Evidence map›Paper›PMID 38890744›Full record

ArticleTrials2024

Enhancing HIV pre-exposure prophylaxis outcomes among Kenyan adolescent girls and young women with a novel pharmacy-based PrEP delivery platform: protocol for a cluster-randomized controlled trial.

Harison K Lagat, Jillian Pintye, Elizabeth Harrington, Samantha Houck, Zachary Kwena, Meena Lenn, Felix Mogaka, Vincent Momanyi, Melissa Mugambi, Bernard Nyerere and 6 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05467306 (Enhancing PrEP Outcomes Among Kenyan Adolescent Girls and Young Women With a Novel Pharmacy-based PrEP Delivery Platform), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05467306 naactive not recruitingnot on this map

Enhancing PrEP Outcomes Among Kenyan Adolescent Girls and Young Women With a Novel Pharmacy-based PrEP Delivery Platform

TypeinterventionalSponsorUniversity of WashingtonRan2023 to 2027Enrolled1,900ConditionsHivArmsNurse-Navigator Enhanced PrEP Support
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Review
  6. Journal of the International Association of Providers of AIDS Care
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Harison K LagatUniversity of Washington, Seattle, WA, USA.
Jillian PintyeUniversity of Washington, Seattle, WA, USA. jpintye@uw.edu.ORCID http://orcid.org/0000-0003-1255-7191
Elizabeth HarringtonUniversity of Washington, Seattle, WA, USA.
Samantha HouckUniversity of Washington, Seattle, WA, USA.
Zachary KwenaKenya Medical Research Institute, Nairobi, Kenya.
Meena LennKenya Medical Research Institute, Nairobi, Kenya.
Felix MogakaKenya Medical Research Institute, Nairobi, Kenya.
Vincent MomanyiKenya Medical Research Institute, Nairobi, Kenya.
Melissa MugambiFred Hutchinson Cancer Center, Seattle, WA, USA.
Bernard NyerereKenya Medical Research Institute, Nairobi, Kenya.
Josephine OdoyoKenya Medical Research Institute, Nairobi, Kenya.
Victor OmolloKenya Medical Research Institute, Nairobi, Kenya.
Katrina F OrtbladFred Hutchinson Cancer Center, Seattle, WA, USA.
Greshon RotaKenya Medical Research Institute, Nairobi, Kenya.
Monisha SharmaUniversity of Washington, Seattle, WA, USA.
Elizabeth A BukusiUniversity of Washington, Seattle, WA, USA.

Funding

University of Washington/Fred Hutch Center for AIDS ResearchP30AI027757 · NIAID · UNIVERSITY OF WASHINGTON · PI CONNIE L CELUM · 1988 to 2026
$104.9M
Evaluating Infant PrEP Exposure During Pregnancy and BreastfeedingR01HD100201 · NICHD · UNIVERSITY OF WASHINGTON · PI PINTYE, JILLIAN · 2019 to 2023
$3.4M
Evaluating sexually transmitted infections among adolescent girls and young women within a pharmacy-based PrEP delivery model in Kenya.R01HD108041 · NICHD · UNIVERSITY OF WASHINGTON · PI BUKUSI, ELIZABETH ANNE, PINTYE, JILLIAN · 2021 to 2025
$3.3M
mWACh-PrEP: A SMS-based Support Intervention to Enhance PrEP Adherence during Pregnancy and BreastfeedingR01NR019220 · NINR · UNIVERSITY OF WASHINGTON · PI KINUTHIA, JOHN, PINTYE, JILLIAN · 2020 to 2024
$2.9M
Peer PrEP referral + HIV self-test for PrEP initiation among young Kenyan womenR00MH121166 · NIMH · FRED HUTCHINSON CANCER RESEARCH CENTER · PI ORTBLAD, KATRINA FRANCES · 2021 to 2024
$866k
The design and evaluation of strategies to implement HIV prevention interventions for pregnant women in community pharmacy settingsK01MH122326 · NIMH · UNIVERSITY OF WASHINGTON · PI MUGAMBI, MELISSA · 2021 to 2024
$582k
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHDEunice Kennedy Shriver National Institute of Child Health and Human Development R01HD108041National Institute of Child Health and Human Development R01HD100201NIAID NIH HHS P30 AI027757NICHD NIH HHS R01 HD100201NICHD NIH HHS R01 HD108041NIMH NIH HHS K01 MH122326NIMH NIH HHS K01MH122326NIMH NIH HHS R00 MH121166NIMH NIH HHS R00MH121166NINR NIH HHS R01 NR019220NINR NIH HHS R01NR019220
6 · The paper itself

Abstract

backgroundIn Kenya, 65% of sexually active unmarried women use modern contraceptives, a population at increased risk of HIV acquisition compared to other populations. Anchoring HIV prevention services, including pre-exposure prophylaxis (PrEP), to trusted contraceptive delivery settings offers opportunities to efficiently reach this important population. In Kenya, almost half (40%) of women accessing contraception services do so outside traditional healthcare facilities, such as retail pharmacies. Thus, integrating PrEP services into retail pharmacies may increase options for reaching adolescent girls and young women (AGYW) who could benefit from PrEP. Efforts are underway to define care pathways for pharmacy-delivered PrEP services in Kenya, including unsupported and supported models with nurse navigators.

methodsThe AGYW Pharmacy PrEP study is an unblinded 2-arm cluster-randomized controlled trial in Kisumu, Kenya. The objective is to determine the effect that unsupported versus supported pharmacy-delivered PrEP services has on PrEP initiation, persistence, and adherence among AGYW seeking contraception. Twenty retail pharmacies offering pharmacy provider-led PrEP delivery will be randomized 1:1 to either receive or not receive a nurse navigator to support PrEP delivery. Eligible AGYW (n = 1900 total, n = 950/arm) will be ≥ 15 years old, purchasing a method of contraception at the pharmacy. Trained pharmacy provider will offer eligible AGYW either daily oral PrEP or the monthly DPV vaginal ring. The primary trial outcomes are PrEP initiation (use of PrEP at 1 month), persistence (use of PrEP at 10 months), and adherence (quantified by levels of TFV or DPV in hair samples). Additionally, several secondary (STI incidence, PrEP method selection, predictors of PrEP adherence) and exploratory outcomes (HIV incidence, quality of care, contraceptive method mix) will be explored. DISCUSSION: We hypothesize pharmacy-delivered PrEP services supported with nurse navigator, versus delivered by pharmacy providers alone, will improve PrEP outcomes among AGYW seeking contraception. Our results will help policy makers better understand how to potentially implement this novel differentiated service model for PrEP and prime pharmacies for the delivery of new PrEP agents in the pipeline (e.g., long-acting injectables and multi-purpose technologies). The study was initiated on May 13, 2023, and is expected to be completed by February 2025.

trial registrationClinicalTrials.gov (NCT05467306), with registration on July 20, 2022.

Indexed as

Anti-HIV AgentsHIV InfectionsPre-Exposure ProphylaxisRandomized Controlled Trials as TopicAdolescentCommunity Pharmacy ServicesFemaleHumansKenyaMedication AdherenceMulticenter Studies as TopicTime FactorsTreatment OutcomeYoung AdultAnti-HIV AgentsAGYWHIV preventionNurse navigatorPharmacy-based deliveryPre-exposure prophylaxisPrEP adherence

Identifiers

PMID38890744
PMCPMC11186170

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.