Ortblad Team

Ortblad Team

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Pharmacy PrEP Delivery

Two photos, first photo man standing outside pharmacy entrance, second photo: Sanaa pharmacy in Juja, Kiambu County, Kenya.

Left: Dr. Laban standing outside his pharmacy 'MediHelp' in Kiambu County, Kenya. Right: Sanaa pharmacy in Juja, Kiambu County, Kenya.

Photos by Fred Hutch. All pharmacy providers gave us permission to use these images.
Graphic of the Pharm PrEP cluster-randomized trial

Fig. 1. The design of the Pharm PrEP cluster-randomized trial testing different economic incentives for pharmacy-delivered PrEP services.

Pharm PrEP Trial

01/01/22-11/14/25
BMGF INV-033052, PI: K Ortblad (Hutch); Kenyan PIs: E Bukusi (KEMRI), K Ngure (JKUAT)
Project Directors: D Were (Jhpiego), C Kiptinness (PHRD), V Omollo (KEMRI), S Roche (Hutch); Project Coordinators: T Kareithi (PHRD), K Harkey (Hutch)

Our formative research and pilot studies suggest that the success and sustainability of pharmacy-delivered PrEP services in Kenya will hinge, in part, on identifying a financial model in which pharmacy providers are sufficiently incentivized to deliver services and clients in need of PrEP services are able to afford services. In a hybrid cluster-randomized trial we will compare two different cost-sharing models and also compare each cost-sharing model to a control scenario in which pharmacies refer clients interested in PrEP to healthcare facilities (thus mimicking the current standard of care at private pharmacies in Kenya). Specifically, we will randomize 60 pharmacies spread across Nairobi, Kiambu, Kisumu, Homa Bay, Migori, and Siaya counties to one of four study arms: 1)  pharmacy-delivered PrEP for a fee paid by clients at each visit; 2) pharmacy-delivered PrEP for free (at no costs to clients; per-visit fee paid by implementors); 3) pharmacy-delivered PrEP with an HIV Testing Services (HTS) counselor to assist with the more time-consuming parts of PrEP delivery (e.g., recruitment, counseling, and HIV testing; and 4] pharmacy provider referral to facility-based PrEP services (with pharmacies receiving a small incentive to screen and refer clients), (Fig. 1).

Our primary effectiveness outcomes will be PrEP initiation and continuation by 60 days. In secondary analyses, we will measure longer-term PrEP continuation outcomes (e.g., continuation by 270 days; stopping and restarting PrEP). We will also assess implementation outcomes, including acceptability, appropriateness, feasibility, and costs. We hypothesize that PrEP initiation and PrEP continuation at 60 days will be greater in private pharmacies that offer the service for free (at no cost to clients) compared to those that offer it for a fee paid by clients. We also anticipate that, regardless of whether clients pay a fee, capacitating pharmacy providers to deliver PrEP will result in greater PrEP initiation and continuation compared to a scenario where they refer clients seeking PrEP services to public health facilities. 

Publications

  1. Roche S, Omollo V, Kiptinness C, Were D, Ongwen P, Venter F, Crawford N, Tung E, Pintye J, Baeten JM, Bukusi E, Ngure K, Ortblad KF. Getting HIV pre-exposure prophylaxis (PrEP) into pharmacies: global delivery models and research directions. Curr HIV/AIDS Rep. 2024; 22:1-5. [commentary]. PMCID: 11129962.

Select conference presentations

  1. Ong’wen P, Roche S, Omollo V, Kareithi T, Juma L, Kiptinness C, Otieno P, Rota G, Anyona M, Banerjee P, Asewe M, Rono B, Gichuru E, Harkey K, Malen R, Irungu E, Were D, Bukusi EA, Ngure K, Ortblad KF. Uptake of HIV Post-Exposure Prophylaxis (PEP) in private retail pharmacies in Kenya: Early findings from the Pharm PrEP study. Oral presentation at AIDS 2024: 25th International AIDS Conference, Munich, Germany, July 22-26, 2024.
  2. Roche SD, Omollo V, Kareithi T, Ong’wen P, Juma L, Kiptinness C, Otieno, Rota G, Anyona M, Banerjee P, Asewe M, Rono B, Gichuru E, Harkey K, Malen RC, Odoyo J, Were D, Bukusi EA, Ngure K, Ortblad KF. Uptake of HIV pre-exposure prophylaxis at private pharmacies in Kenya: Early findings from a cluster randomized controlled trial. Poster presentation at AIDS 2024: 25th International AIDS Conference, Munich, Germany, July 22-26, 2024.
  3. Anyona M^*, Rota G, Gathii P, Ong’wen P, Omollo V, Kareithi T, Roche SD, Bukusi EA, Ngure KN, Ortblad KF, Were D. Public-private partnerships for the delivery of oral HIV pre- and post-exposure prophylaxis: Lessons learned from an implementation study in Kenya. Poster presentation at AIDS 2024: 25th International AIDS Conference, Munich, Germany, July 22-26, 2024.

 

Pharm PrEP Pilot [completed]

08/01/19-06/30/21
NIH R34 MH120106, PI: K Ortblad (Hutch), Kenyan PIs: K Ngure (JKUAT), E Bukusi (KEMRI)
Project Directors: P Mogere (PHRD), V Omollo (KEMRI)

The delivery of HIV pre-exposure prophylaxis (PrEP) at private pharmacies has the potential to overcome barriers to facility-delivered PrEP services, including HIV-associated stigma, long wait times, and overcrowding. In collaboration with Kenyan stakeholders, we developed a model of private pharmacy-delivered PrEP services—one of the first of its kind to be implemented in Africa—that utilizes a standardized prescribing checklist to identify individuals at HIV risk without any medical conditions that might contraindicate PrEP safety and to guide PrEP dispensing (Fig. 2). In a one-arm intervention trial (ClinicalTrials.gov: NCT04558554), we pilot tested this model for 12 months (November 2019 to December 2021) at four pharmacies in Kiambu County (in central Kenya) and Kisumu County (in western Kenya) and measured PrEP initiation, continuation, and implementation outcomes, such as acceptability and cost.  

Care pathway for pharmacy-delivered PrEP services in Kenya

Fig. 2. Care pathway for pharmacy-delivered PrEP services in Kenya (Ortblad KF, BMC Health Serv Res 2020).

Publications

  1. Ortblad KF, Mogere P, Omollo V, Kuo A, Asewe M, Gauko S, Roche S, Mugambi M, Mugambi ML, Stergachis A, Odoyo J, Bukusi E, Ngure K, Baeten JM. Stand-alone model for delivery of oral HIV pre-exposure prophylaxis in Kenya: a single-arm, prospective pilot evaluation. J Int AIDS Soc. 2023; 26(6):e26121. [original work]. PMCID: 10258863.
  2. Omollo V^, Asewe M, Mogere P, Maina G, Kuo AP, Odoyo J, Oware K, Baeten JM, Kohler P, Owens T, Bukusi EA, Ngure K, Ortblad KF. The fidelity of a pharmacy-based oral HIV pre-exposure prophylaxis delivery model in Kenya. J Acquir Immune Defic Syndr. 2023; in press. [original work].
  3. Roche S^, Wairimu N, Mogere P, Kamolloh K, Odoyo J, Kwena Z, Bukusi E, Ngure K, Baeten J, Ortblad KF. Acceptability and feasibility of pharmacy-based delivery of preexposure prophylaxis in Kenya: a qualitative study of client and provider perspectives on PrEP scale-out. AIDS Behav. 2021;25(12):3871-3882. [original work]. PMCID: 8602157.
  4. Ortblad KF, Mogere P, Roche S, Kamolloh K, Odoyo J, Irungu E, Mugo N, Pintye J, Baeten J, Bukusi E, Ngure K. Design of a care pathway for pharmacy-based PrEP delivery in Kenya: results for a collaborative stakeholder consultation. BMC Health Serv Res. 2020;20(1):1034. [original work]. PMCID: 7661206.
  5. Ortblad KF, Mogere P, Bukusi E, Ngure K, Baeten JM. Pharmacy delivery to expand the reach of PrEP in Africa. J Int AIDS Soc. 2020;23(9):e25619. [viewpoint]. PMCID: 7525802.

Select conference presentations

  1. Kuo AP^, Ekwunife O, Mogere P, Omollo V, Odoyo J, Chen Y, Baeten JM, Bukusi E, Ngure K, Ortblad KF, Sharma M. Costs of providing pharmacy-initiated PrEP in Kenya: findings from a pilot study. Poster presentation at CROI 2023: 30th Conference on Retroviruses and Opportunistic Infections, Seattle, USA, February 19-22, 2023. #1090.
  2. Omollo V^, Asewe M, Mogere P, Gakuo S, Kuo A, Odoyo J, Baeten JM, Kohler P, Owens T, Bukusi E, Ngure K, Ortblad KF. The fidelity of a pharmacy-based PrEP delivery model in Kenya: an unannounced standardized patient actor assessment. E-poster presentation at AIDS 2022: 24th International AIDS Conference, Montreal, Canada, July 29 – August 2, 2022.
  3. Mogere P^, Omollo V, Kuo A, Asewe M, Gakuo S, Odoyo J, Roche S, Baeten JM, Bukusi E, Ngure K, Ortblad KF. The acceptability of pharmacy-based HIV PrEP delivery among retail pharmacy clients in Kenya: findings from a pilot study. E-poster presentation at AIDS 2022: 24th International AIDS Conference, Montreal, Canada, July 29 – August 2, 2022.
  4. Ortblad KF, Mogere P, Omollo V, Kuo A, Asewe M, Gakuo S, Mugambi M, Stergachis A, Odoyo J, Bukusi E, Ngure K, Baeten JM. Pharmacy-based PrEP initiation and continuation in Kenya: findings from a pilot study. Poster presentation at CROI 2022: 22nd Conference on Retroviruses and Opportunistic Infections, Virtual, February 12-16, 2022. Abstract 00928.
  5. Nakambale H^, Mogere P, Omollo V, Kuo AP, Baeten JM, Bukusi E, Ngure K, Ortblad KF, Mugambi M. What are the barriers to and provider-developed strategies for early implementation of pharmacy-delivered PrEP services in Kenya? A qualitative study. Poster presentation at D&I 2021: 14th Annual Conference on the Science of Dissemination and Implementation in Health, Virtual, December 14-16, 2021. Abstract 48425.
  6. Asewe M^, Omollo V, Mogere P, Kamolloh K, Odoyo J, Baeten JM, Ngure K, Bukusi E, Ortblad KF. HIV risk behaviors among retail pharmacy clients seeking sexual and reproductive health services in Kenya. On-demand oral presentation at IAS 2021: 11th IAS Conference on HIV Science, Virtual, July 18-21, 2021. Abstract 01888.
  7. Ortblad KF, Mogere P, Roche S, Kamolloh K, Odoyo J, Irungu E, Mugo N, Baeten JM, Bukusi E, Ngure K. Design of a care pathway for pharmacy-based PrEP delivery in Kenya: results from a collaborative stakeholder consultation. Poster presentation at HIVR4P 2021: 4th HIV Research for Prevention Conference, Virtual, January 27-28 and February 3-4, 2021. Abstract 755.
  8.  Roche S^, Ortblad KF, Wairimu N, Mogere P, Kamolloh K, Odoyo J, Kwena Z, Bukuisi E, Ngure K, Baeten J. The feasibility and acceptability of pharmacy-based PrEP delivery in Kenya. Oral presentation at Adherence 2020: 15th International Conference on HIV Treatment and Prevention Adherence, Virtual November 2-3, 2020. Abstract 1072.
  9. Ortblad KF, Roche S, Wairimu N, Mogere P, Kamolloh K, Odoyo J, Kwena Z, Bukuisi E, Baeten J, Ngure K. Client perspectives on the relative advantages of pharmacy-based versus facility-based PrEP delivery in Kenya. Oral presentation at Adherence 2020: 15th International Conference on HIV Treatment and Prevention Adherence, Virtual, November 2-3, 2020. Abstract 1069.

Select invited presentations

  1. Ortblad KF. Lessons from global research in pharmacy-based HIV service delivery, US National Institute of Health (NIH), Meeting on “Pharmacy-centered HIV prevention and care: current landscape and future research frontiers”. Virtual, June 28-29, 2023
  2. Ortblad KF, Pharmacy delivery to expand the reach of PrEP in the USA and Africa. International Pharmaceutical Federation (FIP), World AIDS Day Webinar. Virtual, December 2021.

Pharm PrEP Pilot Extension [completed]  

01/31/21-7/31/21
BMGF INV-033052, PI: K Ortblad (Hutch); Kenyan PIs: K Ngure (JKUAT), E Bukusi (KEMRI)
Project Directors: D Were (Jhpiego), S Roche (Hutch); Project Coordinators: P Mogere (PHRD), V Omollo (KEMRI)

Following the initial Pharm PrEP Pilot Study, we modified the model of pharmacy-delivered PrEP services to address delivery challenges and potential missed opportunities. Specifically, we made one adaptation to the intervention (switching from oral fluid-based to blood-based HIV testing), and we incorporated six implementation strategies in an effort to improve PrEP uptake (Fig. 3). Beginning in January 2022,  we implemented this model for six months in 12 pharmacies (six in Kiambu County and six in Kisumu County). Enrollment ended on July 31, 2022 and analysis is ongoing. In this study, we are measuring PrEP and PEP initiation, PrEP continuation, PEP-to-PrEP transition rate, PrEP adherence, as well as a number of implementation outcomes, including acceptability, feasibility, and cost.

Pharmacy PrEP Pilot Extension care pathway graphic

Fig 3. Pharmacy PrEP Pilot Extension care pathway with new implementation strategies.

Select conference presentations

  1. Roche S, Omollo V, Mogere P, Asewe M, Gakuo G, Banerjee P, Harkey K, Odoyo J, Ongwen P, Were D, Ngure K, Bukusi E, Ortblad KF. Themed discussion at Pharmacy-based PrEP delivery in Kenya: findings from a pilot study extension. CROI 2023: 30th Conference on Retroviruses and Opportunistic Infections, Seattle, USA, February 19-22, 2023. #978.
  2. Omollo V^*, Roche S, Mogere P, Ongwen P, Asewe M, Banjeree P, Mania G, Malen R, Odoyo J, Were D, Bukusi E, Ngure K, Ortblad KF. PrEP continuation among pharmacy clients formerly engaged in PrEP services at private pharmacies participating in a pilot study in Kenya. Poster presentation at IAS 2023: 12th IAS Conference on HIV Science, Brisbane, Australia, July 23-26, 2023. Abstract MOPEC19.
  3. Ekwunife O^, Kuo A, Banerjee P, Kiptinness C, Omollo V, Chen Y, Roche S, Odoyo J, Bukusi E, Ngure K, Sharma M, Ortblad KF. Understanding the cost of pharmacy-delivered HIV pre-and post-exposure prophylaxis service delivery in Kenya: findings from a pilot study. E-poster presentation at IAS 2023: 12th IAS Conference on HIV Science, Brisbane, Australia, July 23-26, 2023. Abstract EPE0887.
  4. Roche S, Omollo V, Mogere P, Asewe M, Gakuo S, Banerjee P, Harkey K, Odoyo J, Ongwen P, Were D, Bukusi E, Ortblad KF, Ngure K. Anticipated preferences for long-acting HIV pre-exposure prophylaxis among current oral PrEP users at pharmacies: finding from a pilot study extension. IAS 2023: 12th IAS Conference on HIV Science, Brisbane, Australia, July 23-26, 2023. Abstract OAE0102. [WINNER: IAS/ANRS Lange/van Tongeren Prize for Young Investigators]
Pharmacy-delivered PrEP refill model

Fig. 4. The design of the pharmacy-delivered PrEP refill model.

Pharm PrEP Refill Pilot [completed]  

02/15/19-02/14/22
NIH P30 AI027757, PI: K Ortblad (Hutch), Kenyan PI: K Ngure (JKUAT)
Project Coordinators: A Kuo (UW), P Mogere (PHRD)

Compared to PrEP initiation, PrEP refilling is a less-complicated medical intervention; thus, we wanted to test a model of facility-based PrEP initiation in which clients had the option to refill their PrEP prescriptions at private pharmacies. Our goal was to understand preferences for PrEP refilling location within this client population and to assess the feasibility of pharmacy-delivered PrEP refills, for which pharmacy providers only needed to assess returning clients for potential PrEP side effects and HIV breakthrough infections. From November 2020 to December 2021, we tested this model (Fig. 4) in Kiambu County, Kenya at two public health facilities, each paired with a study pharmacy for the purposes of this study. Clients ≥18 years old who initiated PrEP at one of the two facilities were eligible to participate. Among those who initiated PrEP, we measured whether and where (healthcare facility or pharmacy) clients refilled PrEP at 1, 4 and 7 months and their preferred PrEP refill location. Additionally, we conducted qualitative interviews with clients who did not opt to refill their PrEP prescription at a private pharmacy to understand what drove this decision (e.g., considerations of cost, burden). The results of this study are forthcoming.

Publications

  1. Ortblad KF, Kuo AP, Mogere P, Kiptinness C, Roche S, Wairimu N, Gakuo S, Baeten JM, Ngure K. Low selection of HIV PrEP refills at private pharmacies among clients who initiated PrEP at public clinics: findings from a mixed-methods study in Kenya. BMC Health Serv. Res. 2024;24(1):618 [pilot study]. PMCID: 11088131.

Select conference presentations

  1. Mogere P^*, Kuo AP, Gakuo S, Wairimu N, Roche S, Mugambi M, Baeten JM, Ngure K, Ortblad KF. Client preferences for PrEP refills at facilities versus pharmacies: a pilot in Kenya. Poster presentation at CROI 2023: 30th Conference on Retroviruses and Opportunistic Infections, Seattle, USA, February 19-22, 2023. Abstract 1091.

Pharmacy-delivered long-acting PrEP: Formative research [completed]

12/1/2022 – 11/30/2024
BMGF INV-041269, Co-PI: K Ortblad (Hutch), Kenyan Co-PI: E Bukusi (KEMRI), Site PIs: K Ngure (JKUAT), V Omollo (KEMRI)
Project Managers: R Malen (Hutch); Project Coordinators: T Kareithi (PHRD), K Harkey (Hutch)

New, long-acting (LA) forms of pre-exposure prophylaxis (PrEP) for HIV prevention—including the monthly dapivirine vaginal ring (DPV-VR] and bimonthly cabotegravir (CAB-LA) injections—are discreet, safe, and highly efficacious alternatives to daily oral PrEP. Early evidence suggests that prospective LA PrEP clients are interested in accessing these products at private pharmacies; however, little is known about whether and how LA PrEP could be feasibly implemented in this delivery setting. To identify potential barriers to implementing LA PrEP delivery in private pharmacies in Kenya and possible ways to address these, we conducted in-depth interviews with (1) current and former PrEP users, some of whom had prior experience accessing oral PrEP at private pharmacies (n=15) and some of whom had only ever accessed it at a public health facility (n=8); (2) pharmacy providers, some of whom had prior experience delivering oral PrEP at their pharmacy (n=8) and some without such experience (n=8); and (3) key stakeholders from PrEP policymaking and regulatory bodies, implementing organizations, and professional pharmacy associations (n=9). Interviewees discussed their interest in or support for the idea of private pharmacies delivering LA PrEP and identified gaps—for example, in policy, regulatory practices, and pharmacy provider competencies—that they felt would need to be addressed for this to become a reality in Kenya. Preliminary findings from this formative research were presented at a stakeholder meeting, held in Nairobi in September 2023. Meeting attendees discussed the identified barriers and potential solutions, provided feedback on a prototype care pathway for delivering LA PrEP at private pharmacies, and brainstormed next steps for generating evidence that could potentially inform future LA PrEP policy and roll-out. 

Select conference presentations

  1. Roche SD, Kamolloh K, Thuo N, Opiyo M, Ogello V, Odira A, Owidi E, Ochwal P, Hewa M, Adiema L, Mogaka F, Omollo V, Malen RC, Harkey K, Stewart J, Bukusi EA, Ortblad KF, Ngure K. Pharmacy-based delivery of long-acting injectable PrEP in Kenya: Provider, client, and key stakeholder perspectives on potential challenges and opportunities. Oral presentation at AIDS 2024: 25th International AIDS Conference, Munich, Germany, July 22-26, 2024.

Abbreviations:
JKUAT: Jomo Kenyatta University
KEMRI: Kenya Medical Research Institute
PHRD: Partners in Health & Research Development
UW: University of Washington 

^Ortblad mentee or team member

^* With mentored Kenyan research team member as lead author

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