Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R34MH103075-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Two-Step Adherence Feedback | Behavioral | 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%. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who report using device is convenient/easy | Feasibility and acceptability of electronic pill container | After Month 1 of intervention |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lisa J Messersmith, PhD, MPH | Boston University Center for Global Health and Development | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mildmay Uganda | Kampala | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35704124 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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) |