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✪ Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics): A cluster-randomized type 3 hybrid effectiveness-implementation trial

Authors:

Sara J. Becker, Cara M. Murphy, Bryan Hartzler, Carla J. Rash, Tim Janssen, Mat Roosa, Lynn M. Madden & Bryan R. Garner

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: October 2021

Read the full text in the open access journal Addiction Science & Clinical Practice

Abstract:

Background

Opioid-related overdoses and harms have been declared a public health emergency in the United States, highlighting an urgent need to implement evidence-based treatments. Contingency management (CM) is one of the most effective behavioral interventions when delivered in combination with medication for opioid use disorder, but its implementation in opioid treatment programs is woefully limited. Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics) was funded by the National Institute on Drug Abuse to identify effective strategies for helping opioid treatment programs improve CM implementation as an adjunct to medication. Specific aims will test the impact of two different strategies on implementation outcomes (primary aim) and patient outcomes (secondary aims), as well as test putative mediators of implementation effectiveness (exploratory aim).

Methods

A 3-cohort, cluster-randomized, type 3 hybrid design is used with the opioid treatment programs as the unit of randomization. Thirty programs are randomized to one of two conditions. The control condition is the Addiction Technology Transfer Center (ATTC) Network implementation strategy, which consists of three core approaches: didactic training, performance feedback, and on-going consultation. The experimental condition is an enhanced ATTC strategy, with the same core ATTC elements plus two additional theory-driven elements. The two additional elements are Pay-for-Performance, which aims to increase implementing staff’s extrinsic motivations, and Implementation & Sustainment Facilitation, which targets staff’s intrinsic motivations. Data will be collected using a novel, CM Tracker tool to document CM session delivery, session audio recordings, provider surveys, and patient surveys. Implementation outcomes include CM Exposure (number of CM sessions delivered per patient), CM Skill (ratings of CM fidelity), and CM Sustainment (number of patients receiving CM after removal of support). Patient outcomes include self-reported opioid abstinence and opioid-related problems (both assessed at 3- and 6-months post-baseline).

Discussion

There is urgent public health need to improve the implementation of CM as an adjunct to medication for opioid use disorder. Consistent with its hybrid type 3 design, Project MIMIC is advancing implementation science by comparing impacts of these two multifaceted strategies on both implementation and patient outcomes, and by examining the extent to which the impacts of those strategies can be explained by putative mediators.

Trial registration

This clinical trial has been registered with clinicaltrials.gov (NCT03931174).

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Community-based postpartum contraceptive counseling in rural Nepal: a mixed-methods evaluation

Authors:

Wan-Ju Wu, Aparna Tiwari, Nandini Choudhury, Indira Basnett, Rita Bhatt, David Citrin, Scott Halliday, Lal Kunwar, Duncan Maru, Isha Nirola, Sachit Pandey, Hari Jung Rayamazi, Sabitri Sapkota, Sita Saud, Aradhana Thapa, Alisa Goldberg, & Sheela Maru

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: June 2020

Read the full text in the open access journal Sexual and Reproductive Health Matters

Abstract:

Unmet need for postpartum contraception in rural Nepal remains high and expanding access to sexual and reproductive healthcare is essential to achieving universal healthcare. We evaluated the impact of an integrated intervention that employed community health workers aided by mobile technology to deliver patient-centred, home-based antenatal and postnatal counseling on postpartum modern contraceptive use. This was a pre–post-intervention study in seven village wards in a single municipality in rural Nepal.

The primary outcome was modern contraceptive use among recently postpartum women. We performed a multivariable logistic regression to examine contraceptive use among postpartum women pre- and one-year post-intervention. We conducted qualitative interviews to explore the implementation process. There were 445 postpartum women in the pre-intervention group and 508 in the post-intervention group.

Modern contraceptive use increased from 29% pre-intervention to 46% post-intervention (p < 0.0001). Adjusting for age, caste, and household expenditure, time since delivery and sex of child in the index pregnancy, postpartum women one-year post-intervention had twice the odds (OR 2.3; CI 1.7, 3.1; p < 0.0001) of using a modern contraceptive method as compared to pre-intervention. Factors at the individual, family, and systems level influenced women’s contraceptive decisions. The intervention contributed to increasing contraceptive use through knowledge transfer, demand generation, referrals to healthcare facilities, and follow-up.

A community-based, patient-centered contraceptive counseling intervention supported by mobile technology and integrated into longitudinal care delivered by community health workers appears to be an effective strategy for improving uptake of modern contraception among postpartum women in rural Nepal.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Study protocol for evaluating Six Building Blocks for opioid management implementation in primary care practices

Authors:

Sarah J. Shoemaker-Hunt, Leigh Evans, Holly Swan, Olivia Bacon, Brooke Ike, Laura-Mae Baldwin, & Michael L. Parchman

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2020

Read the full text in the open access journal Implementation Science Communications

Abstract:

Background

The Six Building Blocks for improving opioid management (6BBs) is a program for improving the management of patients in primary care practices who are on long-term opioid therapy for chronic pain. The 6BBs include building leadership and consensus; aligning policies, patient agreements, and workflows; tracking and monitoring patient care; conducting planned, patient-centered visits; tailoring care for complex patients; and measuring success. The Agency for Healthcare Research and Quality funded the development of a 6BBs implementation guide: a step-by-step approach for independently implementing the 6BBs in a practice. This mixed-method study seeks to assess practices’ use of the implementation guide to implement the 6BBs and the effectiveness of 6BBs implementation on opioid management processes of care among practices using the implementation guide.

Methods

Data collection is guided by the Consolidated Framework for Implementation Research, Proctor’s taxonomy of implementation outcomes, and the Centers for Disease Control and Prevention’s Guideline for Prescribing Opioids for Chronic Pain. A diverse group of health care organizations with primary care clinics across the USA will participate in the study over 15 months. Qualitative data collection will include semi-structured interviews with stakeholders at each organization at two time points, notes from routine check-in calls, and document review. These data will be used to understand practices’ motivation for participation, history with opioid management efforts, barriers and facilitators to implementation, and implementation progress. Quantitative data collection will consist of a provider and staff survey, an implementation milestones assessment, and quarterly opioid prescribing quality measures. These data will supplement our understanding of implementation progress and will allow us to assess changes over time in providers’ opioid prescribing practices, prescribing self-efficacy, challenges to providing guideline-driven care, and practices’ opioid prescribing quality measures. Qualitative data will be coded and analyzed for emergent themes. Quantitative data will be analyzed using descriptive statistics and clustered multivariate regression.

Discussion

This study contributes to the knowledge of the implementation and effectiveness of a team-based approach to opioid management in primary care practices. Information gleaned from this study can be used to inform efforts to curtail opioid prescribing and assist primary care practices considering implementing the 6BBs.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Integrated Delivery of Antiretroviral Treatment and Pre-exposure Prophylaxis to HIV-1–Serodiscordant Couples: A Prospective Implementation Study in Kenya and Uganda

Authors:

Jared M. Baeten, Renee Heffron, Lara Kidoguchi, Nelly R. Mugo, Elly Katabira, Elizabeth A. Bukusi, Stephen Asiimwe, Jessica E. Haberer, Jennifer Morton, Kenneth Ngure, Nulu Bulya, Josephine Odoyo, Edna Tindimwebwa, Craig Hendrix, Mark A. Marzinke, Norma C. Ware, Monique A. Wyatt, Susan Morrison, Harald Haugen, Andrew Mujugira, Deborah Donnell, Connie Celum, & the Partners Demonstration Project Team

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: August 2016

Read the full text in the open access journal PLOS Medicine

Abstract:

Background

Antiretroviral-based interventions for HIV-1 prevention, including antiretroviral therapy (ART) to reduce the infectiousness of HIV-1 infected persons and pre-exposure prophylaxis (PrEP) to reduce the susceptibility of HIV-1 uninfected persons, showed high efficacy for HIV-1 protection in randomized clinical trials. We conducted a prospective implementation study to understand the feasibility and effectiveness of these interventions in delivery settings.

Methods and Findings

Between November 5, 2012, and January 5, 2015, we enrolled and followed 1,013 heterosexual HIV-1-serodiscordant couples in Kenya and Uganda in a prospective implementation study. ART and PrEP were offered through a pragmatic strategy, with ART promoted for all couples and PrEP offered until 6 mo after ART initiation by the HIV-1 infected partner, permitting time to achieve virologic suppression. One thousand thirteen couples were enrolled, 78% of partnerships initiated ART, and 97% used PrEP, during a median follow-up of 0.9 years. Objective measures of adherence to both prevention strategies demonstrated high use (≥85%).

Given the low HIV-1 incidence observed in the study, an additional analysis was added to compare observed incidence to incidence estimated under a simulated counterfactual model constructed using data from a prior prospective study of HIV-1-serodiscordant couples. Counterfactual simulations predicted 39.7 HIV-1 infections would be expected in the population at an incidence of 5.2 per 100 person-years (95% CI 3.7–6.9). However, only two incident HIV-1 infections were observed, at an incidence of 0.2 per 100 person-years (95% CI 0.0–0.9, p < 0.0001 versus predicted). The use of a non-concurrent comparison of HIV-1 incidence is a potential limitation of this approach; however, it would not have been ethical to enroll a contemporaneous population not provided access to ART and PrEP.

Conclusions

Integrated delivery of time-limited PrEP until sustained ART use in African HIV-1-serodiscordant couples was feasible, demonstrated high uptake and adherence, and resulted in near elimination of HIV-1 transmission, with an observed HIV incidence of <0.5% per year compared to an expected incidence of >5% per year.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**