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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: SMS messaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pregnant, HIV-infected, access to a mobile phone, remaining in study area for two years Exclusion Criteria: enrolled in another research study

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Two-way SMS<br>Participants will receive weekly push SMS messaging with a questions and have the ability to text back to the study nurse | Behavioral: SMS messaging<br> <br> |
| Experimental: One-Way SMS<br>Participants will receive weekly push SMS messaging | Behavioral: SMS messaging<br> <br> |
| No Intervention: Control<br>Participants will receive standard of care (no intervention) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Maternal ART Resistance | Incidence of drug resistance on ART will be compared between study arms using Cox proportional hazards regression. | 2 years postpartum | 
| Maternal Perceptions of Intervention and Care Received | Qualitative interviews at exit | 2 years postpartum |