HIV Clinical Trial
Official title:
Improving ART Retention and Adherence in Uganda: The WiseMama Study
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.
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.
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