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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02400671
Other study ID # STUDY00000916
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2015
Est. completion date February 28, 2020

Study information

Verified date October 2022
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The investigators will compare trial arms for impact on maternal retention, adherence, virologic failure and resistance and infant HIV or HIV-free survival. 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.


Recruitment information / eligibility

Status Completed
Enrollment 825
Est. completion date February 28, 2020
Est. primary completion date January 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 14 Years and older
Eligibility Inclusion Criteria: - pregnant, HIV-infected, access to a mobile phone, remaining in study area for two years Exclusion Criteria: - enrolled in another research study

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
SMS messaging


Locations

Country Name City State
Kenya 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

Sponsors (3)

Lead Sponsor Collaborator
University of Washington Kenyatta National Hospital, University of Nairobi

Country where clinical trial is conducted

Kenya, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 Maternal ART Adherence ART adherence, defined as the proportion of days "covered" by ART between pharmacy refills, will be dichotomized and compared between arms using GEE with log-binomial link. 2 years postpartum
Secondary Maternal ART Resistance Incidence of drug resistance on ART will be compared between study arms using Cox proportional hazards regression. 2 years postpartum
Secondary Maternal Perceptions of Intervention and Care Received Qualitative interviews at exit 2 years postpartum
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