N/A Completed N=306 Randomized Single-blind Health Services Research

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

Human Immunodeficiency Virus Infection

Source: ClinicalTrials.gov NCT05343390 ↗

Enrolled (actual)

306

Serious AEs

0.1%

Results posted

Feb 2025

Primary outcomePrimary: Index Client Fidelity Assessment — 66.30; 45.70 score on a scale — p=<0.001

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Index Client Fidelity Assessment	66.30; 45.70	<0.001 sig
PRIMARY Contact Client Fidelity Assessment	63.70; 52.50	<0.001 sig
PRIMARY Index Clients Who Participate in Assisted Contact Tracing	0.56; 0.46	0.14
PRIMARY Contact Clients Elicited	0.19; 0.13	0.006 sig
PRIMARY HIV Self-test Kits Distributed	0.016; 0.006	0.013 sig
PRIMARY Contact Clients Tested	0.11; 0.08	0.01 sig
PRIMARY Contact Clients Living With HIV Identified	0.005; 0.004	0.12
PRIMARY Incremental Cost Per Contact Tested	114	—
PRIMARY Incremental Cost Per Person Living With HIV Diagnosed	1977	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05343390). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.