NCT02400671

Brief Summary

The investigators are conducting a 3-arm randomized trial comparing the effects of unidirectional SMS (ie: "push" messaging to participant) vs. bidirectional SMS dialogue between participant and provider vs. control (no SMS) among HIV-infected Kenyan mothers in Kenyan PMTCT-ART for outcomes of ART adherence and retention in care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
825

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

November 2, 2022

Completed
Last Updated

November 2, 2022

Status Verified

October 1, 2022

Enrollment Period

4.3 years

First QC Date

March 2, 2015

Results QC Date

August 26, 2021

Last Update Submit

October 31, 2022

Conditions

mHealthPMTCTAdherence, MedicationSMSMaternal HealthHIV/AIDS

Outcome Measures

Primary Outcomes (4)

  • Maternal Virologic Failure

    Prevalence of virologic failure (HIV RNA ≥1000 c/ml) after the first 4 months post-ART will be compared between study arms using Generalized Estimating Equations (GEE) with log-binomial link.

    2 years postpartum

  • Retention in Care

    Timely clinic visit attendance during follow-up from enrollment in pregnancy to 12 and 24 months postpartum will be compared between study arms using GEE with log-binomial link.

    Assessed at 24 months postpartum

  • Loss to Follow-up

    The proportions of women lost to follow-up at 12 and 24 months postpartum will be compared between study arms by log-binomial regression.

    Assessed at 24 months postpartum

  • Infant HIV-free Survival

    Incidence of infant HIV acquisition or death (events per person-time of follow-up) will be compared between study arms using Cox proportional hazards regression.

    2 years postpartum

Secondary Outcomes (3)

  • Maternal ART Adherence

    2 years postpartum

  • Maternal ART Resistance

    2 years postpartum

  • Maternal Perceptions of Intervention and Care Received

    2 years postpartum

Study Arms (3)

Two-way SMS

EXPERIMENTAL

Participants will receive weekly push SMS messaging with a questions and have the ability to text back to the study nurse

Behavioral: SMS messaging

One-Way SMS

EXPERIMENTAL

Participants will receive weekly push SMS messaging

Behavioral: SMS messaging

Control

NO INTERVENTION

Participants will receive standard of care (no intervention)

Interventions

SMS messagingBEHAVIORAL
One-Way SMSTwo-way SMS

Eligibility Criteria

Age14 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • pregnant, HIV-infected, access to a mobile phone, remaining in study area for two years

You may not qualify if:

  • enrolled in another research study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Ahero District Hospital

Ahero, Kenya

Location

Bondo District Hospital

Bondo, Kenya

Location

Mathare City Council Clinic

Nairobi, Kenya

Location

Riruta Health Centre

Nairobi, Kenya

Location

Rachuonyo sub-County Hospital

Oyugis, Kenya

Location

Siaya County Referral Hospital

Siaya, Kenya

Location

Related Publications (6)

  • 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.

    PMID: 28315480BACKGROUND

  • 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.

    PMID: 29254362BACKGROUND

  • 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.

    PMID: 31752872BACKGROUND

  • 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.

    PMID: 30026177BACKGROUND

  • 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.

    PMID: 34579601DERIVED

  • 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.

    PMID: 34029338DERIVED

MeSH Terms

Conditions

Medication AdherenceAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
Dr. Keshet Ronen
Organization
University of Washington
keshet@uw.edu
206-685-4363

Study Officials

  • Grace John-Stewart

    UW

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 2, 2015

First Posted

March 27, 2015

Study Start

November 1, 2015

Primary Completion

January 31, 2020

Study Completion

February 28, 2020

Last Updated

November 2, 2022

Results First Posted

November 2, 2022

Record last verified: 2022-10

Locations

KE(6)