MedPath

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

Not Applicable
Completed
Conditions
Human Immunodeficiency Virus
Interventions
Behavioral: Enhanced implementation package
Behavioral: Standard implementation package
Registration Number
NCT05343390
Lead Sponsor
University of North Carolina, Chapel Hill
Brief 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
841
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Enhanced implementation strategyStandard implementation packagedigitally guided training and continuous quality improvement
Standard implementation strategyStandard implementation packagestandard training and clinical support
Enhanced implementation strategyEnhanced implementation packagedigitally guided training and continuous quality improvement
Primary Outcome Measures
NameTimeMethod
HIV self-test kits distributed1 year after training

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)

Contact clients elicited1 year after training

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)

Index client fidelity assessment1 year after training

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)

Contact client fidelity assessment1 year after training

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)

Contact clients tested1 year after training

The number of contact clients tested relative to the number of total potential index clients measured per facility per calendar quarter (3-month period)

Cost per person living with HIV diagnosed1 year after training

The incremental cost per person living with HIV identified

Contact clients living with HIV identified1 year after training

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)

Index clients who participate in assisted contact tracing1 year after training

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)

Cost per contact tested1 year after training

The incremental cost per contact tested

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (33)

Ulongwe Health Centre

🇲🇼

Balaka, Malawi

Balaka OPD Health Centre

🇲🇼

Balaka, Malawi

Kalembo Health Centre

🇲🇼

Balaka, Malawi

Kawinga Dispensary

🇲🇼

Machinga, Malawi

Ngokwe health Centre

🇲🇼

Machinga, Malawi

Namanolo Health Centre

🇲🇼

Balaka, Malawi

Phimbi Health Centre

🇲🇼

Balaka, Malawi

Utale Health Centres

🇲🇼

Balaka, Malawi

Gawanani Health Centre

🇲🇼

Machinga, Malawi

Namandanje Health Centre

🇲🇼

Machinga, Malawi

Ntaja Health Centre

🇲🇼

Machinga, Malawi

Balaka District Hospital

🇲🇼

Balaka, Malawi

Kwitanda Health Centre

🇲🇼

Balaka, Malawi

Machinga District Hospital

🇲🇼

Machinga, Malawi

Mbonechela Dispensary

🇲🇼

Machinga, Malawi

Mposa Health Centre

🇲🇼

Machinga, Malawi

Namanja Health Centre

🇲🇼

Machinga, Malawi

Nayinunje Health Centre

🇲🇼

Machinga, Malawi

Nyambi Health Centre

🇲🇼

Machinga, Malawi

Chiendausiku Health Centre

🇲🇼

Balaka, Malawi

Mbera Health Centre

🇲🇼

Balaka, Malawi

Chikweo Health Centre

🇲🇼

Machinga, Malawi

Mahinga Health Centre

🇲🇼

Machinga, Malawi

Mkwepere Health Centre

🇲🇼

Machinga, Malawi

Mpiri Health Centre

🇲🇼

Machinga, Malawi

Nayuchi Health Centre

🇲🇼

Machinga, Malawi

Nthorowa Health Centre

🇲🇼

Machinga, Malawi

Kankao Health Centre

🇲🇼

Balaka, Malawi

Namdumbo Health Centre

🇲🇼

Balaka, Malawi

Phalula Health Centre

🇲🇼

Balaka, Malawi

Chamba Dispensary

🇲🇼

Machinga, Malawi

Mangamba Health Centre

🇲🇼

Machinga, Malawi

Nsanama Health Centre

🇲🇼

Machinga, Malawi

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