Kenneth Ngure 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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✪ High acceptability, feasibility and sustainability of a direct-to-pharmacy differentiated PrEP delivery model in public health HIV clinics in Kenya: perspectives of PrEP clients and healthcare providers

Abstract:

Introduction

High client opportunity costs and a burdened healthcare system limit oral pre-exposure prophylaxis (PrEP) delivery in Kenyan public HIV clinics. We conducted a qualitative study among PrEP clients and providers to understand the acceptability, feasibility and willingness to implement a client-centred, differentiated direct-to-pharmacy (DTP) PrEP refill visits intervention aimed at improving the efficiency of PrEP implementation in real-world clinics.

Methods

From March 2021 to March 2022, we conducted in-depth interviews with clients and healthcare providers participating in an individual facility pharmacy-based PrEP delivery model for PrEP refills among clients in the continuation phase at two public HIV clinics in central Kenya. The core components of the DTP model included directed-to-PrEP pharmacy refill visits conducted by facility pharmacy staff and client HIV self-testing (HIVST) while waiting for services at the pharmacy. We used semi-structured interview guides informed by the Consolidated Framework for Implementation Research (CFIR). We analysed data using thematic content analysis and organised findings by CFIR constructs.

Results

We interviewed 20 PrEP clients and 20 healthcare providers. PrEP clients included 15 females and had a median age of 39 years (interquartile range [IQR]: 33–48). Providers included 13 females, had a median age of 32 years (IQR: 30–41), and included 10 HIV counsellors, 5 pharmacy and 3 clinical providers. Both providers and clients reported high satisfaction with DTP PrEP refill visits derived from improved clinic flow and quality of service. Among clients, shorter waiting times and less movement between multiple clinic rooms reduced delays, improved privacy and reduced stigma associated with visiting HIV clinics. Furthermore, shorter waiting times and infrequent clinic visits reduced loss of working hours and income among clients, motivating PrEP continuation. Providers reported improved clinic flow, reduced work burden among non-pharmacy providers, improved knowledge and ease of implementing DTP refill visits. However, providers expressed concerns about the potential loss of roles among HIV counsellors and the shifting of workload burden to pharmacy providers.

Conclusions

Differentiated DTP refill visits with HIVST were highly acceptable and feasible among PrEP clients and providers. Context-specific modifications and scale-up of the intervention could improve the efficiency of PrEP delivery within public HIV clinics in Kenya and similar settings.

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✪ “When he is around, I’ll take the PrEP, but when he is not, I will not take PrEP”: key influences on PrEP use decisions among women attending family planning clinics in Kenya

Abstract:

Background

Women of childbearing age in sub-Saharan Africa (SSA) face a disproportionately high risk of HIV acquisition. Although oral PrEP has been universally scaled up for individuals at significant risk of HIV, its uptake and sustained use remain suboptimal. Understanding PrEP use decisions offers insights into context-specific barriers and facilitators to its utilization.

Methods

From September to November 2023, we conducted a qualitative study nested in a larger prospective, open-label clinical trial (FP-Plus). We conducted in-depth interviews (IDIs) with younger women (ages 15–24) and older women (ages ≥25) who declined, delayed, discontinued, or restarted PrEP during the study. IDIs were conducted at two FP clinics by trained Kenyan social scientists and were audio recorded, translated, and transcribed. We analyzed data using inductive and deductive thematic analysis through the lens of the theory of planned behavior (TPB) to explore experiences, beliefs, and rationale among women who made various PrEP decisions.

Results

We interviewed 64 women, including 40 younger women and 24 older women, all of whom declined, delayed, discontinued, or restarted PrEP (n = 16 women/category). The median age of these women was 24 years (IQR, 23–30). The majority of participants (86%, 55/64) were using family planning methods, primarily injectables (42%, 23/64). PrEP discontinuation or restart was primarily influenced by changes in HIV risk dynamics. Agency and perceived HIV risk were pivotal factors in PrEP use decisions, shaping participants’ ability to practice effective prevention adherence (TPB: perceived behavioral control). Women who declined PrEP cited a lack of autonomy, partner influence, and insufficient information (TPB: social and subjective norms). Low self-efficacy influenced decisions to delay or decline PrEP (TPB: behavioral beliefs and attitudes). In addition, challenges with PrEP pill size, taste, and texture were perceived as barriers to swallowing pills among all groups of women. Participants expressed a preference for alternative PrEP formulations, such as injectable PrEP, due to perceived ease of use, privacy, and potential to support adherence.

Conclusions

PrEP discontinuation and restart cycles largely reflected changes in HIV risk. Women who decline or delay PrEP may benefit from personalized support to improve their autonomy, recognizing that HIV risk persists during periods of PrEP delay.

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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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✪ 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.

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✪ Process evaluation of PrEP implementation in Kenya: adaptation of practices and contextual modifications in public HIV care clinics

Abstract:

Introduction

In Africa, oral pre-exposure prophylaxis (PrEP) is largely provided via over-burdened public HIV care clinics. Successfully incorporating PrEP services into these clinics may require adaptations to practices outlined in national implementation guidelines and modifications to routine existing service delivery. We aimed to describe adaptations made by public HIV clinics in Kenya to integrate PrEP delivery into existing services.

Methods

The Partners Scale-Up Project aimed to catalyze integration of PrEP in 25 public HIV care clinics. Between May and December 2018, we conducted qualitative interviews with health providers and documented clinic observations in technical assistance (TA) reports to understand the process of PrEP service integration. We analyzed 36 health provider interview transcripts and 25 TA reports to identify clinic-level adaptations to activities outlined in Kenyan Ministry of Health PrEP guidelines and modifications made to existing service delivery practices to successfully incorporate PrEP services. Identified adaptations were reported using the expanded framework for reporting adaptations and modifications (FRAME).

Results

All clinics (n = 25) performed HIV testing, HIV risk assessment, PrEP education and adherence counseling as stipulated in the guidelines. Most clinics initiated clients on PrEP without creatinine testing if otherwise healthy. While monthly refill appointments are recommended, a majority of clinics issued PrEP users two to three months of pills at a time. Clinics also implemented practices that had not been specified in the guidelines including incorporating PrEP-related topics into routine health talks, calling clients with missed PrEP appointments, discussing PrEP service delivery in regular staff meetings, ‘fast-tracking’ PrEP clients and dispensing PrEP in clinic rooms rather than at clinic-based pharmacies. PrEP initiation numbers were highest among clinics that did not require creatinine testing, conducted peer on-the-job PrEP training and those that discussed PrEP delivery in their routine meetings. Above-average continuation was observed among clinics that discussed PrEP in their routine meetings, dispensed PrEP in clinic rooms and offered PrEP at non-regular hours.

Conclusions

Health providers in public HIV care clinics instituted practices and made innovative adaptations to PrEP delivery to reduce barriers for clients and staff. Encouraging clinic level adaptations to national implementation guidelines will facilitate scale-up of PrEP delivery.

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✪ Low costs and opportunities for efficiency: a cost analysis of the first year of programmatic PrEP delivery in Kenya’s public sector

Abstract:

Background

In 2017, the Kenyan Ministry of Health integrated provision of pre-exposure prophylaxis (PrEP) into public HIV-1 care clinics as a key component of the national HIV-1 prevention strategy. Estimates of the cost of PrEP provision are needed to inform the affordability and cost-effectiveness of PrEP in Kenya.

Methods

We conducted activity-based micro-costing from the payer perspective to estimate both the financial and economic costs of all resources and activities required to provide PrEP in Kenya’s public sector. We estimated total and unit costs in 2019 United States dollars from a combination of project expense reports, Ministry of Health training reports, clinic staff interviews, time-and-motion observations, and routinely collected data from PrEP recipient files from 25 high-volume HIV-1 care clinics.

Results

In the first year of programmatic PrEP delivery in 25 HIV-1 care clinics, 2,567 persons initiated PrEP and accrued 8,847 total months of PrEP coverage, accounting for 2 % of total outpatient clinic visits. The total financial cost to the Ministry of Health was $91,175, translating to an average of $10.31 per person per month. The majority (69 %) of financial costs were attributable to PrEP medication, followed by administrative supplies (17 %) and training (9 %). Economic costs were higher ($188,584 total; $21.32 per person per month) due to the inclusion of the opportunity cost of staff time re-allocated to provide PrEP and a proportional fraction of facility overhead. The vast majority (88 %) of the annual $80,811 economic cost of personnel time was incurred during activities to recruit new clients (e.g., discussion of PrEP within HIV-1 testing and counseling services), while the remaining 12 % was for activities related to both initiation and maintenance of PrEP provision (e.g., client consultations, technical advising, support groups).

Conclusions

Integration of PrEP provision into existing public health HIV-1 care service delivery platforms resulted in minimal additional staff burden and low incremental costs. Efforts to improve the efficiency of PrEP provision should focus on reductions in the cost of PrEP medication and extra-clinic demand creation and community sensitization to reduce personnel time dedicated to recruitment-related activities.

Trial registration

ClinicalTrials.gov registration NCT03052010. Retrospectively registered on February 14, 2017.

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✪ 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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Authors:

✪ Open Access

Read the full text in the open access journal BMJ Open

Abstract:

Introduction

Methods and analysis

Ethics and dissemination

Protocol amendments

Authors:

✪ Open Access

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

Abstract:

Introduction

Methods

Results

Conclusions

Authors:

✪ Open Access

Read the full text in the open access journal Frontiers in Medicine

Abstract:

Background

Methods

Results

Conclusions

Authors:

✪ Open Access

Read the full text in the open access journal JNCI Monographs

Abstract:

Background

Methods

Results

Conclusion

Authors:

✪ Open Access

Read the full text in the open access journal Frontiers in Reproductive Health

Abstract:

Background

Methods

Results

Conclusion

Authors:

✪ Open Access

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

Abstract:

Introduction

Methods

Results

Conclusions

Authors:

✪ Open Access

Read the full text in the open access journal BMC Health Services Research

Abstract:

Background

Methods

Results

Conclusions

Trial registration

Authors:

✪ Open Access

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

Excerpt: