PRACTICEEnhancing HIV-assisted Contact Tracing in Malawi Through Blended Learning: an Implementation Science Study
Enhanced implementation package
+ Standard implementation package
Blood-Borne Infections+13
+ Urogenital Diseases
+ Genital Diseases
Services Research Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.841 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Services Research Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy 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
Balaka District Hospital
Balaka, MalawiBalaka OPD Health Centre
Balaka, MalawiChiendausiku Health Centre
Balaka, Malawi