Acceptability and tolerability of long-acting injectable cabotegravir or rilpivirine in the first cohort of virologically suppressed adolescents living with HIV (IMPAACT 2017/MOCHA): a secondary analysis of a phase 1/2, multicentre, open-label, non-comparative dose-finding study.

BACKGROUND: Long-acting injectable cabotegravir and rilpivirine have demonstrated safety, acceptability, and efficacy in adults living with HIV-1. The IMPAACT 2017 study (MOCHA study) was the first to use these injectable formulations in adolescents (aged 12-17 years) living with HIV-1. Herein, we report acceptability and tolerability outcomes in cohort 1 of the study. METHODS: In this a secondary analysis of a phase 1/2, multicentre, open-label, non-comparative dose-finding study, with continuation of pre-study oral combination antiretroviral treatment (ART), 55 adolescents living with HIV-1 were enrolled to receive sequential doses of either long-acting cabotegravir or rilpivirine and 52 received at least two injections. Participants had a body weight greater than 35 kg and BMI less than 31·5 kg/m2 and had been on stable ART for at least 90 consecutive days with an HIV-1 viral load of less than 50 copies per mL at a participating IMPAACT study site. Participants had to be willing to continue their pre-study ART during cohort 1. The primary objectives of the study were to confirm doses for oral and injectable cabotegravir and for injectable rilpivirine in adolescents living with HIV. This analysis of participant-reported outcomes included a face scale assessment of pain at each injection and a Pediatric Quality of Life Inventory (PedsQL) at baseline and week 16 for participants in the USA, South Africa, Botswana, and Thailand. A subset of 11 adolescents and 11 parents or caregivers in the USA underwent in-depth interviews after receipt of one or two injections. This trial is registered at ClinicalTrials.gov, NCT03497676. FINDINGS: Between March 19, 2019, and Nov 25, 2021, 55 participants were enrolled into cohort 1. Using the six-point face scale, 43 (83%) of participants at week 4 and 38 (73%) at week 8 reported that the injection caused "no hurt" or "hurts little bit", while only a single (2%) participant for each week rated the pain as one of the two highest pain levels. Quality of life was not diminished by the addition of one injectable antiretroviral. In-depth interviews revealed that parents and caregivers in the USA frequently had more hesitancy than adolescents about use of long-acting formulations, but parental acceptance was higher after their children received injections. INTERPRETATION: High acceptability and tolerability of long-acting cabotegravir or rilpivirine injections suggests that these are likely to be favoured treatment options for some adolescents living with HIV. FUNDING: National Institutes of Health and ViiV Healthcare.

Effectiveness of Deworming with Single-Dose Albendazole for Preschool-Aged Children in the Dominican Republic.

Background. The World Health Organization recommends biannual deworming with single-dose albendazole for all children over 1 year in regions where soil-transmitted helminths (STH) are endemic. There are limited data from the Dominican Republic (DR) on the effectiveness of deworming programs. Methods. Between January and June 2019, we enrolled 63 preschool-aged children at a community clinic in the DR. Participants received albendazole at enrollment. Stool samples were collected and examined for parasites at enrollment, 2 to 4 and 12 to 16 weeks post-albendazole. Caregivers were surveyed on home hygiene practices and children's symptoms. Findings. At enrollment, 1 or more parasites were noted in 89% of samples. Ascaris lumbricoides (68%) was the most common species, followed by Entamoeba histolytica (35%) and Giardia intestinalis (8%). Two-to-four weeks post-albendazole, fewer than half of those with A. lumbricoides infections at baseline had cleared the infection. STH symptoms significantly improved between enrollment and 2 to 4 weeks. By 12 to 16 weeks after treatment, A. lumbricoides infections were as high as baseline. Interpretation. Although limited by size and available technology, our study contributes data on STH in the DR. Single-dose deworming with albendazole did not reduce Ascaris lumbricoides infections in our sample. As STH are the most common neglected tropical diseases and negatively impact children's health globally, further studies on both effective deworming programs and interventions to prevent STH are needed.

Parental role alteration strongly influences depressive symptoms in mothers of preoperative infants with congenital heart disease.

BACKGROUND: Mothers of infants with congenital heart disease are at risk for depression. OBJECTIVES: This study explored the influence on maternal depressive symptoms of several known factors for mothers in the pediatric cardiac intensive care unit, including perceived stressors, attachment, and anxiety. METHODS: This study was a secondary analysis of 30 mothers of infants awaiting cardiac surgery. Linear regressions were calculated to determine the relationships between perceived stressors, maternal attachment, anxiety, and maternal depressive symptoms. RESULTS: Nearly half of mothers reported depressive symptoms above the measure cut-off score, indicating they were at risk for likely clinical depression. Subscales of perceived stress explained 61.7% of the variance in depressive symptoms (F = 11.815, p<0.0001) with parental role alteration subscale as the strongest predictor (standardized beta=0.694, p = 0.03). CONCLUSIONS: Findings underscore the importance of mental health screening and instituting nursing practices to enhance parental role for mothers of infants awaiting cardiac surgery.