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This article reviews recent literature in chronic illness or long-term health management including asthma, contraception, diabetes, HIV disease, and hypertension/cardiovascular disease, mental disorders, pain, and other diseases to determine the relationship between regimen factors and adherence to medications. The authors conducted an electronic literature search to detect articles published between 1998 and 2007. Articles were included if they pertained to a chronic illness or to contraception, included a clear definition of how adherence was measured, and included regimen factors as primary or secondary explanatory variables. Methodology of the studies varied greatly, as did methods of measuring adherence and regimen factors. Surprisingly few of these articles concerned (1) chronic treatment, (2) regimen factors such as dosing, pill burden, and regimen complexity, and (3) adherence measured in a clear manner. Most studies failed to use state-of-the-art methods of measuring adherence. Despite these flaws, a suggestive pattern of the importance of regimen factors, specifically dose frequency and regimen complexity, emerged from this review.

Background To reduce substance use and sexual HIV transmission risk among sexual minority men (SMM) requires the development of interventions tailored for those in relationships. In the past 5 years, there have been considerable advances in the development of motivational nterviewing (MI) with couples. The Couples Health Project (CHP) is the first multi-session risk reduction protocol built on this formative research. The purpose of this study is to evaluate the efficacy of CHP relative to a standard of care control – couples HIV testing and counseling (CHTC). Methods Eligibility includes couples where both partners are aged 18 or older, identify as cisgender male (assigned male sex at birth and identify as male gender), live in the US, and can communicate in English. Additionally, at least one partner has to be aged 18–34, HIV-negative, report recent drug use (excluding cannabis) and report condomless anal sex during the past 30 days. Couples are randomized post-baseline assessment to either CHP or CHTC. Follow-up assessments are completed at 3, 6, and 9-months post-randomization. Discussion Findings from this trial will inform the practice of MI with couples. If found efficacious, the CHP intervention would be the first multi-session MI with couples’ risk reduction protocol designed for use by substance use treatment or HIV prevention service providers who wish to engage SMM and their relationship partners. Protocol version 1.0; April 1, 2024. Trial registration ClinicalTrials.gov Protocol Registration; NCT06307977; completed March 6, 2024; https://register.clinicaltrials.gov/ .

Evaluating implementation of digital health interventions (DHIs) in practice settings is complex, involving diverse users and multistep processes. Proactive planning can ensure implementation determinants and outcomes are captured for hybrid studies, but operational guidance for designing or planning hybrid DHI studies is limited. This study aimed to proactively define, prioritize, and operationalize measurement of implementation outcomes and determinants for a DHI hybrid effectiveness-implementation trial. We describe unique advantages and limitations of planning the trial implementation evaluation among a large-scale cohort study population and share results of a pretrial organizational readiness assessment. We planned a cluster-randomized, type II hybrid effectiveness-implementation trial testing PositiveLinks, a smartphone app for HIV care, compared to usual care (n=6 sites per arm), among HIV outpatient sites in the DC Cohort Longitudinal HIV Study in Washington, DC. We (1) defined components of the DHI and associated implementation strategy; (2) selected implementation science frameworks to accomplish evaluation aims; (3) mapped framework dimensions, domains, and constructs to implementation strategy steps; (4) modified or created instruments to collect data for implementation outcome measures and determinants; and (5) developed a compatible implementation science data collection and management plan. Provider baseline surveys administered at intervention sites probed usage of digital tools and assessed provider readiness for implementation with the Organizational Readiness to Implement Change tool. We specified DHI and implementation strategy toward planning measurement of DHI and broader program reach and adoption. Mapping of implementation strategy steps to the Reach Effectiveness Adoption Implementation Maintenance framework prompted considerations for how to capture understudied aspects of each dimension: denominators and demographic representativeness within reach or adoption, and provider or organization-level adaptations, dose, and fidelity within the implementation dimension. Our process also prompted the creation of tools to obtain detailed determinants across domains and constructs of the Consolidated Framework for Implementation Research within a large sample at multiple time points. Some aspects of real-world PositiveLinks implementation were not reflected within the planned hybrid trial (eg, research assistants selected as de facto site implementation leads) or were modified to preserve internal validity of effectiveness measurement (eg, \"Community of Practice\"). Providers and research assistants (n=17) at intervention sites self-reported high baseline use of digital tools to communicate with patients. Readiness assessment revealed high median (48, IQR 45-54) total Organizational Readiness to Implement Change scores, with research assistants scoring higher than physicians (52.5, IQR 44-55 vs 48.0, IQR 46-49). Key takeaways, challenges, and opportunities arose in planning the implementation evaluation within a hybrid DHI trial among a cohort population. Prospective trial planning must balance generalizability of implementation processes to \"real world\" conditions with rigorous procedures to measure intervention effectiveness. Rapid, scalable tools require further study to enable evaluations within large multisite hybrid studies.

A randomized controlled trial evaluated the preliminary efficacy of a dyadically-delivered motivational interviewing (MI) intervention to reduce drug use and sexual risk in a sample of 50 sexual minority (cis)male (SMM) couples. In each couple, at least one partner was aged 18–29; reported drug use and sexual HIV transmission risk; and was HIV-negative. Couples were randomized to either the three-session MI intervention or an attention-matched control, with follow-up surveys completed at 3- and 6-months post-baseline. Between-group differences for all outcomes were non-significant in the overall sample. Subsequent moderation analyses indicated the intervention significantly reduced illicit drug use (excluding marijuana) at 3-month follow-up when either respondents (B = − 1.96; interval rate ratio—IRR 0.02–1.22; p = .001), their partners (B = − 2.60; IRR 0.01–0.64; p = .004), or both (B = − 2.38; IRR 0.01–0.80; p = .001) reported high levels of baseline use. The intervention also reduced condomless anal sex (CAS) with casual partners when both partners reported high frequency baseline CAS (B = − 2.54; IRR 0.01–0.83; p = .047). Findings provide initial evidence of the potential for MI to address drug use and sexual risk-taking among SMM couples at highest risk.Trial Registration ClinicalTrials.gov (NIH U.S. National Library of Medicine) Identifier: #NCT03386110.

PositiveLinks (PL) is a smartphone-based platform designed in partnership with people living with HIV (PLWH) to improve engagement in care. PL provides daily medication reminders, check-ins about mood and stress, educational resources, a community message board, and an ability to message providers. The objective of this study was to evaluate the impact of up to 24 months of PL use on HIV viral suppression and engagement in care and to examine whether greater PL use was associated with improved outcomes. This study occurred between September 2013 and March 2017 at a university-based Ryan White HIV clinic. We assessed engagement in care and viral suppression from study baseline to the 6-, 12-, 18- and 24-month follow-up time periods and compared trends among high vs. low PL users. We compared time to viral suppression, proportion of days virally suppressed, and time to engagement in care in patients with high vs. low PL use. 127 patients enrolled in PL. Engagement in care and viral suppression improved significantly after 6 months of PL use and remained significantly improved after 24 months. Patients with high PL use were 2.09 (95% CI 0.64-6.88) times more likely to achieve viral suppression and 1.52 (95% CI 0.89-2.57) times more likely to become engaged in care compared to those with low PL use. Mobile technology, such as PL, can improve engagement in care and clinical outcomes for PLWH. This study demonstrates long-term acceptability of PL over two years and provides evidence for long-term improvement in engagement in care and viral suppression associated with PL use.

Background. With the Patient Protection and Affordable Care Act, many state AIDS Drug Assistance Programs (ADAPs) shifted their healthcare delivery model from direct medication provision to purchasing qualified health plans (QHPs). The objective of this study was to characterize the demographic and healthcare delivery factors associated with Virginia ADAP clients' QHP enrollment and to assess the relationship between QHP coverage and human immunodeficiency virus (HIV) viral suppression. Methods. The cohort included persons living with HIV who were enrolled in the Virginia ADAP (n = 3933). Data were collected from 1 January 2013 through 31 December 2014. Multivariable binary logistic regression was conducted to assess for associations with QHP enrollment and between QHP coverage and viral load (VL) suppression. Results. In the cohort, 47.1% enrolled in QHPs, and enrollment varied significantly based on demographic and healthcare delivery factors. In multivariable binary logistic regression, controlling for time, age, sex, race/ethnicity, and region, factors significantly associated with achieving HIV viral suppression included QHP coverage (adjusted odds ratio, 1.346; 95% confidence interval, 1.041–1.740; P = .02), an initially undetectable VL (2.809; 2.174–3.636; P < .001), HIV rather than AIDS disease status (1.377; 1.049–1.808; P = .02), and HIV clinic (P < .001). Conclusions. QHP coverage was associated with viral suppression, an essential outcome for individuals and for public health. Promoting QHP coverage in clinics that provide care to persons living with HIV may offer a new opportunity to increase rates of viral suppression.

This study evaluated preliminary reliability and validity evidence for novel scores that extend the motivational interviewing treatment integrity (MITI) coding system to assess elements unique to motivational interviewing (MI) with couples. We recruited 20 cismale couples where at least one partner was aged 18–29; reported substance use; and was HIV-negative. Couples were randomized to a three-session MI or attention-matched education control. Four coders rated audio-recordings of initial sessions in both conditions. Novel global scores had high nearly-exact percent agreement (Decreasing Dyadic Ambivalence = 100%; Facilitating Dyadic Functioning = 94%). Consistency for novel behavior counts was good (ICCdyadic reflections = .72) and above minimum thresholds (nearly-exact agreement for Relationship Affirmations = 78%). MI sessions generated novel and established MITI codes that were significantly better than education sessions, providing preliminary evidence of validity. Findings provided initial support for the use of these novel scores in future research evaluating MI-based substance use and HIV risk reduction studies with couples.

Purpose Ensuring there are clear standards for addressing cancer-related sexual side effects is important. Currently, there are differences in two leading sets of clinical guidelines regarding the inclusion of survivors’ romantic partners into clinical discussions between survivors and their providers about this issue. To help refine guidelines, we examine breast cancer survivor, partner, and oncology provider perspectives about including partners in discussions about cancer-related sexual side effects in a secondary analysis of a broader qualitative study. Methods Partnered female breast cancer survivors ( N  = 29) completed online surveys, and intimate partners of breast cancer survivors ( N  = 12) and breast oncology providers ( N  = 8) completed semi-structured interviews. Themes were derived from thematic content analysis. Results Among survivors who reported a discussion with their provider, fewer than half indicated their partner had been present, despite most survivors expressing it was — or would have been — helpful to include their partner. Partners also largely indicated being included was or would have been helpful, when welcomed by the survivor. Providers similarly emphasized the importance of survivors’ autonomy in deciding whether to discuss sexual concerns in the presence of a partner. Conclusions Partners were infrequently included in conversations about cancer-related sexual side effects, even though survivors, partners, and providers alike expressed value in these discussions occurring with the couple together — when that is the survivor’s preference. Findings suggest future clinical guidelines should emphasize that incorporating partners into clinical discussions about sexual concerns is important for many breast cancer patients. Soliciting and enacting patients’ preferences is essential for truly patient-centered care.

Binge drinking, which is linked to various immediate and long-term negative outcomes, is highly prevalent among US college students. Behavioral interventions delivered via mobile phones have a strong potential to help decrease the hazardous effects of binge drinking by promoting safer drinking behaviors. This study aims to evaluate the preliminary efficacy of bhoos, a novel smartphone app designed to promote safer drinking behaviors among US college students. The app offers on-demand educational content about safer alcohol use, provides dynamic feedback as users log their alcohol consumption, and includes an interactive drink tracker that estimates blood alcohol content in real time. The bhoos app was tested in 2 independent pre-post studies each lasting 4 weeks, among US college students aged 18-35 years. The primary outcome in both trials was students' self-reported confidence in using protective behavioral strategies related to drinking, with self-reported frequency of alcohol consumption over the past month examined as a secondary outcome. In study 1, bhoos was associated with increased confidence in using protective behavioral strategies. Students also endorsed the high usability of the app and reported acceptable levels of engagement. Study 2 replicated findings of increased confidence in using protective behavioral strategies, and demonstrated a reduction in the self-reported frequency of alcohol consumption. Bhoos is a personalized, accessible, and highly scalable digital intervention with a strong potential to effectively address alcohol-related behaviors on college campuses.

Many college women are at risk for pregnancy, and binge drinking college women are often at risk for alcohol-exposed pregnancy. Brief interventions with sustainable outcomes are needed, particularly for college women who are binge drinking, at risk for pregnancy, and at increased risk of alcohol-exposed pregnancy. Two-hundred-twenty-eight women at a Mid-Atlantic urban university at risk for alcohol-exposed pregnancy enrolled in the randomized clinical trial, and 207 completed the 4 month follow-up. The BALANCE intervention used Motivational Interviewing plus feedback to target drinking and contraception behaviors. Main outcome measures included (1) the rate of risk for alcohol-exposed pregnancy, (2) the rate of risk drinking, and (3) the rate of pregnancy risk. At 4-month follow-up, the rate of alcohol-exposed pregnancy risk was significantly lower in the intervention (20.2%) than the control condition (34.9%), ( P  < .02). Assignment to the intervention condition halved the odds of women remaining at risk for alcohol-exposed pregnancy, while not receiving the intervention doubled the odds of continued alcohol-exposed pregnancy risk (OR = 2.18; 95% CI = 1.16–4.09). A baseline history of blackouts, continued high blood alcohol drinking days at 1 month, and continued risk for pregnancy at 1 month independently contributed to a multivariate model of continued alcohol-exposed pregnancy risk at 4 month follow-up. BALANCE reduced alcohol-exposed pregnancy risk, with similar outcomes to longer interventions. Because early response predicted sustained alcohol-exposed pregnancy risk reduction, those who fail to achieve initial change could be identified for further intervention. The BALANCE intervention could be adopted into existing student health or university alcohol programs. The risks of unintended pregnancy and alcohol-exposed pregnancy among binge drinking women in college merit greater prevention efforts.