitive restraint (p < 0.001 vs. men and non-pregnant women). In women with gestational diabetes, emotional eating scores were positively associated with BMI at study enrolment (beta coefficient 7.8 (95% CI 3.9 to 11.7), p < 0.001). CONCLUSIONS: Women with gestational diabetes have favourable eating behaviour compared with other population groups. Because BMI at study enrolment was associated with emotional eating, nutritional strategies which reduce emotional eating may provide new opportunities to improve long-term maternal health after gestational diabetes.

When Shepherds Shed: Trajectories of Weight-Related Behaviors in a Holistic Health Intervention Tailored for US Christian Clergy.

Maintaining healthy behaviors is challenging. Based upon previous reports that in North Carolina (NC), USA, overweight/obese clergy lost weight during a two-year religiously tailored health intervention, we described trajectories of diet, physical activity, and sleep. We investigated whether behavior changes were associated with weight and use of health-promoting theological messages. Improvements were observed in sleep, calorie-dense food intake, and physical activity, with the latter two associated with weight loss. While theological messages were well-retained, their relationship with behaviors depended on the specific message, behavior, and timing. Findings offer insights into weight loss mechanisms, including the role of theological messages in religiously tailored health interventions.

Autism Caregiver Coaching in Africa (ACACIA): Protocol for a type 1-hybrid effectiveness-implementation trial.

Background: While early autism intervention can significantly improve outcomes, gaps in implementation exist globally. These gaps are clearest in Africa, where forty percent of the world's children will live by 2050. Task-sharing early intervention to non-specialists is a key implementation strategy, given the lack of specialists in Africa. Naturalistic Developmental Behavioral Interventions (NDBI) are a class of early autism intervention that can be delivered by caregivers. As a foundational step to address the early autism intervention gap, we adapted a non-specialist delivered caregiver coaching NDBI for the South African context, and pre-piloted this cascaded task-sharing approach in an existing system of care. Objectives: First, we will test the effectiveness of the caregiver coaching NDBI compared to usual care. Second, we will describe coaching implementation factors within the Western Cape Department of Education in South Africa. Methods: This is a type 1 effectiveness-implementation hybrid design; assessor-blinded, group randomized controlled trial. Participants include 150 autistic children (18-72 months) and their caregivers who live in Cape Town, South Africa, and those involved in intervention implementation. Early Childhood Development practitioners, employed by the Department of Education, will deliver 12, one hour, coaching sessions to the intervention group. The control group will receive usual care. Distal co-primary outcomes include the Communication Domain Standard Score (Vineland Adaptive Behavior Scales, Third Edition) and the Language and Communication Developmental Quotient (Griffiths Scales of Child Development, Third Edition). Proximal secondary outcome include caregiver strategies measured by the sum of five items from the Joint Engagement Rating Inventory. We will describe key implementation determinants. Results: Participant enrolment started in April 2023. Estimated primary completion date is March 2027. Conclusion: The ACACIA trial will determine whether a cascaded task-sharing intervention delivered in an educational setting leads to meaningful improvements in communication abilities of autistic children, and identify implementation barriers and facilitators.

Generalizing the information content for stepped wedge designs: A marginal modeling approach.

Stepped wedge trials are increasingly adopted because practical constraints necessitate staggered roll-out. While a complete design requires clusters to collect data in all periods, resource and patient-centered considerations may call for an incomplete stepped wedge design to minimize data collection burden. To study incomplete designs, we expand the metric of information content to discrete outcomes. We operate under a marginal model with general link and variance functions, and derive information content expressions when data elements (cells, sequences, periods) are omitted. We show that the centrosymmetric patterns of information content can hold for discrete outcomes with the variance-stabilizing link function. We perform numerical studies under the canonical link function, and find that while the patterns of information content for cells are approximately centrosymmetric for all examined underlying secular trends, the patterns of information content for sequences or periods are more sensitive to the secular trend, and may be far from centrosymmetric.

Protocol for a pilot randomized controlled trial of a telehealth-delivered counseling intervention to reduce suicidality and improve HIV care engagement in Tanzania.

OBJECTIVE: Suicidal ideation is strikingly common among people living with HIV (PLWH) worldwide, leading to higher burden of disease, poor HIV care engagement, and loss of life. In low- and middle-income countries such as Tanzania, mental health resources are scarce, requiring innovative strategies for treatment. We describe the protocol for a clinical trial of a three-session telehealth counseling intervention to reduce suicidality and improve HIV care engagement in Tanzania. METHODS: In a pilot randomized controlled trial, we will assess the feasibility, acceptability, and potential efficacy of a new telehealth intervention, termed "IDEAS for Hope". A total of 60 PLWH will be enrolled from two HIV clinics in the Kilimanjaro region and connected to telehealth counsellors based at a large regional hospital. Participants will be ≥18 years old and speak either Kiswahili or English. Patient screening will occur during routine HIV clinical care to identify PLWH experiencing suicidal ideation. Baseline surveys will be administered upon enrollment and participants will be randomized 1:1 to receive either IDEAS for Hope or the comparison condition, a brief safety planning session. All participants will receive an additional referral for psychiatric treatment. Follow-up assessment will occur at three months. IDEAS for Hope is informed by a Motivational Interviewing-enhanced safety planning intervention (MI-SafeCope) and our formative work in Tanzania. The model consists of Four Pillars: living healthy with HIV, managing HIV stigma, seeking social support, and meeting basic needs. Together, these mechanisms serve as a foundation for developing a sense of safety and hope for the future. Outcome measures will include intervention feasibility, acceptability, participant suicidality, and HIV care engagement. SIGNIFICANCE: Innovative, telehealth-based counseling represents a promising treatment for suicidality among PLWH in low-resource settings. Results from this pilot trial will inform intervention refinement and parameter estimates for a future clinical trial powered to evaluate effectiveness.

Hip Manipulation Under Anesthesia for Post-Hip Arthroscopy Pericapsular Scarring: Indications and Techniques.

Hip arthroscopy has become an increasingly common procedure with expanding indications over the last several decades. With the increase in number of procedures performed a complication profile has emerged, although there is yet to be a formal classification system for complications. The most cited complications include lateral femoral cutaneous nerve neuropraxia, other sensory deficits, chondral or labral iatrogenic damage, superficial infection and deep vein thrombosis. One complication that has not yet been well documented in the literature is pericapsular scarring/adhesions resulting in decreased hip range of motion and function. If this complication is noted to persist after adequate impingement resection and a rigorous post-operative physical therapy regimen, the senior author has addressed this with a hip manipulation under anesthesia. Therefore, this techniques paper aims to describe pericapsular scarring as a post hip-arthroscopy condition which may cause pain and demonstrate our technique to address this diagnosis through hip manipulation under anesthesia.