Improving ART Retention and Adherence in Uganda: The WiseMama Study

NCT ID: NCT02396394

Last Updated: 2018-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2018-03-31

Brief 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.

Conditions

HIV

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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%.

Group Type: EXPERIMENTAL

Two-Step Adherence Feedback

Intervention Type: 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%.

Interventions

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%.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Lisa J. Messersmith

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lisa J Messersmith, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston University Center for Global Health and Development

Locations

Mildmay Uganda

Kampala, , Uganda

Countries

Uganda

References

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.

Reference Type: DERIVED

PMID: 35704124 (View on PubMed)

Other Identifiers

1R34MH103075-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-32876

Identifier Type: -

Identifier Source: org_study_id