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Specialty:

Infectious Diseases

Keywords:

Implementation Science, HIV, Malawi

Background:

In Malawi, many individuals living with HIV experience cyclical interruption in treatment (IIT), defined as multiple disruptions in antiretroviral therapy (ART) of 28 days or more, due ever-changing socioeconomic complexities impacting healthcare access. Cyclical IIT poses a significant threat to HIV epidemic control by increasing the likelihood of unsurpassed viral loads and, therefore, HIV transmission.

Objectives:

Partners in Hope—Malawi established a cluster randomized clinical trial, called CHOICE, which provides person-centered counseling and ongoing, dynamic choice of differentiated service delivery models for clients with a history of IIT. The CHOICE trial will evaluate the effectiveness of the CHOICE intervention versus Standard of Care (SOC) on viral load suppression among ART clients with IIT at 12 and 24 months. Within the larger trial, the Implementation Science team is evaluating the fidelity and quality of the intervention instituted at intervention-assigned facilities.

Design:

12 facilities across Malawi were randomized into either the CHOICE Intervention or SOC arms (n=6 facilities per arm). At Intervention sites, healthcare workers implement CHOICE through individualized counseling, highlighting topics such as the importance of social support, and helping clients identify preferences for service delivery including medication dispensation intervals (1, 3, or 6 months) and location of dispensation (Facility or in-community). IIT clients also receive provider counseling assessing the clinical appropriateness of stated preferences leading to shared decision making on service delivery details. The intervention’s fidelity and quality are measured through daily facility reports. Data are aggregated and discussed at bi-weekly CHOICE staff meetings and during quarterly, on-site, review meetings with facility staff to assess the effectiveness of intervention implementation and pinpoint necessary protocol adjustments and or trainings.

Impact/Effectiveness:

As of April 13th, 2026, across 1078 completed CHOICE ART visits at intervention facilities, client preferences matched finalized services in 73% of visits—above the high-fidelity threshold defined as, at least, 70% of IIT clients receiving their preferred service delivery strategy. Among clients who had their CHOICE preferences changed, 55% were due to scheduled viral load testing. Follow-up visit data among clients who received the CHOICE intervention show a 100% preference-to-final service match rate during the second CHOICE ART visit. Our Implementation Science team will be conducting recordings and exit surveys in May 2026 to access the quality and fidelity of client counseling sessions.

Lessons Learned:

Supporting implementation since in a unique intersection between research and programmatic intervention has highlighted the importance of attention to detail in documentation and data review, explicit wording, and ensuring personal interpretation of research metrics matches localized understanding. Humility in discussion and acknowledging local facility staff as contextual experts has been key to executing core implementation science strategies, such as tailoring protocol adjustments and increasing stakeholder engagement, to address implementation challenges.

Summary:

Malawians face a diverse assortment of barriers to effective chronic disease management, from a reliance on seasonal labor in Tanzania to farming communities heavily impacted by flooding. CHOICE has the potential to inform personalized, impactful, and scalable strategies for sustained ART engagement and innovative implementation science is pivotal to CHOICE’s success in real-world application.