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Background People who inject drugs (PWID) experience a higher burden of HIV compared to general populations. Social support has been shown to improve disease management and combat stigma for PWID yet remains unexplored among PWID in low- and middle-income countries. Methods We conducted qualitative in-depth interviews to understand social ties and health management among PWID living with HIV in Delhi, India. The research was nested in a factorial randomized controlled trial comparing same-day treatment and community-based care with standard-of-care. Interviews were conducted in Hindi in a private room, audio recorded, transcribed in English, and analyzed inductively using Dedoose. Results We conducted 22 interviews (30 min-two hours) with PWID living with HIV in Delhi (all men, ages 21–38 years). 10 slept in houses, 11 on public streets, and one in a shelter. Participants often experienced isolation in their lives but identified avenues of positive social support from healthcare staff, families, peers (friends or injecting partners), and authority figures/public contacts. Healthcare staff provided information and respectful encouragement to manage health. Outreach workers provided support to remind and accompany participants to clinic visits. Family members offered financial support, medicine reminders, and trust. Authority figures/public contacts included employers, shopkeepers, and vendors who provided a safe place to sleep or store belongings, which proved crucial to consistently store and take pills. In some cases, specific social connections created barriers to health by enabling injecting drug use and carrying out harmful behaviors such as physical attacks, disrespect, and theft. Conclusion Social connections can offer PWID positive emotional and logistical support to access health services and help them persevere through societal and structural stigmas. However, in some cases they may also contribute negatively to health management challenges. As a harm reduction strategy, public health services can work with PWID to consider untapped opportunities to build positive support and resilience through social ties, as well as how to contend with social connections harmful to health management.

Introduction Evaluation of implementation strategies is core to implementation trials, but implementation strategies often deviate from the original plan to adjust to the real-world conditions. The optimal approach to track modifications to implementation strategies is unclear, especially in low-resource settings. Using data from an implementation trial for people who inject drugs (PWID) with HIV in Vietnam, we describe the tracking of implementation strategy modifications and present findings of this process. Methods SNaP ( S ystems N avigation a nd P sychosocial Counseling) is a hybrid type-III effectiveness-implementation randomized controlled trial aiming to scale up the evidence-based intervention, integrated systems navigation and psychosocial counseling, for PWID with HIV in Vietnam. Forty-two HIV testing sites were randomized 1:1 to a standard or tailored arm. While the standard arm (SA) received a uniform package of strategies, implementation strategies for the tailored arm (TA) were tailored to address specific needs of each site. The central research team also met monthly with the TA to document how their tailored strategies were implemented over time. Five components were involved in the tracking process: describing the planned strategies; tracking strategy use; monitoring barriers and solutions; describing modifications; and identifying and describing any additional strategies. Results Our approach allowed us to closely track the modifications to implementation strategies in the tailored arms every month. TA sites originally identified 27 implementation strategies prior to implementation. During implementation, five strategies were dropped by four sites and two new strategies were added to twelve sites. Modifications of five strategies occurred at four sites to accommodate their changing needs and resources. Difficulties related to the COVID-19 pandemic, low number of participants recruited, high workload at the clinic, lack of resources for HIV testing and high staff turnover were among barriers of implementing the strategies. A few challenges to tracking modifications were noted, including the considerable amount of time and efforts needed as well as the lack of motivation from site staff to track and keep written documentations of modifications. Conclusions We demonstrated the feasibility of a systematic approach to tracking implementation strategies for a large-scale implementation trial in a low-resource setting. This process could be further enhanced and replicated in similar settings to balance the rigor and feasibility of implementation strategy tracking. Our findings can serve as additional guidelines for future researchers planning to report and track modifications to implementation strategies in large, complex trials. Trial registration : clinicaltrials.gov ID: NCT03952520 (first posted 2019-05-16).

Peer-driven interventions can be effective in reducing HIV injection risk behaviors among people who inject drugs (PWID). We employed a causal mediation framework to examine the mediating role of recall of intervention knowledge in the relationship between a peer-driven intervention and subsequent self-reported HIV injection-related risk behavior among PWID in the HIV Prevention Trials Network (HPTN) 037 study. For each intervention network, the index participant received training at baseline to become a peer educator, while non-index participants and all participants in the control networks received only HIV testing and counseling; recall of intervention knowledge was measured at the 6-month visit for each participant, and each participant was followed to ascertain HIV injection-related risk behaviors at the 12-month visit. We used inverse probability weighting to fit marginal structural models to estimate the total effect (TE) and controlled direct effect (CDE) of the intervention on the outcome. The proportion eliminated (PE) by intervening to remove mediation by the recall of intervention knowledge was computed. There were 385 participants (47% in intervention networks) included in the analysis. The TE and CDE risk ratios for the intervention were 0.47 [95% confidence interval (CI): 0.28, 0.78] and 0.73 (95% CI: 0.26, 2.06) and the PE was 49%. Compared to participants in the control networks, the peer-driven intervention reduced the risk of HIV injection-related risk behavior by 53%. The mediating role of recall of intervention knowledge accounted for less than 50% of the total effect of the intervention, suggesting that other potential causal pathways between the intervention and the outcome, such as motivation and skill, self-efficacy, social norms and behavior modeling, should be considered in future studies.

Background . Injection risk behavior is a major predictor of HIV infection. The present study was conducted to survey the effect of educational intervention based on the theory of planned behavior on changing high‐risk behaviors (the high‐risk behaviors of injecting and behaviors of transmitting blood diseases to others) of injecting drug users under the coverage of addiction harm reduction centers. Methods . This study is an experimental research on 120 drug addicts in 2021‐2022. Two addiction harm reduction centers in Fasa City, Iran, were chosen randomly (one as the test group and the other as the control group). The data collection tool is made up of two parts. The first part is a questionnaire on demographics. The second part is a questionnaire based on the theory of planned behavior, which was made using information from different sources and studies. The training program was set up based on the pretest results and the theory of planned behavior for the test group. Before and six months after the educational intervention, the experimental and control groups filled out the questionnaire. With a significance level of 0.05, the independent t , chi‐square, and paired t statistical tests were used to examine the data using the SPSS 22 program. Results . In the test group, the average age of addicts was 37.42 ± 10.55 years, while in the control group, the average age was 38.36 ± 10.09 years ( p = 0.244). Six months after the educational intervention, all TPB theory’s constructs (knowledge, attitude, subjective norms and perceived behavioral control, behavioral intention, and behavior of injecting drug users) were higher in the test group than in the control group ( p = 0.001). Conclusion . The results show the effect of this educational intervention in reducing high‐risk behaviors related to injection in injection drug addicts, so it is suggested as a useful method to reduce high‐risk injection behaviors in these people.

Background Disparities persist in testing and treatment for hepatitis C virus (HCV), leaving socially marginalized populations, including people who inject drugs (PWID), less likely to benefit from curative treatment. Linkage services are often insufficient to overcome barriers to navigating the medical system and contextual factors. Methods The You’re Empowered for Treatment Initiation (YETI) Partner trial is a single-site randomized controlled trial evaluating the efficacy of a two-session behavioral intervention that engages injecting partners as peer navigators for HCV treatment. We aim to recruit 250 PWID and their primary injecting partners in San Francisco, California, randomizing them 1:1 to either a control or intervention group. The primary outcome is the initiation of HCV treatment, with secondary outcomes including treatment completion and sustained virologic response 12 weeks post-treatment. Data will be collected through questionnaires and electronic health records and analyzed using intention-to-treat and mixed-effects models. Discussion This trial will provide evidence of a new HCV treatment linkage intervention leveraging the support of primary injecting partners to initiate HCV treatment. If successful, the intervention could inform public health strategies and policies to address HCV in marginalized populations. Trial registration ClinicalTrials.gov NCT06179498. Registered on December 22, 2023.

Background There are currently no approved pharmacotherapies for managing methamphetamine dependence. N -acetylcysteine (NAC) has been found to reduce the craving for methamphetamine and other drugs, but its effect on methamphetamine use and other clinically related endpoints are uncertain. The N-ICE trial is evaluating the safety and efficacy of NAC as a take-home pharmacotherapy for methamphetamine dependence. Methods/design This is a two-arm parallel double-blind placebo-controlled three-site randomised trial (ratio 1:1) using permuted block randomisation, with variable block sizes. It is stratified by site, sex and whether the methamphetamine is injected or not. Participants ( N  = 180; 60 per site) need to be dependent on methamphetamine, interested in reducing their methamphetamine use and not currently receiving treatment for substance use disorders. The trial is being conducted in outpatient settings in Melbourne, Geelong and Wollongong, Australia. Participants will receive either 2400 mg oral NAC or a matched placebo, delivered as a take-home medication for 12 weeks. Two 600 mg capsules are self-administered in the morning and two more in the evening. Adherence is being monitored using eCAP™ medication bottle lids, which record the date and time of each occasion the bottle is opened. The primary outcome is methamphetamine use during the 12-week trial medication period, measured as (a) days of use, assessed using the timeline followback, and (b) methamphetamine-positive saliva tests, taken weekly. Secondary measures include weekly assessment of methamphetamine craving, severity of methamphetamine dependence, methamphetamine withdrawal symptoms and psychiatric symptoms (depression, suicidality, psychotic symptoms and hostility). Adverse events are monitored at each weekly assessment. Tolerability is assessed using the Treatment Satisfaction Questionnaire for Medication. Discussion The N-ICE trial is the first clinical trial to assess whether NAC can reduce methamphetamine use. This trial will improve our understanding of the potential utility of NAC in managing methamphetamine dependence and clinically related outcomes. If found to be effective, take-home NAC could be a potentially scalable and affordable pharmacotherapy option for treating methamphetamine dependence. Trial registration Australian and New Zealand Clinical Trials Registry, ACTRN12618000366257 . Registered on 29 May 2018.

Background Opioid agonist treatment (OAT) is an effective method of addiction treatment and HIV prevention. However, globally, people who inject drugs (PWID) have insufficient OAT uptake. To expand OAT access and uptake, policymakers, program developers and healthcare providers should be aware of barriers to and facilitators of OAT uptake among PWID. Methods As a part of the HPTN 074 study, which assessed the feasibility of an intervention to facilitate HIV treatment and OAT in PWID living with HIV in Indonesia, Ukraine, and Vietnam, we conducted in-depth interviews with 37 HIV-positive PWID and 25 healthcare providers to explore barriers to and facilitators of OAT uptake. All interviews were audio-recorded, transcribed, translated into English, and coded in NVivo for analysis. We developed matrices to identify emergent themes and patterns. Results Despite some reported country-specific factors, PWID and healthcare providers at all geographic locations reported similar barriers to OAT initiation, such as complicated procedures to initiate OAT, problematic clinic access, lack of information on OAT, misconceptions about methadone, financial burden, and stigma toward PWID. However, while PWID reported fear of drug interaction (OAT and antiretroviral therapy), providers perceived that PWID prioritized drug use over caring for their health and hence were less motivated to take up ART and OAT. Motivation for a life change and social support were reported to be facilitators. Conclusion These results highlight a need for support for PWID to initiate and retain in drug treatment. To expand OAT in all three countries, it is necessary to facilitate access and ensure low-threshold, financially affordable OAT programs for PWID, accompanied with supporting interventions. PWID attitudes and beliefs about OAT indicate the need for informational campaigns to counter misinformation and stigma associated with addiction and OAT (especially methadone).

Substance-using men who have sex with men (MSM) are among the groups at highest risk for HIV infection in the United States. We report the results of a randomized trial testing the efficacy of a small group sexual and substance use risk reduction intervention based on empowerment theory compared to an enhanced efficacious control condition among 515 high risk not-in-treatment MSM substance users. Effect sizes for sexual risk and substance use outcomes were moderate to large: HIV transmission risk frequency, d  = 0.71 in the control versus 0.66 in the experimental group; number of anal sex partners, d  = 1.04 versus 0.98; substance dependence symptoms, d  = 0.49 versus 0.53; significant differences were not observed between conditions. Black MSM reduced their risks at a greater rate than White or Latino men. The findings point to a critically important research agenda to reduce HIV transmission among MSM substance users.

We analyzed data from a large randomized HIV/HCV prevention intervention trial with young injection drug users (IDUs) conducted in five U.S. cities. The trial compared a peer education intervention (PEI) with a time-matched, attention control group. Applying categorical latent variable analysis (mixture modeling) to baseline injection risk behavior data, we identified four distinct classes of injection-related HIV/HCV risk: low risk, non-syringe equipment-sharing, moderate-risk syringe-sharing, and high-risk syringe-sharing. The trial participation rate did not vary across classes. We conducted a latent transition analysis using trial baseline and 6-month follow-up data, to test the effect of the intervention on transitions to the low-risk class at follow-up. Adjusting for gender, age, and race/ethnicity, a significant intervention effect was found only for the high-risk class. Young IDU who exhibited high-risk behavior at baseline were 90 % more likely to be in the low-risk class at follow-up after the PEI intervention, compared to the control group.

This study of 632 drug injectors enrolled in eight residential detoxification centers within the National Drug Abuse Treatment Clinical Trials Network tested three interventions to reduce drug and sex risk behaviors. Participants were randomized to: (a) a two-session, HIV/HCV counseling and education (C&E) model added to treatment as usual (TAU), (b) a one-session, therapeutic alliance (TA) intervention conducted by outpatient counselors to facilitate treatment entry plus TAU, or (c) TAU. Significant reductions in drug and sex risk behaviors occurred for all three conditions over a 6-month follow-up period. C&E participants reported significantly greater rates of attending an HIV testing appointment, but this was not associated with better risk reduction outcomes. Reporting treatment participation within 2 months after detoxification and self-efficacy to practice safer injection behavior predicted reductions in injection risk behaviors. Findings indicate that participation in detoxification was followed by significant decreases in drug injection and risk behaviors for up to 6-months; interventions added to standard treatment offered no improvement in risk behavior outcomes.