Mobile Strategies for Women's and Children's Health: Optimizing Adherence and Efficacy of PMTCT/ART

HIV/AIDS Clinical Trial

— Mobile WAChx  

Official title:

Evaluation of Mhealth Strategies to Optimize Adherence and Efficacy of PMTCT/ART

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02400671
• Other study ID #: STUDY00000916
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Adherence, Medication
• HIV Infections
• HIV/AIDS
• Maternal Health
• mHealth
• PMTCT
• SMS

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