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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH124526 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced implementation strategy | Experimental | digitally guided training and continuous quality improvement |
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| Standard implementation strategy | Active Comparator | standard training and clinical support |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced implementation package | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 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. | 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. | 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. | 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. |
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Health worker inclusion criteria:
Health worker exclusion criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Nora E Rosenberg, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Balaka District Hospital | Balaka | Malawi | ||||
| Balaka OPD Health Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41890851 | Derived | 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. | |
| 41825916 | Derived | Rosenberg 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. |
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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.
Beginning 9 months after publication and continuing through 36 months of publication
A repository will be selected that has policies and procedures in place that will provide data access to qualified researchers, fully consistent with NIH data sharing policies and applicable laws and regulations. The researcher will need approval form an Institutional Review Board and an executed data use/sharing agreement with University of North Carolina at Chapel Hill investigators.
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33 clusters were randomized in a 1:2 ratio (Enhanced:Standard). Within these clusters Healthcare workers, Index clients, Contact clients and data from registers were observed. To clearly represent the groups within each arm, four "periods" are shown below. Periods do not reflect a time element, but rather the four populations measured within these clusters (units).
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| ID | Title | Description |
|---|---|---|
| FG000 | Enhanced Implementation Strategy | Digitally guided training and continuous quality improvement 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) 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) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Clusters and Healthcare Workers |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 10, 2023 |
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This is a cluster randomized control trial with 2:1 randomization (standard: enhanced).
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Participants and investigators will not be masked. For fidelity assessments, those coding audio recordings will be masked with respect to study arm.
| Standard implementation package | Behavioral | Individual training with teaching (facilitator-guided, ~2 hours) Small group practice (facilitator-guided, ~1 hour) Ongoing clinic support (facilitator-guided, ~30 minutes/month) |
|
| 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. | 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. | 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. | 1 year after training |
| 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 |
| 38720312 | Derived | 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. |
| 38253452 | Derived | 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. |
| 37720011 | Derived | 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. |
| FG001 | Standard Implementation Strategy | Standard training and clinical support 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) |
| COMPLETED |
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| NOT COMPLETED |
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| Clusters and Index Clients |
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| Clusters and Contact Clients |
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| Clusters and Register-Extracted Data |
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In the Enhanced arm there were 125 Healthcare workers, 124 index clients, and 67 contact clients for a total of 316. In the Standard arm, there were 181 Healthcare workers, 217 Index clients, and 127 Contact clients for a total of 525. The "Cluster and Register-Extracted data" population were not considered as enrolled participants in the study; they were extracted data from register and no data were collected from these individuals.
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| ID | Title | Description |
|---|---|---|
| BG000 | Enhanced Implementation Strategy | Standard training and clinical support + Enhanced digitally guided training and continuous quality improvement |
| BG001 | Standard Implementation Strategy | Standard training and clinical support |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data are reported separately for Heathcare Workers, Index clients, and Contact clients. Data were not provided by 1 healthcare worker. | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Data are reported separately for Heathcare Workers, Index clients, and Contact clients. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Data are reported separately for Heathcare Workers, Index clients, and Contact clients. | Count of Participants | Participants |
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| Race (NIH/OMB) | Data are reported separately for Heathcare Workers, Index clients, and Contact clients. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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) | Data were missing for 2 participants. | Posted | Mean | 95% Confidence Interval | score on a scale | 1 year after training |
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| Primary | 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) | Data were missing for 3 participants. | Posted | Mean | 95% Confidence Interval | score on a scale | 1 year after training |
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| Primary | 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. | Data unavailable for one cluster in Quarter 4 of the standard arm. | Posted | Median | Inter-Quartile Range | proportion of participants | 1 year after training | Cluster-quarters | Cluster-quarters |
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| Primary | 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. | Data unavailable for one cluster in Quarter 4 of the standard arm. | Posted | Median | Inter-Quartile Range | proportion of participants | 1 year after training | Cluster-quarters | Cluster-quarters |
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| Primary | 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. | Data unavailable for one cluster in Quarter 4 of the standard arm. | Posted | Median | Inter-Quartile Range | proportion of participants | 1 year after training | Cluster-quarters | Cluster-quarters |
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| Primary | 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. | Data unavailable for one cluster in Quarter 4 of the standard arm. | Posted | Median | Inter-Quartile Range | proportion of participants | 1 year after training | Cluster-quarters | Cluster-quarters |
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| Primary | 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. | Data unavailable for one cluster in Quarter 4 of the standard arm. | Posted | Median | Inter-Quartile Range | proportion of participants | 1 year after training | Cluster-quarters | Cluster-quarters |
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| Primary | 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. | Calculations were driven from the 'Clusters and Register-Extracted Data' population. The full range of incremental cost was derived based on variability in cost associated with implementation strategy development. Number of participants analyzed in the Standard Arm is Zero due to this outcome being an incremental measure; no additional clients were tested in the Standard Arm. | Posted | Mean | Full Range | US Dollars | 1 year after training |
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| Primary | 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. | Calculations were driven from the 'Clusters and Register-Extracted Data' population. The full range of incremental cost was derived based on variability in cost associated with implementation strategy development. Number of participants analyzed in the Standard Arm is Zero due to this outcome being an incremental measure; no additional clients were diagnosed with HIV in the Standard Arm. | Posted | Mean | Full Range | US Dollars | 1 year after training |
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From the time of enrollment through study completion (approximately 12 months).
The "Cluster and Register-Extracted data" population are not considered enrolled participants in the study. These are extracted data from register and no data were collected from these individuals.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enhanced Implementation Strategy Healthcare Workers | Standard training and clinical support + Enhanced digitally guided training and continuous quality improvement | 0 | 125 | 0 | 125 | 0 | 125 |
| EG001 | Enhanced Implementation Strategy Index Clients | Standard training and clinical support + Enhanced digitally guided training and continuous quality improvement | 0 | 124 | 0 | 124 | 0 | 124 |
| EG002 | Enhanced Implementation Strategy Contact Clients | Standard training and clinical support + Enhanced digitally guided training and continuous quality improvement | 0 | 67 | 0 | 67 | 0 | 67 |
| EG003 | Standard Implementation Strategy Healthcare Workers | Standard training and clinical support | 1 | 181 | 1 | 181 | 0 | 181 |
| EG004 | Standard Implementation Strategy Index Clients | Standard training and clinical support | 0 | 217 | 0 | 217 | 0 | 217 |
| EG005 | Standard Implementation Strategy Contact Clients | Standard training and clinical support | 0 | 127 | 0 | 127 | 0 | 127 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Surgery complication | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nora E. Rosenberg, PhD | University of North Carolina at Chapel Hill | (919) 966-3761 | nrosenbe@email.unc.edu |
| Oct 16, 2024 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 10, 2023 | Apr 16, 2024 | ICF_000.pdf |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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