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Completed

NCT Number: NCT02400671

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

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.

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Key information

Conditions

mHealth Acquired Immunodeficiency Syndrome Adherence, Medication Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections HIV/AIDS Health Behavior Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Maternal Health Medication Adherence PMTCT Patient Acceptance of Health Care Patient Compliance RNA Virus Infections Retroviridae Infections SMS Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Treatment Adherence and Compliance Urogenital Diseases Virus Diseases

Age range

14 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ahero District Hospital, Ahero, Kenya

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • enrolled in another research study

Treatment and study plan

SMS messaging

Behavioral

Primary outcomes

  1. Maternal Virologic Failure

    Time frame: 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.

  2. Retention in Care

    Time frame: 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.

  3. Loss to Follow-up

    Time frame: 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.

  4. Infant HIV-free Survival

    Time frame: 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.

Secondary outcomes

  1. Maternal ART Adherence

    Time frame: 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.

  2. Maternal ART Resistance

    Time frame: 2 years postpartum

    Incidence of drug resistance on ART will be compared between study arms using Cox proportional hazards regression.

  3. Maternal Perceptions of Intervention and Care Received

    Time frame: 2 years postpartum

    Qualitative interviews at exit

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Kenyatta National Hospital
  • University of Nairobi

Registry information

Official study title

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

Acronym: Mobile WAChx

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Mar 27, 2015
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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