Acceptability Archives - Page 8 of 10 - Implementation Science at UW

✪ Prevention of cervical cancer through two HPV-based screen-and-treat implementation models in Malawi: Protocol for a cluster randomized feasibility trial

Abstract:

Background

Cervical cancer is the leading cause of cancer incidence and mortality among Malawian women, despite being a largely preventable disease. Implementing a cervical cancer screening and preventive treatment (CCSPT) program that utilizes rapid human papillomavirus (HPV) testing on self-collected cervicovaginal samples for screening and thermal ablation for treatment may achieve greater coverage than current programs that use visual inspection with acetic acid (VIA) for screening and cryotherapy for treatment. Furthermore, self-sampling creates the opportunity for community-based screening to increase uptake in populations with low screening rates. Malawi’s public health system utilizes regularly scheduled outreach and village-based clinics to provide routine health services like family planning. Cancer screening is not yet included in these community services. Incorporating self-sampled HPV testing into national policy could address cervical cancer screening barriers in Malawi, though at present the effectiveness, acceptability, appropriateness, feasibility, and cost-effectiveness still need to be demonstrated.

Methods

We designed a cluster randomized feasibility trial to determine the effectiveness, acceptability, appropriateness, feasibility, and budget impact of two models for integrating a HPV-based CCSPT program into family planning (FP) services in Malawi: model 1 involves only clinic-based self-sampled HPV testing, whereas model 2 includes both clinic-based and community-based self-sampled HPV testing. Our algorithm involves self-collection of samples for HPV GeneXpert® testing, visual inspection with acetic acid for HPV-positive women to determine ablative treatment eligibility, and same-day thermal ablation for treatment-eligible women. Interventions will be implemented at 14 selected facilities. Our primary outcome will be the uptake of cervical cancer screening and family planning services during the 18 months of implementation, which will be measured through an Endline Household Survey. We will also conduct mixed methods assessments to understand the acceptability, appropriateness, and feasibility of the interventions, and a cost analysis to assess budget impact.

Discussion

Our trial will provide in-depth information on the implementation of clinic-only and clinic-and-community models for integrating self-sampled HPV testing CCSPT with FP services in Malawi. Findings will provide valuable insight for policymakers and implementers in Malawi and other resource-limited settings with high cervical cancer burden.

Trial registration

ClinicalTrials.gov identifier: NCT04286243. Registered on February 26, 2020.

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✪ Acceptability and Feasibility of Pharmacy-Based Delivery of Pre-Exposure Prophylaxis in Kenya: A Qualitative Study of Client and Provider Perspectives

Abstract:

As countries scale up pre-exposure prophylaxis (PrEP) for HIV prevention, diverse PrEP delivery models are needed to expand access to populations at HIV risk that are unwilling or unable to access clinic-based PrEP care. To identify factors that may influence implementation of retail pharmacy-based PrEP delivery in Kenya, we conducted in-depth interviews with 40 pharmacy clients, 16 pharmacy providers, 16 PrEP clients, and 10 PrEP providers from two provinces. Most participants expressed strong support for expanding PrEP to retail pharmacies, though conditioned their acceptance on assurances that care would be private, respectful, safe, and affordable. Participant-reported determinants of feasibility centered primarily on ensuring that the intervention is compatible with retail pharmacy operations (e.g., staffing levels, documentation requirements). Future research is needed to develop and test tailored packages of implementation strategies that are most effective at integrating PrEP delivery into routine pharmacy practice in Kenya and other high HIV prevalence settings.

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

✪ Hypothetical acceptability of hospital-based post-mortem pediatric minimally invasive tissue sampling in Malawi: The role of complex social relationships

Abstract:

Background

Child mortality rates remain unacceptably high in low-resource settings. Cause of death (CoD) is often unknown. Minimally invasive tissue sampling (MITS)–using biopsy needles to obtain post-mortem samples–for histopathological and microbiologic investigation is increasingly being promoted to improve child and adult CoD attribution. “MITS in Malawi” is a sub-study of the Childhood Acute Illness & Nutrition (CHAIN) Network, which aims to identify biological and socioeconomic mortality risk factors among young children hospitalized for acute illness or undernutrition. MITS in Malawi employs standard MITS and a novel post-mortem endoscopic intestinal sampling approach to better understand CoD among children with acute illness and/or malnutrition who die during hospitalization.

Aim

To understand factors that may impact MITS acceptability and inform introduction of the procedure to ascertain CoD among children with acute illness or malnutrition who die during hospitalization in Malawi.

Methods

We conducted eight focus group discussions with key hospital staff and community members (religious leaders and parents of children under 5) to explore attitudes towards MITS and inform consent processes prior to commencing the MITS in Malawi study. We used thematic content analysis drawing on a conceptual framework developed from emergent themes and MITS acceptability literature.

Results

Feelings of power over decision-making within the hospital and household, trust in health systems, and open and respectful health worker communication with parents were important dimensions of MITS acceptability. Other facilitating factors included the potential for MITS to add CoD information to aid sense-making of death and contribute to medical knowledge and new interventions. Potential barriers to acceptability included fears of organ and blood harvesting, disfigurement to the body, and disruption to transportation and burial plans.

Conclusion

Social relationships and power dynamics within healthcare systems and households are a critical component of MITS acceptability, especially given the sensitivity of death and autopsy.

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

✪ Implementing combined WHO mhGAP and adapted group interpersonal psychotherapy to address depression and mental health needs of pregnant adolescents in Kenyan primary health care settings (INSPIRE): a study protocol for pilot feasibility trial of the integrated intervention in LMIC settings

Abstract:

Background

Addressing adolescent pregnancies associated health burden demands new ways of organizing maternal and child mental health services to meet multiple needs of this group. There is a need to strengthen integration of sustainable evidence-based mental health interventions in primary health care settings for pregnant adolescents. The proposed study is guided by implementation science frameworks with key objective of implementing a pilot trial testing a full IPT-G version along with IPT-G mini version under the mhGAP/IPT-G service framework and to study feasibility of the integrated mhGAP/IPT-G adolescent peripartum depression care delivery model and estimate if a low cost and compressed version of IPT-G intervention would result in similar size of effect on mental health and family functioning as the Full IPT-G.

There are two sub- studies embedded which are: 1) To identify multi-level system implementation barriers and strategies guided by the Consolidated Framework for Implementation Research (CFIR) to enhance perinatal mhGAP-depression care and evidence-based intervention integration (i.e., group interpersonal psychotherapy; IPT-G) for pregnant adolescents in primary care contexts; 2) To use findings from aim 1 and observational data from Maternal and Child Health (MCH) clinics that run within primary health care facilities to develop a mental health implementation workflow plan that has buy-in from key stakeholders, as well as to develop a modified protocol and implementation training manual for building health facility staff’s capacity in implementing the integrated mhGAP/IPT-G depression care.

Methods

For the primary objective of studying feasibility of the integrated mhGAP/IPT-G depression care in MCH service context for adolescent perinatal depression, we will recruit 90 pregnant adolescents to a three-arm pilot intervention (unmasked) trial study (IPT-G Full, IPT-G Mini, and wait-list control in the context of mhGAP care). Pregnant adolescents ages 13–18, in their 1st-2nd trimester with a depression score of 13 and above on EPDS would be recruited. Proctor’s implementation evaluation model will be used. Feasibility and acceptability of the intervention implementation and size of effects on mental health and family functioning will be estimated using mixed method data collection from caregivers of adolescents, adolescents, and health care providers. In the two sub-studies, stakeholders representing diverse perspectives will be recruited and focus group discussions data will be gathered.

For aim 2, to build capacity for mhGAP-approach of adolescent depression care and research, the implementation-capacity training manual will be applied to train 20 providers, 12 IPT-G implementers/health workers and 16 Kenyan researchers. Acceptability and appropriateness of the training approach will be assessed. Additional feedback related to co-located service delivery model, task-shifting and task-sharing approach of IPT-G delivery will be gathered for further manual improvement.

Discussion

This intervention and service design are in line with policy priority of Government of Kenya, Kenya Vision 2030, World Health Organization, and UN Sustainable Development Goals that focus on improving capacity of mental health service systems to reduce maternal, child, adolescent health and mental health disparities in LMICs. Successfully carrying out this study in Kenya will provide an evidence-based intervention service development and implementation model for adolescents in other Sub-Saharan African (SSA) countries. The study is funded by FIC/NIH under K43 grant.

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

✪ Implementation of Home-Based Telemental Health in a Large Child Psychiatry Department During the COVID-19 Crisis

✪ Practice facilitation to implement alcohol-related care in Veterans Health Administration liver clinics: a study protocol

Abstract:

Background

Alcohol-related care, including screening, brief intervention, and provision of/referral to medication or behavioral treatments for alcohol use disorder, could be delivered in liver clinics to better reach patients with chronic liver conditions. However, the provision of alcohol-related care in liver clinics is currently suboptimal. Practice facilitation is an evidence-based implementation strategy that may address barriers, harness facilitators, and optimize the implementation of alcohol-related care in liver clinic settings using a clinic-centered approach. We report the protocol of a study to test a practice facilitation intervention to implement alcohol-related care in four Veterans Health Administration liver clinics.

Methods

This study will employ a Hybrid Type 3 effectiveness-implementation design, in which implementation outcomes are considered primary and clinical outcomes secondary. Intervention and evaluation design were informed by the Consolidated Framework for Implementation Research. Qualitative data collected from clinical stakeholders and patients were used to tailor the intervention. The intervention involves a 6-month period of external practice facilitation, including regular meetings to identify clinic goals, challenges, and solutions; engagement of clinic champions; provision of training and development of educational materials for clinic staff and patients; and performance monitoring and feedback. Ongoing formative evaluation involves the collection of quantitative facilitator tracking data and qualitative data from meeting notes and patient interviews to describe intervention acceptability, feasibility, and adoption, and adjust implementation as needed. In the summative evaluation, implementation outcomes (clinic rates of screening, brief intervention, and treatment referral/receipt) and clinical outcomes (unhealthy alcohol use, liver health) will be assessed among patients in participating clinics using secondary electronic health record data and interrupted time series analysis.

Discussion

This will be the first study to our knowledge to test practice facilitation to implement alcohol-related care in liver clinic settings. Results from formative and summative evaluation will inform a framework for the successful implementation of effective alcohol-related care through practice facilitation in liver clinics, which may ultimately lead to better health outcomes for patients with chronic liver disease.

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

An EMR-Based Alert with Brief Provider-Led ART Adherence Counseling: Promising Results of the InfoPlus Adherence Pilot Study Among Haitian Adults with HIV Initiating ART

✪ Implementation Determinants and Outcomes of a Technology-Enabled Service Targeting Suicide Risk in High Schools: Mixed Methods Study

Abstract:

Background

Technology-enabled services (TESs), which integrate human service and digital components, are popular strategies to increase the reach and impact of mental health interventions, but large-scale implementation of TESs has lagged behind their potential.

Objective

This study applied a mixed qualitative and quantitative approach to gather input from multiple key user groups (students and educators) and to understand the factors that support successful implementation (implementation determinants) and implementation outcomes of a TES for universal screening, ongoing monitoring, and support for suicide risk management in the school setting.

Methods

A total of 111 students in the 9th to 12th grade completed measures regarding implementation outcomes (acceptability, feasibility, and appropriateness) via an open-ended survey. A total of 9 school personnel (school-based mental health clinicians, nurses, and administrators) completed laboratory-based usability testing of a dashboard tracking the suicide risk of students, quantitative measures, and qualitative interviews to understand key implementation outcomes and determinants. School personnel were presented with a series of scenarios and common tasks focused on the basic features and functions of the dashboard. Directed content analysis based on the Consolidated Framework for Implementation Research was used to extract multilevel determinants (ie, the barriers or facilitators at the levels of the outer setting, inner setting, individuals, intervention, and implementation process) related to positive implementation outcomes of the TES.

Results

Overarching themes related to implementation determinants and outcomes suggest that both student and school personnel users view TESs for suicide prevention as moderately feasible and acceptable based on the Acceptability of Intervention Measure and Feasibility of Intervention Measure and as needing improvements in usability based on the System Usability Scale. Qualitative results suggest that students and school personnel view passive data collection based on social media data as a relative advantage to the current system; however, the findings indicate that the TES and the school setting need to address issues of privacy, integration into existing workflows and communication patterns, and options for individualization for student-centered care.

Conclusions

Innovative suicide prevention strategies that rely on passive data collection in the school context are a promising and appealing idea. Usability testing identified key issues for revision to facilitate widespread implementation.

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

✪ An implementation study of oral and blood‐based HIV self‐testing and linkage to care among men in rural and peri‐urban KwaZulu‐Natal, South Africa

Abstract:

Introduction

In South Africa, HIV‐infected men are less likely than women to test and know their status (the first UNAIDS “90‐90‐90” target), and men have worse outcomes across the HIV care cascade. HIV self‐testing (HIVST) may address this testing disparity but questions remain over the most effective distribution strategy and linkage following a positive test result. We implemented a men‐focused HIVST distribution programme to evaluate components contributing to participation and retention.

Methods

We conducted an implementation study of multi‐venue HIVST kit distribution in rural and peri‐urban KwaZulu‐Natal (KZN), South Africa. We distributed HIVST kits at community points, workplaces and social venues for on site or take‐home use. Clients could choose blood‐based or oral‐fluid‐based HIVST kits and elect to watch an in‐person or video demonstration. We provided a USD2 incentive to facilitate reporting test results by phone or SMS. Persons with reactive HIVST results were provided immediate confirmatory tests (if used HIVST on site) or were referred for confirmatory testing (if took HIVST off site) and linkage to care for ART initiation. We describe the testing and linkage cascade in this sample and describe predictors of reactive HIVST results and linkage.

Results

Between July and November 2018, we distributed 4496 HIVST kits in two regions of KZN (96% to men, median age 28 (IQR 23 to 35). Most participants (58%) chose blood‐based HIVST and 42% chose oral‐swab kits. 11% of men were testing for the first time. A total of 3902 (83%) of testers reported their test result to the study team, with 314 (8%) screening positive for HIV. Among 274 men with reactive HIVST results, 68% linked to ART; no significant predictors of linkage were identified. 10% of kit users reported they would prefer a different type (oral vs. blood) of kit for repeat testing than the type they used.

Conclusions

HIVST is acceptable to men and rapid distribution with optional testing support is feasible in rural and peri‐urban settings. HIVST kits successfully reached younger men and identified undetected infections. Both oral and blood‐based HIVST were selected. Scaling up HIVST distribution and guidance may increase the number of first‐time testers among men and help achieve the first UNAIDS “90” for men in South Africa.

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

✪ Implementation outcomes and strategies for depression interventions in low- and middle-income countries: A systematic review

Abstract:

Background

We systematically reviewed implementation research targeting depression interventions in low- and middle-income countries (LMICs) to assess gaps in methodological coverage.

Methods

PubMed, CINAHL, PsycINFO, and EMBASE were searched for evaluations of depression interventions in LMICs reporting at least one implementation outcome published through March 2019.

Results

A total of 8714 studies were screened, 759 were assessed for eligibility, and 79 studies met inclusion criteria. Common implementation outcomes reported were acceptability (n = 50; 63.3%), feasibility (n = 28; 35.4%), and fidelity (n = 18; 22.8%). Only four studies (5.1%) reported adoption or penetration, and three (3.8%) reported sustainability. The Sub-Saharan Africa region (n = 29; 36.7%) had the most studies. The majority of studies (n = 59; 74.7%) reported outcomes for a depression intervention implemented in pilot researcher-controlled settings. Studies commonly focused on Hybrid Type-1 effectiveness-implementation designs (n = 53; 67.1), followed by Hybrid Type-3 (n = 16; 20.3%). Only 21 studies (26.6%) tested an implementation strategy, with the most common being revising professional roles (n = 10; 47.6%). The most common intervention modality was individual psychotherapy (n = 30; 38.0%). Common study designs were mixed methods (n = 27; 34.2%), quasi-experimental uncontrolled pre-post (n = 17; 21.5%), and individual randomized trials (n = 16; 20.3).

Conclusions

Existing research has focused on early-stage implementation outcomes. Most studies have utilized Hybrid Type-1 designs, with the primary aim to test intervention effectiveness delivered in researcher-controlled settings. Future research should focus on testing and optimizing implementation strategies to promote scale-up of evidence-based depression interventions in routine care. These studies should use high-quality pragmatic designs and focus on later-stage implementation outcomes such as cost, penetration, and sustainability.

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

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Read the full text open access in the subscription-based Journal of Child and Adolescent Psychopharmacology

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

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Read the full text in the subscription access journal AIDS and Behavior

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Read the full text in the open access journal JMIR Mental Health

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Read the full text in the open access Journal of the International AIDS Society

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Read the full text in the open access journal Global Mental Health

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