Utility of self-report antiretroviral adherence for predicting HIV viral load among persons who inject drugs in Hai Phong Vietnam: assessing differences by methamphetamine use.

ABSTRACTIn resource-limited settings, alternatives to HIV viral load testing may be necessary to monitor the health of people living with HIV. We assessed the utility of self-report antiretroviral therapy (ART) to screen for HIV viral load among persons who inject drugs in Hai Phong Vietnam, and consider differences by recent methamphetamine use. From 2016 to 2018 we recruited PWID through cross sectional surveys and collected self-report ART adherence and HIV viral load to estimate sensitivity, specificity, positive and negative predictive values (PPV, NPV) and likelihood ratios (LR+, LR-) for self-reported ART adherence as a screening test for HIV viral load. We used three HIV viral load thresholds: < 1000, 500 and 250 copies/mL; laboratory-confirmed HIV viral load was the gold standard. Among 792 PWID recruited, PPV remained above 90% regardless of recent methamphetamine use with slightly higher PPV among those not reporting recent methamphetamine use. The results remained consistent across all three HIV viral load thresholds. Our findings suggest that when HIV viral load testing is not possible, self-reported ART adherence may inform decisions about how to prioritize HIV viral load testing among PWID. The high PPV values suggest self-reported high ART adherence indicates likely HIV viral suppression, irrespective of methamphetamine use.

The Psychosocial Impact of the COVID-19 Pandemic on Families of Youth of Color: A Prospective Cohort Study.

OBJECTIVE: Prospectively examine racial and ethnic disparities in exposure to COVID-19-related stressors and their impact on families. METHODS: A racially, ethnically, and socioeconomically diverse cohort of caregivers of youth (n = 1,581) representative of the population served by a pediatric healthcare system completed the COVID-19 Exposure and Family Impact Scales in Oct/Nov 2020 and March/April 2021. Linear mixed-effects models were used to examine exposure to COVID-19-related events (Exposure), impact of the pandemic on family functioning and well-being (Impact), and child and parent distress (Distress) across time and as a function of race and ethnicity, adjusting for other sociodemographic variables. RESULTS: Exposure and Distress increased over time for all participants. After adjusting for sociodemographic factors, caregivers of Black and Hispanic youth reported greater Exposure than caregivers of White youth and caregivers of Black youth had a greater increase in Exposure over time than caregivers of White youth. Caregivers of White youth reported greater Impact than caregivers of Black and Other race youth. CONCLUSIONS: Exposure to and impact of the COVID-19 pandemic on family psychosocial functioning varied by race and ethnicity. Although exposure to COVID-19-related events was greater among Hispanic and non-Hispanic Black families, those of marginalized races reported less family impact than non-Hispanic White families, suggesting resiliency to the pandemic. Research should examine such responses to public health crises in communities of color, with a focus on understanding protective factors. These findings suggest the importance of culturally tailored interventions and policies that support universal psychosocial screenings during times of public health crises.

Acceptability and Feasibility of eSCCIP: Results From a Pilot Study of the Electronic Surviving Cancer Competently Intervention Program.

BACKGROUND: Providing high-quality psychosocial care to parents and other primary caregivers of children with cancer (henceforth referred to as caregivers) is important, given the numerous challenges associated with a pediatric cancer diagnosis and the increased risk for negative psychosocial sequelae among caregivers. The Electronic Surviving Cancer Competently Intervention Program (eSCCIP) is a psychosocial eHealth intervention for caregivers, developed using an iterative, user-centered process. METHOD: eSCCIP was tested in a single-arm pilot trial at Nemours Children's Hospital, Delaware (NCT05333601). The primary outcomes were intervention acceptability and feasibility, assessed via enrollment and retention targets, and item-level acceptability ratings. Enrollment and retention targets of 45% were set based on previous work, and an item-level acceptability threshold of 80% was set. A secondary exploratory analysis was conducted examining acute distress, anxiety, symptoms of post-traumatic stress, and family functioning. RESULTS: 44 caregivers enrolled in the study and 31 completed. The intervention was rated favorably by completers, with over 80% of the sample selecting "mostly true" or "very true" for all items of the eSCCIP Evaluation Questionnaire, which was used to assess acceptability and feasibility. Enrollment and retention rates were 54% and 70%, respectively. Exploratory psychosocial outcomes showed statistically significant decreases from pre-intervention to post-intervention for overall symptoms of post-traumatic stress disorder (PTSD), cluster D symptoms of PTSD (negative mood and cognitions), and anxiety. Small-moderate effect sizes were observed for all psychosocial outcomes of interest. CONCLUSIONS: eSCCIP is an acceptable and feasible intervention for caregivers. Results are promising regarding reductions in symptoms of post-traumatic stress and anxiety.

Trajectories of Traumatic Stress Symptoms Among Siblings of Children With Cancer: The First Two Years Post-Diagnosis.

OBJECTIVE: Identify and describe trajectories of cancer-related posttraumatic stress symptoms (PTSS) among siblings of children with cancer within two years of diagnosis. METHOD: Siblings (aged 8-18; M = 11.2 years) across the United States, and for each, one caregiver, were recruited for a cohort sequential longitudinal study with three data collection points six months apart beginning at 6- or 12-months after cancer diagnosis. Siblings (N = 229; 42% of eligible/approached; 53% identifying as female; 68% identifying as non-Hispanic White) completed the Child Posttraumatic Stress Disorder Symptom Scale. Caregivers completed the Strengths and Difficulties Questionnaire (SDQ). Latent class growth analysis (LCGA) and growth mixture modeling (GMM) identified PTSS patterns across time. RESULTS: Fit statistics supported models with three to five PTSS trajectories. The three-class LCGA model included a large mild PTSS group (61%), a moderate PTSS group (35%), and a small (4%) stable severe PTSS group. The four-class LCGA and three- and four-class GMM included groups improving from moderate to mild PTSS (7-21%) and worsening to moderate PTSS across time (12-17%). Across models, siblings with mild PTSS had fewer caregiver-reported emotional and behavioral difficulties on the SDQ. CONCLUSIONS: A large group of siblings of children with cancer demonstrate resiliency, however, substantial subsets experience patterns of PTSS that include levels in the moderate-to-severe range during the first two years post-diagnosis. Future research should examine these patterns in more diverse/representative samples and identify factors associated with increasing and sustained severe PTSS to inform intervention targets and reduce cancer-related burden on families.

Parental and Other Caregiver Loss Due to COVID-19 in the United States: Prevalence by Race, State, Relationship, and Child Age.

The more than one million COVID-19 deaths in the United States include parents, grandparents, and other caregivers for children. These losses can disrupt the social, emotional, and economic well-being of children, their families, and their communities, and understanding the number and characteristics of affected children is a critical step in responding. We estimate the number of children who lost a parent or other co-residing caregiver to COVID-19 in the U.S. and identify racial, ethnic, and geographic disparities by aligning COVID-19 death counts through mid-May 2022 with household information from a representative sample of individuals. We estimate that 216,617 children lost a co-residing caregiver to COVID-19; 77,283 lost a parent and more than 17,000 children lost the only caregiver with whom they lived. Non-White children were more than twice as likely as White children to experience caregiver loss, and children under 14 years old experienced 70% of caregiver loss. These losses are a salient threat to the functioning of families and the communities in which COVID-19 deaths are concentrated, compounding additional challenges to physical and mental health and economic stability disproportionately imposed by the pandemic on historically disadvantaged populations. Policymakers and systems should take steps to ensure access to appropriate supports.

COVID-19 Exposure and Family Impact Scales for Adolescents and Young Adults.

OBJECTIVE: To understand the impact of the coronavirus disease 2019 (COVID-19) pandemic on adolescents and young adults (AYAs), we adapted the COVID-19 Exposure and Family Impact Scales (CEFIS; Kazak et al., 2021) for AYAs. Here, we report on the development, structure, and psychometric properties of the CEFIS-AYA. METHODS: The CEFIS-AYA was developed by a multidisciplinary, multi-institutional team using a rapid iterative process. Data from 3,912 AYAs from 21 programs at 16 institutions across the United States were collected from May 2020 to April 2021. We examined the underlying structure of the CEFIS-AYA using principal component analysis (PCA), calculated internal consistencies, and explored differences in scores by gender and age. RESULTS: Participants reported exposure to a range of COVID-19-related events (M = 9.08 events, of 28). On the bidirectional 4-point Impact scale, mean item scores were mostly above the midpoint, indicating a slightly negative impact. Kuder-Richardson 20/Cronbach's Alpha was good for Exposure (α = .76) and excellent for Impact (α = .93). PCA identified seven factors for Exposure (Severe COVID-19, Loss of Income, Limited Access to Essentials, COVID-19 Exposure, Disruptions to Activities, Disruptions to Living Conditions, and Designation as an Essential Worker) and five for Impact (Self and Family Relationships, Physical Well-Being, Emotional Well-Being, Social Well-Being, and Distress). Gender and age differences in CEFIS-AYA scores were identified. DISCUSSION: Initial reliability data are strong and support use of the CEFIS-AYA for measuring the effect of the COVID-19 pandemic on AYAs in research and clinical care.

Expansion of Syringe Service Programs in the United States, 2015-2018.

Objectives. To report on the expansion of syringe service programs (SSPs) in the United States from 2015 to 2018.Methods. We obtained data from records of the Buyers' Club of the Dave Purchase Project/North American Syringe Exchange Network (NASEN), including the number of US SSPs and the numbers of sterile syringes purchased by programs. We conducted a subset analysis of states with high numbers of counties defined as "vulnerable" by the Centers for Disease Control and Prevention.Results. SSP participation in the Buyers' Club increased from 141 in 2015 to 292 in 2018, with an increase in syringes purchased from 42 million to 88 million. In addition to these large increases in numbers of programs and in syringes purchased, there were also indications of instability among new programs in vulnerable states.Conclusions. There have been substantial increases in the number of programs established and the number of syringes distributed in response to the opioid epidemic. Ensuring high-quality services in these new programs will be critical to successfully addressing the current epidemic.

Injection and Heterosexual Risk Behaviors for HIV Infection Among Non-gay Identifying Men Who Have Sex with Men and Women.

Non-gay identifying men who have sex with men and women (MSMW) are an important subgroup of men who have sex with men (MSM) and have been underrepresented in studies of MSM that only use gay venues to draw their samples. We assessed heterosexual and drug use risks of MSMW who use drugs in a sample of male entrants to the Mount Sinai Beth Israel drug treatment programs from 2005 to 2018. Blood samples were collected and tested for HIV and HSV-2 infections. Among HIV seronegative participants, MSMW had significantly greater odds of sharing used needles with others, and reporting unprotected sex with female casual partners and female commercial sex partners, compared to their counterparts who reported sex with women exclusively (MSWE). Although not recruited from gay venues, MSMW had a significantly higher HIV prevalence than MSWE (23% vs. 10%, p < 0.001). Interventions that are specifically tailored to HIV prevention among MSMW are needed to ameliorate the prevalence of HIV risks and infection.

Implementing an Updated "Break the Cycle" Intervention to Reduce Initiating Persons into Injecting Drug Use in an Eastern European and a US "opioid epidemic" Setting.

We tested the hypothesis that an updated "Break the Cycle" (BtC) intervention, based in social cognitive theory and motivational interviewing, would reduce the likelihood that current persons who inject drugs (PWID) would assist persons who do not inject drugs (non-PWID) with first injections in Tallinn, Estonia and Staten Island, New York City. 402 PWID were recruited, a baseline interview covering demographics, drug use, and assisting non-PWID with first drug injections was administered, followed by BtC intervention. 296 follow-up interviews were conducted 6 months post-intervention. Percentages assisting with first injections declined from 4.7 to 1.3% (73% reduction) in Tallinn (p < 0.02), and from 15 to 6% (60% reduction) in Staten Island (p < 0.05). Persons assisted with first injections declined from 11 to 3 in Tallinn (p = 0.02) and from 32 to 13 in Staten Island. (p = 0.024). Further implementation research on BtC interventions is urgently needed where injecting drug use is driving HIV/HCV epidemics and areas experiencing opioid epidemics.

Risk Behaviors for HIV and HCV Infection Among People Who Inject Drugs in Hai Phong, Viet Nam, 2014.

We examined the potential for HIV and hepatitis C (HCV) transmission across persons who inject drugs (PWID), men-who-have-sex-with-men (MSM) and female commercial sex workers (CSW) PWID and the potential for sexual transmission of HIV from PWID to the general population in Hai Phong, Viet Nam. Using respondent driven and convenience sampling we recruited 603 participants in 2014. All participants used heroin; 24% used non-injected methamphetamine. HIV prevalence was 25%; HCV prevalence was 67%. HIV infection was associated with HCV prevalence and both infections were associated with length of injecting career. Reported injecting risk behaviors were low; unsafe sexual behavior was high among MSM-PWID and CSW-PWID. There is strong possibility of sexual transmission to primary partners facilitated by methamphetamine use. We would suggest future HIV prevention programs utilize multiple interventions including "treatment as prevention" to potential sexual transmission of HIV among MSM and CSW-PWID and from PWID to the general population.

Decline in Herpes Simplex Virus Type 2 Among Non-Injecting Heroin and Cocaine Users in New York City, 2005 to 2014: Prospects for Avoiding a Resurgence of Human Immunodeficiency Virus.

BACKGROUND: Herpes simplex virus type 2 (HSV-2) infection increases both susceptibility to and transmissibility of human immunodeficiency virus (HIV), and HSV-2 and HIV are often strongly associated in HIV epidemics. We assessed trends in HSV-2 prevalence among non-injecting drug users (NIDUs) when HIV prevalence declined from 16% to 8% among NIDUs in New York City. METHODS: Subjects were current non-injecting users of heroin and/or cocaine and who had never injected illicit drugs. Three thousand one hundred fifty-seven NIDU subjects were recruited between 2005 and 2014 among persons entering Mount Sinai Beth Israel substance use treatment programs. Structured interviews, HIV, and HSV-2 testing were administered. Change over time was assessed by comparing 2005 to 2010 with 2011 to 2014 periods. Herpes simplex virus type 2 incidence was estimated among persons who participated in multiple years. RESULTS: Herpes simplex virus type 2 prevalence was strongly associated with HIV prevalence (odds ratio, 3.9; 95% confidence interval, 2.9-5.1) from 2005 to 2014. Herpes simplex virus type 2 prevalence declined from 60% to 56% (P = 0.01). The percentage of NIDUs with neither HSV-2 nor HIV infection increased from 37% to 43%, (P < 0.001); the percentage with HSV-2/HIV coinfection declined from 13% to 6% (P < 0.001). Estimated HSV-2 incidence was 1 to 2/100 person-years at risk. CONCLUSIONS: There were parallel declines in HIV and HSV-2 among NIDUs in New York City from 2005 to 2014. The increase in the percentage of NIDUs with neither HSV-2 nor HIV infection, the decrease in the percentage with HSV-2/HIV coinfection, and the low to moderate HSV-2 incidence suggest some population-level protection against resurgence of HIV. Prevention efforts should be strengthened to end the combined HIV/HSV-2 epidemic among NIDUs in New York City.

Racial/Ethnic Disparities at the End of an HIV Epidemic: Persons Who Inject Drugs in New York City, 2011-2015.

OBJECTIVES: To examine whether racial/ethnic disparities persist at the "end of the HIV epidemic" (prevalence of untreated HIV infection < 5%; HIV incidence < 0.5 per 100 person-years) among persons who inject drugs (PWID) in New York City. METHODS: We recruited 2404 PWID entering New York City substance use treatment in 2001 to 2005 and 2011 to 2015. We conducted a structured interview, and testing for HIV and herpes simplex virus 2 (HSV-2; a biomarker for high sexual risk). We estimated incidence by using newly diagnosed cases of HIV. Disparity analyses compared HIV, untreated HIV, HIV-HSV-2 coinfection, HIV monoinfection, and estimated HIV incidence among Whites, African Americans, and Latinos. RESULTS: By 2011 to 2015, Whites, African Americans, and Latino/as met both criteria of our operational "end-of-the-epidemic" definition. All comparisons that included HIV-HSV-2-coinfected persons had statistically significant higher rates of HIV among racial/ethnic minorities. No comparisons limited to HIV monoinfected persons were significant. CONCLUSIONS: "End-of-the-epidemic" criteria were met among White, African American, and Latino/a PWID in New York City, but elimination of disparities may require a greater focus on PWID with high sexual risk.

Consistent Estimates of Very Low HIV Incidence Among People Who Inject Drugs: New York City, 2005-2014.

OBJECTIVES: To compare methods for estimating low HIV incidence among persons who inject drugs. METHODS: We examined 4 methods in New York City, 2005 to 2014: (1) HIV seroconversions among repeat participants, (2) increase of HIV prevalence by additional years of injection among new injectors, (3) the New York State and Centers for Disease Control and Prevention stratified extrapolation algorithm, and (4) newly diagnosed HIV cases reported to the New York City Department of Health and Mental Hygiene. RESULTS: The 4 estimates were consistent: (1) repeat participants: 0.37 per 100 person-years (PY; 95% confidence interval [CI] = 0.05/100 PY, 1.33/100 PY); (2) regression of prevalence by years injecting: 0.61 per 100 PY (95% CI = 0.36/100 PY, 0.87/100 PY); (3) stratified extrapolation algorithm: 0.32 per 100 PY (95% CI = 0.18/100 PY, 0.46/100 PY); and (4) newly diagnosed cases of HIV: 0.14 per 100 PY (95% CI = 0.11/100 PY, 0.16/100 PY). CONCLUSIONS: All methods appear to capture the same phenomenon of very low and decreasing HIV transmission among persons who inject drugs. Public Health Implications. If resources are available, the use of multiple methods would provide better information for public health purposes.

Providing ART to HIV Seropositive Persons Who Use Drugs: Progress in New York City, Prospects for "Ending the Epidemic".

New York City has experienced the largest HIV epidemic among persons who use psychoactive drugs. We examined progress in placing HIV seropositive persons who inject drugs (PWID) and HIV seropositive non-injecting drug users (NIDU) onto antiretroviral treatment (ART) in New York City over the last 15 years. We recruited 3511 PWID and 3543 NIDU from persons voluntarily entering drug detoxification and methadone maintenance treatment programs in New York City from 2001 to 2014. HIV prevalence declined significantly among both PWID and NIDU. The percentage who reported receiving ART increased significantly, from approximately 50 % (2001-2005) to approximately 75 % (2012-2014). There were no racial/ethnic disparities in the percentages of HIV seropositive persons who were on ART. Continued improvement in ART uptake and TasP and maintenance of other prevention and care services should lead to an "End of the AIDS Epidemic" for persons who use heroin and cocaine in New York City.

Integrated respondent-driven sampling and peer support for persons who inject drugs in Haiphong, Vietnam: a case study with implications for interventions.

Combined prevention for HIV among persons who inject drugs (PWID) has led to greatly reduced HIV transmission among PWID in many high-income settings, but these successes have not yet been replicated in resource-limited settings. Haiphong, Vietnam experienced a large HIV epidemic among PWID, with 68% prevalence in 2006. Haiphong has implemented needle/syringe programs, methadone maintenance treatment (MMT), and anti-retroviral treatment (ART), but there is an urgent need to identify high-risk PWID and link them to services. We examined integration of respondent-driven sampling (RDS) and strong peer support groups as a mechanism for identifying high-risk PWID and linking them to services. The peer support staff performed the key tasks that required building and maintaining trust with the participants, including recruiting the RDS seeds, greeting and registering participants at the research site, taking electronic copies of participant fingerprints (to prevent multiple participation in the study), and conducting urinalyses. A 6-month cohort study with 250 participants followed the RDS cross-sectional study. The peer support staff maintained contact with these participants, tracking them if they missed appointments, and providing assistance in accessing methadone and ART. The RDS recruitment was quite rapid, with 603 participants recruited in three weeks. HIV prevalence was 25%, Hepatitis C (HCV) prevalence 67%, and participants reported an average of 2.7 heroin injections per day. Retention in the cohort study was high, with 86% of participants re-interviewed at 6-month follow-up. Assistance in accessing services led to half of the participants in need of methadone enrolled in methadone clinics, and half of HIV-positive participants in need of ART enrolled in HIV clinics by the 6-month follow-up. This study suggests that integrating large-scale RDS and strong peer support may provide a method for rapidly linking high-risk PWID to combined prevention and care, and greatly reducing HIV transmission among PWID in resource-limited settings.

Adherence to antiretroviral medications among persons who inject drugs in transitional, low and middle income countries: an international systematic review.

Adherence to antiretroviral (ART) medication is vital to reducing morbidity and mortality among HIV positive persons. People who inject drugs (PWID) are at high risk for HIV infection in transitional/low/middle income countries (TLMIC). We conducted a systematic review of studies reporting adherence to ART among persons with active injection drug use and/or histories of injection drug use in TLMIC. Meta-regression was performed to examine relationships between location, adherence measurements, and follow-up period. Fifteen studies were included from seven countries. Adherence levels ranged from 33 to 97 %; mean weighted adherence was 72 %. ART adherence was associated with different methods of measuring adherence and studies conducted in Eastern Europe and East Asia. The great heterogeneity observed precludes generalization to TLMIC as a whole. Given the critical importance of ART adherence more research is needed on ART adherence among PWID in TLMIC, including the use of standardized methods for reporting adherence to ART.

Use of the "NYC Condom" among people who use drugs.

We assessed awareness and use of the "NYC Condom" among persons who use heroin and cocaine in New York City. The NYC Condom distribution program is the largest free condom distribution program in the USA, with over 30 million condoms distributed per year. It includes a condom social marketing program for a specific brand, the NYC Condom with its own packaging and advertising. People who use heroin and cocaine are at relatively high risk for HIV infection and are an important target population for the program. In order to assess awareness of the NYC Condom, structured interviews and blood testing for HIV, HSV-2, and sexually transmitted infections (STI) were conducted among entrants to the Beth Israel Medical Center drug detoxification and methadone treatment programs. Participants were asked about drug use, sexual risk behaviors, and awareness and use of the NYC Condom. Univariate and multivariable regression analyses were conducted to examine the associations between use of NYC Condoms and consistent condom use with primary and casual sexual partners. A total of 970 subjects were recruited between February 2011 and December 2012. Subjects were primarily African-American and Hispanic, with a mean age of 43. Fifty-five percent of subjects reported being sexually active with primary sexual partners, and 25 % reported being sexually active with a casual partner for the 6 months prior to the interview. Sixty-five percent of subjects had heard of the NYC Condom, 48 % of those who had heard of the condom had used it, and 58 % of those who had ever used it were currently using it (in the previous 6 months). In multivariable regression analyses, current use of NYC Condoms was strongly associated with consistent condom use with primary sexual partners (adjusted odds ratio (AOR) = 3.99, 95 % confidence interval (CI) 1.85-8.58) and consistent condom use with casual sexual partners (AOR = 4.48, 95 % CI 1.49-13.42). In terms of market share, 38 % of subjects consistently using condoms with primary partners were using the NYC Condom, and 47 % of those consistently using condoms with casual partners were using the NYC Condom. The NYC Condom is an important tool for reducing sexual transmission of HIV and STI among persons who use drugs in the city. Given the strong relationship between using the NYC Condom and consistent condom use, further efforts to promote the NYC Condom brand would be easily justified.

A perfect storm: crack cocaine, HSV-2, and HIV among non-injecting drug users in New York City.

Prevalence of human immunodeficiency virus (HIV) infection has reached 16% among non-injecting drug users (NIDU) in New York City, an unusually high prevalence for a predominantly heterosexual population that does not inject drugs. Using a long-term study (1983-2011, >7,000 subjects) among persons entering the Beth Israel drug-treatment programs in New York City, we identified factors that contributed to this high prevalence: a preexisting HIV epidemic among injectors, a crack cocaine epidemic, mixing between injectors and crack users, policy responses not centered on public health, and herpes-simplex virus 2 facilitating HIV transmission. Implications for avoiding high prevalence among NIDU in other areas are discussed.

Comparison of 2 Models of Care for Children With Medical Complexity Following Spinal Fusion.

We conducted a retrospective chart review of patients with neuromuscular scoliosis following spinal fusion surgery who were cared for post-operatively by either a hospitalist/orthopedics co-management team or a complex care clinic (CCC). Assignment to either treatment group was not random. To account for baseline differences between groups, we calculated propensity scores and used these as probability weights in generalized linear models. After matching, the CCC had a shorter length of stay (LOS, coefficient = -2.60; P = .04) without a significant difference in 30-day readmission rate (P = .62). For secondary outcomes, there were some significant resource utilization benefits favoring the complex care group without significant difference in complication outcomes between groups. In managing patients after spinal fusion surgery, both groups had similar LOS compared with prior studies of children after spinal fusion surgery. Management by the CCC may confer some outcome benefits for their patients.

The Electronic Surviving Cancer Competently Intervention Program-a Psychosocial Digital Health Intervention for English- and Spanish-Speaking Parents of Children With Cancer: Protocol for Randomized Controlled Trial.

BACKGROUND: The psychosocial needs and risks of children with cancer and their families are well-documented including increased risk of parental distress, posttraumatic stress, and anxiety. There is a critical need to provide evidence-based psychosocial care to parents and caregivers of children with cancer. Digital health interventions are important to address many barriers to in-person intervention delivery but are not widely used in pediatric psychosocial cancer care. The COVID-19 pandemic has reinforced the need for flexible, acceptable, and accessible psychosocial digital health interventions. The Electronic Surviving Cancer Competently Intervention Program (eSCCIP) is an innovative digital health intervention for parents and caregivers of children with cancer, delivered through a combination of self-guided web-based content and supplemented by 3 telehealth follow-up sessions with a trained telehealth guide. A Spanish language adaptation of eSCCIP, El Programa Electronico de Intervencion para Superar Cancer Competentemente (eSCCIP-SP), has been developed. The self-guided web-based cores of eSCCIP/eSCCIP-SP are a mix of didactic video content, multifamily video discussion groups featuring parents of children with cancer, and hands-on web-based activities. OBJECTIVE: The objective of this study is to test eSCCIP/eSCCIP-SP in a multisite randomized controlled trial, compared to an internet-based education control condition consisting of information specifically focused on concerns relevant to parents and caregivers of children with cancer. METHODS: Using a randomized controlled clinical trial design, 350 eligible parents and caregivers of children with cancer will be randomly assigned to the intervention (eSCCIP/eSCCIP-SP) or an education control condition. Data will be collected at 3 time points: preintervention (prior to randomization), immediately post intervention (after 6 weeks), and at a 3-month follow-up (from baseline). Participants randomized to either condition will receive study material (eSCCIP/eSCCIP-SP intervention or education control website) in English or Spanish, based on the primary language spoken in the home and participant preference. RESULTS: The primary study end point is a reduction in acute distress from baseline to postintervention, with secondary end points focused on reductions in symptoms of posttraumatic stress and anxiety, and improvements in coping self-efficacy and cognitive coping. An additional exploratory aim will be focused on implementation strategies and potential costs and cost-savings of eSCCIP/eSCCIP-SP, laying the groundwork for future trials focused on dissemination and implementation, stepped-care models, and intervention refinement. CONCLUSIONS: This trial will provide necessary data to evaluate the efficacy of eSCCIP/eSCCIP-SP. This intervention has the potential to be an easily scalable and highly impactful psychosocial treatment option for parents and caregivers of children with cancer. TRIAL REGISTRATION: ClinicalTrials.gov NCT05294302; https://clinicaltrials.gov/ct2/show/NCT05294302. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/46339.