Appropriate outcome measures and high-quality intervention trials are critical to advancing care for children with chronic pain. Our aim was to update a core outcome set for pediatric chronic pain interventions. The first phase involved collecting providers', patients', and parents' perspectives about treatment of pediatric chronic pain to understand clinically meaningful outcomes to be routinely measured. The second phase was to reach consensus of mandatory and optional outcome domains following the OMERACT framework. A modified Delphi study with 2 rounds was conducted including 3 stakeholder groups: children with chronic pain (n = 93), their parents (n = 90), and health care providers who treat youth with chronic pain (n = 52). Quantitative and qualitative data from round 1 of the Delphi study were summarized to identify important outcomes, which were condensed to a list of 10 outcome domains. Round 2 surveys were analyzed to determine the importance of the 10 domains and their relative ranking in each stakeholder group. A virtual consensus conference was held with the steering committee to reach consensus on a set of recommended outcome domains for pediatric chronic pain clinical trials. It was determined, by unanimous vote, that pain severity, pain interference with daily living, overall well-being, and adverse events, including death, would be considered mandatory domains to be assessed in all trials of any type of intervention. Emotional functioning, physical functioning, and sleep were important but optional domains. Last, the research agenda identifies several important emerging areas, including biomarkers. Future work includes selecting appropriate validated measures to assess each outcome domain.

Background: Despite the effective scale-up of HIV testing and treatment programs, only 75% of people living with HIV (PLWH) globally know their status, and this rate is lower among men. This highlights the importance of implementing HIV testing and linkage interventions with a high uptake in this population. In a cluster randomized controlled trial conducted in Kenya between 2013 and 2015, we found that assisted partner services (APS) for HIV-exposed partners of newly diagnosed PLWH safely reached more HIV-exposed individuals with HIV testing compared with client referral alone. However, more data are needed to evaluate APS implementation in a real-world setting. Objective: This study aims to evaluate the effectiveness, acceptability, fidelity, and cost of APS when integrated into existing HIV testing services (HTS) in Western Kenya. Methods: Our study team from the University of Washington and PATH is integrating APS into 31 health facilities in Western Kenya. We are enrolling females newly diagnosed with HIV (index clients) who consent to receiving APS, their male sexual partners, and female sexual partners of male sexual partners who tested HIV positive. Female index clients and sexual partners testing HIV positive will be followed up at 6 weeks, 6 months, and 12 months postenrollment to assess linkage to care, antiretroviral therapy initiation, and HIV viral load suppression. We will evaluate the acceptability, fidelity, and cost of real-world implementation of APS via in-depth interviews conducted with national, county, and subcounty-level policy makers responsible for HTS. Facility health staff providing HTS and APS, in addition to staff working with the study project team, will also be interviewed. We will also conduct direct observations of facility infrastructure and clinical procedures and extract data from the facilities and county and national databases. Results: As of March 2020, we have recruited 1724 female index clients, 3201 male partners, and 1585 female partners. We have completed study recruitment as well as 6-week (2936/2973, 98.75%), 6-month (1596/1641, 97.25%), and 12-month (725/797, 90.9%) follow-up visits. Preliminary analyses show that facilities scaling up APS identify approximately 12-18 new HIV-positive males for every 100 men contacted and tested. We are currently completing the remaining follow-up interviews and incorporating an HIV self-testing component into the study in response to the COVID-19 pandemic. Conclusions: The results will help bridge the gap between clinical research findings and real-world practice and provide guidance regarding optimal strategies for APS integration into routine HIV service delivery. International Registered Report Identifier (IRRID): DERR1-10.2196/27262

Introduction: Assisted partner services (APS) is an effective strategy for increasing HIV testing, new diagnosis, and linkage to care among sexual partners of people living with HIV (PLWH). APS can be resource intensive as it requires community tracing to locate each partner named and offer them testing. There is limited evidence for the effectiveness of offering HIV self‐testing (HIVST) as an option for partner testing within APS.Methods: We conducted a cluster randomized controlled trial comparing provider‐delivered HIV testing (Standard APS) versus offering partners the option of provider‐delivered testing or HIVST (APS+HIVST) at 24 health facilities in Western Kenya. Facilities were randomized 1:1 and we conducted intent‐to‐treat analyses using Poisson generalized linear mixed models to estimate intervention impact on HIV testing, new HIV diagnoses, and linkage to care. All models accounted for clustering at the clinic level and new diagnoses and linkage models were adjusted for individual‐level age, sex, and income a priori.Results: From March to December 2021, 755 index clients received APS and named 5054 unique partners. Among these, 1408 partners reporting a prior HIV diagnosis were not eligible for HIV testing and were excluded from analyses. Of the remaining 3646 partners, 96.9% were successfully contacted for APS and tested for HIV: 2111 (97.9%) of 2157 in the APS+HIVST arm and 1422 (95.5%) of 1489 in the Standard APS arm. In the APS+HIVST arm, 84.6% (1785/2111) tested via HIVST and 15.4% (326/2111) received provider‐delivered testing. Overall, 16.7% of the 3533 who tested were newly diagnosed with HIV (APS+HIVST = 357/2111 [16.9%]; Standard APS = 232/1422 [16.3%]). Of the 589 partners who were newly diagnosed, 90.7% were linked to care (APS+HIVST = 309/357 [86.6%]; Standard APS = 225/232 [97.0%]). There were no significant differences between the two arms in HIV testing (relative risk [RR]: 1.02, 95% CI: 0.96–1.10), new HIV diagnoses (adjusted RR [aRR]: 1.03, 95% CI: 0.76–1.39) or linkage to care (aRR: 0.88, 95% CI: 0.74–1.06).Conclusions: There were no differences between APS+HIVST and Standard APS, demonstrating that integrating HIVST into APS continues to be an effective strategy for identifying PLWH by successfully reaching and HIV testing >95% of elicited partners, newly diagnosing with HIV one in six of those tested, >90% of whom were linked to care.Clinical Trial Number: NCT04774835

Integrating HIV self-testing (HIVST) into assisted partner services (APS) has potential to increase identification of people with HIV in the community, but little is known about acceptability of HIVST among partners traced via APS. We assessed characteristics of APS partners testing with HIVST, and factors influencing HIVST uptake and acceptability in a cluster-randomized control trial on APS+HIVST. Using convergent parallel mixed-methods design, we evaluated socio-demographic and behavioral characteristics of APS partners who were offered HIVST or provider-delivered testing, and purposively selected a sub-set of partners for in-depth interviews (IDIs). Descriptive and log-binomial regression analyses were performed controlling for health facility clusters, while IDIs were thematically analyzed applying the theoretical framework of acceptability. Among 3312 partners who were offered HIVST or provider-administered testing through APS, 2724 (82.2%) used HIVST. There was no association between partner demographics and HIVST uptake. HIVST use was less likely than provider-delivered testing among those identified as a casual (adjusted relative risk (aRR) = 0.93; 95% Confidence Interval (CI) 0.88–0.98) or transactional (aRR = 0.90; 95% CI 0.87–0.94) partner compared to those in a defined relationship. HIVST use was slightly lower among those offered the option of an additional kit when compared to those only offered one kit (aRR = 0.93; 95% CI 0.88–0.98). In the IDIs (N = 24), partners reported that HIVST was a viable option for individuals who do not find provider-delivered testing suitable or convenient. For the APS partners, ‘intervention coherence’, ‘self-efficacy’, and ‘ethicality’ presented as most significant theoretical framework of acceptability constructs. APS providers played a critical role in creating HIVST awareness and driving acceptability. Increasing HIVST awareness and providing tailored solutions will empower APS clients optimize their HIV testing decisions. Providers should consider context of the partner’s sexual encounter and extend counselling support when recommending HIVST within APS.