N/A
Completed N=824
Mobile Strategies for Women's and Children's Health: Optimizing Adherence and Efficacy of PMTCT/ART
mHealth · PMTCT · Adherence, Medication · SMS
Source: ClinicalTrials.gov NCT02400671 ↗
Enrolled (actual)
824
Serious AEs
9.0%
Results posted
Nov 2022
Primary outcomePrimary: Maternal Virologic Failure — 90; 119; 99 VL measurements
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maternal Virologic Failure |
90; 119; 99 | — |
| PRIMARY Retention in Care |
3664; 3633; 3709 | — |
| PRIMARY Loss to Follow-up |
63; 62; 58 | — |
| PRIMARY Infant HIV-free Survival |
20; 11; 13 | — |
| SECONDARY Maternal ART Adherence |
2925; 2881; 2953 | — |
| SECONDARY Maternal ART Resistance |
4; 11; 9 | — |
| SECONDARY Maternal Perceptions of Intervention and Care Received |
— | — |
Eligibility Criteria
Inclusion Criteria
- pregnant, HIV-infected, access to a mobile phone, remaining in study area for two years
Exclusion Criteria
- enrolled in another research study
Data sourced from ClinicalTrials.gov (NCT02400671). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.