N/A
N=306
Package of Resources for Assisted Contact Tracing: Implementation, Costs, and Effectiveness
Human Immunodeficiency Virus
Bottom Line
View on ClinicalTrials.gov: NCT05343390 ↗Enrolled (actual)
306
Serious AEs
0.1%
Results posted
Feb 2025
Primary outcome: Primary: Index Client Fidelity Assessment — 66.30; 45.70 score on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Enhanced implementation package (Behavioral); Standard implementation package (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Nov 2023
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 | — |
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.
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
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.