NCT05343390

Package of Resources for Assisted Contact Tracing: Implementation, Costs, and Effectiveness

Enhancing HIV-assisted Contact Tracing in Malawi Through Blended Learning: an Implementation Science Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 841 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Accepted

Summary

Having health workers assist HIV-infected persons with the recruitment and testing of their sexual contacts and biological children is an effective and efficient way of identifying additional HIV-infected persons in need of HIV treatment and HIV-uninfected persons in need of HIV prevention. However, in Malawi, a country with a generalized HIV epidemic, health workers lack the counseling and coordination skills to routinely assist their HIV-infected clients with these services. This study will determine how to help health workers to effectively and efficiently provide these services to their patients through a set of digital capacity-building tools.

Detailed description

Voluntary assisted contact tracing (ACT) is an evidence-based approach that efficiently identifies persons in need of HIV treatment and prevention. Malawi, like many countries in sub-Saharan Africa, has adopted ACT policies to support its "95-95-95" targets for HIV testing, treatment, and viral suppression. However, Malawi's ACT implementation has been poor due to deficits in health worker capacity and clinical coordination. Through preliminary work, our team has 1) developed a set of implementation strategies (theory-based health worker training and continuous quality improvement processes) that address these barriers; 2) packaged these strategies into a blended learning platform that combines digital and face-to-face modalities; and 3) field-tested the package in Malawi with promising preliminary results. In this proposal, the package will be rigorously evaluated in Malawi for implementation, service uptake, and cost-effectiveness outcomes. Through a two-arm pragmatic cluster randomized implementation trial, the proposed research will address these gaps through three specific aims. Twenty Malawian facilities in two districts will be randomized to receive the blended learning implementation package (enhanced) versus standard implementation package (standard). In the first aim, ACT implementation outcomes will be compared between the enhanced and standard arms. Health worker fidelity to ACT procedures will be assessed through audio-recorded ACT encounters. In the second aim, HIV service uptake outcomes will be compared between the enhanced and standard arms. In the third aim, cost and cost-effectiveness outcomes will be examined. The findings will offer important insights and innovations into how to bridge the gap between ACT research and practice, a critical step towards achieving the 95-95-95 targets.

Conditions

• Human Immunodeficiency Virus

Interventions

Type	Name	Description
BEHAVIORAL	Enhanced implementation package	Individual training with teaching and modeling (tablet-guided, \~8 hours) Small group training with practice and feedback (tablet-guided, \~16 hours) Ongoing continuous quality improvement sessions (tablet-guided, \~2 hours/month)
BEHAVIORAL	Standard implementation package	Individual training with teaching (facilitator-guided, \~2 hours) Small group practice (facilitator-guided, \~1 hour) Ongoing clinic support (facilitator-guided, \~30 minutes/month)

Timeline

• Start date: 2021-11-01
• Primary completion: 2023-11-30
• Completion: 2023-11-30
• First posted: 2022-04-25
• Last updated: 2025-02-06
• Results posted: 2025-02-06

Locations

33 sites across 1 country: Malawi