Clinical trial NCT02396394: Improving ART Retention and Adherence in Uganda: The WiseMama Study
Official title: Improving ART Retention and Adherence in Uganda: The WiseMama Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
ART Adherence
Retention in Care
Pregnant Women
Postpartum Women
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2015-03-24
Enrollment: 165
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Difference in proportion of subjects who achieve >/= 95% adherence
timeFrame: Month 6 and Month 9
Secondary outcomes:
measure: Proportion of subjects who achieve >/= 95% cumulative adherence over entire 6 months of intervention period
timeFrame: Month 6 and Month 9 of intervention
measure: 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
timeFrame: Month 10
measure: 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.
timeFrame: Before intervention and at Month 6 (end of intervention)
measure: 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.
timeFrame: At enrollment and Month 7 (post-intervention)
Other outcomes:
measure: Proportion of subjects who report using device is convenient/easy
timeFrame: After Month 1 of intervention
Locations:
city: Kampala
country: Uganda
facility: Mildmay Uganda
Study officials:
affiliation: Boston University Center for Global Health and Development
name: Lisa J Messersmith, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.