Human Immunodeficiency Virus
Conditions
Keywords
blended learning, digital learning, quality improvement, HIV testing, health care worker capacity building
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.
Interventions
BEHAVIORALEnhanced 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)
BEHAVIORALStandard 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)
Sponsors
National Institute of Mental Health (NIMH)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants and investigators will not be masked. For fidelity assessments, those coding audio recordings will be masked with respect to study arm.
Intervention model description
This is a cluster randomized control trial with 2:1 randomization (standard: enhanced).
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes
Inclusion 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Index Client Fidelity Assessment | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
Countries
Malawi
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Enhanced Implementation Strategy Standard training and clinical support
\+ Enhanced digitally guided training and continuous quality improvement | 316 |
| Standard Implementation Strategy Standard training and clinical support | 525 |
| Total | 841 |
Baseline characteristics
| Characteristic | Total | Standard Implementation Strategy | Enhanced Implementation Strategy |
|---|---|---|---|
| Age, Continuous Contact Clients | 37 years | 35 years | 39 years |
| Age, Continuous Healthcare Workers | 34 years | 33 years | 34 years |
| Age, Continuous Index Clients | 34 years | 34 years | 35 years |
| Ethnicity (NIH/OMB) Contact Clients Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Contact Clients Not Hispanic or Latino | 194 Participants | 127 Participants | 67 Participants |
| Ethnicity (NIH/OMB) Contact Clients Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Healthcare Workers Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Healthcare Workers Not Hispanic or Latino | 304 Participants | 181 Participants | 123 Participants |
| Ethnicity (NIH/OMB) Healthcare Workers Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Index Clients Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Index Clients Not Hispanic or Latino | 341 Participants | 217 Participants | 124 Participants |
| Ethnicity (NIH/OMB) Index Clients Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Contact Clients American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Contact Clients Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Contact Clients Black or African American | 194 Participants | 127 Participants | 67 Participants |
| Race (NIH/OMB) Contact Clients More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Contact Clients Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Contact Clients Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Contact Clients White | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Healthcare Workers American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Healthcare Workers Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Healthcare Workers Black or African American | 305 Participants | 180 Participants | 125 Participants |
| Race (NIH/OMB) Healthcare Workers More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Healthcare Workers Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Healthcare Workers Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Healthcare Workers White | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Index Clients American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Index Clients Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Index Clients Black or African American | 341 Participants | 217 Participants | 124 Participants |
| Race (NIH/OMB) Index Clients More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Index Clients Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Index Clients Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Index Clients White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Malawi | 841 participants | 525 participants | 316 participants |
| Sex: Female, Male Contact Clients Female | 86 Participants | 61 Participants | 25 Participants |
| Sex: Female, Male Contact Clients Male | 108 Participants | 66 Participants | 42 Participants |
| Sex: Female, Male Healthcare Workers Female | 146 Participants | 87 Participants | 59 Participants |
| Sex: Female, Male Healthcare Workers Male | 159 Participants | 93 Participants | 66 Participants |
| Sex: Female, Male Index Clients Female | 240 Participants | 159 Participants | 81 Participants |
| Sex: Female, Male Index Clients Male | 101 Participants | 58 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 125 | 0 / 124 | 0 / 67 | 1 / 181 | 0 / 217 | 0 / 127 |
| other Total, other adverse events | 0 / 125 | 0 / 124 | 0 / 67 | 0 / 181 | 0 / 217 | 0 / 127 |
| serious Total, serious adverse events | 0 / 125 | 0 / 124 | 0 / 67 | 1 / 181 | 0 / 217 | 0 / 127 |
Outcome results
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)
Time frame: 1 year after training
Population: Data were missing for 3 participants.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Enhanced Implementation Strategy | Contact Client Fidelity Assessment | 63.70 score on a scale |
| Standard Implementation Strategy | Contact Client Fidelity Assessment | 52.50 score on a scale |
p-value: <0.00195% CI: [5.9, 16.4]Regression, Linear
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.
Time frame: 1 year after training
Population: Data unavailable for one cluster in Quarter 4 of the standard arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enhanced Implementation Strategy | Contact Clients Elicited | 0.19 proportion of participants |
| Standard Implementation Strategy | Contact Clients Elicited | 0.13 proportion of participants |
p-value: 0.00695% CI: [1.1, 1.71]Mixed Models Analysis
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.
Time frame: 1 year after training
Population: Data unavailable for one cluster in Quarter 4 of the standard arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enhanced Implementation Strategy | Contact Clients Living With HIV Identified | 0.005 proportion of participants |
| Standard Implementation Strategy | Contact Clients Living With HIV Identified | 0.004 proportion of participants |
p-value: 0.1295% CI: [0.94, 1.76]Mixed Models Analysis
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.
Time frame: 1 year after training
Population: Data unavailable for one cluster in Quarter 4 of the standard arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enhanced Implementation Strategy | Contact Clients Tested | 0.11 proportion of participants |
| Standard Implementation Strategy | Contact Clients Tested | 0.08 proportion of participants |
p-value: 0.0195% CI: [1.1, 1.92]Mixed Models Analysis
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.
Time frame: 1 year after training
Population: Data unavailable for one cluster in Quarter 4 of the standard arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enhanced Implementation Strategy | HIV Self-test Kits Distributed | 0.016 proportion of participants |
| Standard Implementation Strategy | HIV Self-test Kits Distributed | 0.006 proportion of participants |
p-value: 0.01395% CI: [1.19, 4.4]Mixed Models Analysis
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.
Time frame: 1 year after training
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Enhanced Implementation Strategy | Incremental Cost Per Contact Tested | 114 US Dollars |
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.
Time frame: 1 year after training
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Enhanced Implementation Strategy | Incremental Cost Per Person Living With HIV Diagnosed | 1977 US Dollars |
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)
Time frame: 1 year after training
Population: Data were missing for 2 participants.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Enhanced Implementation Strategy | Index Client Fidelity Assessment | 66.30 score on a scale |
| Standard Implementation Strategy | Index Client Fidelity Assessment | 45.70 score on a scale |
p-value: <0.00195% CI: [16.1, 25.1]Regression, Linear
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.
Time frame: 1 year after training
Population: Data unavailable for one cluster in Quarter 4 of the standard arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enhanced Implementation Strategy | Index Clients Who Participate in Assisted Contact Tracing | 0.56 proportion of participants |
| Standard Implementation Strategy | Index Clients Who Participate in Assisted Contact Tracing | 0.46 proportion of participants |
p-value: 0.1495% CI: [0.93, 1.6]Mixed Models Analysis