Elizabeth Bukusi Archives - Implementation Science at UW

✪ Evaluating the effectiveness of a One-Stop PrEP Care model to enhance HIV prevention: a protocol for a cluster-randomised trial in Kisumu County, Kenya

Abstract:

Introduction

Oral HIV pre-exposure prophylaxis (PrEP) is a highly effective biomedical intervention for HIV prevention, but its access and utilisation are challenging, especially in high-burden settings such as Kenya. For potential PrEP users, long delays and repeated consultations with several providers are obstacles to both PrEP uptake and continuation. The One-Stop PrEP Care project aims to promote the use of PrEP among clients in the health system and enhance client satisfaction by reducing the waiting time.

Methods and analysis

We are conducting a 1:1 cluster-randomised trial to evaluate whether One-Stop PrEP Care achieves equivalent or better PrEP outcomes compared with the standard of care model in 12 high-volume HIV clinics in Kisumu County, Kenya. In the One-Stop model, all core PrEP components, including HIV risk evaluation, HIV testing and PrEP dispensing, are provided by one provider in a single consultation room. Programme data from ≥2400 new PrEP clients will be abstracted for 12 months each to obtain primary endpoints of PrEP initiation and continuation. Adherence will be assessed via blood drug level testing. A nested cohort of up to 300 PrEP clients will be enrolled and followed every 3 months to provide in-depth data on individual HIV prevention behaviour, risk perception and how they align PrEP use with perceived risk. We will also evaluate programme costs.

Ethics and dissemination

Ethical approval was obtained from the University of Washington Institutional Review Board (IRB) on 8 July 2022 (IRB ID: STUDY00015873) and the Kenya Medical Research Institute Scientific and Ethics Review Unit (SERU) with a letter dated 4 May 2023 (Ref: 4697). Project findings will be shared with stakeholders, including the Ministry of Health, County health officials and participants. Results will be disseminated through manuscripts, policy briefs and health meetings.

Protocol amendments

Plans for communicating important protocol modifications include timely notifications to all study team members and training on the changes, and updates to relevant stakeholders, including the two IRBs, through protocol amendment submissions.

Protocol version V. 2.0 dated 21 May 2024.

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✪ Acceptability of single-dose HPV vaccination schedule among health-care professionals in Kenya: a mixed-methods study

Abstract:

Background

The World Health Organization recommends a single-dose human papillomavirus (HPV) vaccination schedule for girls and boys to accelerate progress toward cervical cancer elimination. We applied the Theoretical Framework of Acceptability (TFA) within the context of HPV vaccination to assess the acceptability of a single-dose schedule among health-care professionals in Kenya.

Methods

A REDCap survey was developed using relevant Theoretical Framework of Acceptability domains and validated with health-care professionals. Descriptive analyses and multivariate Poisson regression were conducted to assess factors associated with increased acceptability. Free-text responses were analyzed using a rapid qualitative approach, and findings were presented using a joint display.

Results

Among 385 responses, 74.2% of health-care professionals were female and 48.6% were nurses. On average, respondents had been in their position for 60 months, and one-third (33.2%) were based at level-4 facilities. The majority (75.84%) thought that giving a single-dose of the HPV vaccine to adolescent girls and young women was either acceptable or very acceptable. Qualitative findings highlighted that lack of information was the underlying reason for health-care professionals who were resistant, and most clinicians thought that a singled-dose schedule was less burdensome to clinicians and patients. Hospital directors had a non–statistically significantly lower acceptability likelihood than nurses (incident rate ratio = 0.93, 95% confidence interval = 0.45 to 1.71) and health-care professionals at urban facilities had a non–statistically significantly lower acceptability likelihood than clinicians in rural facilities (incident rate ratio = 0.97, 95% confidence interval = 0.83 to 1.13).

Conclusion

Although not statistically significant, predictors of increased acceptability provide information to tailor strategies to increase HPV vaccination coverage and accelerate progress toward cervical cancer elimination.

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✪ The Effect of Stigma on Family Planning and HIV Pre-exposure Prophylaxis Decisions of Young Women Accessing Post-Abortion Care in Kenya

Abstract:

Adolescent girls and young women (AGYW) in Eastern and Southern Africa face parallel epidemics of unintended pregnancy and HIV. Their sexual health decisions are often dominated by intersecting stigmas. In an implementation science project integrating delivery of daily, oral pre-exposure prophylaxis (PrEP) for HIV prevention into 14 post-abortion care (PAC) clinics in Kenya, we enrolled a subset of PrEP initiating AGYW (aged 15 to 30 years) into a research cohort. Utilizing log binomial models, we estimated the effect of PrEP stigma on PrEP continuation (measured via self-report and urine assay for tenofovir) and abortion stigma on contraceptive initiation. Between April 2022 and February 2023, 401 AGYW were enrolled after initiating PrEP through their PAC provider, of which 120 (29.9%) initiated highly-effective contraception. Overall, abortion and PrEP stigmas were high in this cohort. Abortion stigma was more prevalent among those that were adolescents, unmarried, and reported social harm. Among 114 AGYW returning for the month 1 follow-up visit, 83.5% reported continuing PrEP and 52.5% had tenofovir detected. In this subset, higher levels of PrEP stigma were significantly associated with greater likelihood of PrEP adherence, but not PrEP continuation. For abortion stigma, greater scores in the subdomain of isolation were significantly associated with greater likelihood of initiating a highly-effective contraception, while greater scores in the subdomain of community condemnation were significantly associated with reduced likelihood of initiating a highly-effective contraception. Given the burden of stigma documented by our work, PAC settings are a pivotal space to integrate stigma-informed counseling and to empower young women to optimize contraceptive and PrEP decisions.

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

✪ HPV vaccination in Kenya: a study protocol to assess stakeholders’ perspectives on implementation drivers of HPV vaccination and the acceptability of the reduced dose strategy among providers

Abstract:

Background:

Cervical cancer is the leading cause of cancer-related deaths among Kenyan women. Persistent infection with high-risk oncogenic Human papillomavirus (HPV) genotypes is a necessary cause of cervical cancer. HPV vaccines are safe, durable, and efficacious in preventing incident HPV infections. In Kenya, despite efforts to increase HPV vaccination, coverage remains low. We sought to assess: (1) barriers and facilitators of HPV vaccination from the perspective of adolescent girls and young women (AGYW), their guardians as well as stakeholders involved in HPV vaccine delivery, and (2) the acceptability of the single dose of the HPV vaccination among healthcare providers (HCPs).

Methods:

Our study is nested within the KENya Single-dose HPV-vaccine Efficacy study (KEN SHE) that sought to test the efficacy of single-dose bivalent (HPV 16/18) and single-dose nonavalent (HPV 16/18/31/33/45/52/58/6/11) vaccination. We are conducting this study in Kiambu, Nairobi, and Kisumu counties. In these counties, we are interviewing stakeholders (n = ∼25), selected based on their role in HPV vaccination at the county and national levels. Interviews are audio recorded and conducted in English or Swahili. The semi-structured interview guides were designed based on: (1) the Theoretical Domains Framework (TDF) for AGYW and guardians and (2) the Consolidated Framework for Implementation Research (CFIR) for other stakeholders. The Theoretical Framework of Acceptability (TFA) was leveraged to design the survey administered to HCPs (n = ∼309) involved in HPV vaccination. We will develop a codebook based on emerging codes from the transcripts and constructs from the TDF and CFIR. Emerging themes will be summarized highlighting similarities and differences between and within the different stakeholder groups and counties. Descriptive statistics and a χ2 test will be used to assess the distribution of responses between the different sites and regression analysis will be used to assess factors associated with high acceptability of the single-dose strategy while controlling for confounding variables.

Discussion:

Our study will describe key barriers and facilitators that affect HPV vaccination from the perspective of multiple stakeholders as well as insights on the perspective of HCPs towards the single-dose strategy to inform the designing of strategies to increase HPV vaccination uptake in Kenya and comparable settings.

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

✪ Barriers to and strategies for early implementation of pharmacy-delivered HIV PrEP services in Kenya: An analysis of routine data

Abstract:

Background

For individuals who face challenges accessing clinic-based HIV pre-exposure prophylaxis (PrEP), differentiated service delivery models are needed to expand access and reach. During a pilot study testing a novel pharmacy-delivered oral PrEP model in Kenya, we used routine programmatic data to identify early implementation barriers and actions that providers and study staff took in response to the barriers.

Methods

We trained pharmacy providers at five private pharmacies in Kisumu and Kiambu Counties to initiate and continue clients at risk of HIV acquisition on PrEP for a fee of 300 KES per visit (∼$3 USD) using a prescribing checklist with remote clinician oversight. Research assistants stationed at the pharmacies completed weekly observation reports of pharmacy-delivered PrEP services using a structured template. We analyzed reports from the first 6 month of implementation using content analysis and identified multi-level early implementation barriers and actions taken to address these. We then organized the identified barriers and actions according to the Consolidated Framework for Implementation Research (CFIR).

Results

From November 2020 to May 2021, research assistants completed 74 observation reports (∼18/pharmacy). During this period, pharmacy providers screened 496 potential PrEP clients, identified 425 as eligible for pharmacy-delivered PrEP services, and initiated 230 (54%) on PrEP; 125 of 197 (63%) clients eligible for PrEP continuation refilled PrEP. We identified the following early implementation barriers to pharmacy-delivered PrEP services (by CFIR domain): high costs to clients (intervention characteristics), client discomfort discussing sexual behaviors and HIV testing with providers (outer setting), provider frustrations that PrEP delivery was time-consuming and disruptive to their workflow (inner setting), and provider hesitancy to deliver PrEP due to concerns about encouraging sexual promiscuity (characteristics of individuals). To help address these, pharmacy providers implemented a self-screening option for behavioral HIV risk assessment for prospective PrEP clients, allowed flexible appointment scheduling, and conducted pharmacy PrEP trainings for newly hired staff.

Conclusion

Our study provides insight into early barriers to implementing pharmacy-delivered PrEP services in Kenya and potential actions to mitigate these barriers. It also demonstrates how routine programmatic data can be used to understand the early implementation process.

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

✪ 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**}

✪ Design of a care pathway for pharmacy-based PrEP delivery in Kenya: Results from a collaborative stakeholder consultation

Abstract:

Introduction

In Kenya, pre-exposure prophylaxis (PrEP) for HIV prevention is almost exclusively delivered at HIV clinics. Developing novel PrEP delivery models is important for increasing the reach of PrEP. Delivery of PrEP through pharmacies is one approach utilized in the US to improve accessibility. Retail pharmacies are commonly used as a first-line access point for medical care in Kenya, but have not been utilized for PrEP delivery. We conducted a collaborative consultative meeting of stakeholders to develop a care pathway for pharmacy-based PrEP delivery in Kenya.

Methods

In January 2020, we held a one-day meeting in Nairobi with 36 stakeholders from PrEP regulatory, professional, healthcare service delivery, civil society, and research organizations. Attendees reviewed a theory of change model, results from formative qualitative research with pharmacy providers and clients, and anticipated core components of pharmacy-based PrEP delivery: counseling, HIV testing, prescribing, and dispensing. Stakeholders participated in small and large group discussions to identify potential challenges and solutions. We synthesized the key findings from these discussions.

Results

Stakeholders were enthusiastic about a model for pharmacy-based PrEP delivery. Potential challenges identified included insufficient pharmacy provider knowledge and skills, regulatory hurdles to providing affordable HIV testing at pharmacies, and undefined pathways for PrEP procurement. Potential solutions identified included having pharmacy providers complete the Kenya Ministry of Health-approved PrEP training, use of a PrEP prescribing checklist with remote clinician oversight and provider-assisted HIV self-testing, and having the government provide PrEP and HIV self-testing kits to pharmacies during a pilot test. A care pathway was developed over the course of the meeting.

Conclusions

PrEP delivery stakeholders in Kenya were strongly supportive of developing and testing a model for pharmacy-based PrEP delivery to increase PrEP access. We collaboratively developed a care pathway for pilot testing that has the potential to expand PrEP delivery options in Kenya and other similar settings.

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

✪ Pharmacy delivery to expand the reach of PrEP in Africa

Excerpt:

Several African countries have recently integrated pre‐exposure prophylaxis (PrEP) into their national HIV prevention programmes and are in the process of scaling‐up healthcare facility‐based PrEP delivery. To maximize the public health benefit of PrEP, there is need to prioritize access, minimize the costs of delivery and reach HIV at‐risk populations. Major barriers to facility‐based PrEP delivery exist, including facility‐associated HIV stigma, long waiting times, the costs of staffing and providers’ unfamiliarity with delivering prevention interventions. In Africa, PrEP is also being added to public health infrastructures that are sometimes burdened by overcrowding and drug stock outs. Thus, the ability of African health systems to maximize PrEP access necessitates finding novel models of PrEP delivery.

In low‐resource settings, including a number of African settings, private pharmacies fill an important gap in the medical system and individuals often rely on and prefer the use of pharmacies over healthcare facilities to address their medical needs. Pharmacies can address care needs that are both urgent (e.g. evaluation and medication for sexually transmitted infections) and preventive (e.g. contraception) and have advantages over healthcare facilities, including increased convenience and provider engagement. Compared to providers at healthcare facilities, providers at pharmacies can often spend more time with clients because they do not have to focus on treating sick patients and build better rapport with clients because they are for‐profit businesses that rely on repeat services. In low‐resource settings, it is common for individuals to first go to a pharmacy to address a medical issue (e.g. symptoms of malaria), then only go to a healthcare facility later if the issue is not resolved.

Delivery of PrEP through pharmacies is one approach being utilized in the US to improve PrEP accessibility. In Seattle, the... [READ MORE]

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✪ Scale up of PrEP integrated in public health HIV care clinics: a protocol for a stepped-wedge cluster-randomized rollout in Kenya

Authors:

Kenneth K. Mugwanya, Elizabeth Irungu, Elizabeth Bukusi, Nelly R. Mugo, Josephine Odoyo, Elizabeth Wamoni, Kenneth Ngure, Jennifer F. Morton, Kathryn Peebles, Sarah Masyuko, Gena Barnabee, Deborah Donnell, Ruanne Barnabas, Jessica Haberer, Gabrielle O’Malley, and Jared M. Baeten, for the Partners Scale Up Team

^{University of Washington affiliated authors are displayed in bold.}

✪ Open Access

Published: September 2018

Read the full text in the open access journal Implementation Science

Abstract:

Background

Antiretroviral therapy (ART) for HIV-infected persons and pre-exposure prophylaxis (PrEP) for uninfected persons are extraordinarily effective strategies for HIV prevention. In Africa, the region which shoulders the highest HIV burden, HIV care is principally delivered through public health HIV care clinics, offering an existing platform to incorporate PrEP delivery and maximize ART and PrEP synergies. However, successfully bringing this integrated approach to scale requires an implementation science evaluation in public health settings.

Methods

The Partners Scale Up Project is a prospective, pragmatic implementation evaluation, designed as a stepped-wedge, cluster-randomized trial, operating at 24 clinics in Kenya. In collaboration with the Kenya Ministry of Health, we are catalyzing scaled implementation of PrEP delivery integrated in HIV care clinics. The intervention package includes staff training, clinic streamlined access to PrEP commodity from the Kenya Medical Supply Authority, and ongoing intensive technical assistance to rigorously assess how PrEP delivery is implemented. PrEP service delivery including retention efforts are conducted by the clinic staff with no additional resources from the project. Guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework and Consolidated Framework for Implementation Science Research, project progress and learning are documented through ongoing monitoring and process evaluations, including chart abstraction and individual and key informant interviews, to evaluate pragmatic rollout and understand barriers and facilitators for successful PrEP delivery in this setting. In this staged rollout design, each step provides data for both pre-implementation (baseline) and implementation periods, and we will compare time points across steps in the baseline versus implementation periods.

Discussion

Cost-effective delivery models are urgently needed to maximize the public health impact of PrEP and ART. The Partners Scale Up Project will set the stage for full-scale PrEP implementation fully run and owned by the Kenya Ministry of Health. The work combines nationally sponsored PrEP delivery with technical support and implementation science from academic partners, defining a new but sustainable paradigm for public health collaboration.

Trial registration

Registered with ClinicalTrials.gov on February 14, 2017:NCT03052010.

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

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✪ Open Access

Read the full text in the open access journal BMJ Open

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Introduction

Methods and analysis

Ethics and dissemination

Protocol amendments

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Background

Methods

Results

Conclusion

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Conclusion

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Introduction

Methods

Results

Conclusions

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✪ Open Access

Read the full text in the open access journal Implementation Science

Abstract:

Background

Methods

Discussion

Trial registration