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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Human Immunodeficiency Virus

Intervention / Treatment
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* Behavioral: Enhanced implementation package
* Behavioral: Standard implementation package


Participation Criteria
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Eligibility Criteria
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Health worker inclusion criteria: 18 years of age or older working full-time at one of the health facilities included in the study staff in Malawi's Assisted Contact Tracing program. Health worker exclusion criteria: conditions that would compromise ability of participant to provide informed consent, undergo study procedures safely, or prevent proper conduct of study Patient (index or contact) inclusion criteria: ->=15 years -potential index, contact, or parent or guardian of a potential index or contact Patient (index or contact) exclusion criteria: conditions that would compromise ability of individual to provide informed consent, undergo study procedures safely, or prevent proper conduct of study

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a cluster randomized control trial with 2:1 randomization (standard: enhanced).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced implementation strategy<br>digitally guided training and continuous quality improvement | Behavioral: Enhanced implementation package<br>* 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)<br>Behavioral: Standard implementation package<br>* Individual training with teaching (facilitator-guided,  2 hours) Small group practice (facilitator-guided,  1 hour) Ongoing clinic support (facilitator-guided,  30 minutes/month)<br>|
| Active Comparator: Standard implementation strategy<br>standard training and clinical support | Behavioral: Standard implementation package<br>* Individual training with teaching (facilitator-guided,  2 hours) Small group practice (facilitator-guided,  1 hour) Ongoing clinic support (facilitator-guided,  30 minutes/month)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Index client fidelity assessment | Health care workers will be observed counseling actual index clients. The scores on the 15-item index client fidelity assessment will be compared between arms (range 0-100% with higher scores being better) | 1 year after training | 
| Contact client fidelity assessment | Health care workers will be observed counseling actual contact clients. The scores on the 15-item contact client fidelity assessment will be compared between arms (range 0-100% with higher scores being better) | 1 year after training | 
| Index clients who participate in assisted contact tracing | The total number of index clients who participate in assisted contact tracing relative to the number of total potential index clients measured per facility per calendar quarter (3-month period) | 1 year after training | 
| Contact clients elicited | The number of contact clients listed by participating index clients relative to the number of total potential index clients measured per facility per calendar quarter (3-month period) | 1 year after training | 
| HIV self-test kits distributed | The number of HIV self-test kits distributed relative to the number of total potential index clients measured per facility per calendar quarter (3-month period) | 1 year after training | 
| Contact clients tested | The number of contact clients tested relative to the number of total potential index clients measured per facility per calendar quarter (3-month period) | 1 year after training | 
| Contact clients living with HIV identified | The number of contact clients living with HIV identified relative to the number of total potential index clients measured per facility per calendar quarter (3-month period) | 1 year after training | 
| Cost per contact tested | The incremental cost per contact tested | 1 year after training | 
| Cost per person living with HIV diagnosed | The incremental cost per person living with HIV identified | 1 year after training | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blended learning, digital learning, quality improvement, HIV testing, health care worker capacity building