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

NCT05343390 | Completed Results

• 2 other identifiers: 20-1810R01MH124526
• Study Type: interventional
• Target: 841
• Locations: 1 country
• Sites: 33

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.

Conditions

Human Immunodeficiency Virus

Keywords

blended learning; digital learning; quality improvement; HIV testing; health care worker capacity building

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

Enhanced implementation strategy

EXPERIMENTAL

digitally guided training and continuous quality improvement

Behavioral: Enhanced implementation package; Behavioral: Standard implementation package

Standard implementation strategy

ACTIVE COMPARATOR

standard training and clinical support

Behavioral: Standard implementation package

Interventions

Enhanced implementation package BEHAVIORAL

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)

Enhanced implementation strategy

Standard implementation package BEHAVIORAL

Individual training with teaching (facilitator-guided, \~2 hours) Small group practice (facilitator-guided, \~1 hour) Ongoing clinic support (facilitator-guided, \~30 minutes/month)

Enhanced implementation strategy; Standard implementation strategy

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• conditions that would compromise ability of participant to provide informed consent, undergo study procedures safely, or prevent proper conduct of study
• \>=15 years
• potential index, contact, or parent or guardian of a potential index or contact
• conditions that would compromise ability of individual to provide informed consent, undergo study procedures safely, or prevent proper conduct of study

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (33)

Balaka District Hospital

Balaka, Malawi

Location

Balaka OPD Health Centre

Balaka, Malawi

Location

Chiendausiku Health Centre

Balaka, Malawi

Location

Kalembo Health Centre

Balaka, Malawi

Location

Kankao Health Centre

Balaka, Malawi

Location

Kwitanda Health Centre

Balaka, Malawi

Location

Mbera Health Centre

Balaka, Malawi

Location

Namanolo Health Centre

Balaka, Malawi

Location

Namdumbo Health Centre

Balaka, Malawi

Location

Phalula Health Centre

Balaka, Malawi

Location

Phimbi Health Centre

Balaka, Malawi

Location

Ulongwe Health Centre

Balaka, Malawi

Location

Utale Health Centres

Balaka, Malawi

Location

Chamba Dispensary

Machinga, Malawi

Location

Chikweo Health Centre

Machinga, Malawi

Location

Gawanani Health Centre

Machinga, Malawi

Location

Kawinga Dispensary

Machinga, Malawi

Location

Machinga District Hospital

Machinga, Malawi

Location

Mahinga Health Centre

Machinga, Malawi

Location

Mangamba Health Centre

Machinga, Malawi

Location

Mbonechela Dispensary

Machinga, Malawi

Location

Mkwepere Health Centre

Machinga, Malawi

Location

Mpiri Health Centre

Machinga, Malawi

Location

Mposa Health Centre

Machinga, Malawi

Location

Namandanje Health Centre

Machinga, Malawi

Location

Namanja Health Centre

Machinga, Malawi

Location

Nayinunje Health Centre

Machinga, Malawi

Location

Nayuchi Health Centre

Machinga, Malawi

Location

Ngokwe health Centre

Machinga, Malawi

Location

Nsanama Health Centre

Machinga, Malawi

Location

Ntaja Health Centre

Machinga, Malawi

Location

Nthorowa Health Centre

Machinga, Malawi

Location

Nyambi Health Centre

Machinga, Malawi

Location

Related Publications (3)

• Meek CJ, Munkhondya TEM, Mphande M, Tembo TA, Chitani M, Jean-Baptiste M, Vansia D, Kumbuyo C, Wang J, Simon KR, Rutstein SE, Barrington C, Kim MH, Go VF, Rosenberg NE. Examining the feasibility of assisted index case testing for HIV case-finding: a qualitative analysis of barriers and facilitators to implementation in Malawi. BMC Health Serv Res. 2024 May 9;24(1):606. doi: 10.1186/s12913-024-10988-z.

  PMID: 38720312 DERIVED

• Tembo TA, Mollan K, Simon K, Rutstein S, Chitani MJ, Saha PT, Mbeya-Munkhondya T, Jean-Baptiste M, Meek C, Mwapasa V, Go V, Bekker LG, Kim MH, Rosenberg NE. Does a blended learning implementation package enhance HIV index case testing in Malawi? A protocol for a cluster randomised controlled trial. BMJ Open. 2024 Jan 22;14(1):e077706. doi: 10.1136/bmjopen-2023-077706.

  PMID: 38253452 DERIVED

• Meek CJ, Munkhondya TEM, Mphande M, Tembo TA, Chitani M, Jean-Baptiste M, Vansia D, Kumbuyo C, Simon KR, Rutstein SE, Barrington C, Kim MH, Go VF, Rosenberg NE. Examining the feasibility of assisted index case testing for HIV case-finding: a qualitative analysis of barriers and facilitators to implementation in Malawi. Res Sq [Preprint]. 2023 Sep 8:rs.3.rs-3314925. doi: 10.21203/rs.3.rs-3314925/v1.

  PMID: 37720011 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Nora E. Rosenberg, PhD
• Organization: University of North Carolina at Chapel Hill

nrosenbe@email.unc.edu

(919) 966-3761

Study Officials

• Nora E Rosenberg, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and investigators will not be masked. For fidelity assessments, those coding audio recordings will be masked with respect to study arm.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a cluster randomized control trial with 2:1 randomization (standard: enhanced).

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 25, 2022
• Study Start: November 1, 2021
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: February 6, 2025
• Results First Posted: February 6, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 9 months after publication and continuing through 36 months of publication
• 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.

Locations

MA (33)