Improving ART Retention and Adherence in Uganda: The WiseMama Study

HIV Clinical Trial

— WiseMama  

Official title:

Improving ART Retention and Adherence in Uganda: The WiseMama Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02396394
• Other study ID #: H-32876
• Secondary ID: 1R34MH103075-01A
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: March 2018

Study information

• Verified date: November 2018
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: March 2018
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 59 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• HIV

Intervention

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%.

Locations

Country	Name	City	State
Uganda	Mildmay Uganda	Kampala

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of subjects who report using device is convenient/easy	Feasibility and acceptability of electronic pill container	After Month 1 of intervention
Primary	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	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.	Month 6 and Month 9 of intervention
Secondary	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
Secondary	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)
Secondary	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)