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

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

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.

Study Overview

• Status: Completed
• Conditions: Human Immunodeficiency Virus
• Intervention / Treatment: Behavioral: Enhanced implementation package; Behavioral: Standard implementation package

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.

• Study Type: Interventional
• Enrollment (Actual): 841
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malawi
  • Balaka, 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
  • Machinga, Malawi
    • Machinga District Hospital
  • Machinga, Malawi
    • Chamba Dispensary
  • Machinga, Malawi
    • Chikweo Health Centre
  • Machinga, Malawi
    • Gawanani Health Centre
  • Machinga, Malawi
    • Kawinga Dispensary
  • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enhanced implementation strategy; digitally guided training and continuous quality improvement	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)
Active Comparator: Standard implementation strategy; standard training and clinical support	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)

What is the study measuring?

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). Each cluster contributes 4 quarters of data.	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). Each cluster contributes 4 quarters of data.	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). Each cluster contributes 4 quarters of data.	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). Each cluster contributes 4 quarters of data.	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). Each cluster contributes 4 quarters of data.	1 year after training
Incremental Cost Per Contact Tested	Incremental cost per contact tested for HIV = Total additional cost in enhanced arm ($127,319) / total number of additional individual tested for HIV in the enhanced arm (1119). The outcome is an incremental cost effectiveness ratio. Because no additional cost was incurred in the Standard arm, the value was reported as 0.	1 year after training
Incremental Cost Per Person Living With HIV Diagnosed	Incremental cost per contact tested for HIV = Total additional cost in enhanced arm ($127,319) / total number of additional individual diagnosed with HIV in the enhanced arm (64). The outcome is an incremental cost effectiveness ratio. Because no additional cost was incurred in the Standard arm, the value is reported as 0.	1 year after training

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Nora E Rosenberg, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: April 8, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: HIV testing; quality improvement; blended learning; digital learning; health care worker capacity building
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 20-1810; R01MH124526 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: At the end of the study, all data will be de-identified and shared in compliance with all regulatory bodies and NIH data sharing procedures.
• IPD Sharing Time Frame: Beginning 9 months after publication and continuing through 36 months of publication
• IPD Sharing Access Criteria: A repository will be selected that has policies and procedures in place that will provide data access to qualified researchers, fully consistent with NIH data sharing policies and applicable laws and regulations. The researcher will need approval form an Institutional Review Board and an executed data use/sharing agreement with University of North Carolina at Chapel Hill investigators.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No