Evidence map›Paper›PMID 29501908›Full record

ArticleJournal of biomedical informatics2018

Challenges and solutions implementing an SMS text message-based survey CASI and adherence reminders in an international biomedical HIV PrEP study (MTN 017).

William Brown, Rebecca Giguere, Alan Sheinfil, Mobolaji Ibitoye, Ivan Balan, Titcha Ho, Benjamin Brown, Luis Quispe, Wichuda Sukwicha, Javier R Lama and 2 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of biomedical informatics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01687218 (A Phase 2 Randomized Sequence Open Label Expanded Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel), which is not on this map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 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.

NCT01687218 phase2completednot on this map

A Phase 2 Randomized Sequence Open Label Expanded Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel

TypeinterventionalSponsorCONRADRan2013 to 2015Enrolled195ConditionsHIVArmsOral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet), Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel), Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 1 synthesis or guideline pooled it.

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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

12 authors.

William BrownUniversity of California San Francisco, Department of Medicine, Center for AIDS Prevention Studies, San Francisco, CA, USA; Zuckerberg San Francisco General Hospital, UCSF Center for Vulnerable Populations, Health Communications Research Program, San Francisco, CA, USA; New York State Psychiatric Institute and Columbia University, HIV Center for Clinical and Behavioral Studies, New York, NY, USA. Electronic address: william.brown@ucsf.edu.
Rebecca GiguereNew York State Psychiatric Institute and Columbia University, HIV Center for Clinical and Behavioral Studies, New York, NY, USA.
Alan SheinfilNew York State Psychiatric Institute and Columbia University, HIV Center for Clinical and Behavioral Studies, New York, NY, USA.
Mobolaji IbitoyeNew York State Psychiatric Institute and Columbia University, HIV Center for Clinical and Behavioral Studies, New York, NY, USA; Columbia University, Mailman School of Public Health, Sociomedical Sciences, New York, NY, USA.
Ivan BalanNew York State Psychiatric Institute and Columbia University, HIV Center for Clinical and Behavioral Studies, New York, NY, USA; Columbia University, College of Physicians and Surgeons, Psychiatry, New York, NY, USA.
Titcha HoNew York State Psychiatric Institute and Columbia University, HIV Center for Clinical and Behavioral Studies, New York, NY, USA.
Benjamin BrownDesmond Tutu HIV Foundation, Cape Town, South Africa.
Luis QuispeAsociación Civil Impacta Salud y Educación, Lima, Peru.
Wichuda SukwichaThailand Ministry of Public Health - U.S. Centers for Disease Control and Prevention Collaboration, Nonthaburi, Thailand.
Javier R LamaAsociación Civil Impacta Salud y Educación, Lima, Peru.
Alex Carballo-DiéguezNew York State Psychiatric Institute and Columbia University, HIV Center for Clinical and Behavioral Studies, New York, NY, USA; Columbia University, College of Physicians and Surgeons, Psychiatry, New York, NY, USA.
Ross D CranstonUniversity of Pittsburgh, School of Medicine, Pittsburgh, PA, USA.

Funding

Microbicide Trials NetworkUM1AI068633 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI HILLIER, SHARON L. · 2011 to 2021
$175.0M
Microbicide Trials NetworkU01AI068633 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI HILLIER, SHARON L. · 2006 to 2010
$77.0M
Statistical and Data Management Center (SDMC): Microbicide Trials NetworkUM1AI068615 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI BROWN, ELIZABETH RENATA · 2011 to 2021
$66.5M
Ujima Mentoring ProgramP30MH062246 · NIMH · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI MALLORY O JOHNSON · 2001 to 2026
$57.4M
The Statistics, Data Science, and Data Management (SDM) CoreP30MH043520 · NIMH · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI Claude Ann Mellins · 2003 to 2026
$48.2M
University of Pittsburgh Clinical Trials UnitUM1AI069494 · NIAID · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI SUSAN L KOLETAR, John W Mellors · 2012 to 2026
$38.0M
Training in Biomedical Informatics at Columbia UniversityT15LM007079 · NLM · COLUMBIA UNIV NEW YORK MORNINGSIDE · PI NOEMIE ELHADAD, GEORGE M HRIPCSAK · 1992 to 2026
$28.9M
Laboratory Center (LC): Microbicide Trials NetworkUM1AI106707 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI MELLORS, JOHN W, ROHAN, LISA CENCIA · 2014 to 2021
$27.1M
Social Interventions to address disparities In young adult tobacco useP60MD006902 · NIMHD · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI BIBBINS-DOMINGO, KIRSTEN · 2012 to 2016
$6.4M
SEXUAL RISK BEHAVIOR AND BEHAVIOR CHANGE IN HETEROSEXUAL WOMEN AND MENP50MH043520 · NIMH · NEW YORK STATE PSYCHIATRIC INSTITUTE · PI WARNE, PATRICIA A · 1987 to 2002
$5.0M
The Brown Initiative in HIV and AIDS Clinical Research for Minority CommunitiesR25MH083620 · NIMH · MIRIAM HOSPITAL · PI NUNN, AMY STEWART · 2008 to 2025
$3.7M
The Next Frontier in Diabetes Communication: Promoting Health Literacy in the Era of Secure MessagingR01LM012355 · NLM · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI KARTER, ANDREW JOHN, SCHILLINGER, DEAN · 2015 to 2018
$2.8M
NIAID NIH HHS U01 AI068633NIAID NIH HHS UM1 AI068615NIAID NIH HHS UM1 AI068633NIAID NIH HHS UM1 AI069494NIAID NIH HHS UM1 AI106707NICHD NIH HHS F31 HD089592NIMHD NIH HHS L60 MD007456NIMHD NIH HHS P60 MD006902NIMH NIH HHS P30 MH043520NIMH NIH HHS P30 MH062246NIMH NIH HHS R25 MH083620NLM NIH HHS R01 LM012355NLM NIH HHS T15 LM007079
6 · The paper itself

Abstract

backgroundWe implemented a text message-based Short Message Service computer-assisted self-interviewing (SMS-CASI) system to aid adherence and monitor behavior in MTN-017, a phase 2 safety and acceptability study of rectally-applied reduced-glycerin 1% tenofovir gel compared to oral emtricitabine/tenofovir disoproxil fumarate tablets. We sought to implement SMS-based daily reminders and product use reporting, in four countries and five languages, and centralize data management/automated-backup.

methodsWe assessed features of five SMS programs against study criteria. After identifying the optimal program, we systematically implemented it in South Africa, Thailand, Peru, and the United States. The system consisted of four windows-based computers, a GSM dongle and sim card to send SMS. The SMS-CASI was, designed for 160 character SMS. Reminders and reporting sessions were initiated by date/time triggered messages. System, questions, responses, and instructions were triggered by predetermined key words.

resultsThere were 142,177 total messages: sent 86,349 (60.73%), received 55,573 (39.09%), failed 255 (0.18%). 6153 (4.33%) of the message were errors generated from either our SMS-CASI system or by participants. Implementation challenges included: high message costs; poor data access; slow data cleaning and analysis; difficulty reporting information to sites; a need for better participant privacy and data security; and mitigating variability in system performance across sites. We mitigated message costs and poor data access by federating the SMS-CASI system, and used secure email protocols to centralize data backup. We developed programming syntaxes to facilitate daily data cleaning and analysis, and a calendar template for reporting SMS behavior. Lastly, we ambiguated text message language to increase privacy, and standardized hardware and software across sites, minimizing operational variability.

conclusionWe identified factors that aid international implementation and operation of SMS-CASI for real-time adherence monitoring. The challenges and solutions we present can aid other researchers to develop and manage an international multilingual SMS-based adherence reminder and CASI system.

Indexed as

Patient ComplianceText MessagingComputer SecurityHIV InfectionsHumansInternationalityPre-Exposure ProphylaxisTelemedicineAdherenceComputer-assisted self-interviewHIVmHealthPrEPShort Message Service (SMS) text messaging

Identifiers

PMID29501908
PMCPMC5920551

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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.