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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
825
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, Kenya
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2 years postpartum
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.
Time frame: 2 years postpartum
Maternal ART Resistance
Incidence of drug resistance on ART will be compared between study arms using Cox proportional hazards regression.
Time frame: 2 years postpartum
Maternal Perceptions of Intervention and Care Received
Qualitative interviews at exit
Time frame: 2 years postpartum
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