Ongoing Dynamic Choice to Address HIV Treatment Interruption in Malawi
NCT ID: NCT07220278
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
800 participants
INTERVENTIONAL
2025-11-17
2029-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Long-term, dynamic choice of services is one way to provide responsive services and promotes client ownership over care. The investigators propose to give TI clients long-term, dynamic choice of what services they receive and how they receive it (drawing from key building blocks of DSD). Long-term, dynamic choice puts clients in the driver's seat and may be the best practical strategy to provide long-term and responsive TI interventions that are tailored to clients' evolving life circumstances. Dynamic choice is frequently used for HIV prevention and family planning products, whereby clients select the type of health product that works best for them (i.e., condoms, injectables, etc.). Choice of these services is strongly associated with improved outcomes.
The goal of this clinical trial is to determine if CHOICE can improve outcomes in TI clients, compared to standard of care (SOC). Participants will be randomly assigned to either the CHOICE or SOC group, and follow them for 12 months. The primary outcome will be viral suppression at 12 months.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Current TI services do not work in the long-term. The few evidence-based TI interventions that exist are extremely limited in duration (usually only \~1-3 intervention visits) and services offered (counseling alone or counseling + home-based initiation). Yet reasons for TI are different for each client and change over time. TI is rarely a one-time event. Short term interventions can improve return to care, but do not address repeat TI. The investigators' recent R01 (ENGAGE; R01MH122308-05, n=735) and BMGF (IDEAL; n=569) trials with men experiencing TI in Malawi show that short-term person-centered counseling + variations of short-term home-based ART dramatically improve return to care after TI (\~96% re-initiated vs 67% in standard of care - SOC; p\<0.001). But rates of continued ART engagement at 6-months after re-initiation (4-5 months after interventions completed) was unacceptably low (\~64% were continuously in care without repeat TI vs 48% in SOC, p\<0.001).
Recent trials found that clients with repeat TI had many unexpected and changing barriers that require long-term solutions. In-depth interviews with repeat TI clients in ENGAGE and IDEAL trials (n=67) showed that clients want long-term services responsive to their changing needs, and the ability to choose services.
TI clients need long-term, dynamic choice of differentiated service delivery (DSD) options. There are no one-size fits all interventions for TI clients because they experience vastly changing and different barriers to care, from distance to facility to lack of social support to limited HIV-related literacy. Ongoing person-centered counseling and choice of how services are delivered facilitates responsive services and promotes client ownership over care. Long-term and dynamic choice of DSD may be the best practical strategy to provide long-term, responsive TI interventions. There are no evidence-based dynamic choice interventions for TI clients.
The investigators piloted a novel intervention, called CHOICE, that provides person-centered counseling (building on the success of our prior trials) + ongoing, dynamic choice of DSD services to TI clients. The pilot (n=125) found that counseling + dynamic choice of DSD was feasible, acceptable, and showed signs of efficacy to reduce repeat TI (15% vs 50% at 3-months). A full trial is needed to test the impact on viral suppression long-term (at 12- and 24-months) and cost-effectiveness.
The investigators propose to evaluate CHOICE in a randomized control trial (RCT) with TI clients in Malawi. TI clients will receive person-centered counseling + ongoing, dynamic choice of how services are delivered (drawing on DSD models) over 24-months. Clients can combine multiple choices for service delivery at any given time to create personalized intervention packages. Choice of service delivery include: 1) ART dispensing intervals (1, 3, 6months), location of ART distribution (facility, home, or community), and peer mentorship (varying frequency and meeting location). Clients can adjust their choice at each ART visit or via hotline throughout study period. The investigators will compare CHOICE to SOC (1-3 counseling sessions + routine facility-based services - no choice available \<6-months after TI. Specific aims are:
Aim 1. Test the effectiveness of CHOICE versus SOC on 12-month viral suppression among TI clients. The investigators will conduct an individually randomized trial at 12 health facilities (n=800 individuals). Primary outcome is viral suppression (\<50copies/mL) at 12-months (study collected sample). Secondary outcomes are: presence of repeat TI, time to repeat TI, and ART coverage (days with ART in possession) across 24-months.
Aim 2: Systematically evaluate the implementation of CHOICE. The investigators will use mixed-methods to understand barriers, facilitators and needed improvements to HCW implementation of CHOICE, clients' ability to choose DSDs, and equity in intervention implementation and outcomes.
Aim 3. Estimate cost and cost-effectiveness of CHOICE. The investigators will use a micro-costing approach to estimate the distribution of care costs by study arm, differences between arms, and incremental cost effectiveness. The investigators will draw on patient-level resource use and unit costs developed from clinic and implementation financial data.
CHOICE will inform strategies for sustained retention among TI clients regionally and globally. The study is timely, of high-impact, and highly feasible within the Malawi health system and with our team. Malawi has a strong track record of implementing scientifically tested innovations into SOC that are high-impact and scalable, including several guidelines informed by our previous trials.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CHOICE
The CHOICE intervention will provide long-term person-centered counseling + long-term, dynamic choice of DSD services to TI clients in Malawi over a 24-month period.
CHOICE
Routine HIV counselors will provide person-centered counseling and guide clients through a facilitated choice process to select DSDs and other support services routinely available to participating facilities. ART providers will review client preferences alongside client clinical assessments, resulting in a shared decision making of what DSD and support services is clinical safe and preferred for the client. Clients can change their preferred choice at any point throughout study enrollment. Ongoing, dynamic choice of available DSD models is a feasible and likely safe way to optimize the benefits of choice and provide responsive services for TI clients.
Standard of Care
TI clients will be offered long-term person-centered counseling tailored to TI clients. The Malawi Ministry of Health adopted findings from previous trials and is incorporating short-term person-centered counseling into standard of care (SOC) for TI clients. This will be the SOC control condition.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CHOICE
Routine HIV counselors will provide person-centered counseling and guide clients through a facilitated choice process to select DSDs and other support services routinely available to participating facilities. ART providers will review client preferences alongside client clinical assessments, resulting in a shared decision making of what DSD and support services is clinical safe and preferred for the client. Clients can change their preferred choice at any point throughout study enrollment. Ongoing, dynamic choice of available DSD models is a feasible and likely safe way to optimize the benefits of choice and provide responsive services for TI clients.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* living with HIV;
* initiated ART for the first time\>3-months ago (i.e., not a new initiate);
* non-pregnant;
* experienced Treatment Interuptions during their most recent ARTappointment (\>28 days late).
Exclusion Criteria
15 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Mental Health (NIMH)
NIH
Partners in Hope, Inc.
INDUSTRY
Boston University
OTHER
University of California, Los Angeles
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kathryn L. Dovel, PhD
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kathryn L Dovel, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Augustine Choko, PhD
Role: PRINCIPAL_INVESTIGATOR
Partners in Hope, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Partners in Hope
Lilongwe, , Malawi
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Augustine Choko, PhD
Role: primary
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.