Trial Outcomes & Findings for Human-centered Design and Communities of Practice to Improve Home-based Tuberculosis Contact Investigation in Uganda (NCT NCT05640648)
NCT ID: NCT05640648
Last Updated: 2025-03-30
Results Overview
The percentage of participants (close contacts) who are experiencing TB symptoms who complete TB evaluation within 60 days of the TB patient's treatment initiation date
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10477 participants
Primary outcome timeframe
60 days
Results posted on
2025-03-30
Participant Flow
In this stepped-wedge, cluster-randomized trial, 12 health facilities progress from Standard Contact Investigation \[Control\] to User-centered Contact Investigation \[Intervention\] in 6 clusters of randomly assigned pairs that cross over one cluster at a time \[Sequences\] at randomly assigned 8-week intervals \[Periods\]. All clusters start in Standard for 8 weeks, then 1 cluster crosses over to User-centered every 8 weeks for 48 weeks, and finally all clusters are in User-centered for 8 weeks.
Unit of analysis: Pairs of Health Facilities
Participant milestones
| Measure |
Standard Contact Investigation [Control]: Sequence 1 [2 Health Facilities]
Cluster 1: 8 weeks of standard, then 8 weeks of transition, then 48 weeks of user-centered
\----------------- Standard contact investigation consists of 1) evidence-based procedures for TB contact investigation, introduced with 2) a standard implementation strategy.
1. Standard contact investigation:
1. Once an eligible TB patient agrees to participate, CHWs will visit the patient to assess the eligibility of close contacts to participate.
2. For eligible contacts who agree to participate, the CHW will perform TB symptom screening and arrange subsequent microbiologic, clinical, and/or radiographic evaluation. c) Those screening TB symptom-positive will be asked to expectorate a sputum sample, unless under age 5. If under age 5 or unable to produce sputum, contacts will be referred to the health centre for evaluation. A CHW will transport sputum samples to the health-centre laboratory for microbiologic evaluation and later report the test results back to the contact.
2. Standard Implementation Strategy:
CHWs at all sites will receive the standard TB program training on TB contact investigation and supportive supervision from the on-site National TB Program focal person.
|
User-centered Contact Investigation [Intervention]: Sequence 1 [2 Health Facilities]
Cluster 1: 8 weeks of standard, then 8 weeks of transition, then 48 weeks of user-centered
\----------------- User-centered Contact Investigation includes 4 client-facing adaptations of standard contact investigation and 3 CHW-facing implementation strategies
1. Client-centered adaptations of contact investigation delivered as a branded package called Tuli Wamu Nawe: Four novel tools
1. TB education pamphlet to help index TB persons disclose the need for TB screening to close contacts.
2. Contact identification algorithm to help CHWs and index TB persons accurately enumerate contacts.
3. Sputum collection video to instruct contacts to expectorate good-quality sputum.
4. Community Health Riders to transport CHWs, index persons with TB, and contacts by motorcycle taxi, and collect and transport sputum.
2. CHW-centered Implementation Strategy: Three components
1. Weekly CHW meetings to create communities of practice (CoP), which consist of professionals organized for peer support and systematic learning.
2. Audit and feedback reports on contact investigation performance indicators delivered weekly (individual CHW) and monthly (health facility).
3. A group-chat application to facilitate peer support among CHWs.
|
Standard Contact Investigation [Control]: Sequence 2 [2 Health Facilities]
Cluster 2: 16 weeks of standard, then 8 weeks of transition, then 40 weeks of user-centered
\----------------- Standard contact investigation consists of 1) evidence-based procedures for TB contact investigation, introduced with 2) a standard implementation strategy.
1. Standard contact investigation:
1. Once an eligible TB patient agrees to participate, CHWs will visit the patient to assess the eligibility of close contacts to participate.
2. For eligible contacts who agree to participate, the CHW will perform TB symptom screening and arrange subsequent microbiologic, clinical, and/or radiographic evaluation. c) Those screening TB symptom-positive will be asked to expectorate a sputum sample, unless under age 5. If under age 5 or unable to produce sputum, contacts will be referred to the health centre for evaluation. A CHW will transport sputum samples to the health-centre laboratory for microbiologic evaluation and later report the test results back to the contact.
2. Standard Implementation Strategy:
CHWs at all sites will receive the standard TB program training on TB contact investigation and supportive supervision from the on-site National TB Program focal person.
|
User-centered Contact Investigation [Intervention]: Sequence 2 [2 Health Facilities]
Cluster 2: 16 weeks of standard, then 8 weeks of transition, then 40 weeks of user-centered
\----------------- User-centered Contact Investigation includes 4 client-facing adaptations of standard contact investigation and 3 CHW-facing implementation strategies
1. Client-centered adaptations of contact investigation delivered as a branded package called Tuli Wamu Nawe: Four novel tools
1. TB education pamphlet to help index TB persons disclose the need for TB screening to close contacts.
2. Contact identification algorithm to help CHWs and index TB persons accurately enumerate contacts.
3. Sputum collection video to instruct contacts to expectorate good-quality sputum.
4. Community Health Riders to transport CHWs, index persons with TB, and contacts by motorcycle taxi, and collect and transport sputum.
2. CHW-centered Implementation Strategy: Three components
1. Weekly CHW meetings to create communities of practice (CoP), which consist of professionals organized for peer support and systematic learning.
2. Audit and feedback reports on contact investigation performance indicators delivered weekly (individual CHW) and monthly (health facility).
3. A group-chat application to facilitate peer support among CHWs.
|
Standard Contact Investigation [Control]: Sequence 3 [2 Health Facilities]
Cluster 3: 24 weeks of standard, then 8 weeks of transition, then 32 weeks of user-centered
\----------------- Standard contact investigation consists of 1) evidence-based procedures for TB contact investigation, introduced with 2) a standard implementation strategy.
1. Standard contact investigation:
1. Once an eligible TB patient agrees to participate, CHWs will visit the patient to assess the eligibility of close contacts to participate.
2. For eligible contacts who agree to participate, the CHW will perform TB symptom screening and arrange subsequent microbiologic, clinical, and/or radiographic evaluation. c) Those screening TB symptom-positive will be asked to expectorate a sputum sample, unless under age 5. If under age 5 or unable to produce sputum, contacts will be referred to the health centre for evaluation. A CHW will transport sputum samples to the health-centre laboratory for microbiologic evaluation and later report the test results back to the contact.
2. Standard Implementation Strategy:
CHWs at all sites will receive the standard TB program training on TB contact investigation and supportive supervision from the on-site National TB Program focal person.
|
User-centered Contact Investigation [Intervention]: Sequence 3 [2 Health Facilities]
Cluster 3: 24 weeks of standard, then 8 weeks of transition, then 36 weeks of user-centered
\----------------- User-centered Contact Investigation includes 4 client-facing adaptations of standard contact investigation and 3 CHW-facing implementation strategies
1. Client-centered adaptations of contact investigation delivered as a branded package called Tuli Wamu Nawe: Four novel tools
1. TB education pamphlet to help index TB persons disclose the need for TB screening to close contacts.
2. Contact identification algorithm to help CHWs and index TB persons accurately enumerate contacts.
3. Sputum collection video to instruct contacts to expectorate good-quality sputum.
4. Community Health Riders to transport CHWs, index persons with TB, and contacts by motorcycle taxi, and collect and transport sputum.
2. CHW-centered Implementation Strategy: Three components
1. Weekly CHW meetings to create communities of practice (CoP), which consist of professionals organized for peer support and systematic learning.
2. Audit and feedback reports on contact investigation performance indicators delivered weekly (individual CHW) and monthly (health facility).
3. A group-chat application to facilitate peer support among CHWs.
|
Standard Contact Investigation [Control]: Sequence 4 [2 Health Facilities]
Cluster 4: 32 weeks of standard, then 8 weeks of transition, then 24 weeks of user-centered
\----------------- Standard contact investigation consists of 1) evidence-based procedures for TB contact investigation, introduced with 2) a standard implementation strategy.
1. Standard contact investigation:
1. Once an eligible TB patient agrees to participate, CHWs will visit the patient to assess the eligibility of close contacts to participate.
2. For eligible contacts who agree to participate, the CHW will perform TB symptom screening and arrange subsequent microbiologic, clinical, and/or radiographic evaluation. c) Those screening TB symptom-positive will be asked to expectorate a sputum sample, unless under age 5. If under age 5 or unable to produce sputum, contacts will be referred to the health centre for evaluation. A CHW will transport sputum samples to the health-centre laboratory for microbiologic evaluation and later report the test results back to the contact.
2. Standard Implementation Strategy:
CHWs at all sites will receive the standard TB program training on TB contact investigation and supportive supervision from the on-site National TB Program focal person.
|
User-centered Contact Investigation [Intervention]: Sequence 4 [2 Health Facilities]
Cluster 4: 32 weeks of standard, then 8 weeks of transition, then 24 weeks of user-centered
\----------------- User-centered Contact Investigation includes 4 client-facing adaptations of standard contact investigation and 3 CHW-facing implementation strategies
1. Client-centered adaptations of contact investigation delivered as a branded package called Tuli Wamu Nawe: Four novel tools
1. TB education pamphlet to help index TB persons disclose the need for TB screening to close contacts.
2. Contact identification algorithm to help CHWs and index TB persons accurately enumerate contacts.
3. Sputum collection video to instruct contacts to expectorate good-quality sputum.
4. Community Health Riders to transport CHWs, index persons with TB, and contacts by motorcycle taxi, and collect and transport sputum.
2. CHW-centered Implementation Strategy: Three components
1. Weekly CHW meetings to create communities of practice (CoP), which consist of professionals organized for peer support and systematic learning.
2. Audit and feedback reports on contact investigation performance indicators delivered weekly (individual CHW) and monthly (health facility).
3. A group-chat application to facilitate peer support among CHWs.
|
Standard Contact Investigation [Control]: Sequence 5 [2 Health Facilities]
Cluster 5: 40 weeks of standard, then 8 weeks of transition, then 16 weeks of user-centered
\----------------- Standard contact investigation consists of 1) evidence-based procedures for TB contact investigation, introduced with 2) a standard implementation strategy.
1. Standard contact investigation:
1. Once an eligible TB patient agrees to participate, CHWs will visit the patient to assess the eligibility of close contacts to participate.
2. For eligible contacts who agree to participate, the CHW will perform TB symptom screening and arrange subsequent microbiologic, clinical, and/or radiographic evaluation. c) Those screening TB symptom-positive will be asked to expectorate a sputum sample, unless under age 5. If under age 5 or unable to produce sputum, contacts will be referred to the health centre for evaluation. A CHW will transport sputum samples to the health-centre laboratory for microbiologic evaluation and later report the test results back to the contact.
2. Standard Implementation Strategy:
CHWs at all sites will receive the standard TB program training on TB contact investigation and supportive supervision from the on-site National TB Program focal person.
|
User-centered Contact Investigation [Intervention]: Sequence 5 [2 Health Facilities]
Cluster 5: 40 weeks of standard, then 8 weeks of transition, then 16 weeks of user-centered
\----------------- User-centered Contact Investigation includes 4 client-facing adaptations of standard contact investigation and 3 CHW-facing implementation strategies
1. Client-centered adaptations of contact investigation delivered as a branded package called Tuli Wamu Nawe: Four novel tools
1. TB education pamphlet to help index TB persons disclose the need for TB screening to close contacts.
2. Contact identification algorithm to help CHWs and index TB persons accurately enumerate contacts.
3. Sputum collection video to instruct contacts to expectorate good-quality sputum.
4. Community Health Riders to transport CHWs, index persons with TB, and contacts by motorcycle taxi, and collect and transport sputum.
2. CHW-centered Implementation Strategy: Three components
1. Weekly CHW meetings to create communities of practice (CoP), which consist of professionals organized for peer support and systematic learning.
2. Audit and feedback reports on contact investigation performance indicators delivered weekly (individual CHW) and monthly (health facility).
3. A group-chat application to facilitate peer support among CHWs.
|
Standard Contact Investigation [Control]: Sequence 6 [2 Health Facilities]
Cluster 6: 48 weeks of standard, then 8 weeks of transition, then 8 weeks of user-centered
\----------------- Standard contact investigation consists of 1) evidence-based procedures for TB contact investigation, introduced with 2) a standard implementation strategy.
1. Standard contact investigation:
1. Once an eligible TB patient agrees to participate, CHWs will visit the patient to assess the eligibility of close contacts to participate.
2. For eligible contacts who agree to participate, the CHW will perform TB symptom screening and arrange subsequent microbiologic, clinical, and/or radiographic evaluation. c) Those screening TB symptom-positive will be asked to expectorate a sputum sample, unless under age 5. If under age 5 or unable to produce sputum, contacts will be referred to the health centre for evaluation. A CHW will transport sputum samples to the health-centre laboratory for microbiologic evaluation and later report the test results back to the contact.
2. Standard Implementation Strategy:
CHWs at all sites will receive the standard TB program training on TB contact investigation and supportive supervision from the on-site National TB Program focal person.
|
User-centered Contact Investigation [Intervention]: Sequence 6 [2 Health Facilities]
Cluster 6: 48 weeks of standard, then 8 weeks of transition, then 8 weeks of user-centered
\----------------- User-centered Contact Investigation includes 4 client-facing adaptations of standard contact investigation and 3 CHW-facing implementation strategies
1. Client-centered adaptations of contact investigation delivered as a branded package called Tuli Wamu Nawe: Four novel tools
1. TB education pamphlet to help index TB persons disclose the need for TB screening to close contacts.
2. Contact identification algorithm to help CHWs and index TB persons accurately enumerate contacts.
3. Sputum collection video to instruct contacts to expectorate good-quality sputum.
4. Community Health Riders to transport CHWs, index persons with TB, and contacts by motorcycle taxi, and collect and transport sputum.
2. CHW-centered Implementation Strategy: Three components
1. Weekly CHW meetings to create communities of practice (CoP), which consist of professionals organized for peer support and systematic learning.
2. Audit and feedback reports on contact investigation performance indicators delivered weekly (individual CHW) and monthly (health facility).
3. A group-chat application to facilitate peer support among CHWs.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1 (Weeks 1-8)
STARTED
|
85 1
|
0 0
|
297 1
|
0 0
|
111 1
|
0 0
|
134 1
|
0 0
|
110 1
|
0 0
|
176 1
|
0 0
|
|
Period 1 (Weeks 1-8)
Index Participants
|
24 1
|
0 0
|
53 1
|
0 0
|
31 1
|
0 0
|
35 1
|
0 0
|
22 1
|
0 0
|
51 1
|
0 0
|
|
Period 1 (Weeks 1-8)
Close Contacts
|
61 1
|
0 0
|
244 1
|
0 0
|
80 1
|
0 0
|
99 1
|
0 0
|
88 1
|
0 0
|
125 1
|
0 0
|
|
Period 1 (Weeks 1-8)
COMPLETED
|
85 1
|
0 0
|
297 1
|
0 0
|
111 1
|
0 0
|
134 1
|
0 0
|
110 1
|
0 0
|
176 1
|
0 0
|
|
Period 1 (Weeks 1-8)
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Period 2 (Weeks 9-16)
STARTED
|
0 0
|
0 0
|
353 1
|
0 0
|
167 1
|
0 0
|
98 1
|
0 0
|
124 1
|
0 0
|
266 1
|
0 0
|
|
Period 2 (Weeks 9-16)
Index Participants
|
0 0
|
0 0
|
64 1
|
0 0
|
43 1
|
0 0
|
30 1
|
0 0
|
25 1
|
0 0
|
69 1
|
0 0
|
|
Period 2 (Weeks 9-16)
Close Contacts
|
0 0
|
0 0
|
289 1
|
0 0
|
124 1
|
0 0
|
68 1
|
0 0
|
99 1
|
0 0
|
197 1
|
0 0
|
|
Period 2 (Weeks 9-16)
COMPLETED
|
0 0
|
0 0
|
353 1
|
0 0
|
167 1
|
0 0
|
98 1
|
0 0
|
124 1
|
0 0
|
266 1
|
0 0
|
|
Period 2 (Weeks 9-16)
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Period 3 (Weeks 17-24)
STARTED
|
0 0
|
304 1
|
0 0
|
0 0
|
238 1
|
0 0
|
73 1
|
0 0
|
155 1
|
0 0
|
217 1
|
0 0
|
|
Period 3 (Weeks 17-24)
Index Participants
|
0 0
|
53 1
|
0 0
|
0 0
|
49 1
|
0 0
|
20 1
|
0 0
|
29 1
|
0 0
|
55 1
|
0 0
|
|
Period 3 (Weeks 17-24)
Close Contacts
|
0 0
|
251 1
|
0 0
|
0 0
|
189 1
|
0 0
|
53 1
|
0 0
|
126 1
|
0 0
|
162 1
|
0 0
|
|
Period 3 (Weeks 17-24)
COMPLETED
|
0 0
|
304 1
|
0 0
|
0 0
|
238 1
|
0 0
|
73 1
|
0 0
|
155 1
|
0 0
|
217 1
|
0 0
|
|
Period 3 (Weeks 17-24)
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Period 4 (Weeks 25-32)
STARTED
|
0 0
|
311 1
|
0 0
|
495 1
|
0 0
|
0 0
|
166 1
|
0 0
|
105 1
|
0 0
|
227 1
|
0 0
|
|
Period 4 (Weeks 25-32)
Index Participants
|
0 0
|
62 1
|
0 0
|
69 1
|
0 0
|
0 0
|
48 1
|
0 0
|
17 1
|
0 0
|
55 1
|
0 0
|
|
Period 4 (Weeks 25-32)
Close Contacts
|
0 0
|
249 1
|
0 0
|
426 1
|
0 0
|
0 0
|
118 1
|
0 0
|
88 1
|
0 0
|
172 1
|
0 0
|
|
Period 4 (Weeks 25-32)
COMPLETED
|
0 0
|
311 1
|
0 0
|
495 1
|
0 0
|
0 0
|
166 1
|
0 0
|
105 1
|
0 0
|
227 1
|
0 0
|
|
Period 4 (Weeks 25-32)
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Period 5 (Weeks 33-40)
STARTED
|
0 0
|
247 1
|
0 0
|
385 1
|
0 0
|
563 1
|
0 0
|
0 0
|
175 1
|
0 0
|
163 1
|
0 0
|
|
Period 5 (Weeks 33-40)
Index Participants
|
0 0
|
38 1
|
0 0
|
43 1
|
0 0
|
71 1
|
0 0
|
0 0
|
29 1
|
0 0
|
40 1
|
0 0
|
|
Period 5 (Weeks 33-40)
Close Contacts
|
0 0
|
209 1
|
0 0
|
342 1
|
0 0
|
492 1
|
0 0
|
0 0
|
146 1
|
0 0
|
123 1
|
0 0
|
|
Period 5 (Weeks 33-40)
COMPLETED
|
0 0
|
247 1
|
0 0
|
385 1
|
0 0
|
563 1
|
0 0
|
0 0
|
175 1
|
0 0
|
163 1
|
0 0
|
|
Period 5 (Weeks 33-40)
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Period 6 (Week 41-48)
STARTED
|
0 0
|
193 1
|
0 0
|
414 1
|
0 0
|
395 1
|
0 0
|
241 1
|
0 0
|
0 0
|
277 1
|
0 0
|
|
Period 6 (Week 41-48)
Index Participants
|
0 0
|
38 1
|
0 0
|
56 1
|
0 0
|
50 1
|
0 0
|
42 1
|
0 0
|
0 0
|
54 1
|
0 0
|
|
Period 6 (Week 41-48)
Close Contacts
|
0 0
|
155 1
|
0 0
|
358 1
|
0 0
|
345 1
|
0 0
|
199 1
|
0 0
|
0 0
|
223 1
|
0 0
|
|
Period 6 (Week 41-48)
COMPLETED
|
0 0
|
193 1
|
0 0
|
414 1
|
0 0
|
395 1
|
0 0
|
241 1
|
0 0
|
0 0
|
277 1
|
0 0
|
|
Period 6 (Week 41-48)
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Period 7 (Weeks 49-56)
STARTED
|
0 0
|
273 1
|
0 0
|
367 1
|
0 0
|
257 1
|
0 0
|
283 1
|
0 0
|
216 1
|
0 0
|
0 0
|
|
Period 7 (Weeks 49-56)
Index Participants
|
0 0
|
46 1
|
0 0
|
50 1
|
0 0
|
37 1
|
0 0
|
53 1
|
0 0
|
29 1
|
0 0
|
0 0
|
|
Period 7 (Weeks 49-56)
Close Contacts
|
0 0
|
227 1
|
0 0
|
317 1
|
0 0
|
220 1
|
0 0
|
230 1
|
0 0
|
187 1
|
0 0
|
0 0
|
|
Period 7 (Weeks 49-56)
COMPLETED
|
0 0
|
273 1
|
0 0
|
367 1
|
0 0
|
257 1
|
0 0
|
283 1
|
0 0
|
216 1
|
0 0
|
0 0
|
|
Period 7 (Weeks 49-56)
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Period 8 (Weeks 57-64)
STARTED
|
0 0
|
188 1
|
0 0
|
322 1
|
0 0
|
448 1
|
0 0
|
317 1
|
0 0
|
227 1
|
0 0
|
314 1
|
|
Period 8 (Weeks 57-64)
Index Participants
|
0 0
|
36 1
|
0 0
|
41 1
|
0 0
|
48 1
|
0 0
|
61 1
|
0 0
|
35 1
|
0 0
|
41 1
|
|
Period 8 (Weeks 57-64)
Close Contacts
|
0 0
|
152 1
|
0 0
|
281 1
|
0 0
|
400 1
|
0 0
|
256 1
|
0 0
|
192 1
|
0 0
|
273 1
|
|
Period 8 (Weeks 57-64)
COMPLETED
|
0 0
|
188 1
|
0 0
|
322 1
|
0 0
|
448 1
|
0 0
|
317 1
|
0 0
|
227 1
|
0 0
|
314 1
|
|
Period 8 (Weeks 57-64)
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Human-centered Design and Communities of Practice to Improve Home-based Tuberculosis Contact Investigation in Uganda
Baseline characteristics by cohort
| Measure |
Standard Contact Investigation: Index Participants
n=843 Participants
Standard contact investigation consists of 1) evidence-based procedures for TB contact investigation, introduced with 2) a standard implementation strategy.
Standard contact investigation:
Once an eligible TB patient agrees to participate, CHWs will visit the patient to assess the eligibility of close contacts to participate.
For eligible contacts who agree to participate, the CHW will perform TB symptom screening and arrange subsequent microbiologic, clinical, and/or radiographic evaluation. Those screening TB symptom-positive will be asked to expectorate a sputum sample, unless under age 5. If under age 5 or unable to produce sputum, contacts will be referred to the health centre for evaluation. A CHW will transport sputum samples to the health-centre laboratory for microbiologic evaluation and later report the test results back to the contact.
Standard Implementation Strategy:
CHWs at all sites will receive the standard TB program training on TB contact investigation and supportive supervision from the on-site National TB Program focal person.
|
Standard Contact Investigation: Household Contacts
n=2874 Participants
Standard contact investigation consists of 1) evidence-based procedures for TB contact investigation, introduced with 2) a standard implementation strategy.
Standard contact investigation:
Once an eligible TB patient agrees to participate, CHWs will visit the patient to assess the eligibility of close contacts to participate.
For eligible contacts who agree to participate, the CHW will perform TB symptom screening and arrange subsequent microbiologic, clinical, and/or radiographic evaluation. Those screening TB symptom-positive will be asked to expectorate a sputum sample, unless under age 5. If under age 5 or unable to produce sputum, contacts will be referred to the health centre for evaluation. A CHW will transport sputum samples to the health-centre laboratory for microbiologic evaluation and later report the test results back to the contact.
Standard Implementation Strategy:
CHWs at all sites will receive the standard TB program training on TB contact investigation and supportive supervision from the on-site National TB Program focal person.
|
User-centered Contact Investigation: Index Participants
n=999 Participants
User-centered Contact Investigation includes 4 client-facing adaptations of standard contact investigation and 3 CHW-facing implementation strategies Client-centered adaptations of contact investigation delivered as a branded package called Tuli Wamu Nawe: Four novel tools TB education pamphlet to help index TB persons disclose the need for TB screening to close contacts.
Contact identification algorithm to help CHWs and index TB persons accurately enumerate contacts.
Sputum collection video to instruct contacts to expectorate good-quality sputum.
Community Health Riders to transport CHWs, index persons with TB, and contacts by motorcycle taxi, and collect and transport sputum.
CHW-centered Implementation Strategy: Three components Weekly CHW meetings to create communities of practice (CoP), which consist of professionals organized for peer support and systematic learning.
Audit and feedback reports on contact investigation performance indicators delivered weekly (individual CHW) and monthly (health facility).
A group-chat application to facilitate peer support among CHWs.
|
User-centered Contact Investigation: Household Contacts
n=5761 Participants
User-centered Contact Investigation includes 4 client-facing adaptations of standard contact investigation and 3 CHW-facing implementation strategies Client-centered adaptations of contact investigation delivered as a branded package called Tuli Wamu Nawe: Four novel tools TB education pamphlet to help index TB persons disclose the need for TB screening to close contacts.
Contact identification algorithm to help CHWs and index TB persons accurately enumerate contacts.
Sputum collection video to instruct contacts to expectorate good-quality sputum.
Community Health Riders to transport CHWs, index persons with TB, and contacts by motorcycle taxi, and collect and transport sputum.
CHW-centered Implementation Strategy: Three components Weekly CHW meetings to create communities of practice (CoP), which consist of professionals organized for peer support and systematic learning.
Audit and feedback reports on contact investigation performance indicators delivered weekly (individual CHW) and monthly (health facility).
A group-chat application to facilitate peer support among CHWs.
|
Total
n=10477 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<5 years
|
81 Participants
n=93 Participants
|
310 Participants
n=4 Participants
|
63 Participants
n=27 Participants
|
648 Participants
n=483 Participants
|
1102 Participants
n=36 Participants
|
|
Age, Customized
5-14 years
|
51 Participants
n=93 Participants
|
808 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
1603 Participants
n=483 Participants
|
2511 Participants
n=36 Participants
|
|
Age, Customized
≥15 years
|
711 Participants
n=93 Participants
|
1756 Participants
n=4 Participants
|
887 Participants
n=27 Participants
|
3510 Participants
n=483 Participants
|
6864 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
379 Participants
n=93 Participants
|
1591 Participants
n=4 Participants
|
415 Participants
n=27 Participants
|
2987 Participants
n=483 Participants
|
5372 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
464 Participants
n=93 Participants
|
1283 Participants
n=4 Participants
|
584 Participants
n=27 Participants
|
2774 Participants
n=483 Participants
|
5105 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
843 Participants
n=93 Participants
|
2874 Participants
n=4 Participants
|
999 Participants
n=27 Participants
|
5761 Participants
n=483 Participants
|
10477 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
843 Participants
n=93 Participants
|
2874 Participants
n=4 Participants
|
999 Participants
n=27 Participants
|
5761 Participants
n=483 Participants
|
10477 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
Uganda
|
843 participants
n=93 Participants
|
2874 participants
n=4 Participants
|
999 participants
n=27 Participants
|
5761 participants
n=483 Participants
|
10477 participants
n=36 Participants
|
|
Person living with HIV
|
343 participants
n=93 Participants
|
142 participants
n=4 Participants
|
461 participants
n=27 Participants
|
235 participants
n=483 Participants
|
1181 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 60 daysPopulation: Only those who screened positive for symptoms of TB are included in this analysis
The percentage of participants (close contacts) who are experiencing TB symptoms who complete TB evaluation within 60 days of the TB patient's treatment initiation date
Outcome measures
| Measure |
Standard Implementation Strategy Period
n=560 Participants
During the standard implementation strategy period, CHWs at all sites will receive the standard TB program training on TB contact investigation and supportive supervision from the on-site National TB Program focal person.
Standard Implementation Strategy: Once an eligible TB patient agrees to participate, CHWs will visit the patient to assess the eligibility of close contacts to participate. For eligible contacts who agree to participate, the CHW will perform TB symptom screening and arrange subsequent microbiologic, clinical, and/or radiographic evaluation. Those screening TB symptom-positive will be asked to expectorate a sputum sample, unless under age 5. If under age 5 or unable to produce sputum, contacts will be referred to the health centre for evaluation. A CHW will transport sputum samples to the health-centre laboratory for microbiologic evaluation and later report the test results back to the contact. During the standard implementation strategy period, CHWs at all sites will receive the standard TB program training on TB contact investigation and supportive supervision from the on-site National TB Program focal person.
|
Enhanced Contact Investigation Intervention Period
n=1329 Participants
The enhanced contact investigation strategy includes 4 implementation facilitation tools and 3 continuous quality improvement techniques delivered as a branded package. Implementation tools include 1) a TB education pamphlet, 2) a contact identification algorithm, 3) an instructional video on sputum collection, and 4) community health riders who transport clients, community health workers, and sputum samples by motorcycle. The continuous quality improvement techniques delivered as the community of practice package include 1) community of practice meetings, 2) audit and feedback reports and 3) a group chat application.
User-Centered Implementation Strategy: 1) 4 participant-facing components: 1a) TB education pamphlet helps index TB persons disclose the need for household screening to contacts. 1b) Contact identification algorithm helps CHWs and index TB persons accurately enumerate contacts. 1c) Sputum collection video instructs contacts to expectorate good-quality sputum. 1d) Community Health Riders transport CHWs, index persons with TB, and contacts by motorcycle taxi, and collect and transport sputum.
2\) 3 community health-worker-facing components: a) Weekly CHW meetings create communities of practice (CoP), professionals organized for peer support and systematic learning. 2b) Audit and feedback reports on contact investigation performance indicators weekly (individual CHW) and monthly (health facility). 2c) A group-chat application facilitates peer support among CHWs.
|
|---|---|---|
|
Completion of TB Evaluation
|
266 Participants
|
1144 Participants
|
SECONDARY outcome
Timeframe: 60 daysThe difference between study periods in percentage of contacts diagnosed with active TB and initiated on treatment within 60 days of the TB patient's treatment initiation
Outcome measures
| Measure |
Standard Implementation Strategy Period
n=2874 Participants
During the standard implementation strategy period, CHWs at all sites will receive the standard TB program training on TB contact investigation and supportive supervision from the on-site National TB Program focal person.
Standard Implementation Strategy: Once an eligible TB patient agrees to participate, CHWs will visit the patient to assess the eligibility of close contacts to participate. For eligible contacts who agree to participate, the CHW will perform TB symptom screening and arrange subsequent microbiologic, clinical, and/or radiographic evaluation. Those screening TB symptom-positive will be asked to expectorate a sputum sample, unless under age 5. If under age 5 or unable to produce sputum, contacts will be referred to the health centre for evaluation. A CHW will transport sputum samples to the health-centre laboratory for microbiologic evaluation and later report the test results back to the contact. During the standard implementation strategy period, CHWs at all sites will receive the standard TB program training on TB contact investigation and supportive supervision from the on-site National TB Program focal person.
|
Enhanced Contact Investigation Intervention Period
n=5761 Participants
The enhanced contact investigation strategy includes 4 implementation facilitation tools and 3 continuous quality improvement techniques delivered as a branded package. Implementation tools include 1) a TB education pamphlet, 2) a contact identification algorithm, 3) an instructional video on sputum collection, and 4) community health riders who transport clients, community health workers, and sputum samples by motorcycle. The continuous quality improvement techniques delivered as the community of practice package include 1) community of practice meetings, 2) audit and feedback reports and 3) a group chat application.
User-Centered Implementation Strategy: 1) 4 participant-facing components: 1a) TB education pamphlet helps index TB persons disclose the need for household screening to contacts. 1b) Contact identification algorithm helps CHWs and index TB persons accurately enumerate contacts. 1c) Sputum collection video instructs contacts to expectorate good-quality sputum. 1d) Community Health Riders transport CHWs, index persons with TB, and contacts by motorcycle taxi, and collect and transport sputum.
2\) 3 community health-worker-facing components: a) Weekly CHW meetings create communities of practice (CoP), professionals organized for peer support and systematic learning. 2b) Audit and feedback reports on contact investigation performance indicators weekly (individual CHW) and monthly (health facility). 2c) A group-chat application facilitates peer support among CHWs.
|
|---|---|---|
|
TB Yield (Diagnosis and Treatment Initiation)
|
36 Participants
|
187 Participants
|
SECONDARY outcome
Timeframe: 60 daysPopulation: Only those eligible for TPT are included in this analysis. Those that have been newly diagnosed with TB, regardless of treatment status, are not eligible for TPT and are therefore excluded from this analysis
The difference between study periods in percentage of contacts initiating TB preventative therapy (TPT) within 60 days of the TB patient's treatment initiation
Outcome measures
| Measure |
Standard Implementation Strategy Period
n=2829 Participants
During the standard implementation strategy period, CHWs at all sites will receive the standard TB program training on TB contact investigation and supportive supervision from the on-site National TB Program focal person.
Standard Implementation Strategy: Once an eligible TB patient agrees to participate, CHWs will visit the patient to assess the eligibility of close contacts to participate. For eligible contacts who agree to participate, the CHW will perform TB symptom screening and arrange subsequent microbiologic, clinical, and/or radiographic evaluation. Those screening TB symptom-positive will be asked to expectorate a sputum sample, unless under age 5. If under age 5 or unable to produce sputum, contacts will be referred to the health centre for evaluation. A CHW will transport sputum samples to the health-centre laboratory for microbiologic evaluation and later report the test results back to the contact. During the standard implementation strategy period, CHWs at all sites will receive the standard TB program training on TB contact investigation and supportive supervision from the on-site National TB Program focal person.
|
Enhanced Contact Investigation Intervention Period
n=5560 Participants
The enhanced contact investigation strategy includes 4 implementation facilitation tools and 3 continuous quality improvement techniques delivered as a branded package. Implementation tools include 1) a TB education pamphlet, 2) a contact identification algorithm, 3) an instructional video on sputum collection, and 4) community health riders who transport clients, community health workers, and sputum samples by motorcycle. The continuous quality improvement techniques delivered as the community of practice package include 1) community of practice meetings, 2) audit and feedback reports and 3) a group chat application.
User-Centered Implementation Strategy: 1) 4 participant-facing components: 1a) TB education pamphlet helps index TB persons disclose the need for household screening to contacts. 1b) Contact identification algorithm helps CHWs and index TB persons accurately enumerate contacts. 1c) Sputum collection video instructs contacts to expectorate good-quality sputum. 1d) Community Health Riders transport CHWs, index persons with TB, and contacts by motorcycle taxi, and collect and transport sputum.
2\) 3 community health-worker-facing components: a) Weekly CHW meetings create communities of practice (CoP), professionals organized for peer support and systematic learning. 2b) Audit and feedback reports on contact investigation performance indicators weekly (individual CHW) and monthly (health facility). 2c) A group-chat application facilitates peer support among CHWs.
|
|---|---|---|
|
Initiation of TB Preventative Therapy
|
122 Participants
|
264 Participants
|
SECONDARY outcome
Timeframe: 60 daysThe difference between study periods in counts of the number of contacts diagnosed with active TB
Outcome measures
| Measure |
Standard Implementation Strategy Period
n=2874 Participants
During the standard implementation strategy period, CHWs at all sites will receive the standard TB program training on TB contact investigation and supportive supervision from the on-site National TB Program focal person.
Standard Implementation Strategy: Once an eligible TB patient agrees to participate, CHWs will visit the patient to assess the eligibility of close contacts to participate. For eligible contacts who agree to participate, the CHW will perform TB symptom screening and arrange subsequent microbiologic, clinical, and/or radiographic evaluation. Those screening TB symptom-positive will be asked to expectorate a sputum sample, unless under age 5. If under age 5 or unable to produce sputum, contacts will be referred to the health centre for evaluation. A CHW will transport sputum samples to the health-centre laboratory for microbiologic evaluation and later report the test results back to the contact. During the standard implementation strategy period, CHWs at all sites will receive the standard TB program training on TB contact investigation and supportive supervision from the on-site National TB Program focal person.
|
Enhanced Contact Investigation Intervention Period
n=5761 Participants
The enhanced contact investigation strategy includes 4 implementation facilitation tools and 3 continuous quality improvement techniques delivered as a branded package. Implementation tools include 1) a TB education pamphlet, 2) a contact identification algorithm, 3) an instructional video on sputum collection, and 4) community health riders who transport clients, community health workers, and sputum samples by motorcycle. The continuous quality improvement techniques delivered as the community of practice package include 1) community of practice meetings, 2) audit and feedback reports and 3) a group chat application.
User-Centered Implementation Strategy: 1) 4 participant-facing components: 1a) TB education pamphlet helps index TB persons disclose the need for household screening to contacts. 1b) Contact identification algorithm helps CHWs and index TB persons accurately enumerate contacts. 1c) Sputum collection video instructs contacts to expectorate good-quality sputum. 1d) Community Health Riders transport CHWs, index persons with TB, and contacts by motorcycle taxi, and collect and transport sputum.
2\) 3 community health-worker-facing components: a) Weekly CHW meetings create communities of practice (CoP), professionals organized for peer support and systematic learning. 2b) Audit and feedback reports on contact investigation performance indicators weekly (individual CHW) and monthly (health facility). 2c) A group-chat application facilitates peer support among CHWs.
|
|---|---|---|
|
Number of Contacts Diagnosed With Active TB
|
45 Participants
|
201 Participants
|
SECONDARY outcome
Timeframe: 60 daysPopulation: This outcome is only for those eligible to initiate TPT. Those who have been newly diagnosed, regardless of treatment status, are not eligible for TPT and are therefore excluded from this outcome.
The difference between study periods in counts of the number of contacts initiating TPT
Outcome measures
| Measure |
Standard Implementation Strategy Period
n=2829 Participants
During the standard implementation strategy period, CHWs at all sites will receive the standard TB program training on TB contact investigation and supportive supervision from the on-site National TB Program focal person.
Standard Implementation Strategy: Once an eligible TB patient agrees to participate, CHWs will visit the patient to assess the eligibility of close contacts to participate. For eligible contacts who agree to participate, the CHW will perform TB symptom screening and arrange subsequent microbiologic, clinical, and/or radiographic evaluation. Those screening TB symptom-positive will be asked to expectorate a sputum sample, unless under age 5. If under age 5 or unable to produce sputum, contacts will be referred to the health centre for evaluation. A CHW will transport sputum samples to the health-centre laboratory for microbiologic evaluation and later report the test results back to the contact. During the standard implementation strategy period, CHWs at all sites will receive the standard TB program training on TB contact investigation and supportive supervision from the on-site National TB Program focal person.
|
Enhanced Contact Investigation Intervention Period
n=5560 Participants
The enhanced contact investigation strategy includes 4 implementation facilitation tools and 3 continuous quality improvement techniques delivered as a branded package. Implementation tools include 1) a TB education pamphlet, 2) a contact identification algorithm, 3) an instructional video on sputum collection, and 4) community health riders who transport clients, community health workers, and sputum samples by motorcycle. The continuous quality improvement techniques delivered as the community of practice package include 1) community of practice meetings, 2) audit and feedback reports and 3) a group chat application.
User-Centered Implementation Strategy: 1) 4 participant-facing components: 1a) TB education pamphlet helps index TB persons disclose the need for household screening to contacts. 1b) Contact identification algorithm helps CHWs and index TB persons accurately enumerate contacts. 1c) Sputum collection video instructs contacts to expectorate good-quality sputum. 1d) Community Health Riders transport CHWs, index persons with TB, and contacts by motorcycle taxi, and collect and transport sputum.
2\) 3 community health-worker-facing components: a) Weekly CHW meetings create communities of practice (CoP), professionals organized for peer support and systematic learning. 2b) Audit and feedback reports on contact investigation performance indicators weekly (individual CHW) and monthly (health facility). 2c) A group-chat application facilitates peer support among CHWs.
|
|---|---|---|
|
Number of Contacts Initiating TB Preventative Therapy
|
122 Participants
|
264 Participants
|
SECONDARY outcome
Timeframe: 60 daysThe difference between study periods in percentage of all TB cases among contacts
Outcome measures
| Measure |
Standard Implementation Strategy Period
n=2874 Participants
During the standard implementation strategy period, CHWs at all sites will receive the standard TB program training on TB contact investigation and supportive supervision from the on-site National TB Program focal person.
Standard Implementation Strategy: Once an eligible TB patient agrees to participate, CHWs will visit the patient to assess the eligibility of close contacts to participate. For eligible contacts who agree to participate, the CHW will perform TB symptom screening and arrange subsequent microbiologic, clinical, and/or radiographic evaluation. Those screening TB symptom-positive will be asked to expectorate a sputum sample, unless under age 5. If under age 5 or unable to produce sputum, contacts will be referred to the health centre for evaluation. A CHW will transport sputum samples to the health-centre laboratory for microbiologic evaluation and later report the test results back to the contact. During the standard implementation strategy period, CHWs at all sites will receive the standard TB program training on TB contact investigation and supportive supervision from the on-site National TB Program focal person.
|
Enhanced Contact Investigation Intervention Period
n=5761 Participants
The enhanced contact investigation strategy includes 4 implementation facilitation tools and 3 continuous quality improvement techniques delivered as a branded package. Implementation tools include 1) a TB education pamphlet, 2) a contact identification algorithm, 3) an instructional video on sputum collection, and 4) community health riders who transport clients, community health workers, and sputum samples by motorcycle. The continuous quality improvement techniques delivered as the community of practice package include 1) community of practice meetings, 2) audit and feedback reports and 3) a group chat application.
User-Centered Implementation Strategy: 1) 4 participant-facing components: 1a) TB education pamphlet helps index TB persons disclose the need for household screening to contacts. 1b) Contact identification algorithm helps CHWs and index TB persons accurately enumerate contacts. 1c) Sputum collection video instructs contacts to expectorate good-quality sputum. 1d) Community Health Riders transport CHWs, index persons with TB, and contacts by motorcycle taxi, and collect and transport sputum.
2\) 3 community health-worker-facing components: a) Weekly CHW meetings create communities of practice (CoP), professionals organized for peer support and systematic learning. 2b) Audit and feedback reports on contact investigation performance indicators weekly (individual CHW) and monthly (health facility). 2c) A group-chat application facilitates peer support among CHWs.
|
|---|---|---|
|
TB Yield (All Contacts)
|
45 Participants
|
201 Participants
|
Adverse Events
Standard Contact Investigation [Control]: Sequence 1 [2 Health Facilities]
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
User-centered Contact Investigation [Intervention]: Sequence 1 [2 Health Facilities]
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Contact Investigation [Control]: Sequence 2 [2 Health Facilities]
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
User-centered Contact Investigation [Intervention]: Sequence 2 [2 Health Facilities]
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Contact Investigation [Control]: Sequence 3 [2 Health Facilities]
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
User-centered Contact Investigation [Intervention]: Sequence 3 [2 Health Facilities]
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Contact Investigation [Control]: Sequence 4 [2 Health Facilities]
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
User-centered Contact Investigation [Intervention]: Sequence 4 [2 Health Facilities]
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Contact Investigation [Control]: Sequence 5 [2 Health Facilities]
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
User-centered Contact Investigation [Intervention]: Sequence 5 [2 Health Facilities]
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Contact Investigation [Control]: Sequence 6 [2 Health Facilities]
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
User-centered Contact Investigation [Intervention]: Sequence 6 [2 Health Facilities]
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place