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

University of Washington

Status: Completed

Conditions: Adherence, Medication; SMS; PMTCT; mHealth; HIV/AIDS; Maternal Health

Treatments: Behavioral: SMS messaging

Study type: Interventional

Funder types: Other

Identifiers

NCT02400671

STUDY00000916

Details and patient eligibility

About

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.

Full 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.

Enrollment: 825 patients

Sex: Female

Ages: 14+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• enrolled in another research study

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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825 participants in 3 patient groups

Two-way SMS

Experimental group

Description:

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

Treatment:

Behavioral: SMS messaging

One-Way SMS

Experimental group

Description:

Participants will receive weekly push SMS messaging

Treatment:

Behavioral: SMS messaging

Control

No Intervention group

Description:

Participants will receive standard of care (no intervention)