Skip to content

✪ 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**

✪ Characterizing provider-led adaptations to mobile phone delivery of the Adolescent Transition Package (ATP) in Kenya using the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS): a mixed methods approach

Authors:

Dorothy Imbuka Mangale, Alvin Onyango, Cyrus Mugo, Caren Mburu, Nok Chhun, Dalton Wamalwa, Irene Njuguna, Arianna Rubin Means, Grace John-Stewart, Bryan J. Weiner & Kristin Beima-Sofie

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 Communication

Abstract:

Background

The COVID-19 pandemic resulted in disruptions to routine HIV services for youth living with HIV (YLH), provoking rapid adaptation to mitigate interruptions in care. The Adolescent Transition to Adult Care for HIV-infected adolescents (ATTACH) study (NCT03574129) was a hybrid I cluster randomized trial testing the effectiveness of a healthcare worker (HCW)-delivered disclosure and transition intervention — the Adolescent Transition Package (ATP). During the pandemic, HCWs leveraged phone delivery of the ATP and were supported to make adaptations. We characterized real-time, provider-driven adaptations made to support phone delivery of the ATP.

Methods

We conducted continuous quality improvement (CQI) meetings with HCWs involved in phone delivery of the ATP at 10 intervention sites. CQI meetings used plan-do-study-act (PDSA) cycles and were audio-recorded. Adaptations were coded by two-independent coders using the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS). Adaptation testing outcomes (adopt, retest, or abandon) and provider experience implementing the adaptations were also recorded. We summarized adaptation characteristics, provider experience, and outcomes.

Results

We identified 72 adaptations, 32 were unique. Overall, adaptations included modification to context (53%, n = 38), content (49%, n = 35), and evaluation processes (13%, n = 9). Context adaptations primarily featured changes to personnel, format, and setting, while content and evaluation adaptations were frequently achieved by simple additions, repetition, and tailoring/refining of the phone delivery strategy. Nine adaptations involved abandoning, then returning to phone delivery. HCWs sought to increase reach, improve fidelity, and intervention fit within their context. Most adaptations (96%, n = 69) were perceived to increase the feasibility of phone delivery when compared to before the changes were introduced, and HCWs felt 83% (n = 60) of adaptations made phone delivery easier. Most adaptations were either incorporated into routine workflows (47%) or tested again (47%).

Conclusion

Adaptation of phone delivery was a feasible and effective way of addressing challenges with continuity of care for YLH during the COVID-19 pandemic. Adaptations were primarily context adaptions. While FRAME-IS was apt for characterizing adaptations, more use cases are needed to explore the range of its utility.

Trial registration

Trial registered on ClinicalTrial.gov as NCT03574129.

**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**

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

From research to international scale-up: stakeholder engagement essential in successful design, evaluation and implementation of paediatric HIV testing intervention

Authors:

Cyrus Mugo, Irene Njuguna, Margaret Nduati, Vincent Omondi, Verlinda Otieno, Florence Nyapara, Elizabeth Mabele, Hellen Moraa, Kenneth Sherr, Irene Inwani, Elizabeth Maleche-Obimbo, Dalton Wamalwa, Grace John-Stewart, Jennifer Slyker, Anjuli D Wagner

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: September 2020

Read the full text in the subscription access journal Health Policy and Planning

✪ Defining gaps in pre-exposure prophylaxis delivery for pregnant and post-partum women in high-burden settings using an implementation science framework

Authors:

Jillian Pintye, Dvora L. Joseph Davey, Anjuli D. Wagner, Grace John-Stewart, Rachel Baggaley, Linda-Gail Bekker, Connie Celum, Benjamin H. Chi, Thomas J. Coates, Allison K. Groves, Jessica E. Haberer, Renee Heffron, John Kinuthia, Lynn T. Matthews, James A. McIntyre, Dhayendre Moodley, Lynne M. Mofenson, Nelly Mugo, Andrew Mujugira, Landon Myer, Steven Shoptaw, Lynda Stranix-Chibanda, Jared M. Baeten, for the PrEP in Pregnancy Working Group

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: August 2020

Read the full text open access in the subscription access journal The Lancet: HIV

Use of the Consolidated Framework for Implementation Research (CFIR) to Characterize Healthcare Workers’ Perspectives on Financial Incentives to Increase Pediatric HIV Testing

Authors:

Dana Atkins, Anjuli D. Wagner, Junyi Zhang, Irene N. Njuguna, Jillian Neary, Vincent O. Omondi, Verlinda A. Otieno, Kenneth Ondeng'e, Dalton C. Wamalwa, Grace John-Stewart, Jennifer A. Slyker, and Kristin Beima-Sofie

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: May 2020

Read the full text in the subscription access journal JAIDS

Cascade Analysis: An Adaptable Implementation Strategy Across HIV and Non-HIV Delivery Platforms

Anjuli D. Wagner, Sarah Gimbel, Kristjana H. Ásbjörnsdóttir, Peter Cherutich, Joana Coutinho, Jonny Crocker, Emiliae Cruz, Fatima Cuembelo, Vasco Cumbe, McKenna Eastment, Jennifer Einberg, Florencia Floriano, Douglas Gaitho, Brandon L. Guthrie, Grace John-Stewart, Alex H. Kral, Barrot H. Lambdin, Shan Liu, Martin Bcom Maina, Nelia Manaca, Mika Matsuzaki, Loris Mattox, Nancy Mburu, R. Scott McClelland, Mark A. Micek, Ana Olga Mocumbi, Albertoe Muanido, Ruth Nduati, Irene N. Njuguna, Geoffrey Oluoch, Laura B. Oyiengo, Keshet Ronen, Caroline Soi, Bradley H. Wagenaar, George Wanje, Lynn D. Wenger, and Kenneth Sherr

University of Washington affiliated authors are displayed in bold.

Published: December 2019

Read the full text in the subscription access JAIDS: Journal of Acquired Immune Deficiency Syndromes

✪ Scaling-up the Systems Analysis and Improvement Approach for prevention of mother-to-child HIV transmission in Mozambique (SAIA-SCALE): a stepped-wedge cluster randomized trial

Authors:

Kenneth Sherr, Kristjana Ásbjörnsdóttir, Jonny Crocker, Joana Coutinho, Maria de Fatima Cuembelo, Esperança Tavede, Nélia Manaca, Keshet Ronen, Felipe Murgorgo, Ruanne Barnabas, Grace John-Stewart, Sarah Holte, Bryan J. Weiner, James Pfeiffer & Sarah Gimbel

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: April 2019

Read the full text in the open access journal Implementation Science

Abstract:

Background

The introduction of option B+ — rapid initiation of lifelong antiretroviral therapy regardless of disease status for HIV-infected pregnant and breastfeeding women — can dramatically reduce HIV transmission during pregnancy, birth, and breastfeeding. Despite significant investments to scale-up Option B+, results have been mixed, with high rates of loss to follow-up, sub-optimal viral suppression, continued pediatric HIV transmission, and HIV-associated maternal morbidity. The Systems Analysis and Improvement Approach (SAIA) cluster randomized trial demonstrated that a package of systems engineering tools improved flow through the prevention of mother-to-child HIV transmission (PMTCT) cascade. This five-step, facility-level intervention is designed to improve understanding of gaps (cascade analysis), guide identification and prioritization of low-cost workflow modifications (process mapping), and iteratively test and redesign these modifications (continuous quality improvement). This protocol describes a novel model for SAIA delivery (SAIA-SCALE) led by district nurse supervisors (rather than research nurses), and evaluation procedures, to serve as a foundation for national scale-up.

Methods

The SAIA-SCALE stepped wedge trial includes three implementation waves, each 12 months in duration. Districts are the unit of assignment, with four districts randomly assigned per wave, covering all 12 districts in Manica province, Mozambique. In each district, the three highest volume health facilities will receive the SAIA-SCALE intervention (totaling 36 intervention facilities). The RE-AIM framework will guide SAIA-SCALE’s evaluation. Reach describes the proportion of clinics and population in Manica province reached, and sub-groups not reached. Effectiveness assesses impact on PMTCT process measures and patient-level outcomes. Adoption describes the proportion of districts/clinics adopting SAIA-SCALE, and determinants of adoption using the Organizational Readiness for Implementing Change (ORIC) tool. Implementation will identify SAIA-SCALE core elements and determinants of successful implementation using the Consolidated Framework for Implementation Research (CFIR). Maintenance describes the proportion of districts sustaining the intervention. We will also estimate the budget and program impact from the payer perspective for national scale-up.

Discussion

SAIA packages user-friendly systems engineering tools to guide decision-making by frontline health workers, and to identify low-cost, contextually appropriate PMTCT improvement strategies. By integrating SAIA delivery into routine management structures, this pragmatic trial is designed to test a model for national intervention scale-up.

Trial Registration

ClinicalTrials.gov NCT03425136 (registered 02/06/2018).

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