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Improving ART Retention and Adherence in Uganda: The WiseMama Study

NCT02396394 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2018-11-15

No results posted yet for this study

Summary

WiseMama is designed to improve our understanding of interventions that are feasible and effective in helping HIV-positive pregnant and postpartum women to maintain high adherence to antiretroviral medications. The study will involve: a) assessing the feasibility and acceptability of the use of an innovative pill container equipped with real-time electronic data monitoring capacity by HIV positive pregnant and postpartum women in Uganda; b) generating preliminary effectiveness data of a 2-step feedback intervention on retention in care, antiretroviral therapy adherence, and clinical outcomes (CD4 and HIV viral load (VL)); c) exploring patient and provider perspectives on barriers and facilitators to retention in care and adherence to antiretroviral therapy in our study population.

Conditions

Interventions

BEHAVIORAL

Two-Step Adherence Feedback

Intervention subjects will use an electronic pill container to hold their antiretroviral medications. Throughout the 6-month intervention (until subjects are 3 months post-partum), whenever an intervention subject fails to open her electronic pill container within 60 minutes of dose time (as indicated by lack of a pill container opening), she will be sent a text message reminder. Each intervention subject will also participate in monthly counseling sessions informed by the subject's most recent adherence data generated by the electronic pill container. The counselor will review the adherence report with the patient and 1) provide positive feedback when adherence is ≥95% in the previous month, or 2) discuss reasons for lapses and strategies for improving adherence when adherence is \<95%.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Boston University

    lead OTHER

Principal Investigators

  • Lisa J Messersmith, PhD, MPH · Boston University Center for Global Health and Development

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2017-03-31
Completion
2018-03-31

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02396394 on ClinicalTrials.gov