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✪ Impact of a stakeholder selected implementation strategy package – fast tracking, provider re-training, and co-location – on PrEP implementation for pregnant women in antenatal care clinics in western Kenya

Authors:

Joseph Sila, Anjuli Dawn Wagner, Felix Abuna, Julia C Dettinger, Ben Odhiambo, Nancy Ngumbau, George Oketch, Enock Sifuna, Laurén Gómez, Sarah Hicks, Bryan J. Weiner, Grace John-Stewart & John Kinuthia

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: May 2025

Read the full text in the open access journal Implementation Science Communications

Abstract:

Background

Pre-exposure prophylaxis (PrEP) is recommended for HIV prevention in pregnant and postpartum women at substantial ongoing risk for HIV. In resource-limited settings, there exist gaps in the integration of PrEP into antenatal care.

Methods

We conducted a difference-in-differences analytic approach (3 months pre- and 3 months post) between January 2022 and July 2022 in 8 facilities (4 intervention and 4 comparison) in western Kenya. During the 6-month period, we tested a combination of 2 stakeholder selected implementation strategies – retraining health providers and fast tracking PrEP clients– to improve PrEP delivery. All study facilities dispensed PrEP in the Maternal and Child health clinics (MCH). We evaluated absolute changes in: PrEP penetration, PrEP fidelity, client PrEP knowledge, client satisfaction, and client waiting and service times as outcomes specified a priori while PrEP offer and HIV testing were outcomes specified post hoc. We measured acceptability and appropriateness by providers of the implementation strategies using AIM and IAM respectively.

Results

We observed statistically significant improvements in PrEP penetration and PrEP offer (p < 0.05) and non-significant improvements in fidelity. PrEP penetration increased 6 percent points (p = 0.002), PrEP offer increased nearly 6 percentage points (p = 0.002), and PrEP fidelity increased 4 percentage points (p = 0.202) in intervention vs comparison facilities. Client PrEP knowledge increased 0.45 out of 7 total points (p < 0.001) and PrEP screening increased 13 percentage points (p = 0.001). We observed no significant changes in service time (0.13-min increase; p = 0.249), waiting time (0.03-min decrease; p = 0.796), or client satisfaction (0.04/24 total point decrease; p = 0.849) in intervention vs comparison facilities. HIV testing did not significantly change (7 percentage point decrease, p = 0.305). The implementation strategy bundle was deemed appropriate and acceptable by the providers (appropriateness: 18.5/20; acceptability: 18.5/20). Overall, the implementation strategy bundle was associated with larger increases in implementation outcomes among women receiving a visit other than their first ANC visit, as well as among sites without stockouts of HIV test kits.

Conclusions

A stakeholder-selected implementation strategy bundle that included retraining healthcare workers, fast tracking PrEP clients to reduce waiting time, and PrEP dispensing in MCH improved several implementation outcomes without significantly affecting waiting time or reducing service time.

Contributions to the literature

  • Evidence is sparse on effective implementation strategies that focus on structural- and provider-level barriers to enhance delivery of integrated care in resource-limited settings.
  • Stakeholder-selected strategies are hypothesized to have a better fit to local context and potentially be more effective than externally selected strategies.
    We tested a package of two stakeholder-selected implementation strategies – retraining health providers, fast tracking PrEP clients in a difference-in-differences study in 8 clinics in Kenya.
  • The package was associated with significant improvements in PrEP penetration, PrEP offer, PrEP knowledge, and PrEP screening. It was not associated with significant changes in PrEP fidelity, HIV testing, service time, waiting time, or client satisfaction.
  • The improvement associated with the package was most pronounced among clinics that did not experience substantial stockouts of supplies, suggesting that implementation strategies are not sufficient to overcome gaps in basic resourcing in the presence of critical events.

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

✪ Digital communication between mothers and community health workers to support neonatal health (CHV-NEO): study protocol for a randomized controlled trial

Authors:

Keshet Ronen, Lincoln C. Pothan, Violet Apondi, Felix A. Otieno, Daniel Mwakanema, Felix O. Otieno, Lusi Osborn, Julia C. Dettinger, Priyanka Shrestha, Helena Manguerra, Ferdinand Mukumbang, Millicent Masinde, Evelyn Waweru, Mercy Amulele, Christine Were, Beatrice Wasunna, Grace John-Stewart, Bryan Weiner, Arianna Rubin Means, Barbra A. Richardson, Anna B. Hedstrom, Jennifer A. Unger & John Kinuthia

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: October 2024

Read the full text in the open access journal Trials

Abstract:

Background

Provision of essential newborn care at home, rapid identification of illness, and care-seeking by caregivers can prevent neonatal mortality. Mobile technology can connect caregivers with information and healthcare worker advice more rapidly and frequently than healthcare visits. Community health workers (CHWs) are well-suited to deliver such interventions. We developed an interactive short message service (SMS) intervention for neonatal health in Kenya, named CHV-NEO. CHV-NEO sends automated, theory-based, actionable, messages throughout the peripartum period that guide mothers to evaluate maternal and neonatal danger signs and facilitate real-time dialogue with a CHW via SMS. We integrated this intervention into Kenya’s national electronic community health information system (eCHIS), which is currently used at scale to support CHW workflow.

Methods

The effect of CHV-NEO on clinical and implementation outcomes will be evaluated through a non-blinded cluster randomized controlled trial. Twenty sites across Kisumu County in Western Kenya were randomized 1:1 to provide either the national eCHIS with integrated CHV-NEO messaging (intervention) or standard of care using eCHIS without CHV-NEO (control). We will compare neonatal mortality between arms based on abstracted eCHIS data from 7200 pregnant women. Secondary outcomes include self-reported provision of essential newborn care (appropriate cord care, thermal care, and timely initiation of breastfeeding), knowledge of neonatal danger signs, and care-seeking for neonatal illness, compared between arms based on questionnaires with a subgroup of 2000 women attending study visits at enrollment in pregnancy and 6 weeks postpartum. We will also determine CHV-NEO’s effect on CHW workflows and evaluate determinants of intervention acceptability, adoption, and fidelity of use through questionnaires, individual interviews, and messaging data.

Discussion

We hypothesize that the CHV-NEO direct-to-client communication strategy can be successfully integrated within existing CHW workflows and infrastructure, improve the provision of at-home essential newborn care, increase timely referral of neonatal illness to facilities, and reduce neonatal mortality. The intervention’s integration into the national eCHIS tool will facilitate rapid scale-up if it is clinically effective and successfully implemented.

Trial registration

ClinicalTrials.gov, NCT05187897. The CHV-NEO study was registered on January 12, 2022.

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

✪ An implementation strategy package (video education, HIV self-testing, and co-location) improves PrEP implementation for pregnant women in antenatal care clinics in western Kenya

Authors:

Joseph Sila, Anjuli D. Wagner, Felix Abuna, Julia C. Dettinger, Ben Odhiambo, Nancy Ngumbau, George Oketch, Enock Sifuna Laurén Gómez, Sarah Hicks, Grace John-Stewart, & John Kinuthia

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: November 2023

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

Abstract:

Background

Pre-exposure prophylaxis (PrEP) is recommended by the World Health Organization and the Kenyan Ministry of Health for HIV prevention in pregnancy and postpartum for women at risk for HIV. Integration of PrEP into antenatal care is promising, but delivery gaps exist in the face of healthcare provider shortages in resource-limited settings.

Methods

Between May and November 2021, we conducted a difference-in-differences study (3 months pre-intervention data collection and 3 months post-intervention data collection) analyzing four intervention facilities, where the strategies were implemented, and four comparison facilities, where no strategies were implemented. We tested a combination of three implementation strategies—video-based PrEP information in the waiting bay, HIV self-testing, and dispensing of PrEP in the antenatal care rooms—to improve PrEP delivery. We compared absolute changes in the proportion of antenatal attendees screened for PrEP (PrEP penetration), the proportion receiving all PrEP-specific steps in a visit (HIV testing, risk screening, and PrEP counseling) (PrEP fidelity), and client PrEP knowledge, client satisfaction, and waiting time and service time (a priori outcomes); post hoc, we compared the proportion offered PrEP (PrEP offer) and completing HIV testing. We measured provider perceptions of the acceptability and appropriateness of the implementation strategies.

Results

We observed significant improvements in PrEP penetration, PrEP offer, satisfaction, and knowledge (p < 0.05) and improvements in fidelity that trended towards significance (p = 0.057). PrEP penetration increased 5 percentage points (p = 0.008), PrEP fidelity increased 8 percentage points (p = 0.057), and PrEP offer increased 4 percentage points (p = 0.003) in intervention vs. comparison facilities. Client PrEP knowledge increased by 1.7 out of 6 total points (p < 0.001) and client satisfaction increased by 0.7 out of 24 total points (p = 0.003) in intervention vs. comparison facilities. We observed no changes in service time (0.09-min decrease; p = 0.435) and a small increase in waiting time (0.33-min increase; p = 0.005). HIV testing among those eligible did not change (1.5 percentage point decrease, p = 0.800). Providers felt the implementation strategies were acceptable and appropriate (median acceptability: 20/20; median appropriateness: 19.5/20). However, absolute levels of each step of the PrEP cascade remained suboptimal

Conclusions

An implementation strategy package with video information, HIV self-testing, and co-location of medication dispensing enhanced PrEP delivery across several implementation outcomes and client satisfaction, while not substantially increasing wait time or decreasing provider-client contact time.

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

✪ Implementation determinants and strategies in integration of PrEP into maternal and child health and family planning services: experiences of frontline healthcare workers in Kenya

Authors:

Anjuli D. Wagner, Kristin Beima-Sofie, Mercy Awuor, Winnie Owade, Jillian Neary, Julia C. Dettinger, Jillian Pintye, Felix Abuna, Harison Lagat, Bryan J. Weiner, Pamela Kohler, John Kinuthia, Grace John-Stewart, and Gabrielle O’Malley

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: September 2023

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

Abstract:

Background

Delivery of PrEP to adolescent girls and young women (AGYW) and to pregnant women through maternal and child health (MCH) and family planning (FP) clinics is scaling up in Kenya. Evaluation of implementation challenges and strategies is critical to optimize delivery.

Methods

We conducted focus group discussions (FGDs) with healthcare workers (HCWs) in MCH and FP clinics offering PrEP in a large implementation project in Kisumu, Kenya. Discussion guides were based on the Consolidated Framework for Implementation Research (CFIR). FGDs were audio recorded and transcribed. Directed content analysis was used to identify implementation challenges and strategies to overcome them.

Results

Fifty HCWs from 26 facilities participated in 8 FGDs. HCWs believed PrEP integration was appropriate because it met the needs of AGYW and pregnant women by providing a female-controlled prevention strategy and aligned with policy priorities of elimination of vertical HIV transmission. They were universally accepting of PrEP provision, especially through MCH clinics, noting the relative advantage of this approach because it: (1) enabled high coverage, (2) harmonized PrEP and MCH visits, and (3) minimized stigma compared to PrEP offered through HIV care clinics. However, HCWs noted implementation challenges affecting feasibility and adoption including: (1) increased workload and documentation burden amid workforce shortages, (2) insufficient health care worker knowledge (3) multiple implementing partners with competing priorities (4) drug and documentation form stockouts. HCWs employed various implementation strategies to overcome challenges, including task shifting from nurses to HIV testing providers, patient flow modifications (e.g., fast-tracking PrEP clients to reduce wait times), PrEP demand generation and myth clarification during health talks, provider education, dedicated PrEP delivery rooms, and coordination with adolescent-friendly services. Additional suggested strategies to improve PrEP integration included community education to increase broader PrEP awareness and enable shorter counseling sessions, and task-shifting data entry and client risk assessments.

Conclusions

HCWs were enthusiastic about the appropriateness and acceptability of integrating PrEP services into MCH and FP clinics but noted challenges to adoption and feasibility. Strategies to address challenges focused on improving provider time and space constraints, and increasing provider and client knowledge.

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

✪ Selecting implementation strategies to improve implementation of integrated PrEP for pregnant and postpartum populations in Kenya: a sequential explanatory mixed methods analysis

Authors:

Sarah Hicks, Ben Odhiambo, Felix Abuna, Julia C. Dettinger, Nancy Ngumbau, Laurén Gómez, Joseph Sila, George Oketch, Enock Sifuna, Bryan J. Weiner, Grace John-Stewart, John Kinuthia & Anjuli D. Wagner

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: August 2023

Read the full text in the open access journal Implementation Science Communications

Abstract:

Background

There is a higher risk for HIV acquisition during pregnancy and postpartum. Pre-exposure prophylaxis (PrEP) is recommended during this period for those at high risk of infection; integrated delivery in maternal and child health (MCH) clinics is feasible and acceptable but requires implementation optimization.

Methods

The PrEP in Pregnancy, Accelerating Reach and Efficiency study (PrEPARE; NCT04712994) engaged stakeholders to prioritize determinants of PrEP delivery (using Likert scores) and prioritize PrEP delivery implementation strategies. Using a sequential explanatory mixed methods design, we conducted quantitative surveys with healthcare workers at 55 facilities in Western Kenya and a stakeholder workshop (including nurses, pharmacists, counselors, and county and national policymakers), yielding visual plots of stakeholders’ perceived feasibility and effectiveness of the strategies. A stepwise elimination process was used to identify seven strategies for empirical testing. Facilitator debriefing reports from the workshop were used to qualitatively assess the decision-making process.

Results

Among 146 healthcare workers, the strongest reported barriers to PrEP delivery were insufficient providers and inadequate training, insufficient space, and high volume of patients. Sixteen strategies were assessed, 14 of which were included in the final analysis. Among rankings from 182 healthcare workers and 44 PrEP policymakers and implementers, seven strategies were eliminated based on low post-workshop ranking scores (bottom 50th percentile) or being perceived as low feasibility or low effectiveness for at least 50% of the workshop groups. The top seven strategies included delivering PrEP within MCH clinics instead of pharmacies, fast-tracking PrEP clients to reduce waiting time, delivering PrEP-related health talks in waiting bays, task shifting PrEP counseling, task shifting PrEP risk assessments, training different providers to deliver PrEP, and retraining providers on PrEP delivery. All top seven ranked strategies were grouped into bundles for subsequent testing. Facilitator debriefing reports generally aligned with rankings but noted how stakeholders’ decision-making changed when considering the impact of strategies on facility staff and non-PrEP clients.

Conclusions

The most impactful barriers to integrated PrEP delivery in MCH clinics were insufficient staffing and space. Implementation strategies prioritized through multiple methods of stakeholder input focused on co-location of services and increasing clinic efficiency. Future testing of these stakeholder-prioritized strategy bundles will be conducted to assess the effectiveness and implementation outcomes.

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

✪ Comparison of methods to engage diverse stakeholder populations in prioritizing PrEP implementation strategies for testing in resource-limited settings: a cross-sectional study

Authors:

Sarah Hicks, Felix Abuna, Ben Odhiambo, Julia C. Dettinger, Nancy Ngumbau, Laurén Gómez, Joseph Sila, George Oketch, Enock Sifuna, Bryan J. Weiner, Grace C. John-Stewart, John Kinuthia & Anjuli D. Wagner

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: July 2023

Read the full text in the open access journal Implementation Science Communications

Abstract:

Background

There is a lack of consensus about how to prioritize potential implementation strategies for HIV pre-exposure prophylaxis (PrEP) delivery. We compared several prioritization methods for their agreement and pragmatism in practice in a resource-limited setting.

Methods

We engaged diverse stakeholders with clinical PrEP delivery and PrEP decision-making experience across 55 facilities in Kenya to prioritize 16 PrEP delivery strategies. We compared four strategy prioritization methods: (1) “past experience surveys” with experienced practitioners reflecting on implementation experience (N = 182); (2 and 3) “pre- and post-small-group ranking” surveys before and after group discussion (N = 44 and 40); (4) “go-zone” quadrant plots of perceived effectiveness vs feasibility. Kendall’s correlation analysis was used to compare strategy prioritization using the four methods. Additionally, participants were requested to group strategies into three bundles with up to four strategies/bundle by phone and online survey.

Results

The strategy ranking correlation was strongest between the pre- and post-small-group rankings (Tau: 0.648; p < 0.001). There was moderate correlation between go-zone plots and post-small-group rankings (Tau: 0.363; p = 0.079) and between past-experience surveys and post-small-group rankings (Tau: 0.385; p = 0.062). For strategy bundling, participants primarily chose bundles of strategies in the order in which they were listed, reflecting option ordering bias. Neither the phone nor online approach was effective in selecting strategy bundles. Participants agreed that the strategy ranking activities conducted during the workshop were useful in prioritizing a final set of strategies.

Conclusions

Both experienced and inexperienced stakeholder participants’ strategy rankings tended to prioritize strategies perceived as feasible. Small group discussions focused on feasibility and effectiveness revealed moderately different priorities than individual rankings. The strategy bundling approach, though less time- and resource-intensive, was not effective. Future research should further compare the relative effectiveness and pragmatism of methodologies to prioritize implementation strategies.

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

✪ Online HIV prophylaxis delivery: Protocol for the ePrEP Kenya pilot study

Authors:

Catherine Kiptinness, Paulami Naik, Nicholas Thuo, Rachel C. Malen, Julia C. Dettinger, Jillian Pintye, Maeve Rafferty, Edwin Jomo, Nicky Nyamasyo, Tony Wood, Paul Isabelli, Sarah Morris, David Hattery, Andy Stergachis, Daniel Were, Monisha Sharma, Kenneth Ngure, Melissa Latigo Mugambi, and Katrina F. Ortblad

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2023

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

Abstract:

Background

Online pharmacies in Kenya provide sexual and reproductive health products (e.g., HIV self-testing, contraception) and could be leveraged to increase the reach of HIV pre-exposure and post-exposure prophylaxis (PrEP/PEP) to populations who do not frequently attend health facilities. To date, evidence is limited for operationalizing online PrEP/PEP delivery and the type of populations reached with this differential service delivery model.

Methods

The ePrEP Kenya Pilot will deliver daily oral PrEP and PEP via MYDAWA, a private online pharmacy retailer, to clients in Nairobi for 18 months. Potential clients will obtain information about PrEP/PEP on MYDAWA's sexual wellness page and self-screen for HIV risk. Individuals ≥18 years, identified as at HIV risk, and willing to pay for a blood-based HIV self-test and PrEP/PEP delivery will be eligible for enrollment. To continue with online PrEP/PEP initiation, eligible clients will purchase a blood-based HIV self-test for 250 KES (~USD 2) [delivered to their setting of choice for 99 KES (~USD 1)], upload an image of their self-test result, and attend a telemedicine visit with a MYDAWA provider. During the telemedicine visit, providers will screen clients for PrEP/PEP eligibility, including clinical concerns (e.g., kidney disease), discuss self-test results, and complete counseling on PrEP/PEP use and safety. Providers will refer clients who self-test HIV positive or report any existing medical conditions to the appropriate services at healthcare facilities that meet their preferences. Eligible clients will be prescribed PrEP (30-day PrEP supply at initiation; 90-day PrEP supply at follow-up visits) or PEP (28-day supply) for free and have it delivered for 99 KES (~USD 1). We will measure PrEP and PEP initiation among eligible clients, PEP-to-PrEP transition, PrEP continuation, and implementation outcomes (e.g., feasibility, acceptability, and costs).

Discussion

Establishing pathways to increase PrEP and PEP access is crucial to help curb new HIV infections in settings with high HIV prevalence. The findings from this study will provide evidence on the implementation of online pharmacy PrEP and PEP service delivery that can help inform guidelines in Kenya and similar settings.

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

✪ Risk-based versus universal PrEP delivery during pregnancy: a cluster randomized trial in Western Kenya from 2018 to 2019

Authors:

John Kinuthia, Julia C. Dettinger, Joshua Stern, Nancy Ngumbau, Ben Ochieng, Laurén Gómez, Felix Abuna, Salphine Watoyi, Mary Marwa, Daniel Odinga, Anjuli D. Wagner, Barbra A. Richardson, Jillian Pintye, Jared M. Baeten & Grace John-Stewart

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2023

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

Abstract:

Introduction

Integrating pre-exposure prophylaxis (PrEP) delivery for pregnant and postpartum women within maternal and child health (MCH) clinics is feasible and acceptable. It is unknown whether a risk-guided model would facilitate appropriate PrEP use among MCH attendees better than universally offering PrEP.

Methods

The PrEP Implementation for Mothers in Antenatal Care (PrIMA) study was a cluster randomized trial to assess two models for PrEP delivery among pregnant women seeking routine MCH care at 20 public clinics in Kenya between January 2018 and July 2019 (NCT03070600). In the Universal arm, all participants received PrEP counselling and self-selected whether to initiate PrEP. In the Targeted arm, participants underwent an HIV risk assessment, including an objective risk-scoring tool and an offer of HIV self-tests for at-home partner testing; those determined to be at high risk received a PrEP offer. Participants were followed through 9 months postpartum. Primary outcomes included incident HIV and appropriate PrEP use (defined as PrEP uptake among those at high risk and no PrEP uptake for those not at risk). Outcomes were compared using intention-to-treat analyses, adjusting for baseline HIV risk and marital status.

Results

Among 4447 women enrolled, the median age was 24.0 years (interquartile range [IQR]: 20.9, 28.3), and most were married (84.8%). The median gestational age at enrolment was 24 weeks (IQR: 20, 30). Women in the Targeted arm were more likely to be at high risk for HIV acquisition at baseline (51.6% vs. 33.3%). During 4638 person-years (p-yr) of follow-up, there were 16 maternal HIV infections with no difference in maternal HIV incidence between arms: 0.31/100 p-yr (95% CI: 0.15, 0.65) Targeted and 0.38/100p-yr (95% CI: 0.20, 0.73) Universal (adjusted relative risk [aRR]: 0.85 [CI: 0.28, 2.55]). There was no significant difference in the frequency of appropriate PrEP use between the arms (68.2% vs. 59.1% in Targeted vs. Universal, respectively) (aRR: 1.03 [CI: 0.96, 1.10]).

Conclusions

Given comparable maternal HIV incidence and PrEP uptake in Universal and Targeted approaches, and the simplicity that universal PrEP offers, our findings suggest that universal PrEP counselling is optimal for integrating PrEP in MCH systems.

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