An interventional study of Two-Step Adherence Feedback in HIV, sponsored by Boston University. Completed at 1 site in Uganda. Open to female participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-15.
Sponsored by Boston University · Not applicable, Interventional, and Treatment
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:
Boston University is the lead sponsor of 266 studies on the registry; 37 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 24 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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%.
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.
Time frame: Month 6 and Month 9
Proportion of subjects who achieve >/= 95% cumulative adherence over entire 6 months of intervention period
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: At enrollment and Month 7 (post-intervention)
Proportion of subjects who report using device is convenient/easy
Feasibility and acceptability of electronic pill container
Time frame: After Month 1 of intervention
Plan to share: Undecided
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Boston University