Real-Time Antiretroviral Therapy Adherence Intervention in Uganda

Status Completed

Clinical Trial Summary

Development of Real-Time Antiretroviral Therapy Adherence Intervention in Uganda (The Wisepill Study).

Clinical Trial Description

In this study, the investigators propose to develop a real-time adherence intervention based on SMS (i.e., text messages), wireless adherence monitoring (with the Wisepill device), and engagement of social support that is tailored to rural sub-Saharan Africa. The investigators will build on research by others who have shown SMS reminders improve adherence and viral suppression in Kenya, albeit with relatively small effect sizes and suboptimal virologic failure rates even in the intervention arm. Moreover, little is known about which patients benefit from SMS, why they benefit, and what can be done to further improve adherence and treatment success rates. Understanding the mechanisms of effect will make it possible to design and test evidence-based interventions with the highest likelihood for efficacy.

In a cohort of HIV-infected individuals starting ART and being monitored with Wisepill, the investigators will test 1) daily SMS reminders, 2) weekly SMS reminders, 3) SMS reminders linked to real-time detection of missed doses, and 4) SMS reminders plus SMS notifications of 48+hour gaps in adherence to members of social support networks. The investigators will conduct qualitative interviews to learn the experiences of participants and members of their social support networks with the different types of SMS. This staged approach will allow us to fully understand and compare the additive effects and acceptability of SMS-based interventions. The investigators will also determine behavioral effect mechanisms, as well as compare the impact of each type of SMS with a control population receiving only Wisepill monitoring on adherence and HIV RNA. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01957865
Study type	Interventional
Source	Massachusetts General Hospital
Contact
Status	Completed
Phase	N/A
Start date	September 2013
Completion date	June 2015

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03413696` - Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
Completed	`NCT03215901` - Life Plans Intervention Study	N/A
Completed	`NCT03289676` - Storytelling Narrative Communication Intervention for Smoking Cessation in Women Living With HIV	Phase 1
Completed	`NCT03268551` - MEMO-Medical Marijuana and Opioids Study
Active, not recruiting	`NCT04064567` - Linking High-Risk Jail Detainees to HIV Pre-Exposure Prophylaxis: PrEP-LINK	N/A
Completed	`NCT04121962` - A Pilot Peer Mentor Intervention That Trains Black Men Who Have Sex With Men (BMSM) to Use and Promote Uptake of HIV/STI Self-Testing to Peers and Sex Partners: STAR Study (Self-Testing at Your Residence)	N/A
Completed	`NCT04013295` - Prize-linked Savings Initiatives for Promoting Better Health and Economic Outcomes in Kenya	N/A
Recruiting	`NCT04405700` - Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Recruiting	`NCT03984136` - HIV Results Exchange Mechanism on Promoting HIV Testing Among MSM	N/A
Completed	`NCT02928900` - Patient Actor Training to Improve HIV Services for Adolescents in Kenya	N/A
Recruiting	`NCT03268109` - COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old
Not yet recruiting	`NCT05813964` - Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF/FTC in MSM in Thailand and France.	Phase 3
Completed	`NCT02797262` - Measuring and Monitoring Adherence to ART With Pill Ingestible Sensor System	N/A
Completed	`NCT02376582` - Safety and Immunogenicity Study of a DNA Vaccine Combined With Protein Vaccine Against HIV/AIDS	Phase 1
Terminated	`NCT01443923` - Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV	Phase 4
Completed	`NCT01616940` - Minority AIDS Initiative Retention and Re-Engagement Project	N/A
Completed	`NCT01910714` - Adapting and Evaluating an EBI to Prevent HIV/AIDS Risk Among Apache Youth	N/A
Completed	`NCT01084421` - A Computer-Based Parent/Adolescent HIV Communication Intervention for Latinos	N/A
Completed	`NCT01596322` - International HIV Antiretroviral Adherence, Resistance and Survival	N/A
Completed	`NCT03643705` - A Nurse-led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention	N/A