Human Immunodeficiency VirusPRACTICENCT05343390
Package of Resources for Assisted Contact Tracing: Implementation, Costs, and Effectiveness
A study testing Enhanced implementation package and Standard implementation package in people with Human Immunodeficiency Virus, run by University of North Carolina, Chapel Hill at 33 sites in Malawi.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Enhanced implementation package and Standard implementation package
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 841 participants
- Where
- 33 sitesMalawi
- Study dates
- 1 Nov 2021to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
Malawi33 sites
Balaka District Hospital
Balaka
Balaka OPD Health Centre
Balaka
Chiendausiku Health Centre
Balaka
Kalembo Health Centre
Balaka
Kankao Health Centre
Balaka
Kwitanda Health Centre
Balaka
Mbera Health Centre
Balaka
Namanolo Health Centre
Balaka
Namdumbo Health Centre
Balaka
Phalula Health Centre
Balaka
Phimbi Health Centre
Balaka
Ulongwe Health Centre
Balaka
Utale Health Centres
Balaka
Chamba Dispensary
Machinga
Chikweo Health Centre
Machinga
Gawanani Health Centre
Machinga
Kawinga Dispensary
Machinga
Machinga District Hospital
Machinga
Mahinga Health Centre
Machinga
Mangamba Health Centre
Machinga
Mbonechela Dispensary
Machinga
Mkwepere Health Centre
Machinga
Mpiri Health Centre
Machinga
Mposa Health Centre
Machinga
Namandanje Health Centre
Machinga
Namanja Health Centre
Machinga
Nayinunje Health Centre
Machinga
Nayuchi Health Centre
Machinga
Ngokwe health Centre
Machinga
Nsanama Health Centre
Machinga
Ntaja Health Centre
Machinga
Nthorowa Health Centre
Machinga
Nyambi Health Centre
Machinga
About this study
Official title: Enhancing HIV-assisted Contact Tracing in Malawi Through Blended Learning: an Implementation Science Study
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.
Read the 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.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Enhanced implementation package, Standard implementation package
- Keywords
- blended learning, digital learning, quality improvement, HIV testing, health care worker capacity building
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced implementation packageBehavioural
Individual training with teaching and modeling (tablet-guided, ~8 hours) Small group training with practice and feedback (tablet-guided, ~16 hours) Ongoing continuous quality improvement sessions (tablet-guided, ~2 hours/month)
Standard implementation packageBehavioural
Individual training with teaching (facilitator-guided, ~2 hours) Small group practice (facilitator-guided, ~1 hour) Ongoing clinic support (facilitator-guided, ~30 minutes/month)
| Study group | Role | What they receive |
|---|---|---|
| Enhanced implementation strategy | Experimental | digitally guided training and continuous quality improvement Receives: Behavioral: Enhanced implementation package; Behavioral: Standard implementation package |
| Standard implementation strategy | Active comparator | standard training and clinical support Receives: Behavioral: Standard implementation package |
What is being measured
The primary outcome is the main question the study is designed to answer.
Index Client Fidelity Assessment
Health care workers will be observed counseling actual index clients. The scores on the 15-item index client fidelity assessment will be compared between arms (range 0-100% with higher scores being better)
Measured: 1 year after training
Contact Client Fidelity Assessment
Health care workers will be observed counseling actual contact clients. The scores on the 15-item contact client fidelity assessment will be compared between arms (range 0-100% with higher scores being better)
Measured: 1 year after training
Index Clients Who Participate in Assisted Contact Tracing
The total number of index clients who participate in assisted contact tracing relative to the number of total potential index clients measured per facility per calendar quarter (3-month period). Each cluster contributes 4 quarters of data.
Measured: 1 year after training
Contact Clients Elicited
The number of contact clients listed by participating index clients relative to the number of total potential index clients measured per facility per calendar quarter (3-month period). Each cluster contributes 4 quarters of data.
Measured: 1 year after training
HIV Self-test Kits Distributed
The number of HIV self-test kits distributed relative to the number of total potential index clients measured per facility per calendar quarter (3-month period). Each cluster contributes 4 quarters of data.
Measured: 1 year after training
Contact Clients Tested
The number of contact clients tested relative to the number of total potential index clients measured per facility per calendar quarter (3-month period). Each cluster contributes 4 quarters of data.
Measured: 1 year after training
Contact Clients Living With HIV Identified
The number of contact clients living with HIV identified relative to the number of total potential index clients measured per facility per calendar quarter (3-month period). Each cluster contributes 4 quarters of data.
Measured: 1 year after training
Incremental Cost Per Contact Tested
Incremental cost per contact tested for HIV = Total additional cost in enhanced arm ($127,319) / total number of additional individual tested for HIV in the enhanced arm (1119). The outcome is an incremental cost effectiveness ratio. Because no additional cost was incurred in the Standard arm, the value was reported as 0.
Measured: 1 year after training
Incremental Cost Per Person Living With HIV Diagnosed
Incremental cost per contact tested for HIV = Total additional cost in enhanced arm ($127,319) / total number of additional individual diagnosed with HIV in the enhanced arm (64). The outcome is an incremental cost effectiveness ratio. Because no additional cost was incurred in the Standard arm, the value is reported as 0.
Measured: 1 year after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 Nov 2021
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a cluster randomized control trial with 2:1 randomization (standard: enhanced).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 841 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Nora E Rosenberg, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343390
- Sponsor's protocol ID
- 20-1810
- Other IDs
- R01MH124526
- Acronym
- PRACTICE
- Status last verified
- Apr 2024
- First submitted
- 8 Apr 2022
- Last updated
- 6 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the end of the study, all data will be de-identified and shared in compliance with all regulatory bodies and NIH data sharing procedures.
Publications
Tembo TA, Jean-Baptiste M, Mbeya-Munkhondya T, Mphande M, Chitani MJ, Mkandawire A, Kumbuyo C, Simon KR, Ahmed S, Go VF, Bekker LG, Rosenberg NE. Understanding how digital training enhances healthcare worker perceptions of HIV index case testing: a qualitative explanatory analysis. Res Sq [Preprint]. 2026 Mar 22:rs.3.rs-8853616. doi: 10.21203/rs.3.rs-8853616/v1.
PubMed 41890851Rosenberg N, Mollan K, Wang J, Tembo T, Chitani M, Wetzel E, Rutstein SE, Mwapasa V, Phiri D, Mkandawire A, Go V, Kim M, Ahmed S, Simon KR. Effect of a digital training package on clinical outcomes in Malawi's index case testing programme: a cluster randomised controlled trial. BMJ Glob Health. 2026 Mar 13;11(3):e022563. doi: 10.1136/bmjgh-2025-022563.
PubMed 41825916Meek CJ, Munkhondya TEM, Mphande M, Tembo TA, Chitani M, Jean-Baptiste M, Vansia D, Kumbuyo C, Wang J, Simon KR, Rutstein SE, Barrington C, Kim MH, Go VF, Rosenberg NE. Examining the feasibility of assisted index case testing for HIV case-finding: a qualitative analysis of barriers and facilitators to implementation in Malawi. BMC Health Serv Res. 2024 May 9;24(1):606. doi: 10.1186/s12913-024-10988-z.
PubMed 38720312Tembo TA, Mollan K, Simon K, Rutstein S, Chitani MJ, Saha PT, Mbeya-Munkhondya T, Jean-Baptiste M, Meek C, Mwapasa V, Go V, Bekker LG, Kim MH, Rosenberg NE. Does a blended learning implementation package enhance HIV index case testing in Malawi? A protocol for a cluster randomised controlled trial. BMJ Open. 2024 Jan 22;14(1):e077706. doi: 10.1136/bmjopen-2023-077706.
PubMed 38253452Meek CJ, Munkhondya TEM, Mphande M, Tembo TA, Chitani M, Jean-Baptiste M, Vansia D, Kumbuyo C, Simon KR, Rutstein SE, Barrington C, Kim MH, Go VF, Rosenberg NE. Examining the feasibility of assisted index case testing for HIV case-finding: a qualitative analysis of barriers and facilitators to implementation in Malawi. Res Sq [Preprint]. 2023 Sep 8:rs.3.rs-3314925. doi: 10.21203/rs.3.rs-3314925/v1.
PubMed 37720011
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing HIV-assisted Contact Tracing in Malawi Through Blended Learning: an Implementation Science Study
- ClinicalTrials.gov ID
- NCT05343390
- Acronym / sponsor ID
- PRACTICE / 20-1810
- Conditions
- Human Immunodeficiency Virus
- Keywords
- blended learning, digital learning, quality improvement, HIV testing, health care worker capacity building
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 841 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Posted 6 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a cluster randomized control trial with 2:1 randomization (standard: enhanced).
| Arm | Type | Receives |
|---|---|---|
| Enhanced implementation strategy | Experimental | Behavioral: Enhanced implementation package, Behavioral: Standard implementation packagedigitally guided training and continuous quality improvement |
| Standard implementation strategy | Active comparator | Behavioral: Standard implementation packagestandard training and clinical support |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced implementation packageIndividual training with teaching and modeling (tablet-guided, ~8 hours) Small group training with practice and feedback (tablet-guided, ~16 hours) Ongoing continuous quality improvement sessions (tablet-guided, ~2 hours/month) | Behavioural | Enhanced implementation strategy |
| Standard implementation packageIndividual training with teaching (facilitator-guided, ~2 hours) Small group practice (facilitator-guided, ~1 hour) Ongoing clinic support (facilitator-guided, ~30 minutes/month) | Behavioural | Enhanced implementation strategy, Standard implementation strategy |
Primary outcome
Index Client Fidelity Assessment
Time frame: 1 year after training
Health care workers will be observed counseling actual index clients. The scores on the 15-item index client fidelity assessment will be compared between arms (range 0-100% with higher scores being better)
Contact Client Fidelity Assessment
Time frame: 1 year after training
Health care workers will be observed counseling actual contact clients. The scores on the 15-item contact client fidelity assessment will be compared between arms (range 0-100% with higher scores being better)
Index Clients Who Participate in Assisted Contact Tracing
Time frame: 1 year after training
The total number of index clients who participate in assisted contact tracing relative to the number of total potential index clients measured per facility per calendar quarter (3-month period). Each cluster contributes 4 quarters of data.
Contact Clients Elicited
Time frame: 1 year after training
The number of contact clients listed by participating index clients relative to the number of total potential index clients measured per facility per calendar quarter (3-month period). Each cluster contributes 4 quarters of data.
HIV Self-test Kits Distributed
Time frame: 1 year after training
The number of HIV self-test kits distributed relative to the number of total potential index clients measured per facility per calendar quarter (3-month period). Each cluster contributes 4 quarters of data.
Contact Clients Tested
Time frame: 1 year after training
The number of contact clients tested relative to the number of total potential index clients measured per facility per calendar quarter (3-month period). Each cluster contributes 4 quarters of data.
Contact Clients Living With HIV Identified
Time frame: 1 year after training
The number of contact clients living with HIV identified relative to the number of total potential index clients measured per facility per calendar quarter (3-month period). Each cluster contributes 4 quarters of data.
Incremental Cost Per Contact Tested
Time frame: 1 year after training
Incremental cost per contact tested for HIV = Total additional cost in enhanced arm ($127,319) / total number of additional individual tested for HIV in the enhanced arm (1119). The outcome is an incremental cost effectiveness ratio. Because no additional cost was incurred in the Standard arm, the value was reported as 0.
Incremental Cost Per Person Living With HIV Diagnosed
Time frame: 1 year after training
Incremental cost per contact tested for HIV = Total additional cost in enhanced arm ($127,319) / total number of additional individual diagnosed with HIV in the enhanced arm (64). The outcome is an incremental cost effectiveness ratio. Because no additional cost was incurred in the Standard arm, the value is reported as 0.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41890851Tembo TA, Jean-Baptiste M, Mbeya-Munkhondya T, Mphande M, Chitani MJ, Mkandawire A, Kumbuyo C, Simon KR, Ahmed S, Go VF, Bekker LG, Rosenberg NE. Understanding how digital training enhances healthcare worker perceptions of HIV index case testing: a qualitative explanatory analysis. Res Sq [Preprint]. 2026 Mar 22:rs.3.rs-8853616. doi: 10.21203/rs.3.rs-8853616/v1.
- Derived from this study: PubMed 41825916Rosenberg N, Mollan K, Wang J, Tembo T, Chitani M, Wetzel E, Rutstein SE, Mwapasa V, Phiri D, Mkandawire A, Go V, Kim M, Ahmed S, Simon KR. Effect of a digital training package on clinical outcomes in Malawi's index case testing programme: a cluster randomised controlled trial. BMJ Glob Health. 2026 Mar 13;11(3):e022563. doi: 10.1136/bmjgh-2025-022563.
- Derived from this study: PubMed 38720312Meek CJ, Munkhondya TEM, Mphande M, Tembo TA, Chitani M, Jean-Baptiste M, Vansia D, Kumbuyo C, Wang J, Simon KR, Rutstein SE, Barrington C, Kim MH, Go VF, Rosenberg NE. Examining the feasibility of assisted index case testing for HIV case-finding: a qualitative analysis of barriers and facilitators to implementation in Malawi. BMC Health Serv Res. 2024 May 9;24(1):606. doi: 10.1186/s12913-024-10988-z.
- Derived from this study: PubMed 38253452Tembo TA, Mollan K, Simon K, Rutstein S, Chitani MJ, Saha PT, Mbeya-Munkhondya T, Jean-Baptiste M, Meek C, Mwapasa V, Go V, Bekker LG, Kim MH, Rosenberg NE. Does a blended learning implementation package enhance HIV index case testing in Malawi? A protocol for a cluster randomised controlled trial. BMJ Open. 2024 Jan 22;14(1):e077706. doi: 10.1136/bmjopen-2023-077706.
- Derived from this study: PubMed 37720011Meek CJ, Munkhondya TEM, Mphande M, Tembo TA, Chitani M, Jean-Baptiste M, Vansia D, Kumbuyo C, Simon KR, Rutstein SE, Barrington C, Kim MH, Go VF, Rosenberg NE. Examining the feasibility of assisted index case testing for HIV case-finding: a qualitative analysis of barriers and facilitators to implementation in Malawi. Res Sq [Preprint]. 2023 Sep 8:rs.3.rs-3314925. doi: 10.21203/rs.3.rs-3314925/v1.
- Individual participant dataSharing planned: Yes. At the end of the study, all data will be de-identified and shared in compliance with all regulatory bodies and NIH data sharing procedures.
Related trials for Human Immunodeficiency Virus
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nora E Rosenberg, PhD principal investigator
University of North Carolina, Chapel Hill
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced implementation package and Standard implementation package in people with Human Immunodeficiency Virus, run by University of North Carolina, Chapel Hill at 33 sites in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Index Client Fidelity Assessment (time frame: 1 year after training). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05343390, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.