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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02400671
Acronym
Mobile WAChx
Enrollment
825
Registered
2015-03-27
Start date
2015-11-30
Completion date
2020-02-28
Last updated
2022-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BEHAVIORALSMS messaging

Sponsors

University of Nairobi
CollaboratorOTHER
Kenyatta National Hospital
CollaboratorOTHER_GOV
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
14 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* enrolled in another research study

Design outcomes

Primary

MeasureTime frameDescription
Maternal Virologic Failure2 years postpartumPrevalence 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.
Retention in CareAssessed at 24 months postpartumTimely 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-upAssessed at 24 months postpartumThe proportions of women lost to follow-up at 12 and 24 months postpartum will be compared between study arms by log-binomial regression.
Infant HIV-free Survival2 years postpartumIncidence of infant HIV acquisition or death (events per person-time of follow-up) will be compared between study arms using Cox proportional hazards regression.

Secondary

MeasureTime frameDescription
Maternal ART Resistance2 years postpartumIncidence of drug resistance on ART will be compared between study arms using Cox proportional hazards regression.
Maternal Perceptions of Intervention and Care Received2 years postpartumQualitative interviews at exit
Maternal ART Adherence2 years postpartumART 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.

Countries

Kenya

Participant flow

Recruitment details

Between November 22, 2015 and May 4, 2017, participants were recruited from 6 public maternal child health (MCH) clinics in Kenya: 2 in peri-urban Nairobi County and 4 in rural Siaya, Kisumu, and Homa Bay Counties

Pre-assignment details

825 participants were enrolled but it was later identified that one participant was enrolled twice. Only one of these records is included in analysis for a total participant number of 824

Participants by arm

ArmCount
Two-way SMS
Participants will receive weekly push SMS messaging with a questions and have the ability to text back to the study nurse SMS messaging
276
One-Way SMS
Participants will receive weekly push SMS messaging SMS messaging
271
Control
Participants will receive standard of care (no intervention)
277
Total824

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyDeath534
Overall StudyLost to Follow-up202724
Overall StudyWithdrawal by Subject220

Baseline characteristics

CharacteristicTwo-way SMSOne-Way SMSControlTotal
Age, Continuous27 years28 years27 years27 years
Employed133 Participants126 Participants159 Participants418 Participants
On antiretroviral therapy (ART) >=4 months160 Participants161 Participants149 Participants470 Participants
Primigravida49 Participants40 Participants26 Participants115 Participants
Race and Ethnicity Not Collected———0 Participants
Region of Enrollment
Kenya
276 participants271 participants277 participants824 participants
Sex: Female, Male
Female
276 Participants271 Participants277 Participants824 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants
Shares phone81 Participants77 Participants87 Participants245 Participants
Viral load (VL) >=1000 at enrollment88 Participants75 Participants81 Participants244 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
5 / 2763 / 2714 / 277
other
Total, other adverse events
15 / 27617 / 27114 / 277
serious
Total, serious adverse events
32 / 27618 / 27124 / 277

Outcome results

Primary

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

Population: Participants with live-born infants

ArmMeasureValue (NUMBER)
Two-way SMSInfant HIV-free Survival20 Events
One-Way SMSInfant HIV-free Survival11 Events
ControlInfant HIV-free Survival13 Events
Primary

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

Population: Participants still enrolled in the study at 24 months postpartum

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Two-way SMSLoss to Follow-up63 Participants
One-Way SMSLoss to Follow-up62 Participants
ControlLoss to Follow-up58 Participants
Primary

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

Population: Participants with VL data available \>=4 months post-ART initiation

ArmMeasureValue (COUNT_OF_UNITS)
Two-way SMSMaternal Virologic Failure90 VL measurements
One-Way SMSMaternal Virologic Failure119 VL measurements
ControlMaternal Virologic Failure99 VL measurements
Primary

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

Population: Participants with clinic visits scheduled during the study period

ArmMeasureValue (COUNT_OF_UNITS)
Two-way SMSRetention in Care3664 Scheduled visits
One-Way SMSRetention in Care3633 Scheduled visits
ControlRetention in Care3709 Scheduled visits
Secondary

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

Population: Participants with pharmacy refill data available

ArmMeasureValue (COUNT_OF_UNITS)
Two-way SMSMaternal ART Adherence2925 Refill visits
One-Way SMSMaternal ART Adherence2881 Refill visits
ControlMaternal ART Adherence2953 Refill visits
Secondary

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

Population: Participants without ART resistance at enrollment

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Two-way SMSMaternal ART Resistance4 Participants
One-Way SMSMaternal ART Resistance11 Participants
ControlMaternal ART Resistance9 Participants
Secondary

Maternal Perceptions of Intervention and Care Received

Qualitative interviews at exit

Time frame: 2 years postpartum

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026