Mobile Strategies for Women's and Children's Health: Optimizing Adherence and Efficacy of PMTCT/ART
- Conditions
- Maternal HealthAdherence, MedicationPMTCTHIV/AIDSmHealthSMS
- Interventions
- Behavioral: SMS messaging
- Registration Number
- NCT02400671
- Lead Sponsor
- University of Washington
- 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 825
- pregnant, HIV-infected, access to a mobile phone, remaining in study area for two years
- enrolled in another research study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description One-Way SMS SMS messaging Participants will receive weekly push SMS messaging Two-way SMS SMS messaging Participants will receive weekly push SMS messaging with a questions and have the ability to text back to the study nurse
- Primary Outcome Measures
Name Time Method Infant HIV-free Survival 2 years postpartum 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.
Retention in Care Assessed at 24 months postpartum 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.
Loss to Follow-up Assessed at 24 months postpartum The proportions of women lost to follow-up at 12 and 24 months postpartum will be compared between study arms by log-binomial regression.
Maternal Virologic Failure 2 years postpartum 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.
- Secondary Outcome Measures
Name Time Method Maternal ART Resistance 2 years postpartum Incidence of drug resistance on ART will be compared between study arms using Cox proportional hazards regression.
Maternal ART Adherence 2 years postpartum 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.
Maternal Perceptions of Intervention and Care Received 2 years postpartum Qualitative interviews at exit
Trial Locations
- Locations (6)
Riruta Health Centre
🇰🇪Nairobi, Kenya
Rachuonyo sub-County Hospital
🇰🇪Oyugis, Kenya
Mathare City Council Clinic
🇰🇪Nairobi, Kenya
Ahero District Hospital
🇰🇪Ahero, Kenya
Bondo District Hospital
🇰🇪Bondo, Kenya
Siaya County Referral Hospital
🇰🇪Siaya, Kenya