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Mother Infant Retention for Health (MIR4Health): Study Design, Adaptations, and Challenges With PMTCT Implementation Science Research.

ABSTRACT: BACKGROUND:Effective retention of HIV-infected mothers and their infants is fraught with multiple challenges, resulting in loss across the continuum of prevention of mother-to-child HIV transmission (PMTCT) care and missed opportunities to offer life-saving HIV prevention and treatment. METHODS:The Mother Infant Retention for Health study is an individual-randomized study evaluating the effectiveness of active patient follow-up compared with standard of care on the combined outcome of attrition of HIV-infected women and their infants at 6 months postpartum. Lay counselors administered the active patient follow-up package of interventions, including individualized health education, use of flip charts during clinic visits, and at home, phone and short message service appointment reminders, active phone and physical tracking of patients immediately after missed clinic visits, and individualized retention and adherence support. RESULTS:Use of study visits to indicate participant progression along the PMTCT cascade highlights the nature of loss among women and infants in PMTCT care because of issues such as pregnancy complications, infant deaths, and transfer out. Delay in implementation of Option B+, unanticipated slow enrollment, a health-care worker strike, rapid HIV test kit shortages, and changes in national PMTCT guidelines necessitated several modifications to the protocol design and implementation to ensure successful completion of the study. CONCLUSIONS:Flexibility when operationalizing an implementation science study is critical in the context of the shifting landscape in a noncontrolled "real-world" setting. TRIAL REGISTRATION:Clinicaltrials.gov NCT01962220.

SUBMITTER: Fayorsey RN

PROVIDER: S-EPMC5113246 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

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Mother Infant Retention for Health (MIR4Health): Study Design, Adaptations, and Challenges With PMTCT Implementation Science Research.

Fayorsey Ruby N RN Chege Duncan D Wang Chunhui C Reidy William W Peters Zachary Z Syengo Masila M Barasa Chrisostim C Owino Samuel O SO Sirengo Martin M Hawken Mark P MP Abrams Elaine J EJ

Journal of acquired immune deficiency syndromes (1999) 20160801

<h4>Background</h4>Effective retention of HIV-infected mothers and their infants is fraught with multiple challenges, resulting in loss across the continuum of prevention of mother-to-child HIV transmission (PMTCT) care and missed opportunities to offer life-saving HIV prevention and treatment.<h4>Methods</h4>The Mother Infant Retention for Health study is an individual-randomized study evaluating the effectiveness of active patient follow-up compared with standard of care on the combined outcom ...[more]

PMID: 27355501

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Project description:Operational research (OR) is the discipline of using models, either quantitative or qualitative, to aid decision-making in complex implementation problems. The methods of OR have been used in healthcare since the 1950s in diverse areas such as emergency medicine and the interface between acute and community care; hospital performance; scheduling and management of patient home visits; scheduling of patient appointments; and many other complex implementation problems of an operational or logistical nature.To date, there has been limited debate about the role that operational research should take within implementation science. I detail three such roles for OR all grounded in upfront system thinking: structuring implementation problems, prospective evaluation of improvement interventions, and strategic reconfiguration. Case studies from mental health, emergency medicine, and stroke care are used to illustrate each role. I then describe the challenges for applied OR within implementation science at the organisational, interventional, and disciplinary levels. Two key challenges include the difficulty faced in achieving a position of mutual understanding between implementation scientists and research users and a stark lack of evaluation of OR interventions. To address these challenges, I propose a research agenda to evaluate applied OR through the lens of implementation science, the liberation of OR from the specialist research and consultancy environment, and co-design of models with service users. Operational research is a mature discipline that has developed a significant volume of methodology to improve health services. OR offers implementation scientists the opportunity to do more upfront system thinking before committing resources or taking risks. OR has three roles within implementation science: structuring an implementation problem, prospective evaluation of implementation problems, and a tool for strategic reconfiguration of health services. Challenges facing OR as implementation science include limited evidence and evaluation of impact, limited service user involvement, a lack of managerial awareness, effective communication between research users and OR modellers, and availability of healthcare data. To progress the science, a focus is needed in three key areas: evaluation of OR interventions, embedding the knowledge of OR in health services, and educating OR modellers about the aims and benefits of service user involvement.

Project description:BACKGROUND:To improve the care and treatment of HIV-exposed children, early infant diagnosis (EID) using dried blood spot (DBS) sampling has been performed in Senegal since 2007, making molecular diagnosis accessible for patients living in decentralized settings. This study aimed to determine the evolution of the HIV transmission rate in children from 2008 to 2015 and to analyze associated factors, particularly the mother's treatment status and/or child's prophylaxis status and the feeding mode. METHODS:The data were analyzed using EID reports from the reference laboratory. Information related to sociodemographic characteristics, HIV profiles, the mother's treatment status, the child's prophylaxis status, and the feeding mode was included. Descriptive statistics were calculated, and bivariate and multivariate logistic regression analyses were performed. RESULTS:During the study period, a total of 5418 samples (5020 DBS and 398 buffy coat) from 168 primary prevention of HIV mother-to-child transmission (PMTCT) intervention sites in Senegal were tested. The samples were collected from 4443 children with a median age of 8 weeks (1-140 weeks) and a sex ratio (M/F) of 1.1 (2309/2095). One-third (35.2%; N = 1564) of the children were tested before 6 weeks of age. Twenty percent (N = 885) underwent molecular diagnostic testing more than once. An increased number of mothers receiving treatment (57.4%; N = 2550) and children receiving prophylaxis (52.1%; N = 2315) for protection against HIV infection during breastfeeding was found over the study period. The transmission rate decreased from 14.8% (95% confidence interval (CI): 11.4-18.3) in 2008 to 4.1% (95% CI: 2.5-7.5) in 2015 (p < 0.001). However, multivariate logistic regression analysis revealed that independent predictors of HIV mother-to-child transmission included lack of mother's treatment (adjusted odd ratio (aOR) = 3.8, 95% CI: 1.9-7.7; p?0.001), lack of child's prophylaxis (aOR = 7.8, 95% CI: 1.7-35.7; p = 0.009), infant age at diagnosis (aOR = 2.2, 95% CI: 1.1-4.3 for ?6 weeks versus 12-24 weeks; p = 0.025) and protective effect of breastfeeding on ART against formula feeding (aOR = 0.4, 95% CI: 0.2, 0.7; p = 0.005). CONCLUSION:This study demonstrates the effectiveness of PMTCT interventions in Senegal but indicates also that increased efforts should be continued to reduce the MTCT rate to less than 2%.

Project description:IntroductionChild mortality rates remain high in sub-Saharan Africa, including Ethiopia. We are conducting a cluster randomised control trial in the Gondar zone of the Amhara region to determine the impact of pairing Orthodox priests with community health workers, known locally as the Health Development Army (HDA), on newborns' nutritional status, early illness identification and treatment, and vaccination completeness.Ensuring intervention efficacy with scientific rigour is essential, but there are often delays in adopting evidence into policy and programmes. Here, we present a protocol for conducting parallel implementation research alongside an efficacy study to understand intervention implementability and scalability. This will help develop a scale-up strategy for effective elements of the intervention to ensure rapid implementation at scale.Methods and analysisWe will conduct a stakeholder analysis of key implementation stakeholders and readiness surveys to assess their readiness to scale up the intervention. We will conduct semistructured interviews and focus group discussions with stakeholders, including HDA members, health workers, Orthodox priests, and caregivers, to determine the core intervention elements that need to be scaled, barriers and facilitators to scaling up the intervention in diverse sociocultural settings, as well as the human and technical requirements for national and regional implementation. Finally, to determine the financial resources necessary for sustaining and scaling the intervention, we will conduct activity-based costing to estimate implementation costs from the provider's perspective.Ethics and disseminationThe study received approval from the University of Gondar Institutional Review Board (approval no: VP/RTT/05/1030/2022) and the University of Washington Human Subjects Division (approval no: STUDY00015369). Participants will consent to participate. Results will be disseminated through workshops with stakeholders, local community meetings, presentations at local and international conferences, and journal publications. The study will provide evidence for factors to consider in developing a scale-up strategy to integrate the intervention into routine health system practices.

Project description:BackgroundInterventions are often adapted; some adaptations may provoke more favorable outcomes, whereas some may not. A better understanding of the adaptations and their intended goals may elucidate which adaptations produce better outcomes. Improved methods are needed to better capture and characterize the impact of intervention adaptations.MethodsWe used multiple data collection and analytic methods to characterize adaptations made by practices participating in a hybrid effectiveness-implementation study of a complex, multicomponent diabetes intervention. Data collection methods to identify adaptations included interviews, observations, and facilitator sessions resulting in transcripts, templated notes, and field notes. Adaptations gleaned from these sources were reduced and combined; then, their components were cataloged according to the framework for reporting adaptations and modifications to evidence-based interventions (FRAME). Analytic methods to characterize adaptations included a co-occurrence table, statistically based k-means clustering, and a taxonomic analysis.ResultsWe found that (1) different data collection methods elicited more overall adaptations, (2) multiple data collection methods provided understanding of the components of and reasons for adaptation, and (3) analytic methods revealed ways that adaptation components cluster together in unique patterns producing adaptation "types." These types may be useful for understanding how the "who, what, how, and why" of adaptations may fit together and for analyzing with outcome data to determine if the adaptations produce more favorable outcomes rather than by adaptation components individually.ConclusionAdaptations were prevalent and discoverable through different methods. Enhancing methods to describe adaptations may better illuminate what works in providing improved intervention fit within context.Trial registrationThis trial is registered on clinicaltrials.gov under Trial number NCT03590041 , posted July 18, 2018.

Project description:BACKGROUND:The Prevention of Mother-to-Child Transmission of HIV (PMTCT) program in India is one of the largest in the world. It uses outreach workers (ORWs) to facilitate patient uptake of services, however, the challenges faced by the ORWs, and their views about the effectiveness of this program are unknown. METHODS:The COMmunity-Home Based INDia (COMBIND) Prevention of Mother to Child Transmission of HIV study evaluated an integrated mobile health and behavioral intervention to enhance the capacity of ORWs in India. To understand the challenges faced by ORWs, and their perceptions of opportunities for program improvement, four group discussions were conducted among 60 ORW from four districts of Maharashtra, India, as part of the baseline assessment for COMBIND. Data were qualitatively analyzed using a thematic approach. RESULTS:Numerous personal-, social-, and structural-level challenges existed for ORW as they engaged with their patients. Personal-level challenges for ORWs included disclosure of their own HIV status and travelling costs for home visits. Personal-level challenges for patients included financial costs of travelling to ART centers, non-adherence to ART, loss of daily wages, non-affordability of infant formula, lack of awareness of the baby's needs, financial dependence on family, four time points (6weeks, 6 months, 12 months and 18 months) for HIV tests, and need for nevirapine (NVP) prophylaxis. Social-level challenges included lack of motivation by patients and/or health care staff, social stigma, and rude behavior of health care staff and their unwillingness to provide maternity services to women in the PMTCT programme. Structural-level challenges included cultural norms around infant feeding, shortages of HIV testing kits, shortages of antiretroviral drugs and infant NVP prophylaxis, and lack of training/knowledge related to PMTCT infant feeding guidelines by hospital staff. The consensus among ORWs was that there was a critical need for tools and training to improve their capacity to effectively engage with patients, and deliver appropriate care, and for motivation through periodic feedback. CONCLUSIONS:Given the significant challenges in PMTCT programme implementation reported by ORW, novel strategies to address these challenges are urgently needed to improve patient engagement, and access to and retention in care.

Dataset Information

Mother Infant Retention for Health (MIR4Health): Study Design, Adaptations, and Challenges With PMTCT Implementation Science Research.

Publications

Mother Infant Retention for Health (MIR4Health): Study Design, Adaptations, and Challenges With PMTCT Implementation Science Research.

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