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Physician-delivered motivational interviewing to improve adherence and retention in care among challenging HIV-infected patients in Argentina (COPA2): study protocol for a cluster randomized controlled trial.

ABSTRACT: BACKGROUND:"Challenging" HIV-infected patients, those not retained in treatment, represent a critical focus for positive prevention, as linkage to care, early initiation of antiretroviral therapy, adherence and retention in treatment facilitate viral suppression, thus optimizing health and reducing HIV transmission. Argentina was one of the first Latin American countries to guarantee HIV prevention, diagnosis and comprehensive care services, including antiretroviral medication, which removed cost and access as barriers. Yet, dropout occurs at every stage of the HIV continuum. An estimated 110,000 individuals are HIV-infected in Argentina; of these, 70% have been diagnosed and 54% were linked to care. However, only 36% have achieved viral suppression and 31% of those diagnosed delayed entry to care. To achieve meaningful reductions in HIV infection at the community level, innovative strategies must be developed to re-engage patients. Motivational Interviewing (MI) is a patient-centered approach and has been used by therapists in Central and South America to enhance motivation and commitment in substance use and risk reduction. Our pilot feasibility study utilized culturally tailored MI in physicians to target patients not retained in treatment in public and private clinics in Buenos Aires, Argentina. Results demonstrated that a physician-based MI intervention was feasible and effective in enhanced and sustained patient adherence, viral suppression, and patient-physician communication and attitudes about treatment among these patients at 6 and 9 months post baseline. METHODS/DESIGN:This clinical trial seeks to extend these findings in public and private clinics in four urban population centers in Argentina, in which clinics (n =?6 clinics, six MDs per clinic site) are randomized to experimental (physician MI Intervention) (n =?3) or control (physician Standard of Care) (n =?3) conditions in a 3:3 ratio. Using a cluster randomized clinical trial design, the study will test the effectiveness of a physician-based MI intervention to improve and sustain retention, adherence, persistence, and viral suppression among "challenging" patients (n =?420) over 24 months. DISCUSSION:Results are anticipated to have significant public health implications for the implementation of MI to re-engage and retain patients in HIV treatment and care and improve viral suppression through high levels of medication adherence. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT02846350 . Registered on 1 July 2016.

SUBMITTER: Sued O

PROVIDER: S-EPMC6056946 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Physician-delivered motivational interviewing to improve adherence and retention in care among challenging HIV-infected patients in Argentina (COPA2): study protocol for a cluster randomized controlled trial.

Sued Omar O Cassetti Isabel I Cecchini Diego D Cahn Pedro P de Murillo Lina Bofill LB Weiss Stephen M SM Mandell Lissa N LN Soni Manasi M Jones Deborah L DL

Trials 20180724 1

<h4>Background</h4>"Challenging" HIV-infected patients, those not retained in treatment, represent a critical focus for positive prevention, as linkage to care, early initiation of antiretroviral therapy, adherence and retention in treatment facilitate viral suppression, thus optimizing health and reducing HIV transmission. Argentina was one of the first Latin American countries to guarantee HIV prevention, diagnosis and comprehensive care services, including antiretroviral medication, which rem ...[more]

PMID: 30041703

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Project description:IntroductionSuboptimal and differential participant engagement in randomized trials-including retention at primary outcome assessments and attendance at intervention sessions-undermines rigor, internal validity, and trial conclusions.MethodsFirst, this study describes Methods-Motivational Interviewing approach and strategies for implementation. This approach engages potential participants before randomization through interactive, prerequisite orientation sessions that illustrate the scientific rationale behind trial methods in accessible language and use motivational interviewing to diffuse ambivalence about participation. Then, this study examines the potential improvements in retention (proportion of participants assessed at follow-up visits) and attendance (e.g., mean percentage of intervention sessions attended, percentage of participants who attended 0 sessions) in 3 randomized weight-management trials that quickly added prerequisite orientations to their protocols following early signs of suboptimal or differential participant engagement (Supporting Health by Integrating Nutrition and Exercise [2009-2013, n=194]; Get Social [2016-2020, n=217]; GestationaL Weight Gain and Optimal Wellness [2014-2018, n=389]). Using a pre-post analytical design, adjusted estimates from regression models controlling for condition and assessment timepoint (analyses from 2020) are reported.ResultsAfter adding prerequisite orientations, all 3 trials attained higher participant engagement. Retention at assessments was 11.4% and 17.3% higher (Get Social and Supporting Health by Integrating Nutrition and Exercise, respectively). Mean percentage of attendance at intervention sessions was 8.8% higher (GestationaL Weight Gain and Optimal Wellness), and 10.1% fewer participants attended 0 intervention sessions (Get Social). Descriptively, all the remaining retention and attendance outcomes were consistently higher but were nonsignificant. Across the trials, adding prerequisite orientations did not impact the proportion of eligible participants enrolled or the baseline demographics.ConclusionsThe Methods-Motivational Interviewing approach shows promise for increasing the rigor of randomized trials and is readily adaptable to in-person, webinar, and conference call formats.Trial registrationAll 3 trials are registered at www.clinicaltrials.gov (Supporting Health by Integrating Nutrition and Exercise: NCT00960414; Get Social: NCT02646618; and GestationaL Weight Gain and Optimal Wellness: NCT02130232).

Project description:BackgroundAdolescent HIV patients face enormous difficulty in accessing HIV care services. Given their vulnerability to risk-taking behaviour, this group also have worse treatment outcomes compared to other age groups. Poor treatment outcomes will impact negatively on HIV/AIDS management and control particularly in sub-Saharan Africa (SSA) as more than eight out of ten of the world's HIV-infected adolescents live in this region of the world. Limited evidence exists on the effectiveness of service delivery interventions to support adolescents' retention on antiretroviral therapy (ART) and adherence to ART. This trial is designed to evaluate the impact of conditional economic incentive and motivational interviewing on adolescents' retention in HIV care and adherence to ART in Anambra State, Southeast Nigeria.Methods/designThe study will be a cluster randomised controlled trial that will be conducted in selected HIV treatment hospitals in Anambra State, Nigeria. Based on sample size calculation, 12 HIV treatment hospitals from Anambra will be selected for the study. Six HIV treatment hospitals each will be randomised to either the intervention or the control arm. A structured adherence support scheme termed the 'Incentive Scheme' will be applied to the intervention arm while the control arm will receive routine HIV care (usual care). Additionally, patients in the intervention arm will receive motivational interviewing at baseline and following initiation of antiretroviral therapy (ART), they will receive a gift voucher of US$5.6 when HIV viral load (VL) is <?20 copies/mL at 12?weeks, a gift voucher of US$2.8 if the VL remains suppressed for the next 3?months, and the next 6?months, and finally a gift voucher of US$5.6 if the VL remains <?20 copies/mL at 1?year. All gift vouchers will be conditional not only on VL results but attending the motivational interviews. The primary outcome for the trial will be the difference between groups in the proportion with HIV VL suppression (??20 copies/mL) by 12?months and then 24?months after withdrawal of incentive.DiscussionThe findings of this proposed trial will provide evidence on the feasibility of applying conditional economic incentives combined with motivational interviewing to improve retention and adherence to antiretroviral therapy of adolescents living with HIV in Nigeria and possibly in other sub-Saharan African countries.Trial registrationRegistered in the Pan African Clinical Trials Registry, ID: PACTR201806003040425 . Registered on 2 February 2018.

Project description:BackgroundIt is known that making people change their habits is challenging. It is crucial to identify the most effective approach that general practitioners (GPs) should use to help their patients change unhealthy habits. The objective this study was to assess the efficacy of a multifactorial intervention based on Motivational Interviewing performed by general practitioners to enhance lipid levels in patients with dyslipidemia, as compared to standard care.MethodsA multicenter, controlled, randomized, cluster, two-parallel arm trial with a 12-month follow-up conducted in 25 community health centers of the Spanish. 38 GPs and 227 primary care patients with uncontrolled dyslipidemia were included in the trial. GPs performed an intervention based either on Motivational Interviewing (MI) or standard practice. Lipid levels were measured, and the control degree was analyzed based on the criteria of clinical guidelines.Results107 were assigned to the Experimental Group (EG) and 120 to the Control Group (CG). An overall improvement was achieved in total cholesterol levels (Mean Difference -MD- = -19.60; 95 % CI: -15.33 at -23.87 mg/dl; p < 0.001), LDL-cholesterol levels (MD = -13.78; 95 % CI: -9.77 at -17.79 mg/dl; p < 0.001) and triglycerides (MD = -19.14; CI 95 %: -11.29 at -26.99 mg/dl; p < 0.001). No differences were found between the two groups. However, when we assessed the degree of lipid control by combining cholesterol <200 mg/dl and LDL-cholesterol < 130 mg/dl parameters, it was observed that a higher percentage of patients achieved target figures in the EG versus CG (13.1 % vs. 5.0 %; adjusted OR = 5.77, 95 % CI: 1.67-19.91).ConclusionA Motivational Interviewing-based approach conducted by Primary Care physicians aimed at patients with dyslipidemia, achieved a significant reduction in all lipid parameters, cardiovascular risk, weight reduction and the adherence to the Mediterranean diet, similar to that obtained with the usual intervention and superior in the proportion of patients achieving combined lipid control goals and the level of physical exercise.Trial registrationthe trial is registered in ClinicalTrials.gov ( NCT01282190 ; January 21, 2011).

Project description:BackgroundMotivational interviewing (MI) can increase health-promoting behaviors and decrease health-damaging behaviors. However, MI is often resource intensive, precluding its use with people with limited financial or time resources. Mobile health-based versions of MI interventions or technology-delivered adaptations of MI (TAMIs) might increase reach.ObjectiveWe aimed to understand the characteristics of existing TAMIs. We were particularly interested in the inclusion of people from marginalized sociodemographic groups, whether the TAMI addressed sociocontextual factors, and how behavioral and health outcomes were reported.MethodsWe employed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines for scoping reviews to conduct our scoping review. We searched PubMed, CINAHL, and PsycInfo from January 1, 1996, to April 6, 2022, to identify studies that described interventions incorporating MI into a mobile or electronic health platform. For inclusion, the study was required to (1) describe methods/outcomes of an MI intervention, (2) feature an intervention delivered automatically via a mobile or electronic health platform, and (3) report a behavioral or health outcome. The exclusion criteria were (1) publication in a language other than English and (2) description of only in-person intervention delivery (ie, no TAMI). We charted results using Excel (Microsoft Corp).ResultsThirty-four studies reported the use of TAMIs. Sample sizes ranged from 10 to 2069 participants aged 13 to 70 years. Most studies (n=27) directed interventions toward individuals engaging in behaviors that increased chronic disease risk. Most studies (n=22) oversampled individuals from marginalized sociodemographic groups, but few (n=3) were designed specifically with marginalized groups in mind. TAMIs used text messaging (n=8), web-based intervention (n=22), app + text messaging (n=1), and web-based intervention + text messaging (n=3) as delivery platforms. Of the 34 studies, 30 (88%) were randomized controlled trials reporting behavioral and health-related outcomes, 23 of which reported statistically significant improvements in targeted behaviors with TAMI use. TAMIs improved targeted health behaviors in the remaining 4 studies. Moreover, 11 (32%) studies assessed TAMI feasibility, acceptability, or satisfaction, and all rated TAMIs highly in this regard. Among 20 studies with a disproportionately high number of people from marginalized racial or ethnic groups compared with the general US population, 16 (80%) reported increased engagement in health behaviors or better health outcomes. However, no TAMIs included elements that addressed sociocontextual influences on behavior or health outcomes.ConclusionsOur findings suggest that TAMIs may improve some health promotion and disease management behaviors. However, few TAMIs were designed specifically for people from marginalized sociodemographic groups, and none included elements to help address sociocontextual challenges. Research is needed to determine how TAMIs affect individual health outcomes and how to incorporate elements that address sociocontextual factors, and to identify the best practices for implementing TAMIs into clinical practice.

Project description:BackgroundNon-adherence to antipsychotic medication is commonly found in schizophrenia and other psychotic disorders, thus forming a major obstacle to long-term maintenance treatment and contributing to high relapse rates. With limited evidence on the success of interventions in enhancing medication adherence, this controlled trial was designed to test and evaluate the effectiveness of an adherence therapy (AT) for outpatients with schizophrenia spectrum disorders, based on a motivational interviewing approach over a six-month follow-up period.MethodsA single-blind, randomized controlled trial with a repeated-measures, two parallel groups design was conducted in a random sample of 114 participants with schizophrenia spectrum disorders in one community psychiatric nursing service. After pre-test, the participants were randomly assigned to either an eight-session course of AT plus usual care or usual psychiatric care (n = 57 per group). The main outcomes, including medication adherence, symptom severity, insight into treatment, hospitalization rate, and functioning, were measured at baseline and immediately and six months post-intervention.ResultsA total of 110 participants completed this trial and thus the attrition rate was 3.5%. Results of repeated-measures analysis of variance followed by Helmert's contrasts test indicated that the AT participants reported significantly greater improvements in their insight into illness and/or treatment, psychosocial functioning, symptom severity, number of re-hospitalizations, and medication adherence (F = 5.01 to 7.45, P = 0.007 to 0.030) over six months follow-up, when compared with usual care.ConclusionsMotivational interviewing-based AT for people with schizophrenia can be effective to reduce symptom severity and re-hospitalizations, and improve medication adherence, functioning, and insight into illness and/or treatment over a medium term (six months) period of follow-up. Further study on the effects of AT in people with psychotic disorders in terms of diverse sociodemographic and illness characteristics, and a longer term (for example, over 12 months) follow-up period is recommended.Trial registrationThe trial was registered at Clinicaltrials.gov (identifier: NCT01780116) on 6 July 2014.

Dataset Information

Physician-delivered motivational interviewing to improve adherence and retention in care among challenging HIV-infected patients in Argentina (COPA2): study protocol for a cluster randomized controlled trial.

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Physician-delivered motivational interviewing to improve adherence and retention in care among challenging HIV-infected patients in Argentina (COPA2): study protocol for a cluster randomized controlled trial.

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