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

Human Immunodeficiency Virus Clinical Trial

— PRACTICE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05343390
• Other study ID #: 20-1810
• Secondary ID: R01MH124526
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: April 2024
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 841
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus

Intervention

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)
• 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)

Locations

Country	Name	City	State
Malawi	Balaka District Hospital	Balaka
Malawi	Balaka OPD Health Centre	Balaka
Malawi	Chiendausiku Health Centre	Balaka
Malawi	Kalembo Health Centre	Balaka
Malawi	Kankao Health Centre	Balaka
Malawi	Kwitanda Health Centre	Balaka
Malawi	Mbera Health Centre	Balaka
Malawi	Namanolo Health Centre	Balaka
Malawi	Namdumbo Health Centre	Balaka
Malawi	Phalula Health Centre	Balaka
Malawi	Phimbi Health Centre	Balaka
Malawi	Ulongwe Health Centre	Balaka
Malawi	Utale Health Centres	Balaka
Malawi	Chamba Dispensary	Machinga
Malawi	Chikweo Health Centre	Machinga
Malawi	Gawanani Health Centre	Machinga
Malawi	Kawinga Dispensary	Machinga
Malawi	Machinga District Hospital	Machinga
Malawi	Mahinga Health Centre	Machinga
Malawi	Mangamba Health Centre	Machinga
Malawi	Mbonechela Dispensary	Machinga
Malawi	Mkwepere Health Centre	Machinga
Malawi	Mpiri Health Centre	Machinga
Malawi	Mposa Health Centre	Machinga
Malawi	Namandanje Health Centre	Machinga
Malawi	Namanja Health Centre	Machinga
Malawi	Nayinunje Health Centre	Machinga
Malawi	Nayuchi Health Centre	Machinga
Malawi	Ngokwe health Centre	Machinga
Malawi	Nsanama Health Centre	Machinga
Malawi	Ntaja Health Centre	Machinga
Malawi	Nthorowa Health Centre	Machinga
Malawi	Nyambi Health Centre	Machinga

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Cost per contact tested	The incremental cost per contact tested	1 year after training
Primary	Cost per person living with HIV diagnosed	The incremental cost per person living with HIV identified	1 year after training