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✪ Assessing the sustainability of the Systems Analysis and Improvement Approach to increase HIV testing in family planning clinics in Mombasa, Kenya: results of a cluster randomized trial

Authors:

Jessica E. Long, McKenna C. Eastment, George Wanje, Barbra A. Richardson, Emily Mwaringa, Mwanakarama Athman Mohamed, Kenneth Sherr, Ruanne V. Barnabas, Kishorchandra Mandaliya, Walter Jaoko, and R. Scott McClelland

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: October 2022

Read the full text in the open access journal Implementation Science

Abstract:

Background

In Kenya, HIV incidence is highest among reproductive-age women. A key HIV mitigation strategy is the integration of HIV testing and counseling (HTC) into family planning services, but successful integration remains problematic. We conducted a cluster-randomized trial using the Systems Analysis and Improvement Approach (SAIA) to identify and address bottlenecks in HTC integration in family planning clinics in Mombasa County, Kenya. This trial (1) assessed the efficacy of this approach and (2) examined if SAIA could be sustainably incorporated into the Department of Health Services (DOHS) programmatic activities. In Stage 1, SAIA was effective at increasing HTC uptake. Here, we present Stage 2, which assessed if SAIA delivery would be sustained when implemented by the Mombasa County DOHS and if high HTC performance would continue to be observed.

Methods

Twenty-four family planning clinics in Mombasa County were randomized to either the SAIA implementation strategy or standard care. In Stage 1, the study staff conducted all study activities. In Stage 2, we transitioned SAIA implementation to DOHS staff and compared HTC in the intervention versus control clinics 1-year post-transition. Study staff provided training and minimal support to DOHS implementers and collected quarterly HTC outcome data. Interviews were conducted with family planning clinic staff to assess barriers and facilitators to sustaining HTC delivery.

Results

Only 39% (56/144) of planned SAIA visits were completed, largely due to the COVID-19 pandemic and a prolonged healthcare worker strike. In the final study quarter, 81.6% (160/196) of new clients at intervention facilities received HIV counseling, compared to 22.4% (55/245) in control facilities (prevalence rate ratio [PRR]=3.64, 95% confidence interval [CI]=2.68–4.94). HIV testing was conducted with 60.5% (118/195) of new family planning clients in intervention clinics, compared to 18.8% (45/240) in control clinics (PRR=3.23, 95% CI=2.29–4.55). Interviews with family planning clinic staff suggested institutionalization contributed to sustained HTC delivery, facilitated by low implementation strategy complexity and continued oversight.

Conclusions

Intervention clinics demonstrated sustained improvement in HTC after SAIA was transitioned to DOHS leadership despite wide-scale healthcare disruptions and incomplete delivery of the implementation strategy. These findings suggest that system interventions may be sustained when integrated into DOHS programmatic activities.

Trial registration

ClinicalTrials.gov (NCT02994355) registered on 16 December 2016.

**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

Authors:

Elzette Rousseau , Ariana W. K. Katz, Shannon O’Rourke, Linda-Gail Bekker, Sinead Delany-Moretlwe, Elizabeth Bukusi, Danielle Travill, Victor Omollo, Jennifer F. Morton, Gabrielle O’Malley, Jessica E. Haberer, Renee Heffron, Rachel Johnson, Connie Celum, Jared M. Baeten, & Ariane van der Straten

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: October 2021

Read the full text in the open access journal PLOS ONE

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

Authors:

Elizabeth M. Irungu, Josephine Odoyo, Elizabeth Wamoni, Elizabeth A. Bukusi, Nelly R. Mugo, Kenneth Ngure, Jennifer F. Morton, Kenneth K. Mugwanya, Jared M. Baeten, & Gabrielle O'Malley, for the Partners Scale-Up Project Team

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: September 2021

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

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

Authors:

Kathryn Peebles, Kenneth K. Mugwanya, Elizabeth Irungu, Josephine Odoyo, Elizabeth Wamoni, Jennifer F. Morton, Kenneth Ngure, Elizabeth A. Bukusi, Nelly R. Mugo, Sarah Masyuko, Irene Mukui, Jared M. Baeten, & Ruanne V. Barnabas for the Partners Scale-Up Project Team

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: August 2021

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

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**

Male Caregiver Barriers to HIV Index Case Testing of Untested Children

Authors:

Jillian Neary, Anjuli D Wagner, Vincent Omondi, Verlinda Otieno, Cyrus Mugo, Dalton C Wamalwa, Elizabeth Maleche-Obimbo, Grace C John-Stewart, Jennifer A Slyker, & Irene N Njuguna

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: July 2021

Read the full text in the subscription access Journal of Acquired Immune Deficiency Syndrome

Financial Incentives for Pediatric HIV Testing (FIT): Caregiver Insights on Incentive Mechanisms, Focus Populations, and Acceptability for Programmatic Scale Up

Authors:

Junyi Zhang, Dana L. Atkins, Anjuli D. Wagner, Irene N. Njuguna, Jillian Neary, Vincent O. Omondi, Verlinda A. Otieno, Winnie O. Atieno, Merceline Odhiambo, Dalton C. Wamalwa, Grace John-Stewart, Jennifer A. Slyker, Bryan J. Weiner, & Kristin Beima-Sofie

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: June 2021

Read the full text in the subscription access journal AIDS and Behavior

✪ Using Assisted Partner Services for HIV Testing and the Treatment of Males and Their Female Sexual Partners: Protocol for an Implementation Science Study

Authors:

Edward Kariithi, Monisha Sharma, Emily Kemunto, Harison Lagat, George Otieno, Beatrice M. Wamuti, David A. Katz, Christopher Obong'o, Paul Macharia, Rose Bosire, Sarah Masyuko, Mary Mugambi, Carol E. Levin, Wenjia Liu, Unmesha Roy Paladhi, Bryan J. Weiner, & Carey Farquhar

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: May 2021

Read the full text in the open access journal JMIR Research Protocols

Abstract:

Background

Despite the effective scale-up of HIV testing and treatment programs, only 75% of people living with HIV (PLWH) globally know their status, and this rate is lower among men. This highlights the importance of implementing HIV testing and linkage interventions with a high uptake in this population. In a cluster randomized controlled trial conducted in Kenya between 2013 and 2015, we found that assisted partner services (APS) for HIV-exposed partners of newly diagnosed PLWH safely reached more HIV-exposed individuals with HIV testing compared with client referral alone. However, more data are needed to evaluate APS implementation in a real-world setting.

Objective

This study aims to evaluate the effectiveness, acceptability, fidelity, and cost of APS when integrated into existing HIV testing services (HTS) in Western Kenya.

Methods

Our study team from the University of Washington and PATH is integrating APS into 31 health facilities in Western Kenya. We are enrolling females newly diagnosed with HIV (index clients) who consent to receiving APS, their male sexual partners, and female sexual partners of male sexual partners who tested HIV positive. Female index clients and sexual partners testing HIV positive will be followed up at 6 weeks, 6 months, and 12 months postenrollment to assess linkage to care, antiretroviral therapy initiation, and HIV viral load suppression. We will evaluate the acceptability, fidelity, and cost of real-world implementation of APS via in-depth interviews conducted with national, county, and subcounty-level policy makers responsible for HTS. Facility health staff providing HTS and APS, in addition to staff working with the study project team, will also be interviewed. We will also conduct direct observations of facility infrastructure and clinical procedures and extract data from the facilities and county and national databases.

Results

As of March 2020, we have recruited 1724 female index clients, 3201 male partners, and 1585 female partners. We have completed study recruitment as well as 6-week (2936/2973, 98.75%), 6-month (1596/1641, 97.25%), and 12-month (725/797, 90.9%) follow-up visits. Preliminary analyses show that facilities scaling up APS identify approximately 12-18 new HIV-positive males for every 100 men contacted and tested. We are currently completing the remaining follow-up interviews and incorporating an HIV self-testing component into the study in response to the COVID-19 pandemic.

Conclusions

The results will help bridge the gap between clinical research findings and real-world practice and provide guidance regarding optimal strategies for APS integration into routine HIV service delivery.

International Registered Report Identifier (IRRID)

DERR1-10.2196/27262

**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

Authors:

Stephanie D. Roche, Njeri Wairimu, Peter Mogere, Kevin Kamolloh, Josephine Odoyo, Zachary A. Kwena, Elizabeth A. Bukusi, Kenneth Ngure, Jared M. Baeten, & Katrina F. Ortblad

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: April 2021

Read the full text in the open access journal AIDS and Behavior

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**

✪ Incorporating Method Dissatisfaction into Unmet Need for Contraception: Implications for Measurement and Impact

Authors:

Claire W. Rothschild, Win Brown, & Alison L. Drake

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2021

Read the full text in the open access journal Studies in Family Planning

Abstract:

While unmet need for contraception is commonly used to assess programmatic needs, it inadequately captures the complexity of fertility and contraceptive preferences, including women's satisfaction with their contraceptive method. In their 2019 commentary, Sarah Rominski and Rob Stephenson propose reclassifying dissatisfied current users as having an unmet need for contraception. As revising the current definition based on their proposal would require significant investment to update survey and monitoring systems, understanding the potential impact on current estimates of unmet need is critical.

We estimated the impact of this approach in a Kenyan cohort of modern contraceptive users. We found the prevalence of method dissatisfaction ranges from 6.6% (95% confidence interval [CI] 5.6–7.8%) to 18.9% (95% CI 17.1–20.9%); if applied nationally, this results in a large (approximately 25–70%) increase in Kenya's current estimate of unmet need for any contraception. Our findings suggest a large impact on unmet need estimates for equivalent populations.

Overall, we advocate for better measurements of method satisfaction and acceptability, with metrics developed that are robust to socioeconomic gradients and validated in low- and middle-income settings to ensure women's contraceptive needs are captured equitably.

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

Identifying challenges and recommendations for advancing global mental health implementation research: A key informant study of the National Institute of Mental Health Scale-Up Hubs

Authors:

John A.Naslund, Jasmine Kalha, Juliana L. Restivo, Ishmael Amarreh, Tamora Callands, Hongtu Chen, Carlos Gomez-Restrepo, Hesham M. Hamoda, Arjun Kapoor, Sue Levkoff, Jones Masiye, Maria A. Oquendo, Vikram Patel, Inge Petersen, Ozge Sensoy Bahar, Laura Shields-Zeeman, Fred M. Ssewamala, Deepak Tugnawat, José Miguel Uribe-Restrepo, Lakshmi Vijayakumar, Bradley H. Wagenaar, Milton L.Wainberg, Larry Wissow, Haja Ramatulai Wurie, Chifundo Zimba, & Soumitra Pathare

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: January 2021

Read the full text in the subscription access journal Asian Journal of Psychiatry