Improving ART Retention and Adherence in Uganda: The WiseMama Study
Condition: HIV
Study type: Interventional

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.
    

Detailed description: 
      The investigators will implement WiseMama over 2.5 years by using a randomized controlled
      trial design to assess the 2-step feedback intervention. Researchers will also investigate
      barriers and facilitators to retention in care and antiretroviral therapy adherence using
      quantitative and qualitative research methods. 130 pregnant women will be enrolled in two
      (three if needed) clinic sites Uganda where "Option B+" is the standard of care. HIV-positive
      pregnant women enrolled in the study will be randomized to either an intervention or
      comparison group for the approximately 6-month intervention. The study will follow all women
      for an additional 3 months to determine the potential sustainability of the impact of the
      intervention. In addition to adherence and clinical data, quantitative and qualitative data
      will be collected using survey instruments, focus groups, and in-depth interviews. Analysis
      of these data will enable achievement of the specific aims and contribute to the scientific
      evidence base on effective approaches to promoting antiretroviral therapy adherence among
      pregnant and postpartum HIV positive women in Uganda and other similar populations in
      low-resource settings.

      The specific aims of the study are to:

        1. Test the acceptability and feasibility of the use of an electronic pill container by
           pregnant and postpartum women. Acceptability and feasibility of the device among
           pregnant and postpartum women in Uganda through the implementation of a randomized
           controlled trial (RCT, see specific aim 2).

        2. Evaluate preliminary effectiveness of 2-step feedback on retention in care and ART
           adherence, and clinical outcomes of pregnant and postpartum women. We will evaluate
           preliminary effectiveness of the intervention by conducting a RCT.

        3. Explore patient and provider perspectives on barriers and facilitators to retention in
           care and adherence to ART. We will use a mixed methods research approach to collect data
           from pregnant and postpartum women, health care providers, and counselors to elicit
           in-depth information regarding the behavioral, health systems-related, community, and
           social factors that influence adherence and retention in care.
    

Intervention name(s): Two-Step Adherence Feedback
Intervention type(s): Behavioral
Intervention description(s): 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%.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; ART Adherence; Retention in Care; Pregnant Women; Postpartum Women