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Evaluation of Oral Pre-exposure Prophylaxis (prep) Implementation in Public HIV Care Clinics in Kenya

Evaluation of Oral Pre-exposure Prophylaxis (prep) Implementation in Public HIV Care Clinics in Kenya
Author: Elizabeth M. Irungu
Publisher:
Total Pages: 138
Release: 2021
Genre:
ISBN:

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Daily, oral pre-exposure prophylaxis (PrEP) with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) is a highly potent HIV prevention intervention with potential to reduce HIV incidence among populations at risk of HIV in Africa if delivered with sufficient coverage. There are extensive data from high-income countries describing diverse settings in which PrEP services are offered. However, data describing PrEP scale-up models in low- and middle-income countries are limited. Public HIV care and treatment programs in Africa have been very successful at scaling up antiretroviral therapy (ART) over the last 15 years and are an attractive choice for integration of PrEP delivery. The main objective of the work described in this dissertation was to evaluate the effectiveness of PrEP implementation and integration in public HIV care clinics. The specific aims include to 1) conduct a step wedge cluster randomized trial of PrEP integration in public health HIV care clinics (the Partners Scale-Up Project) and evaluate impact; 2) conduct a process evaluation of PrEP integration in public HIV care clinics in Kenya, focusing on adaptation; 3) develop and evaluate the effectiveness of an on-site modular training approach to amplify the number of health care providers trained to deliver PrEP in public HIV care clinics in Kenya; and 4) summarize early PrEP rollout in African settings, challenges encountered and opportunities to expand implementation. We found evidence that integration of PrEP in public HIV clinics was feasible. By improving the capacity of health providers in those care clinics to offer PrEP services through training and technical support, PrEP uptake increased more than 20-fold and was sustained. With existing personnel and infrastructure, the high-volume HIV care clinics efficiently reached partners of HIV infected persons and other populations at HIV risk. PrEP users had reasonable continuation rates and objective evidence of high adherence. Using qualitative methods, we found that clinics made pragmatic, effective adaptations to non-core components of PrEP delivery services and to their routine practice to address challenges in PrEP delivery. We established that clinics that instituted some of the adaptations had above average monthly PrEP initiation and continuation rates. To amplify PrEP delivery in public health facilities, we developed and evaluated an innovative on-site modular training approach. We found that this approach was acceptable and it enabled many health providers to receive PrEP training conveniently and at a relatively low cost. Finally, our summary of early PrEP roll out in Africa revealed that there was high interest in PrEP among all populations at risk of acquiring HIV, but individuals did not continue use as expected. We suggested strategies to make PrEP delivery efficient, including delivery within community pharmacies, use of peers, services availed in low tier facilities and exploration of one-stop services to make PrEP delivery less burdensome. The collective results presented in this dissertation illustrate that integration of PrEP services in public HIV care clinics in Kenya is a successful and sustainable model for PrEP implementation. We posit that this model can be scaled up in African countries planning to set up PrEP programs.


Scaling Up and Out

Scaling Up and Out
Author: Stephanie Roche
Publisher:
Total Pages: 105
Release: 2021
Genre:
ISBN:

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In Kenya, daily oral pre-exposure prophylaxis (PrEP) for HIV prevention is a key component of the country’s national HIV/AIDS response. Since its approval by the Kenya national drug regulatory authority in 2015, PrEP has been rolled out predominantly in HIV clinics; however, the country’s 5-year plan for implementing PrEP at scale calls for integration of PrEP into other service delivery models and more efficient use of available resources. Currently, there is limited implementation science research to inform PrEP scale-up (i.e., expansion to additional HIV clinics) and scale-out (i.e., expansion to new service delivery models and populations) in Kenya. Our objective was to identify barriers and facilitators of PrEP integration and/or optimization in three healthcare settings: HIV clinics, family planning (FP) clinics, and retail pharmacies. In Aim 1, we analyzed data from a prospective cohort study delivering integrated PrEP-FP services to adolescent girls and young women (AGYW) at two FP clinics in Kisumu, Kenya. Using the Consolidated Framework for Implementation Research (CFIR) and the Expert Recommendations for Implementing Change (ERIC) compilation, we identified supply-side implementation strategies for integrating PrEP into routine FP services and contextual factors influencing strategy choice and outcome, as captured in routine monitoring and evaluation documents (n=213) and key informant interviews (n=15). We found that, overall, implementing PrEP was more labor intensive at a public FP clinic compared to a private, youth-friendly clinic because it required a series of implementation strategies to make the physical and social environment conductive to offering AGYW-centered care. Nevertheless, provider adoption of PrEP delivery was low at both clinics, likely due to the widespread perception that PrEP was not within their scope of work. We recommend that PrEP implementers approach PrEP implementation, in part, as a behavioral intervention for FP providers and specifically assess the need for implementation strategies that support providers’ clinical decision-making, address workload constraints, and establish clear worker expectations. In Aim 2, we conducted a pilot study of a one-stop shop (OSS) model for PrEP delivery at four public clinics in Western Province, Kenya and evaluated whether this model could improve care efficiency and acceptability without negatively impacting PrEP uptake or continuation. Interviews with clients (n=15) and providers (n=14), technical assistance reports (n=69), and clinic flow maps indicate that the OSS achieved efficiency gains by redirecting PrEP clients away from bottlenecks, moving steps closer together (e.g., relocating supplies; cross-training and task-shifting), and differentiating clients based on the subset of services needed. Analysis of time-and-motion observations (n=47) revealed that, following OSS implementation, median client wait time dropped significantly from 31 minutes to 6 minutes (p=0.02) while median time spent with a provider remained around 23 minutes (p=0.4). Clients and providers expressed a strong preference for the OSS model and additionally identified increased privacy, reduced stigma, and higher quality client-provider interactions as benefits of the OSS model. Controlled interrupted time series analysis of PrEP initiations (n=1227) and follow-up visits (n=2696) revealed no significant difference between intervention and control clinics in terms of trends in PrEP initiation and on-time returns (all p>0.05). We conclude that the OSS model is a promising option for reducing variability in service time and increasing client and provider satisfaction without adding additional human resources. In Aim 3, we conducted a formative research study to understand the acceptability and feasibility of retail pharmacy-based PrEP delivery. Using the CFIR, we conducted and analyzed in-depth interviews with 40 pharmacy clients, 16 pharmacy providers, 16 PrEP clients, and 10 PrEP providers from Kisumu and Kiambu Counties, Kenya. 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., adequate staffing; use of documentation systems that meet PrEP reporting requirements). Our findings may inform the development of a tailored package of implementation strategies for integrating PrEP into routine pharmacy practice.


Improving Pre-exposure Prophylaxis Delivery for Young Women in Kenya

Improving Pre-exposure Prophylaxis Delivery for Young Women in Kenya
Author: Valentine Adhiambo Wanga
Publisher:
Total Pages: 82
Release: 2020
Genre:
ISBN:

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The rollout of pre-exposure prophylaxis (PrEP) for HIV prevention to priority populations, including young women, is expanding in sub-Saharan Africa. However, existing barriers to PrEP rollout at the individual, community and policy levels could slow progress and impede the success of PrEP implementation programs. In order to achieve success in HIV prevention, it is crucial to address these barriers, particularly among young women, a population especially vulnerable to HIV. In this dissertation, we evaluated the links among risk perception, sexual behavior and PrEP adherence in serodiscordant couples, evaluated the impact of incorporating HIVST in PrEP delivery for young women and assessed the cost of delivering PrEP to young women. In Aim 1, we used data from HIV-negative adults enrolled in a study of PrEP and antiretroviral therapy for HIV-serodiscordant couples in Kenya and Uganda to examine associations between: 1) condom use and risk perception and 2) risk perception and PrEP adherence. In Aim 2, we offered HIV self-testing (HIVST) to young women enrolled in a PrEP implementation study in two family planning clinics and assessed satisfaction with HIV testing and clinic experience, and the impact of HIVST on PrEP delivery procedures. In Aim 3, using the same population as that in Aim 2, we used micro-costing methods to estimate the incremental cost of delivering PrEP to young women. We found that sexual behavior aligned with perceived HIV risk, which can facilitate an HIV-negative individual's decisions about PrEP use. Additionally, we found HIVST to be feasible and acceptable for young women using PrEP, highlighting the need to evaluate its utility to streamline PrEP delivery and provide more testing options for young women on PrEP. Lastly, using practical data from PrEP implementation, we estimated the cost of delivering PrEP to young women, providing valuable data to inform budget impact and cost-effectiveness analyses as well as local resource allocation for scale-up of PrEP delivery to young women. Collectively, these studies addressed some of the barriers to PrEP delivery, proposed solutions to these barriers and drew attention to priority research needs for PrEP delivery to young women.


Modeling to Inform the Delivery of HIV Pre-exposure Prophylaxis in Sub-Saharan Africa

Modeling to Inform the Delivery of HIV Pre-exposure Prophylaxis in Sub-Saharan Africa
Author: David Allen Roberts
Publisher:
Total Pages: 0
Release: 2022
Genre:
ISBN:

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Daily oral tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) as HIV pre-exposure prophylaxis (PrEP) is a safe and effective method for HIV prevention and offers potential to substantially reduce HIV incidence in sub-Saharan Africa. Mathematical models are commonly used to project the cost-effectiveness of investments in PrEP in comparison to alternative resource allocation strategies. Predictive modeling can also identify individuals at elevated risk who may benefit most from PrEP. The studies contained in this dissertation address fundamental issues in estimating the cost and potential impact of PrEP implementation in sub-Saharan Africa. First, we estimated the cost of routine PrEP delivery through maternal and child health (MCH) and family planning (FP) clinics in western Kenya (Chapter 1). PrEP delivery through MCH and FP leverages existing service delivery platforms that reach a large fraction of women at elevated HIV risk. Using data from over 20,000 PrEP encounters through 16 clinics, we estimated that the cost per client-month of PrEP dispensed to be $26.52 (2017 USD), with personnel (43%), drugs (25%), and laboratory testing (14%) accounting for the majority of costs. Postponing creatinine testing from PrEP initiation to the first follow-up visit could save 8% of total program costs. Under Ministry of Health implementation, we projected costs would decrease by 38%, but estimates were sensitive to changes in PrEP uptake and retention. Second, we used an individual-based transmission model calibrated to Eswatini to evaluate the sensitivity of model projections of PrEP impact and efficiency to specification HIV exposure heterogeneity (Chapter 2). A common method for introducing HIV exposure heterogeneity into a model is to stratify the population into “risk group” categories with different average sexual behavior parameters, allowing PrEP coverage to vary by risk group without having to explicitly represent individual partnerships. We found that this specification leads to a sharp tradeoff between total impact and efficiency depending on PrEP coverage levels in each risk group. In comparison, PrEP use among the general population is projected to be two times more efficient if PrEP use is prioritized during partnerships and over six times more efficient if use is further prioritized among individuals with HIV-positive partners. In addition, large incidence reductions can be achieved at low levels of PrEP coverage if PrEP use in the general population is concentrated when HIV exposure is more likely, but high levels of PrEP coverage are needed if time-varying individual risk is ignored. Third, we developed and validated HIV risk prediction models incorporating individual-level and geospatial covariates using data from nearly 20,000 individuals in a population-based cohort in rural KwaZulu-Natal, South Africa (Chapter 3). Individual-level predictors included demographic, socioeconomic, and sexual behavior measures, while geospatial covariates included local estimates of community HIV prevalence and viral load. We compared full models to simpler models restricted to only individual-level covariates or only age and geospatial covariates. Models using only age group and geospatial covariates had similar performance (women: area under the receiver operating characteristic curve (AUROC) = 0.65, men: AUROC = 0.71) to the full models (women: AUROC = 0.68, men: AUROC = 0.72). In addition, geospatial models more accurately identified high incidence regions than individual-level models; the 20% of the study area with the highest predicted risk accounted for 60% of the high incidence areas when using geospatial models but only 13% using models with only individual-level covariates. These findings have implications for PrEP policies. Our primary costing study identified service delivery bottlenecks and cost drivers that can inform efforts to streamline PrEP delivery. By ignoring the alignment of PrEP use with time-varying individual HIV exposure, models using a risk group specification may overestimate the cost and underestimate the impact of widespread PrEP availability. Finally, local estimates of HIV prevalence can help identify individuals and areas to prioritize for PrEP services to maximize impact.


Guidelines for the Psychosocially Assisted Pharmacological Treatment of Opioid Dependence

Guidelines for the Psychosocially Assisted Pharmacological Treatment of Opioid Dependence
Author: World Health Organization. Department of Mental Health and Substance Abuse
Publisher: World Health Organization
Total Pages: 133
Release: 2009
Genre: Medical
ISBN: 9241547545

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"These guidelines were produced by the World Health Organization (WHO), Department of Mental Health and Substance Abuse, in collaboration with the United Nations Office on Drugs and Crime (UNODC) a Guidelines Development Group of technical experts, and in consultation with the International Narcotics Control Board (INCB) secretariat and other WHO departments. WHO also wishes to acknowledge the financial contribution of UNODC and the Joint United Nations Programme on HIV/AIDS (UNAIDS) to this project. " - p. iv


Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection

Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection
Author: World Health Organization
Publisher:
Total Pages: 429
Release: 2016
Genre: AIDS (Disease)
ISBN: 9789241549684

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These guidelines provide guidance on the diagnosis of human immunodeficiency virus (HIV) infection, the use of antiretroviral (ARV) drugs for treating and preventing HIV infection and the care of people living with HIV. They are structured along the continuum of HIV testing, prevention, treatment and care. This edition updates the 2013 consolidated guidelines on the use of antiretroviral drugs following an extensive review of evidence and consultations in mid-2015, shared at the end of 2015, and now published in full in 2016. It is being published in a changing global context for HIV and for health more broadly.


The Massachusetts General Hospital Handbook of Behavioral Medicine

The Massachusetts General Hospital Handbook of Behavioral Medicine
Author: Ana-Maria Vranceanu
Publisher: Humana Press
Total Pages: 338
Release: 2016-11-17
Genre: Medical
ISBN: 3319292943

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This text outlines the importance of biopsychosocial factors in improving medical care, and illustrates evidence-based, state-of-the-art interventions for patients with a variety of medical conditions. Each chapter is focused on a particular health concern or illness, which is described both in terms of prevalence and frequent psychological and psychiatric comorbidities that may present to clinicians working with these populations. Consistent with evidence-based care, information on the efficacy of the treatments being described is presented to support their continued use. To accommodate the needs of clinicians, we describe population specific approaches to treatment, including goal settings, modules and skills as well as strategies to assess and monitor progress. To facilitate learning, each chapter contains one or more case examples that explicate the skills described to convey change within a behavioral medicine protocol. Each chapter also includes resources in the form of books and websites to gain additional knowledge and detail as needed. Authors are experts in the field of each chapter, ensuring that information presented is recent and of high quality.


Disease Control Priorities, Third Edition (Volume 6)

Disease Control Priorities, Third Edition (Volume 6)
Author: King K. Holmes
Publisher: World Bank Publications
Total Pages: 1027
Release: 2017-11-06
Genre: Medical
ISBN: 1464805253

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Infectious diseases are the leading cause of death globally, particularly among children and young adults. The spread of new pathogens and the threat of antimicrobial resistance pose particular challenges in combating these diseases. Major Infectious Diseases identifies feasible, cost-effective packages of interventions and strategies across delivery platforms to prevent and treat HIV/AIDS, other sexually transmitted infections, tuberculosis, malaria, adult febrile illness, viral hepatitis, and neglected tropical diseases. The volume emphasizes the need to effectively address emerging antimicrobial resistance, strengthen health systems, and increase access to care. The attainable goals are to reduce incidence, develop innovative approaches, and optimize existing tools in resource-constrained settings.


Making Health Services Adolescent Friendly

Making Health Services Adolescent Friendly
Author: World Health Organization
Publisher:
Total Pages: 0
Release: 2013
Genre: Medical
ISBN: 9789241503594

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"This guidebook sets out the public health rationale for making it easier for adolescents to obtain the health services that they need to protect and improve their health and well-being, including sexual and reproductive health services. It defines 'adolescent-friendly health services' from the perspective of quality, and provides step-by-step guidance on developing quality standards for health service provision to adolescents. Drawing upon international experience, it is also tailored to national epidemiological, social, cultural and economic realities, and provides guidance on identifying what actions need to be taken to assess whether appropriate standards have been achieved."--Introduction, page v.