Completed

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

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What is being tested

Enhanced implementation package

+ Standard implementation package

Behavioral
Who is being recruted

Blood-Borne Infections+13

+ Urogenital Diseases

+ Genital Diseases

Over 15 Years
See all eligibility criteria
How is the trial designed

Services Research Study

Interventional
Study Start: November 2021
See protocol details

Summary

Principal SponsorUniversity of North Carolina, Chapel Hill
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2021

Actual date on which the first participant was enrolled.

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.

Official TitleEnhancing HIV-assisted Contact Tracing in Malawi Through Blended Learning: an Implementation Science Study
NCT05343390
Principal SponsorUniversity of North Carolina, Chapel Hill
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

841 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 15 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesAcquired Immunodeficiency SyndromeCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralHIV InfectionsLentivirus Infections

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
digitally guided training and continuous quality improvement

Group II

Active Comparator
standard training and clinical support

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 33 locations

Suspended

Phalula Health Centre

Balaka, MalawiOpen Phalula Health Centre in Google Maps
Suspended

Balaka District Hospital

Balaka, Malawi
Suspended

Balaka OPD Health Centre

Balaka, Malawi
Suspended

Chiendausiku Health Centre

Balaka, Malawi
Completed33 Study Centers