Efficiency of 6-month PrEP dispensing with HIV self-testing in Kenya: an open-label, randomised, non-inferiority, implementation trial

Ngure, Kenneth; Ortblad, Katrina F; Mogere, Peter; Bardon, Ashley; Thomas, Katherine; Mangale, Dorothy I.; Kiptinness, Catherine; Gakuo, Stephen; Mbaire, Sarah; Nyokabi, Jacinta; Mugo, Nelly; Baeten, Jared M.

doi:10.1016/s2352-3018(22)00126-6

Cited by 34 publications

(24 citation statements)

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“…nurses vs. clinicians [7]) as well as when and where services are being delivered (e.g. quarterly vs. biannual clinic visits [8],…”

Section: Introductionmentioning

confidence: 99%

“…nurses vs. clinicians [ 7 ]) as well as when and where services are being delivered (e.g. quarterly vs. biannual clinic visits [ 8 ], or family planning vs. HIV clinics [ 9 ]). During the COVID‐19 pandemic, the importance and development of these models increased to maintain access to essential HIV prevention and treatment services during periods of lockdown; for example, mobile clinics delivered HIV testing and pre‐exposure prophylaxis (PrEP) directly to communities [ 10 , 11 ] and programmes for home delivery of HIV self‐tests [ 12 ] and antiretroviral therapy (ART) [ 13 ] were developed.…”

Section: Introductionmentioning

confidence: 99%

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The effectiveness, feasibility and acceptability of HIV service delivery at private pharmacies in sub‐Saharan Africa: a scoping review

et al. 2022

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Introduction: Private pharmacies are an understudied setting for differentiated delivery of HIV services that may address barriers to clinic-delivered services, such as stigma and long wait times. To understand the potential for pharmacy-delivered HIV services in sub-Saharan Africa, we conducted a scoping review of the published and grey literature. Methods: Using a modified Cochrane approach, we searched electronic databases through March 2022 and HIV conference abstracts in the past 5 years for studies that: (1) focused on the delivery of HIV testing, antiretroviral therapy (ART) and/or pre-exposure prophylaxis (PrEP) at private pharmacies in sub-Saharan Africa; (2) reported on effectiveness outcomes (e.g. HIV incidence) or implementation outcomes, specifically feasibility and/or acceptability; and (3) were published in English. Two authors identified studies and extracted data on study setting, population, design, outcomes and findings by HIV service type. Results and discussion: Our search identified 1646 studies. After screening and review, we included 28 studies: seven on HIV testing, nine on ART delivery and 12 on PrEP delivery. Most studies (n = 16) were conducted in East Africa, primarily in Kenya. Only two studies evaluated effectiveness outcomes; the majority (n = 26) reported on feasibility and/or acceptability outcomes. The limited effectiveness data (n = 2 randomized trials) suggest that pharmacy-delivered HIV services can increase demand and result in comparable clinical outcomes (e.g. viral load suppression) to standard-of-care clinic-based models. Studies assessing implementation outcomes found actual and hypothetical models of pharmacy-delivered HIV services to be largely feasible (e.g. high initiation and continuation) and acceptable (e.g. preferable to facility-based models and high willingness to pay/provide) among stakeholders, providers and clients. Potential barriers to implementation included a lack of pharmacy provider training on HIV service delivery, costs to clients and providers, and perceived low quality of care. Conclusions: The current evidence suggests that pharmacy-delivered HIV services may be feasible to implement and acceptable to clients and providers in parts of sub-Saharan Africa. However, limited evidence outside East Africa exists, as does limited evidence on the effectiveness of and costs associated with pharmacy-delivered HIV services. More research of this nature is needed to inform the scale-up of this new differentiated service delivery model throughout the region.

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“…nurses vs. clinicians [7]) as well as when and where services are being delivered (e.g. quarterly vs. biannual clinic visits [8],…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

The effectiveness, feasibility and acceptability of HIV service delivery at private pharmacies in sub‐Saharan Africa: a scoping review

et al. 2022

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“…The current proposed model refers AGYW to clinics, as that is where PrEP is primarily available in Kenya; however, to mitigate common access-to-care barriers faced by AGYW, implementers of this referral model may consider incorporating additional implementation strategies that could support follow-through on referrals, such as transportation vouchers ( 53 ), peer accompaniment to clinics ( 54 ), and linkages to PrEP programs, like DREAMS, that initiate and continue clients on PrEP in community-based safe spaces, outside of health facilities ( 55 ). Lastly, in addition to pilot testing this model and evaluating its acceptability, feasibility, and effect on HIVST and PrEP uptake, future research should explore variants of this model that may further reduce barriers to PrEP for AGYW, such as having peer providers distribute an initial supply of PrEP along with the HIVST kit ( 56 ) or refer peer clients to retail pharmacies that offer PrEP ( 57 – 59 ).…”

Section: Discussionmentioning

confidence: 99%

Assessing young Kenyan women's willingness to engage in a peer-delivered HIV self-testing and referral model for PrEP initiation: A qualitative formative research study

McGowan

Casmir

Wairimu

et al. 2022

Front. Public Health

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BackgroundPre-exposure prophylaxis (PrEP) is highly effective for HIV prevention, but uptake remains low, especially among adolescent girls and young women (AGYW) in Kenya. A model in which trained AGYW using PrEP deliver HIV self-tests to their close friends and refer them to PrEP may help increase PrEP uptake in this population. To understand AGYW's potential willingness to engage in such a model, we conducted a qualitative formative study in Kenya.MethodWe conducted semi-structured in-depth interviews (IDIs) with AGYW (16 to 24 years) in Kiambu County who were determined at risk of HIV acquisition. We purposively recruited “PrEP-naïve” (no prior PrEP use) and “PrEP-experienced” AGYW who used PrEP for at least 1 month within the previous year. We solicited perspectives on initiating/engaging in conversations about HIV risk and PrEP, distributing/receiving HIV self-test kits, and referring/following through on a referral to clinic-based HIV services. We analyzed verbatim transcripts using rapid qualitative analysis and a combination of inductive and deductive approaches, with the latter informed by the Integrated Behavior Model (IBM).ResultsFrom August to December 2020, we conducted 30 IDIs: 15 with PrEP-experienced and 15 with PrEP-naïve AGYW. Participants' median age was 20 [interquartile range (IQR): 20–22]. Overall, most participants anticipated that they would be willing to engage in this model. PrEP-experienced AGYW emphasized the salience of their concerns about friends' HIV risk behaviors, with several noting that they are already in the habit of discussing PrEP with friends. Many additionally expressed positive attitudes toward the proposed target behaviors, perceived these to be normative among AGYW, and expressed confidence in their ability to carry out the behaviors with proper support. Although few participants had HIVST experience, nearly all anticipated they would be able to use an HIV self-test kit correctly if provided instruction.ConclusionThe Kenyan AGYW who participated in this study generally anticipated that they would be willing to engage in a formal peer PrEP referral model enhanced with peer-delivered HIV self-tests. Future research is needed to pilot test this model to determine its acceptability, feasibility, and effect on HIVST and PrEP uptake within this population.

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“…HIV self-testing (HIVST) is a relatively new technology that has the potential to simplify and address barriers to clinic-delivered PrEP services. For example, HIVST could be used by clients while waiting to reduce their time spent at clinics or to replace clinic visits that are required for quarterly HIV testing . A recent systematic literature review on HIVST-supported models of PrEP delivery found that these models were largely perceived as feasible and acceptable among PrEP clinicians and clients, but robust evidence on their effectiveness was limited, and the limited effectiveness studies only measured short-term PrEP continuation outcomes (ie, engagement in care ≤6 months).…”

Section: Introductionmentioning

confidence: 91%

Effect of 6-Month HIV Preexposure Prophylaxis Dispensing With Interim Self-testing on Preexposure Prophylaxis Continuation at 12 Months

et al. 2023

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ImportanceDaily oral HIV preexposure prophylaxis (PrEP) delivery requires quarterly clinic visits for HIV testing and drug refilling that are costly to health systems and clients.ObjectiveTo evaluate whether 6-month PrEP dispensing supported with interim HIV self-testing (HIVST) results in noninferior PrEP continuation outcomes at 12 months compared with standard quarterly clinic visits.Design, Setting, and ParticipantsThis randomized noninferiority trial was conducted from May 2018 to May 2021 with 12 months of follow-up among PrEP clients aged 18 years or older who were returning for their first refill at a research clinic in Kiambu County, Kenya.InterventionParticipants were randomized 2:1 to (1) 6-month PrEP dispensing with semiannual clinic visits and interim HIVST at 3 months or (2) standard-of-care (SOC) PrEP delivery with 3-month dispensing, quarterly clinic visits, and clinic-based HIV testing.Main Outcomes and MeasuresPrespecified 12-month outcomes included recent HIV testing (any in past 6 months), PrEP refilling, and PrEP adherence (detectable tenofovir-diphosphate concentrations in dried blood spots). Binomial regression models were used to estimate risk differences (RDs), and a 1-sided 95% CI lower bound (LB) of −10% or greater was interpreted as noninferior.ResultsA total of 495 participants were enrolled, with 329 enrolled in the intervention group and 166 enrolled in the SOC group; 330 (66.7%) were women, 295 (59.6%) were in serodifferent relationships, and the median (IQR) age was 33 (27-40) years. At 12 months, 241 individuals in the intervention group (73.3%) and 120 in the SOC group (72.3%) returned to clinic. In the intervention group, recent HIV testing was noninferior (230 individuals [69.9%]) compared with the SOC group (116 [69.9%]; RD, −0.33%, 95% CI LB, −7.44%). PrEP refilling in the intervention group (196 [59.6%]) was inconclusive compared with the SOC group (104 [62.7%]; RD, −3.25%; 95% CI LB, −10.84%), and PrEP adherence was noninferior in the intervention group (151 [45.9%]) compared with the SOC group (70 [42.2%]; RD, 4.96%; 95% CI LB, −2.46%). No HIV seroconversions were observed over the follow-up period.Conclusions and RelevanceIn this analysis of secondary trial end points at 1 year, semiannual PrEP dispensing with interim HIVST resulted in noninferior recent HIV testing and PrEP adherence compared with SOC quarterly PrEP dispensing. This novel model has the potential to optimize PrEP delivery.Trial RegistrationClinicalTrials.gov Identifier: NCT03593629

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Efficiency of 6-month PrEP dispensing with HIV self-testing in Kenya: an open-label, randomised, non-inferiority, implementation trial

Cited by 34 publications

References 28 publications

The effectiveness, feasibility and acceptability of HIV service delivery at private pharmacies in sub‐Saharan Africa: a scoping review

The effectiveness, feasibility and acceptability of HIV service delivery at private pharmacies in sub‐Saharan Africa: a scoping review

Assessing young Kenyan women's willingness to engage in a peer-delivered HIV self-testing and referral model for PrEP initiation: A qualitative formative research study

Effect of 6-Month HIV Preexposure Prophylaxis Dispensing With Interim Self-testing on Preexposure Prophylaxis Continuation at 12 Months

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