Jennifer F. Morton 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.

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

✪ “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.

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

✪ Adolescent girls and young women’s PrEP-user journey during an implementation science study in South Africa and Kenya

Abstract:

Successful scale-up of PrEP for HIV prevention in African adolescent girls and young women (AGYW) requires integration of PrEP into young women’s everyday lives. We conducted interviews and focus group discussions with 137 AGYW PrEP users aged 16–25 from South Africa and Kenya. Individual and relational enablers and disablers were explored at key moments during their PrEP-user journey from awareness, initiation and early use through persistence, including PrEP pauses, restarts, and discontinuation. PrEP uptake was facilitated when offered as part of an integrated sexual reproductive health service, but hampered by low awareness, stigma and misconceptions about PrEP in the community. Daily pill-taking was challenging for AGYW due to individual, relational and structural factors and PrEP interruptions (intended or unintended) were described as part of AGYW’s PrEP-user journey. Disclosure, social support, adolescent-friendly health counseling, and convenient access to PrEP were reported as key enablers for PrEP persistence.

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

✪ 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.

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

✪ 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.

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

✪ 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**}

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 Frontiers in Medicine

Abstract:

Background

Methods

Results

Conclusions

Authors:

✪ Open Access

Read the full text in the open access journal PLOS ONE

Abstract:

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 Implementation Science

Abstract:

Background

Methods

Discussion

Trial registration