Clinical trial NCT05343390: Package of Resources for Assisted Contact Tracing: Implementation, Costs, and Effectiveness
Official title: Enhancing HIV-assisted Contact Tracing in Malawi Through Blended Learning: an Implementation Science Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Keywords: blended learning
digital learning
quality improvement
HIV testing
health care worker capacity building
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-04-25
Enrollment: 841
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a cluster randomized control trial with 2:1 randomization (standard: enhanced).
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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.

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

Primary outcomes:
measure: Index Client Fidelity Assessment
timeFrame: 1 year after training
measure: Contact Client Fidelity Assessment
timeFrame: 1 year after training
measure: Index Clients Who Participate in Assisted Contact Tracing
timeFrame: 1 year after training
measure: Contact Clients Elicited
timeFrame: 1 year after training
measure: HIV Self-test Kits Distributed
timeFrame: 1 year after training
measure: Contact Clients Tested
timeFrame: 1 year after training
measure: Contact Clients Living With HIV Identified
timeFrame: 1 year after training
measure: Incremental Cost Per Contact Tested
timeFrame: 1 year after training
measure: Incremental Cost Per Person Living With HIV Diagnosed
timeFrame: 1 year after training
Secondary outcomes:
Other outcomes:
Locations:
city: Balaka
country: Malawi
facility: Balaka District Hospital
city: Balaka
country: Malawi
facility: Balaka OPD Health Centre
city: Balaka
country: Malawi
facility: Chiendausiku Health Centre
city: Balaka
country: Malawi
facility: Kalembo Health Centre
city: Balaka
country: Malawi
facility: Kankao Health Centre
city: Balaka
country: Malawi
facility: Kwitanda Health Centre
city: Balaka
country: Malawi
facility: Mbera Health Centre
city: Balaka
country: Malawi
facility: Namanolo Health Centre
city: Balaka
country: Malawi
facility: Namdumbo Health Centre
city: Balaka
country: Malawi
facility: Phalula Health Centre
city: Balaka
country: Malawi
facility: Phimbi Health Centre
city: Balaka
country: Malawi
facility: Ulongwe Health Centre
city: Balaka
country: Malawi
facility: Utale Health Centres
city: Machinga
country: Malawi
facility: Chamba Dispensary
city: Machinga
country: Malawi
facility: Chikweo Health Centre
city: Machinga
country: Malawi
facility: Gawanani Health Centre
city: Machinga
country: Malawi
facility: Kawinga Dispensary
city: Machinga
country: Malawi
facility: Machinga District Hospital
city: Machinga
country: Malawi
facility: Mahinga Health Centre
city: Machinga
country: Malawi
facility: Mangamba Health Centre
city: Machinga
country: Malawi
facility: Mbonechela Dispensary
city: Machinga
country: Malawi
facility: Mkwepere Health Centre
city: Machinga
country: Malawi
facility: Mpiri Health Centre
city: Machinga
country: Malawi
facility: Mposa Health Centre
city: Machinga
country: Malawi
facility: Namandanje Health Centre
city: Machinga
country: Malawi
facility: Namanja Health Centre
city: Machinga
country: Malawi
facility: Nayinunje Health Centre
city: Machinga
country: Malawi
facility: Nayuchi Health Centre
city: Machinga
country: Malawi
facility: Ngokwe health Centre
city: Machinga
country: Malawi
facility: Nsanama Health Centre
city: Machinga
country: Malawi
facility: Ntaja Health Centre
city: Machinga
country: Malawi
facility: Nthorowa Health Centre
city: Machinga
country: Malawi
facility: Nyambi Health Centre
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Nora E Rosenberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: