Evidence map›Paper›PMID 33662265›Full record

Trial reportThe lancet. HIV2021

Effect of SMS reminders on PrEP adherence in young Kenyan women (MPYA study): a randomised controlled trial.

Jessica E Haberer, Elizabeth A Bukusi, Nelly R Mugo, Maria Pyra, Catherine Kiptinness, Kevin Oware, Lindsey E Garrison, Katherine K Thomas, Nicholas Musinguzi, Susan Morrison and 4 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The lancet. HIV, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02915367 (Next Generation Real-time Monitoring for PrEP Adherence in Young Kenyan Women), which is not on this map. Cited by 55 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 4 pooled it
–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.

NCT02915367 nacompletednot on this map

Next Generation Real-time Monitoring for PrEP Adherence in Young Kenyan Women

TypeinterventionalSponsorMassachusetts General HospitalRan2016 to 2020Enrolled348ConditionsHIV/AIDS, AdherenceArmsSMS Reminders
3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Jessica E HabererCenter for Global Health, Massachusetts General Hospital, Boston, MA, USA; Department of Medicine, Harvard Medical School, Boston, MA, USA. Electronic address: jhaberer@mgh.harvard.edu.
Elizabeth A BukusiCentre for Microbiology Research, Kenya Medical Research Institute, Kisumu, Kenya; Department of Global Health, University of Washington, Seattle, WA, USA.
Nelly R MugoDepartment of Global Health, University of Washington, Seattle, WA, USA; Center for Clinical Research, Kenya Medical Research Institute, Thika, Kenya.
Maria PyraDepartment of Medicine, University of Chicago, Chicago, IL, USA.
Catherine KiptinnessCenter for Clinical Research, Kenya Medical Research Institute, Thika, Kenya.
Kevin OwareCentre for Microbiology Research, Kenya Medical Research Institute, Kisumu, Kenya.
Lindsey E GarrisonCenter for Global Health, Massachusetts General Hospital, Boston, MA, USA.
Katherine K ThomasDepartment of Global Health, University of Washington, Seattle, WA, USA.
Nicholas MusinguziGlobal Health Collaborative, Mbarara, Uganda.
Susan MorrisonDepartment of Global Health, University of Washington, Seattle, WA, USA.
Peter L AndersonDepartment of Pharmaceutical Sciences, University of Colorado, Denver, CO, USA.
Kenneth NgureCenter for Clinical Research, Kenya Medical Research Institute, Thika, Kenya; Department of Community Heath, Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya.
Jared M BaetenDepartment of Global Health, University of Washington, Seattle, WA, USA; Department of Medicine and Department of Epidemiology, University of Washington, Seattle, WA, USA; Gilead Sciences, Redwood City, CA, USA.
MPYA Study Team

Funding

INTERNATIONAL TRAINING GRANT IN EPIDEMIOLOGYD43TW000007 · FIC · UNIVERSITY OF WASHINGTON · PI FARQUHAR, CAREY · 1988 to 2012
$16.3M
Women and HIV: Translation of Research into Practice-WLHIV Post-Graduate Research FellowshipD43TW009783 · FIC · UNIVERSITY OF WASHINGTON · PI Elizabeth Anne BUKUSI, CAREY FARQUHAR · 2015 to 2026
$4.1M
Next generation real-time monitoring for PrEP adherence in young Kenyan womenR01MH109309 · NIMH · MASSACHUSETTS GENERAL HOSPITAL · PI BAETEN, JARED, HABERER, JESSICA ELIZABETH · 2016 to 2019
$2.7M
FIC NIH HHS D43 TW000007FIC NIH HHS D43 TW009783NIMH NIH HHS R01 MH109309
6 · The paper itself

Abstract

backgroundPre-exposure prophylaxis (PrEP) is highly effective for preventing HIV acquisition. However, adherence among young women (aged 18-24 years) has been challenging. SMS reminders have been shown to improve adherence to antiretroviral therapy in some contexts, including in combination with real-time adherence monitoring. We aimed to determine the effect of SMS reminders on PrEP adherence among young women in Kenya over a 2-year period.

methodsThe monitoring PrEP among young adult women (MPYA) study was an open label randomised controlled trial involving young adult women at high risk of HIV in Thika and Kisumu, Kenya. Participants were recruited from colleges, vocational institutions, informal settlements, and community-based organisations supporting young women. Women had to be aged 18-24 years and at high risk of HIV acquisition (defined as a VOICE risk score of 5 or higher, or being in a serodiscordant relationship). Study staff randomly assigned participants (1:1) to receive either SMS reminders (SMS reminder group) or no reminders (no SMS reminder group). Study group assignment was known to trial staff but masked to investigators. Reminders were initially sent daily and participants could switch to as-needed reminders (ie, sent only if they missed opening the monitor as expected) after 1 month. Study visits occurred at 1 month, 3 months, and then quarterly (ie, every 3 months). The primary outcome was PrEP adherence over 24 months measured with a real-time electronic monitor and assessed by negative binomial models adjusted for the study site and quarter among participants who collected PrEP. This trial is registered with ClinicalTrials.gov, NCT02915367.

findingsOf 642 women initially approached, 348 eligible women were enrolled between Dec 21, 2016, and Feb 5, 2018. Participants were randomly assigned to either the SMS reminder group (n=173) or the no SMS reminder group (n=175). The median age was 21 years (IQR 19-22) and 228 (66%) of the 348 participants reported condomless sex in the month before baseline. 24 (14%) of the 173 participants assigned to receive daily SMS reminders later opted for as-needed reminders. 69 291 (97%) of 71 791 SMS reminders were sent as planned. Among participants collecting PrEP (thus potentially suggesting a desire for HIV protection), electronically monitored adherence averaged 26·8% over 24 months and was similar by study group (27·0% with SMS, 26·6% without SMS, adjusted incidence rate ratio 1·16 [95% CI 0·93-1·45], p=0·19). There were no serious adverse events related to trial participation; five social harms occurred in each study group, primarily related to PrEP use.

interpretationSMS reminders were ineffective in promoting PrEP adherence among young Kenyan women. Given the overall low adherence in the trial, additional interventions are needed to support PrEP use in this population.

fundingUS National Institute of Mental Health.

Indexed as

Drug MonitoringText MessagingAdolescentAnti-HIV AgentsFemaleHIV-1HIV InfectionsHumansKenyaPre-Exposure ProphylaxisRiskTenofovirUnsafe SexYoung AdultAnti-HIV AgentsTenofovir

Identifiers

PMID33662265
PMCPMC8289198

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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.