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Effect of Patient Navigation With or Without Financial Incentives on Viral Suppression Among Hospitalized Patients With HIV Infection and Substance Use: A Randomized Clinical Trial.

ABSTRACT: Substance use is a major driver of the HIV epidemic and is associated with poor HIV care outcomes. Patient navigation (care coordination with case management) and the use of financial incentives for achieving predetermined outcomes are interventions increasingly promoted to engage patients in substance use disorders treatment and HIV care, but there is little evidence for their efficacy in improving HIV-1 viral suppression rates.To assess the effect of a structured patient navigation intervention with or without financial incentives to improve HIV-1 viral suppression rates among patients with elevated HIV-1 viral loads and substance use recruited as hospital inpatients.From July 2012 through January 2014, 801 patients with HIV infection and substance use from 11 hospitals across the United States were randomly assigned to receive patient navigation alone (n?=?266), patient navigation plus financial incentives (n?=?271), or treatment as usual (n?=?264). HIV-1 plasma viral load was measured at baseline and at 6 and 12 months.Patient navigation included up to 11 sessions of care coordination with case management and motivational interviewing techniques over 6 months. Financial incentives (up to $1160) were provided for achieving targeted behaviors aimed at reducing substance use, increasing engagement in HIV care, and improving HIV outcomes. Treatment as usual was the standard practice at each hospital for linking hospitalized patients to outpatient HIV care and substance use disorders treatment.The primary outcome was HIV viral suppression (?200 copies/mL) relative to viral nonsuppression or death at the 12-month follow-up.Of 801 patients randomized, 261 (32.6%) were women (mean [SD] age, 44.6 years [10.0 years]). There were no differences in rates of HIV viral suppression versus nonsuppression or death among the 3 groups at 12 months. Eighty-five of 249 patients (34.1%) in the usual-treatment group experienced treatment success compared with 89 of 249 patients (35.7%) in the navigation-only group for a treatment difference of 1.6% (95% CI, -6.8% to 10.0%; P?=?.80) and compared with 98 of 254 patients (38.6%) in the navigation-plus-incentives group for a treatment difference of 4.5% (95% CI -4.0% to 12.8%; P?=?.68). The treatment difference between the navigation-only and the navigation-plus-incentives group was -2.8% (95% CI, -11.3% to 5.6%; P?=?.68).Among hospitalized patients with HIV infection and substance use, patient navigation with or without financial incentives did not have a beneficial effect on HIV viral suppression relative to nonsuppression or death at 12 months vs treatment as usual. These findings do not support these interventions in this setting.clinicaltrials.gov Identifier: NCT01612169.

SUBMITTER: Metsch LR

PROVIDER: S-EPMC5339876 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature

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Effect of Patient Navigation With or Without Financial Incentives on Viral Suppression Among Hospitalized Patients With HIV Infection and Substance Use: A Randomized Clinical Trial.

Metsch Lisa R LR Feaster Daniel J DJ Gooden Lauren L Matheson Tim T Stitzer Maxine M Das Moupali M Jain Mamta K MK Rodriguez Allan E AE Armstrong Wendy S WS Lucas Gregory M GM Nijhawan Ank E AE Drainoni Mari-Lynn ML Herrera Patricia P Vergara-Rodriguez Pamela P Jacobson Jeffrey M JM Mugavero Michael J MJ Sullivan Meg M Daar Eric S ES McMahon Deborah K DK Ferris David C DC Lindblad Robert R VanVeldhuisen Paul P Oden Neal N Castellón Pedro C PC Tross Susan S Haynes Louise F LF Douaihy Antoine A Sorensen James L JL Metzger David S DS Mandler Raul N RN Colfax Grant N GN del Rio Carlos C

JAMA 20160701 2

<h4>Importance</h4>Substance use is a major driver of the HIV epidemic and is associated with poor HIV care outcomes. Patient navigation (care coordination with case management) and the use of financial incentives for achieving predetermined outcomes are interventions increasingly promoted to engage patients in substance use disorders treatment and HIV care, but there is little evidence for their efficacy in improving HIV-1 viral suppression rates.<h4>Objective</h4>To assess the effect of a stru ...[more]

PMID: 27404184

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Project description:BACKGROUND AND AIMS:While patient navigation has been shown to be an effective approach for linking persons to HIV care, and contingency management is effective at improving substance use-related outcomes, Project HOPE combined these two interventions in a novel way to engage HIV-positive patients with HIV and substance use treatment. The aims of this paper are to examine patient navigator views regarding how contingency management interacted with and affected their navigation process. DESIGN:Semi-structured qualitative interviews. PARTICIPANTS:22 patient navigators from the original 10 Project HOPE study sites. MEASUREMENTS:Individual, semi-structured interviews lasting approximately 60?min addressed the patient navigator's professional background, descriptions of the participant population, substance use disorder versus HIV treatment entry and engagement issues, and the use of contingency management within the navigation service delivery protocol. FINDINGS:Patient navigators believed that financial incentives helped motivate participant attendance at navigation sessions, particularly early in study involvement, which helped them to establish rapport and develop relationships with participants. Patient navigators often noted that financial incentives positively influenced targeted HIV health-related behaviors, such as attending medical appointments, which provided a rapid pay-off with an escalating sum. Contingency management was more complex when used by the patient navigators for substance use-related behaviors, particularly when incentives revolved around negative urine screening. Patient navigators noted that not all participants responded the same way to the contingency management and that the incentives were particularly helpful when participants were financially strained with limited resources or when internal motivation was lacking. CONCLUSIONS:Overall patient navigators found the inclusion of contingency management to be helpful and affective at influencing participant behaviors, particularly concerning navigation session attendance and HIV healthcare-related participation. However, issues and concerns surrounding the inclusion of contingency management for drug-related behaviors as delivered in Project HOPE were noted. CLINICAL TRIALS REGISTRATION:NCT01612169.

Project description:BACKGROUND:Viral suppression among HIV-positive individuals is essential for protecting health and preventing HIV transmission. Financial incentives have shown promise in modifying various health behaviours in low-income countries but few studies have assessed whether they can improve HIV treatment outcomes. We aimed to determine the impact of time-limited financial incentives on viral suppression among HIV-positive adults in rural Uganda. METHODS:We did a randomised controlled trial in four rural Ugandan parishes. We recruited HIV-positive individuals (aged ?18 years) from community health campaigns that included HIV testing services or at a local government health facility where HIV treatment is offered. Participants included those who were initiating antiretroviral therapy (ART) or already receiving ART. Eligibility to participate in the study did not depend on current ART or viral suppression status. Participants were randomly allocated (1:1) to the financial incentive intervention or the control group in computer-generated blocks (block size 10 participants) and pre-printed scratch cards were used to reveal study group assignment. We measured participants' viral load at baseline and at weeks 6, 12, 24, and 48. At each timepoint, we provided results and viral load counselling. Participants in the intervention group received financial incentives for viral suppression at weeks 6, 12, and 24, with incentive amounts increasing from US$4 to $12·5. The primary outcome was viral suppression (viral load <400 copies per mL) at 24 weeks in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT02890459. FINDINGS:Between June 27, 2016, and May 25, 2018, we enrolled 400 adults in the study, of whom 203 were randomly assigned to the intervention group and 197 to the control group. Of these, 324 were enrolled from community health campaigns and 76 from the government clinic. Eight (2%) withdrew from the study and were not included in analyses. Over the 48-week follow-up period, 35 (9%) died or were lost-to-follow-up. Participants' median daily income was $0·79. At baseline, 300 participants (77%) were virally suppressed. In intention-to-treat analyses, 168 participants (84%) in the intervention group and 156 (82%) in the control group were virally suppressed at 24 weeks (odds ratio 1·14, 95% CI 0·68-1·93, p=0·62). Six participants (3%) in the control group and four (2%) in the intervention group had adverse events. Six of the adverse events were serious, including two deaths in the intervention group, three deaths in the control group, and one serious injury (tibia fracture) after an auto accident. No adverse events or deaths were related to study participation. INTERPRETATION:Financial incentives had no effect on viral suppression among HIV-positive adults. High baseline viral suppression and provision of viral load results might have contributed to high viral suppression among participants. These findings highlight the need for interventions that promote achievement of viral suppression among unsuppressed individuals. FUNDING:National Institute of Mental Health at the US National Institutes of Health.

Project description:ImportanceAchieving linkage to care and viral suppression in human immunodeficiency virus (HIV)-positive patients improves their well-being and prevents new infections. Current gaps in the HIV care continuum substantially limit such benefits.ObjectiveTo evaluate the effectiveness of financial incentives on linkage to care and viral suppression in HIV-positive patients.Design, setting, and participantsA large community-based clinical trial that randomized 37 HIV test and 39 HIV care sites in the Bronx, New York, and Washington, DC, to financial incentives or standard of care.InterventionsParticipants at financial incentive test sites who had positive test results for HIV received coupons redeemable for $125 cash-equivalent gift cards upon linkage to care. HIV-positive patients receiving antiretroviral therapy at financial incentive care sites received $70 gift cards quarterly, if virally suppressed.Main outcomes and measuresLinkage to care: proportion of HIV-positive persons at the test site who linked to care within 3 months, as indicated by CD4+ and/or viral load test results done at a care site. Viral suppression: proportion of established patients at HIV care sites with suppressed viral load (<400 copies/mL), assessed at each calendar quarter. Outcomes assessed through laboratory test results reported to the National HIV Surveillance System.ResultsA total of 1061 coupons were dispensed for linkage to care at 18 financial incentive test sites and 39 359 gift cards were dispensed to 9641 HIV-positive patients eligible for gift cards at 17 financial incentive care sites. Financial incentives did not increase linkage to care (adjusted odds ratio, 1.10; 95% CI, 0.73-1.67; P = .65). However, financial incentives significantly increased viral suppression. The overall proportion of patients with viral suppression was 3.8% higher (95% CI, 0.7%-6.8%; P = .01) at financial incentive sites compared with standard of care sites. Among patients not previously consistently virally suppressed, the proportion virally suppressed was 4.9% higher (95% CI, 1.4%-8.5%; P = .007) at financial incentive sites. In addition, continuity in care was 8.7% higher (95% CI, 4.2%-13.2%; P < .001) at financial incentive sites.Conclusions and relevanceFinancial incentives, as used in this study (HPTN 065), significantly increased viral suppression and regular clinic attendance among HIV-positive patients in care. No effect was noted on linkage to care. Financial incentives offer promise for improving adherence to treatment and viral suppression among HIV-positive patients.Trial registrationclinicaltrials.gov Identifier: NCT01152918.

Project description:BackgroundViral suppression among people living with HIV (PLHIV) is essential for protecting health and preventing HIV transmission, yet globally, rates of viral suppression are sub-optimal. Interventions to improve HIV prevention and care cascade outcomes remain vital. Financial incentives hold promise for improving these outcomes, yet to date, clinical trial results have been mixed.MethodsThis qualitative sub-study, embedded in a trial (NCT02890459) in Uganda to test whether incentives are effective for achieving viral suppression in PLHIV, sought to enhance our understanding of the factors that influence this outcome. Forty-nine (n = 49) PLHIV, purposely sampled to balance across gender, study arm, and viral suppression status, were interviewed to explore barriers and motivations for care engagement, adherence, and viral suppression, and attributions for decision-making, including perceived influence of incentives on behaviors.ResultsWhile many participants with undetectable viral load (VL) who received incentives said the incentives motivated their ART adherence, others expressed intrinsic motivation for adherence. All felt that incentives reduced burdens of transport costs, lost income due to time spent away from work, and food insecurity. Incentives may have activated attention and memory for some, as excitement about anticipating incentives helped them adhere to medication schedules. In comparison, participants who were randomized to receive incentives but had detectable VL faced a wider range, complexity and severity of challenges to care engagement. Notably, their narratives included more accounts of poor treatment in clinics, food insecurity, and severe forms of stigma. With or without incentives, adherence was reinforced through experiencing restored health due to ART, social support (especially from partners), and good quality counseling and clinical care.ConclusionsIn considering why incentives sometimes fail to achieve behavior change, it may be helpful to attend to the full set of factors- psychological, interpersonal, social and structural- that militate against the behavior change required to achieve behavioral outcomes. To be effective, incentives may need to be combined with other interventions to address the spectrum of barriers to care engagement.

Project description:Interventions are needed to improve viral suppression rates among persons with HIV and substance use. A 3-arm randomized multi-site study (Metsch et al. in JAMA 316:156-70, 2016) was conducted to evaluate the effect on HIV outcomes of usual care referral to HIV and substance use services (N = 253) versus patient navigation delivered alone (PN: N = 266) or together with contingency management (PN + CM; N = 271) that provided financial incentives targeting potential behavioral mediators of viral load suppression.This secondary analysis evaluates the effects of financial incentives on attendance at PN sessions and the relationship between session attendance and viral load suppression at end of the intervention.Frequency of sessions attended was analyzed over time and by distribution of individual session attendance frequency (PN vs PN + CM). Percent virally suppressed (?200 copies/mL) at 6 months was compared for low, medium and high rate attenders. In PN + CM a total of $220 could be earned for attendance at 11 PN sessions over the 6-month intervention with payments ranging from $10 to $30 under an escalating schedule.The majority (74%) of PN-only participants attended 6 or more sessions but only 28% attended 10 or more and 16% attended all eleven sessions. In contrast, 90% of PN + CM attended 6 or more visits, 69% attended 10 or more and 57% attended all eleven sessions (attendance distribution ?2[11] = 105.81; p < .0001). Overall (PN and PN + CM participants combined) percent with viral load suppression at 6-months was 15, 38 and 54% among those who attended 0-5, 6-9 and 10-11 visits, respectively (?2(2) = 39.07, p < .001).In this secondary post hoc analysis, contact with patient navigators was increased by attendance incentives. Higher rates of attendance at patient navigation sessions was associated with viral suppression at the 6-month follow-up assessment. Study results support use of attendance incentives to improve rates of contact between service providers and patients, particularly patients who are difficult to engage in care. Trial Registration clinicaltrials.govIdentifier: NCT01612169.

Project description:BackgroundFinancial incentives promote use of HIV services and might support adherence to the sustained antiretroviral therapy (ART) necessary for viral suppression, but few studies have assessed a biomarker of adherence or evaluated optimal implementation. We sought to determine whether varying sized financial incentives for clinic attendance effected viral suppression in patients starting ART in Tanzania.MethodsIn a three-arm, parallel-group, randomised controlled trial at four health facilities in Shinyanga region, Tanzania, adults aged 18 years or older with HIV who had started ART within the past 30 days were randomly assigned (1:1:1) using a tablet-based application (stratified by site) to receive usual care (control group) or to receive a cash incentive for monthly clinic attendance in one of two amounts: 10 000 Tanzanian Shillings (TZS; about US$4·50) or 22 500 TZS (about $10·00). There were no formal exclusion criteria. Participants were masked to the existence of two incentive sizes. Incentives were provided for up to 6 months via mobile health technology (mHealth) that linked biometric attendance monitoring to automated mobile payments. We evaluated the primary outcome of retention in care with viral suppression (<1000 copies per mL) at 6 months using logistic regression. This trial is registered with ClinicalTrials.gov, NCT03351556.FindingsBetween April 24 and Dec 14, 2018, 530 participants were randomly assigned to an incentive strategy (184 in the control group, 172 in the smaller incentive group, and 174 in the larger incentive group). All participants were included in the primary intention-to-treat analysis. At 6 months, approximately 134 (73%) participants in the control group remained in care and had viral suppression, compared with 143 (83%) in the smaller incentive group (risk difference [RD] 9·8, 95% CI 1·2 to 18·5) and 150 (86%) in the larger incentive group (RD 13·0, 4·5 to 21·5); we identified a positive trend between incentive size and viral suppression (p trend=0·0032), although the incentive groups did not significantly differ (RD 3·2, -4·6 to 11·0). Adverse events included seven (4%) deaths in the control group and 11 (3%) deaths in the intervention groups, none related to study participation.InterpretationSmall financial incentives delivered using mHealth can improve retention in care and viral suppression in adults starting HIV treatment. Although further research should investigate the durability of effects from short-term incentives, these findings strengthen the evidence for implementing financial incentives within standard HIV care.FundingNational Institute of Mental Health at the US National Institutes of Health.

Dataset Information

Effect of Patient Navigation With or Without Financial Incentives on Viral Suppression Among Hospitalized Patients With HIV Infection and Substance Use: A Randomized Clinical Trial.

Publications

Effect of Patient Navigation With or Without Financial Incentives on Viral Suppression Among Hospitalized Patients With HIV Infection and Substance Use: A Randomized Clinical Trial.

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