Dataset Information

A Randomized Controlled Trial of Cash Incentives or Peer Support to Increase HCV Treatment for Persons With HIV Who Use Drugs: The CHAMPS Study.

ABSTRACT:

Background

Despite access to direct-acting antivirals, barriers to a hepatitis C virus (HCV) cure persist, especially among persons living with human immunodeficiency virus (HIV) (PLWH) who use drugs. Interventions such as peer mentors or cash incentives may improve the care continuum.

Methods

The CHAMPS (Chronic HepAtitis C Management to ImProve OutcomeS) study randomized 144 PLWH, recruited from an outpatient clinic, with substance use disorders into three treatment groups: usual care (UC) (n = 36), UC plus cash incentives (n = 54), and UC plus peer mentors (n = 54) to evaluate HCV treatment uptake and cure. All participants received 12-weeks of ledipasvir/sofosbuvir (LDV/SOF). Trained peer mentors had well-controlled HIV and HCV. Cash incentives were contingent on visit attendance (maximum $220). The primary endpoint was HCV treatment initiation; secondary endpoints included sustained virologic response (SVR) and HCV reinfection.

Results

The majority of participants were male (61%), Black (93%), and unemployed (85%). Depression and active drug and alcohol use were common. Overall, 110 of 144 (76%) participants initiated LDV/SOF. Although treatment initiation rates were higher in PLWH randomized to peers (83%, 45 of 54) or cash (76%, 41 of 54) compared to UC (67%, 24 of 36), these differences were not statistically significant (P = .11). Most PLWH who initiated treatment achieved SVR (100 of 110, 91%). LDV/SOF was well tolerated; peers and cash had no effect on drug and alcohol use during therapy. One individual from the cash cohort experienced HCV reinfection.

Conclusion

After removal of system barriers, one-third of PLWH in UC did not initiate HCV treatment. Among those who initiated, SVR rates were high. Research involving PLWH who use drugs should focus on overcoming barriers to treatment initiation.

Clinical trial information

The registration data for the trial are in the ClinicalTrials.gov database, number NCT02402218.

SUBMITTER: Ward KM

PROVIDER: S-EPMC6488268 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A Randomized Controlled Trial of Cash Incentives or Peer Support to Increase HCV Treatment for Persons With HIV Who Use Drugs: The CHAMPS Study.

Ward Kathleen M KM Falade-Nwulia Oluwaseun O Moon Juhi J Sutcliffe Catherine G CG Brinkley Sherilyn S Haselhuhn Taryn T Katz Stephanie S Herne Kayla K Arteaga Lilian L Mehta Shruti H SH Latkin Carl C Brooner Robert K RK Sulkowski Mark S MS

Open forum infectious diseases 20190409 4

<h4>Background</h4>Despite access to direct-acting antivirals, barriers to a hepatitis C virus (HCV) cure persist, especially among persons living with human immunodeficiency virus (HIV) (PLWH) who use drugs. Interventions such as peer mentors or cash incentives may improve the care continuum.<h4>Methods</h4>The CHAMPS (Chronic HepAtitis C Management to ImProve OutcomeS) study randomized 144 PLWH, recruited from an outpatient clinic, with substance use disorders into three treatment groups: usua ...[more]

PMID: 31049365

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Project description:IntroductionTargeted, tailored interventions to test high-risk individuals for HIV and hepatitis C virus (HCV) are vital to achieving HIV control and HCV microelimination in Africa. Compared with the general population, people who inject drugs (PWID) are at increased risk of HIV and HCV and are less likely to be tested or successfully treated. Assisted partner services (APS) increases HIV testing among partners of people living with HIV and improves case finding and linkage to care. We describe a study in Kenya examining whether APS can be adapted to find, test and link to HIV care the partners of HIV-positive PWID using a network of community-embedded peer educators (PEs). Our study also identifies HCV-positive partners and uses phylogenetic analysis to determine risk factors for onward transmission of both viruses.MethodsThis prospective cohort study leverages a network of PEs to identify 1000 HIV-positive PWID for enrolment as index participants. Each index completes a questionnaire and provides names and contact information of all sexual and injecting partners during the previous 3 years. PEs then use a stepwise locator protocol to engage partners in the community and bring them to study sites for enrolment, questionnaire completion and rapid HIV and HCV testing. Outcomes include number and type of partners per index who are mentioned, enrolled, tested, diagnosed with HIV and HCV and linked to care.Ethics and disseminationPotential index participants are screened for intimate partner violence (IPV) and those at high risk are not eligible to enrol. Those at medium risk are monitored for IPV following enrolment. A community advisory board engages in feedback and discussion between the community and the research team. A safety monitoring board discusses study progress and reviews data, including IPV monitoring data. Dissemination plans include presentations at quarterly Ministry of Health meetings, local and international conferences and publications.Trial registration numberNCT03447210, Pre-results stage.

Project description:BackgroundPersons with HIV (PWH) can now achieve a near-normal life expectancy due to antiretroviral therapy (ART). Despite widespread availability of ART in the United States (US), many of the country's approximate 1.1 million PWH are not achieving viral suppression due to poor ART adherence. Viral suppression rates are particularly low in Alabama (AL, 62%) and New York City (NYC, 67%). There is mixed evidence on the efficacy of community health workers (CHW) and mHealth interventions for improving ART adherence and viral suppression in PWH thus, we sought to combine these interventions and test the efficacy for improving health outcomes in PWH.MethodsThe CHAMPS study is a two-arm randomized controlled trial among 300 PWH with suboptimal primary care appointment adherence (n = 150 in AL and 150 in NYC) over the course of 12 months. Participants are randomly assigned to CHAMPS (intervention) or a standard-of-care (control) arm. Participants in the intervention arm are given a CleverCap pill bottle that syncs to the WiseApp to track medication adherence, reminds users to take their medication at a set time, and enables communication with CHW. All participants complete baseline, 6-month, and 12-month follow-up visits where surveys are administered and, CD4 and HIV-1 viral load are obtained through blood draw.DiscussionMaintaining ART adherence has significant implications in HIV management and transmission. mHealth technologies have been shown to optimize the provision of health services, produce positive changes in health behavior, and significantly improve health outcomes. CHW interventions also provide personal support to PWH. The combination of these strategies may provide the necessary intensity to increase ART adherence and clinic attendance among PWH at highest risk for low engagement. Delivering care remotely enables CHW to contact, assess, and support numerous participants throughout the day, reducing burden on CHW and potentially improving intervention durability for PWH. The adoption of the WiseApp coupled with community health worker sessions in the CHAMPS study has the potential to improve HIV health outcomes, and will add to the growing knowledge of mHealth and CHW efforts to improve PWH medication adherence and viral suppression.Trial registrationThis trial was registered with Clinicaltrials.gov (NCT04562649) on 9/24/20.

Dataset Information

A Randomized Controlled Trial of Cash Incentives or Peer Support to Increase HCV Treatment for Persons With HIV Who Use Drugs: The CHAMPS Study.

Background

Methods

Results

Conclusion

Clinical trial information

Publications

A Randomized Controlled Trial of Cash Incentives or Peer Support to Increase HCV Treatment for Persons With HIV Who Use Drugs: The CHAMPS Study.

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