The STEP into Action study: a peer-based, personal risk network-focused HIV prevention intervention with injection drug users in Baltimore, Maryland

Aims To assess the effectiveness of a peer‐based, personal risk network‐focused HIV prevention intervention to (i) train injection drug users (IDUs) to reduce injection and sex risk behaviors, (ii) conduct outreach to behaviorally risky individuals in their personal social networks [called risk network members (RNM)], and (iii) reduce RNM HIV risk behaviors. Design Randomized controlled trial with prospective data collection at 6, 12 and 18 months. Intervention condition consisted of five group sessions, one individual session and one session with Index and the RNM. Setting This study was conducted in Baltimore, Maryland from March 2004 to March 2006. Participants (i) Index participants were aged ≥18 years and self‐reported injection drug use in the prior 6 months and (ii) their RNM who were aged ≥18 years and drug users or sex partners of Index. Measurements Outcomes included: (i) injection risk based on sharing needles, cookers and cotton for injection and drug splitting, (ii) sex risk based on number of sex partners, condom use and exchanging sex and (iii) Index HIV outreach behaviors. Findings A total of 227 Index participants recruited 336 RNM. Retention of Index at 18‐month follow‐up exceeded 85%. Findings suggest that the experimental condition was efficacious at 18 months in reducing Index participant injection risk [odds ratio (OR) = 0.38; 95% confidence interval (CI) = 0.18–0.77), drug‐splitting risk (OR = 0.46; 95% CI = 0.25–0.88) and sex risk among Index (OR = 0.53; 95% CI = 0.34–0.86). Significant intervention effect on increased condom use among female RNM was observed (OR = 0.34; 95% CI = 0.18–0.62). Conclusions Training active IDU to promote HIV prevention with behaviorally risky individuals in their networks is feasible, efficacious and sustainable.     

Happy ending: a randomized controlled trial of a digital multi-media smoking cessation intervention

AIMS: To assess the long-term efficacy of a fully automated digital multi-media smoking cessation intervention. DESIGN: Two-arm randomized control trial (RCT). Setting World Wide Web (WWW) study based in Norway. PARTICIPANTS: Subjects (n = 396) were recruited via internet advertisements and assigned randomly to conditions. Inclusion criteria were willingness to quit smoking and being aged 18 years or older. INTERVENTION: The treatment group received the internet- and cell-phone-based Happy Ending intervention. The intervention programme lasted 54 weeks and consisted of more than 400 contacts by e-mail, web-pages, interactive voice response (IVR) and short message service (SMS) technology. The control group received a self-help booklet. Additionally, both groups were offered free nicotine replacement therapy (NRT). MEASUREMENTS: Abstinence was defined as 'not even a puff of smoke, for the last 7 days', and assessed by means of internet surveys or telephone interviews. The main outcome was repeated point abstinence at 1, 3, 6 and 12 months following cessation. FINDINGS: Participants in the treatment group reported clinically and statistically significantly higher repeated point abstinence rates than control participants [22.3% versus 13.1%; odds ratio (OR) = 1.91, 95% confidence interval (CI): 1.12-3.26, P = 0.02; intent-to-treat). Improved adherence to NRT and a higher level of post-cessation self-efficacy were observed in the treatment group compared with the control group. CONCLUSIONS: As the first RCT documenting the long-term treatment effects of such an intervention, this study adds to the promise of digital media in supporting behaviour change.     

Reducing risky relationships: a multisite randomized trial of a prison-based intervention for reducing HIV sexual risk behaviors among women with a history of drug use

Women involved in the criminal justice system, particularly those with a history of drug use, are at elevated risk of HIV infection, yet few HIV prevention interventions have been tailored for delivery to incarcerated women. Drawing on the Relational Model, the Reducing Risky Relationships for HIV (RRR-HIV) intervention was developed and evaluated in a multisite randomized clinical trial. Women with weekly drug use prior to incarceration (n = 444) who were incarcerated within correctional institutions in four states were randomized to (1) the RRR-HIV intervention consisting of an HIV educational video, five group sessions, and one postrelease booster session or (2) a control condition consisting of the HIV educational video. The RRR-HIV intervention combined didactic and interactive content regarding seven “thinking myths” about intimate relationships that may result in decisions to engage in risky sexual behaviors. Data were collected while women were still incarcerated and approximately 90 days following release from prison by trained interviewers. A negative binomial regression (NBR) model of unprotected sexual behaviors at the 90-day follow-up indicated that RRR-HIV participants reported fewer unprotected sexual behaviors than women in the control condition once the analysis was adjusted for study site. Future studies should examine the sustainability of the RRR-HIV intervention's effect on risk reduction. Implementation research is needed to determine whether delivery of this intervention by correctional staff or peers, rather than research staff, yields similar reductions in unprotected sexual behaviors.     

Smoking cessation intervention in parents of young children: a randomised controlled trial

OBJECTIVE: To examine whether telephone counselling based on the stages of change component of Transtheoretical model of behaviour change together with educational materials could help non-motivated smoking parents of young children to cease. DESIGN: Randomised controlled trial. SETTING: Hong Kong Special Administrative Region, PR China. PARTICIPANTS: 952 smoker fathers and mothers of Chinese children aged 5 years. INTERVENTION: Participants were randomly allocated into two groups: the intervention group received printed self-help materials and three-session telephone-based smoking cessation counselling delivered by trained counsellors; the control group received printed self-help materials only. A structured questionnaire was used for data collection at baseline and at 1, 3 and 6 month follow up. MAIN OUTCOME MEASURES: The main outcome is 7 day point prevalence quit rate at 6 months (defined as not smoking during the 7 days preceding the 6 month follow up) determined by self reports. Other secondary outcomes were self reported 24 h point prevalence quit rate and self-reported continuous quit rate and bio-chemically validated quit rate at 6 months. RESULTS: A total of 952 smoker fathers and mothers were randomized to the intervention (n = 467) and control (n = 485) groups. Most were daily smokers (92.4%) and the mean number of cigarettes smoked per day was 14.5 (SD = 8.9). By using intention-to-treat analysis, the 7 day point prevalence quit rate at 6 month follow up was significantly greater in the intervention group (15.3%; 68/444) than the control group (7.4%; 34/459) (P < 0.001). The absolute risk reduction was 7.9% (95% confidence interval: 3.78% to 12.01%). The number needed to treat to get one additional smoker to quit was 13 (95% CI: 8-26). The crude odds ratio of quitting was 2.3(95% CI: 1.5-3.5). The adjusted odds ratio was 2.1 (95% CI: 1.4-3.4) (adjusted for age, number of years smoked, and alcohol dependency). CONCLUSION: Proactive telephone counselling is an effective aid to promote smoking cessation among parents of young children.     

Incarceration and drug use patterns among a cohort of injection drug users

Aims   Drug law enforcement remains the dominant response to drug-related harm. However, the impact of incarceration on deterring drug use remains under-evaluated. We sought to explore the relationship between incarceration and patterns of drug use among people who inject drugs (IDU).
Design   Using generalized estimating equations (GEE), we examined the prevalence and correlates of injection cessation among participants in the Vancouver Injection Drug User Study followed over 9 years. In subanalyses, we used McNemar's tests and linear growth curve analyses to assess changes in drug use patterns before and after a period of incarceration among participants reporting incarceration and those not incarcerated.
Findings   Among 1603 IDU, 842 (53%) reported injection cessation for at least 6 months at some point during follow-up. In multivariate GEE analyses, recent incarceration was associated negatively with injection cessation [adjusted odds ratio (AOR) = 0.43, 95% confidence interval (CI) 0.37–0.50], whereas the use of methadone was associated positively with cessation (AOR = 1.38, 95% CI 1.22–1.56). In subanalyses assessing longitudinal patterns of drug use among incarcerated individuals and those not incarcerated over the study period, linear growth curve analyses indicated that there were no statistically significant differences in patterns of drug use between the two groups (all P  > 0.05).
Conclusions   These observational data suggest that incarceration does not reduce drug use among IDU. Incarceration may inhibit access to mechanisms that promote injection cessation among IDU. In contrast, results indicate that methadone use is associated positively with injection cessation, independent of previous frequency of drug use.     

Cessation of injection drug use and change in injection frequency: the Chicago Needle Exchange Evaluation Study

AIMS: To examine the effect of a needle exchange program (NEP) on incidence of injection cessation and change in injection frequency; to explore predictors for injection cessation and change in injection frequency; and to assess whether injection quitters transitioned to non-injected drug use. DESIGN AND SETTING: Between 1997 and 2002, 901 injection drug users (IDUs) were recruited from an NEP program or an area with no NEP in Chicago, Illinois, interviewed for drug use behaviors, tested for HIV and followed for three annual visits. All participants were exposed to prevention services targeting HIV and drug abuse. MEASUREMENTS: Injection cessation was defined as no injection drug use since the last interview, and changes in the number of injections in a typical month were examined. FINDINGS: Sixteen per cent of study participants reported stopping injection for a median duration of 16 months, and most of them also ceased rather than initiated the use of non-injected drugs. Those who continued injecting reduced their injection frequency by 12% per year, on average. Independent predictors of injection cessation were infrequent injection at baseline, younger age and injecting with others. NEP use was not associated with injection cessation and change in injection frequency. CONCLUSION: These results did not support the hypothesis that NEP use influences the frequency of injection over time. One-sixth of IDUs stopped injection for more than 1 year, providing a substantial window for relapse prevention interventions.     

Fall prevention in residential care: a cluster, randomized, controlled trial

OBJECTIVES: To establish the effectiveness of a fall-prevention program in reducing falls and injurious falls in older residential care residents. DESIGN: Cluster, randomized, controlled trial. SETTING: Fourteen randomly selected residential care homes in Auckland, New Zealand. PARTICIPANTS: All older residents (n=628, 95% participation rate). INTERVENTION: Residential care staff, using existing resources, implemented systematic individualized fall-risk management for all residents using a fall-risk assessment tool, high-risk logo, and strategies to address identified risks. MEASUREMENTS: Number of residents sustaining a fall, falls, and injurious-falls incidence rates. RESULTS: During 12 months of follow-up, 103 (43%) residents in the control group and 173 (56%) residents in the intervention group fell (P<.018). There was a significantly higher incidence rate of falls in intervention homes than in control homes (incident rate ratio=1.34, 95% confidence interval=1.06-1.72) during the intervention period after adjusting for dependency level (type of home), baseline fall rate, and clustering. There was no difference in the injurious fall incidence rate or incidence of serious injuries. CONCLUSION: This fall-prevention intervention did not reduce falls or injury from falls. Low-intensity intervention may be worse than usual care.     

A randomized placebo-controlled trial of adefovir dipivoxil in advanced HIV infection: the ADHOC trial

Objectives

To assess the efficacy and safety of adefovir dipivoxil (ADV) added to stable background antiretroviral therapy (ART) in HIV‐infected individuals with advanced HIV disease.

Methods

ADHOC was a randomized, double‐blind, placebo‐controlled, international multicentre trial. Three hundred and one individuals with CD4 cell counts < 100 cells/μL or < 200 cells/μL with nadir < 50 cells/μL were allocated to receive either 120 mg ADV (subsequently 60 mg) (n = 161) or matching placebo (n = 140) once daily.

Results

Over a median follow‐up of 76 weeks, 23 (14%) and 18 (13%) participants assigned ADV and placebo, respectively, developed a new AIDS event or died (hazard ratio = 1.23, 95% confidence interval 0.66–2.29, P= 0.51). There was a lower incidence of new or recurrent herpes events in the ADV group (P = 0.009). The mean increase in CD4 cell count from baseline to week 24 was 23.0 and 24.4 cells/µL in ADV and placebo groups, respectively (P = 0.89), and the mean decrease in RNA was 0.32 and 0.35 log₁₀ copies/mL at week 24 (P = 0.87) in a subset of participants. There was greater weight loss in the ADV group during the trial (P = 0.007). One hundred and twenty‐four participants (41%) had stable background ART in the 8 weeks prior to and the 24 weeks after randomization. There was no significant imbalance in background ART regimens between the two treatment groups. Ninety‐seven serious adverse events (SAEs) occurred, 65 and 32 in the ADV and placebo groups, respectively, with significantly shorter time to first SAE in the ADV group (P = 0.002). A total of 33 participants developed proximal renal tubular dysfunction during the trial, all but one in the ADV group.

Conclusions

Due to the early termination of recruitment, ADHOC was unable to assess the original objective of clinical disease progression. Adding ADV to background antiretroviral therapy in advanced HIV disease did not provide immunological or virological improvement compared with placebo. Furthermore, at the doses used in this trial, ADV was associated with a significantly higher incidence of SAEs.

     

A randomized controlled trial of adding the nicotine patch to rimonabant for smoking cessation: efficacy, safety and weight gain

Aims Because smoking cessation rates might be improved by combining drugs and by reducing post‐cessation weight gain, we tested the smoking cessation efficacy, safety and effect on body weight of adding the nicotine patch to rimonabant, a cannabanoid type‐1 receptor antagonist that reduces body weight. Design Randomized double‐blind placebo‐controlled trial. Setting Fifteen US research centers. Participants A total of 755 smokers (≥15 cigarettes/day). Intervention Rimonabant (20 mg daily) was given open‐label for 9 weeks. The 735 participants completing week 1 were randomized at day 8 (target quit day) to add a nicotine patch (n = 369) or placebo patch (n = 366) for 10 weeks (21 mg daily for 8 weeks plus a 2‐week taper). Participants received weekly smoking counseling and were followed for 24 weeks. Measurements Biochemically validated 4‐week continuous abstinence at end‐of‐treatment (weeks 6–9; primary end‐point); 7‐day point prevalence abstinence at weeks 9 and 24; sustained abstinence (weeks 6–24); change in body weight; and adverse events. Findings Rimonabant plus nicotine patch was superior to rimonabant plus placebo in validated continuous abstinence at weeks 6–9 (39.0% versus 21.3%; odds ratio 2.36, 95% confidence interval: 1.71–2.37; P < 0.01) and in all other efficacy measures. Mean end‐of‐treatment weight gain among quitters did not differ between groups (0.04 kg for combination versus 0.49 kg for rimonabant only, P = 0.15) and was similar in weight‐concerned smokers. Serious adverse event rates did not differ between groups. Depression‐ and anxiety‐related adverse events occurred in 32 (4.2%) and 44 (5.8%) subjects, respectively; eight (1.1%) and nine (1.2%) subjects stopped the drug due to depression and anxiety, respectively. Conclusions Adding a nicotine patch to rimonabant was well tolerated and increased smoking cessation rates over rimonabant alone. There was little post‐cessation weight gain in either group, even among weight‐concerned smokers, during drug treatment.     

Intensity of drug injection as a determinant of sustained injection cessation among chronic drug users: the interface with social factors and service utilization

AIMS: The objective of this study was to identify factors associated with sustained injection cessation and to examine further the relationship between the occurrence of sustained injection cessation of injection drug users (IDUs) and prior injection frequency. DESIGN AND SETTING: IDUs in the Montreal St Luc Cohort who had at least three consecutive interviews between 1995 and 1999 were included. Sustained injection cessation was defined as a period of at least 7 consecutive months without injection. All IDUs completed interview-administered questionnaires on socio-demographic characteristics, drug and sexual behaviours and health-related issues. Logistic regression was used for analyses. FINDINGS: A total of 186/1004 (18.5%) IDUs reported a period of sustained injection cessation during the study period. In multivariate analysis, HIV-positive status, 'booting' and cumulative time spent in prison were negatively associated with injection cessation, while injection initiation after 35 years of age and frequent crack use were positively associated with injection cessation. We found a negative association between the occurrence of injection cessation and the frequency of injection; the odds ratios (OR) for cessation were 0.49 [95% confidence interval (CI): 0.03, 0.78] for IDUs who injected 30-100 times and 0.21 (95% CI: 0.10, 0.46) for IDUs who injected more than 100 times in the previous month. Attending needle exchange programmes (NEPs) or pharmacies appeared to be a modifier of the relation between cessation and prior injection frequency. The OR was 0.68 (95% CI: 0.42, 1.12) for IDUs who injected 30-100 times prior to injection and attended NEPs or pharmacies and was 0.07 (0.01, 0.30) for IDUs who did not use these services. CONCLUSIONS: Overall, a fifth of IDUs experienced at least one episode of injection cessation of 7 months or more during a period of 4.5 years. Our data suggest that NEPs and pharmacies may have played a role in inducing injection cessation episodes in a subgroup of IDUs. Research is needed to better identify the characteristics of IDUs who could benefit from an injection cessation intervention strategy. This information is important for social and health policy planning.     

Helping smokers to decide on the use of efficacious smoking cessation methods: a randomized controlled trial of a decision aid

AIMS: Most smokers attempt to stop smoking without using help. We evaluated the efficacy of a decision aid to motivate quitters to use efficacious treatment. SETTING AND PARTICIPANTS, A total of 1,014 were recruited from a convenience sample of 3,391 smokers who intended to quit smoking within 6 months. DESIGN AND Smokers were assigned randomly to either receive the decision aid or no intervention. The decision aid was expected to motivate quitters to use efficacious cessation methods and contained neutral information on treatment methods, distinguishing between efficacious and non-efficacious treatments. MEASUREMENTS Baseline questionnaire and follow-ups were used 2 weeks and 6 months after the start of the intervention. FINDINGS: The decision aid increased knowledge of cessation methods and induced a more positive attitude towards these methods. Furthermore, 45% reported increased confidence about being able to quit and 43% said it helped them to choose between treatments. However, no clear effect on usage of treatment aids was found, but the intervention group had more quit attempts (OR=1.52, 95% CI 1.14-2.02) and higher point prevalence abstinence at 6-month follow-up (20.2% versus 13.6%; OR=1.51, 95% CI=1.07-2.11). CONCLUSIONS An aid to help smokers decide to use efficacious treatment when attempting to quit smoking had a positive effect on smoking cessation, while failing to increase the usage of efficacious treatment. This finding lends support to the notion that the mere promotion of efficacious treatments for tobacco addiction might increase the number of quit attempts, irrespective of the actual usage of treatment.     

Efficacy and safety of Shenkang injection in the treatment of chronic renal failure: A protocol of a randomized controlled trial

Background:Chronic renal failure (CRF) is the final outcome of the development of multiple kidney diseases, and there is no effective method at home and abroad. Traditional Chinese medicine is found to play a major role in the treatment of the non-replacement stage of CRF. Shenkang injection can not only nourish the kidney, but also promote blood circulation and remove blood stasis, which is suitable for the treatment of CRF. This study aims to explore the efficacy and safety of Shenkang injection for CRF and provide evidence for clinical practice.Methods:This was a prospective randomized controlled trial. One hundred four patients with CRF were randomly divided into treatment groups and control groups according to 1:1, with 52 patients in each group. The control group received basic treatment of western medicine and the treatment group was given Shenkang injection intravenously on the basis of control group. Both groups were given standard treatment for 4 weeks with concurrent follow-up for 1 month. The outcome indicators included: total efficiency, symptom scores, creatinine clearance rate, serum creatinine, blood urea nitrogen, CystatinC, liver function, blood routine, urine routine, incidence of adverse reactions, etc. Data analysis was performed using SPSS 25.0 software.Discussion:This study will evaluate the efficacy and safety of Shenkang injection for CRF, and the results of this trial will provide clinical evidence for the treatment of CRF.Trial registration:OSF Registration number: DOI 10.17605/OSF.IO/K9C5T.     

A randomized controlled trial of a multifactorial falls prevention intervention for older fallers presenting to emergency departments

OBJECTIVES: To investigate the effect of a referral‐based targeted multifactorial falls prevention intervention on the occurrence of recurrent falls and injuries in older people presenting to an emergency department (ED) after a fall and discharged directly home from the ED. DESIGN: Randomized controlled trial. Assessors of outcomes were unaware of group allocation. SETTING: Seven EDs in metropolitan Melbourne, Australia. PARTICIPANTS: Inclusion criteria were community dwelling, aged 60 and older, presenting to an ED after a fall, and discharged directly home. Exclusion criteria were unable to follow simple instructions or walk independently. INTERVENTION: Targeted referrals to existing community services and health promotion recommendations, based on the falls risk factors found in a baseline assessment. MEASUREMENTS: Primary outcome measures were falls and resultant injuries occurring over the 12‐month follow‐up period. Falls and injury data were collected using falls calendars supported by medical record reviews. RESULTS: Three hundred sixty‐one participants were randomized to the standard care group and 351 to the intervention group. No significant difference was found between the two groups over the 12‐month follow‐up period in number of fallers (relative risk (RR)=1.11, 95% confidence interval (CI)=0.95–1.31] or number of participants sustaining an injury from a fall (RR=1.06, 95% CI=0.86–1.29). CONCLUSION: This study does not support the use of a referral‐based targeted multifactorial intervention program to reduce subsequent falls or fall injuries in older people who present to an ED after a fall.     

Randomized controlled trial of a brief behavioural intervention for reducing hepatitis C virus risk practices among injecting drug users

AIM: To develop and evaluate a brief intervention for reducing risk behaviours associated with HCV transmission in injecting drug users (IDU). DESIGN: Randomized controlled trial of an individually tailored brief behavioural intervention (BBI) (experimental) versus a standardized educational intervention (control). SETTING: Specialist drug treatment facility in Melbourne, Australia. PARTICIPANTS: One hundred and forty-five IDU (aged 18 or over, injecting at least weekly in the preceding 6 months) recruited and randomized to the experimental condition (n = 73) or the control condition (n = 72). INTERVENTIONS: The BBI was based on the Blood-Borne Virus Transmission Risk Assessment Questionnaire (BBV-TRAQ)-a standardized blood-borne virus risk assessment instrument comprising injecting risk, sexual risk and other skin penetration risk subscales. The BBV-TRAQ was used to identify individual HCV risk practices and to tailor the 30-minute experimental BBI. Control participants received a standardized HCV educational session, using current educational materials. MAIN OUTCOME MEASURES: BBV-TRAQ subscale and total scores and measures of participant satisfaction. RESULTS: One hundred and twenty-four participants (86%) were followed-up at 4 weeks (+/-7 days). Analyses revealed a significant reduction in HCV risk behaviours for both groups at 1-month follow-up, with participants in the experimental BBI condition reporting higher overall satisfaction with the intervention compared to the control group. CONCLUSIONS: Both groups reported significant reductions in risk behaviour, indicating that while BBI methods hold promise for HCV education and prevention, they were not demonstrated to be more effective than the provision of standard educational materials. Future research could evaluate the efficacy of the BBV-TRAQ as a risk behaviour intervention and counselling tool in clinical, NSP and peer education settings.