Mobile Strategies for Women's and Children's Health: Optimizing Adherence and Efficacy of PMTCT/ART
NCT ID: NCT02400671
Last Updated: 2022-11-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
825 participants
INTERVENTIONAL
2015-11-30
2020-02-28
Brief Summary
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Detailed Description
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The investigators will determine correlates of maternal loss to follow-up and virologic failure and correlates of infant HIV in the overall study and stratified by trial arm. In the bidirectional SMS arm, the investigators will determine the rate of SMS interactivity, impact of critical time-points on messaging, and characteristics of high and low 'interactors'.
The investigators will determine cost-effectiveness of unidirectional and bidirectional SMS interventions. These data will contribute a potential scale-able strategy to improve PMTCT-ART as programs aspire to 'virtual elimination' of infant HIV.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Two-way SMS
Participants will receive weekly push SMS messaging with a questions and have the ability to text back to the study nurse
SMS messaging
One-Way SMS
Participants will receive weekly push SMS messaging
SMS messaging
Control
Participants will receive standard of care (no intervention)
No interventions assigned to this group
Interventions
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SMS messaging
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
14 Years
FEMALE
Yes
Sponsors
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University of Nairobi
OTHER
Kenyatta National Hospital
OTHER_GOV
University of Washington
OTHER
Responsible Party
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Grace John-Stewart
Professor
Principal Investigators
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Grace John-Stewart
Role: PRINCIPAL_INVESTIGATOR
UW
Locations
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Ahero District Hospital
Ahero, , Kenya
Bondo District Hospital
Bondo, , Kenya
Mathare City Council Clinic
Nairobi, , Kenya
Riruta Health Centre
Nairobi, , Kenya
Rachuonyo sub-County Hospital
Oyugis, , Kenya
Siaya County Referral Hospital
Siaya, , Kenya
Countries
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References
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Drake AL, Unger JA, Ronen K, Matemo D, Perrier T, DeRenzi B, Richardson BA, Kinuthia J, John-Stewart G. Evaluation of mHealth strategies to optimize adherence and efficacy of Option B+ prevention of mother-to-child HIV transmission: Rationale, design and methods of a 3-armed randomized controlled trial. Contemp Clin Trials. 2017 Jun;57:44-50. doi: 10.1016/j.cct.2017.03.007. Epub 2017 Mar 14.
Ronen K, Unger JA, Drake AL, Perrier T, Akinyi P, Osborn L, Matemo D, O'Malley G, Kinuthia J, John-Stewart G. SMS messaging to improve ART adherence: perspectives of pregnant HIV-infected women in Kenya on HIV-related message content. AIDS Care. 2018 Apr;30(4):500-505. doi: 10.1080/09540121.2017.1417971. Epub 2017 Dec 18.
Lewis K, Harrington EK, Matemo D, Drake AL, Ronen K, O'Malley G, Kinuthia J, John-Stewart G, Unger JA. Utilizing perspectives from HIV-infected women, male partners and healthcare providers to design family planning SMS in Kenya: a qualitative study. BMC Health Serv Res. 2019 Nov 21;19(1):870. doi: 10.1186/s12913-019-4708-7.
Fairbanks J, Beima-Sofie K, Akinyi P, Matemo D, Unger JA, Kinuthia J, O'Malley G, Drake AL, John-Stewart G, Ronen K. You Will Know That Despite Being HIV Positive You Are Not Alone: Qualitative Study to Inform Content of a Text Messaging Intervention to Improve Prevention of Mother-to-Child HIV Transmission. JMIR Mhealth Uhealth. 2018 Jul 19;6(7):e10671. doi: 10.2196/10671.
Osborn L, Ronen K, Larsen AM, Richardson B, Khasimwa B, Chohan B, Matemo D, Unger J, Drake AL, Kinuthia J, John-Stewart G. Antenatal depressive symptoms in Kenyan women living with HIV: contributions of recent HIV diagnosis, stigma, and partner violence. AIDS Care. 2022 Jan;34(1):69-77. doi: 10.1080/09540121.2021.1981216. Epub 2021 Sep 27.
Kinuthia J, Ronen K, Unger JA, Jiang W, Matemo D, Perrier T, Osborn L, Chohan BH, Drake AL, Richardson BA, John-Stewart G. SMS messaging to improve retention and viral suppression in prevention of mother-to-child HIV transmission (PMTCT) programs in Kenya: A 3-arm randomized clinical trial. PLoS Med. 2021 May 24;18(5):e1003650. doi: 10.1371/journal.pmed.1003650. eCollection 2021 May.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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STUDY00000916
Identifier Type: -
Identifier Source: org_study_id
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