Package of Resources for Assisted Contact Tracing: Implementation, Costs, and Effectiveness

NCT ID: NCT05343390

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 841 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2023-11-30

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.

Conditions

Human Immunodeficiency Virus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Enhanced implementation strategy

digitally guided training and continuous quality improvement

Group Type: EXPERIMENTAL

Enhanced implementation package

Intervention Type: BEHAVIORAL

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 package

Intervention Type: BEHAVIORAL

Individual training with teaching (facilitator-guided, \~2 hours) Small group practice (facilitator-guided, \~1 hour) Ongoing clinic support (facilitator-guided, \~30 minutes/month)

Standard implementation strategy

standard training and clinical support

Group Type: ACTIVE_COMPARATOR

Standard implementation package

Intervention Type: BEHAVIORAL

Individual training with teaching (facilitator-guided, \~2 hours) Small group practice (facilitator-guided, \~1 hour) Ongoing clinic support (facilitator-guided, \~30 minutes/month)

Interventions

Enhanced implementation package

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)

Intervention Type: BEHAVIORAL

Standard implementation package

Individual training with teaching (facilitator-guided, \~2 hours) Small group practice (facilitator-guided, \~1 hour) Ongoing clinic support (facilitator-guided, \~30 minutes/month)

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

->=15 years

-potential index, contact, or parent or guardian of a potential index or contact

Exclusion Criteria

• conditions that would compromise ability of participant to provide informed consent, undergo study procedures safely, or prevent proper conduct of study

• conditions that would compromise ability of individual to provide informed consent, undergo study procedures safely, or prevent proper conduct of study

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nora E Rosenberg, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

Balaka District Hospital

Balaka, , Malawi

Balaka OPD Health Centre

Balaka, , Malawi

Chiendausiku Health Centre

Balaka, , Malawi

Kalembo Health Centre

Balaka, , Malawi

Kankao Health Centre

Balaka, , Malawi

Kwitanda Health Centre

Balaka, , Malawi

Mbera Health Centre

Balaka, , Malawi

Namanolo Health Centre

Balaka, , Malawi

Namdumbo Health Centre

Balaka, , Malawi

Phalula Health Centre

Balaka, , Malawi

Phimbi Health Centre

Balaka, , Malawi

Ulongwe Health Centre

Balaka, , Malawi

Utale Health Centres

Balaka, , Malawi

Chamba Dispensary

Machinga, , Malawi

Chikweo Health Centre

Machinga, , Malawi

Gawanani Health Centre

Machinga, , Malawi

Kawinga Dispensary

Machinga, , Malawi

Machinga District Hospital

Machinga, , Malawi

Mahinga Health Centre

Machinga, , Malawi

Mangamba Health Centre

Machinga, , Malawi

Mbonechela Dispensary

Machinga, , Malawi

Mkwepere Health Centre

Machinga, , Malawi

Mpiri Health Centre

Machinga, , Malawi

Mposa Health Centre

Machinga, , Malawi

Namandanje Health Centre

Machinga, , Malawi

Namanja Health Centre

Machinga, , Malawi

Nayinunje Health Centre

Machinga, , Malawi

Nayuchi Health Centre

Machinga, , Malawi

Ngokwe health Centre

Machinga, , Malawi

Nsanama Health Centre

Machinga, , Malawi

Ntaja Health Centre

Machinga, , Malawi

Nthorowa Health Centre

Machinga, , Malawi

Nyambi Health Centre

Machinga, , Malawi

Countries

Malawi

References

Meek 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.

Reference Type: DERIVED

PMID: 38720312 (View on PubMed)

Tembo 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.

Reference Type: DERIVED

PMID: 38253452 (View on PubMed)

Meek 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.

Reference Type: DERIVED

PMID: 37720011 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01MH124526

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-1810

Identifier Type: -

Identifier Source: org_study_id