NCT02396394

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started May 2015

Typical duration for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

November 15, 2018

Status Verified

November 1, 2018

Enrollment Period

1.8 years

First QC Date

March 18, 2015

Last Update Submit

November 14, 2018

Conditions

HIV

Keywords

HIVART AdherenceRetention in CarePregnant WomenPostpartum Women

Outcome Measures

Primary Outcomes (1)

  • Difference in proportion of subjects who achieve >/= 95% adherence

    Subjects will participate in the 6-month real-time feedback intervention using electronic pill container/device and data-informed counseling. Comparison patients will continue to be monitored by electronic pill container, but they will remain blinded to the adherence information generated by the devices, as will their counselors. The 6-month period will be followed by passive monitoring for 3 months.

    Month 6 and Month 9

Secondary Outcomes (4)

  • Proportion of subjects who achieve >/= 95% cumulative adherence over entire 6 months of intervention period

    Month 6 and Month 9 of intervention

  • Difference in proportion of subjects who achieve: a) attend all scheduled visits; b) collect ART medications pre- and post-delivery; and c) give birth at clinic site

    Month 10

  • Difference in mean change in CD4 count between Months 0 and 7 (baseline/pre-intervention and post-intervention) in each study arm, measured as cells/µl.

    Before intervention and at Month 6 (end of intervention)

  • Difference in % undetectable viral load (UDVL) (using a lower limit of detection of 50 copies/mL of HIV plasma) in Month 7 (post-intervention) in each study arm.

    At enrollment and Month 7 (post-intervention)

Other Outcomes (1)

  • Proportion of subjects who report using device is convenient/easy

    After Month 1 of intervention

Study Arms (1)

Two-Step Adherence Feedback

EXPERIMENTAL

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%.

Behavioral: Two-Step Adherence Feedback

Interventions

Two-Step Adherence FeedbackBEHAVIORAL

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%.

Two-Step Adherence Feedback

Eligibility Criteria

Age18 Years - 59 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • HIV positive pregnant women
  • Who are 18 years of age and above
  • Who receive antenatal care, are ART-naive, and initiate ART at one of study sites in Central Uganda
  • Pregnant women must be between 18 and 26 weeks of estimated gestation
  • Be able to use a cell phone that can receive text messages
  • Provide written informed consent.

You may not qualify if:

  • Women who have had any previous experience with ARV medications, who cannot receive text messages in the home, or who are unwilling to provide written informed consent will not be allowed to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mildmay Uganda

Kampala, Uganda

Location

Related Publications (1)

  • Sabin LL, Simmons E, Halim N, Hamer DH, Gifford AL, West RL, Larson A, Bonawitz R, Aroda P, Banigbe B, Holderman AJ, Murray L, DeSilva MB, Gasuza J, Mukasa B, Messersmith LJ. Real-time Feedback to Improve HIV Treatment Adherence in Pregnant and Postpartum Women in Uganda: A Randomized Controlled Trial. AIDS Behav. 2022 Dec;26(12):3834-3847. doi: 10.1007/s10461-022-03712-7. Epub 2022 Jun 15.

    PMID: 35704124DERIVED

Study Officials

  • Lisa J Messersmith, PhD, MPH

    Boston University Center for Global Health and Development

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 18, 2015

First Posted

March 24, 2015

Study Start

May 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2018

Last Updated

November 15, 2018

Record last verified: 2018-11

Locations

UG(1)