Trial Outcomes & Findings for Interrupting HIV and TB Stigma in the Household in Uganda (NCT NCT05124665)

NCT ID: NCT05124665

Last Updated: 2024-02-14

Results Overview

To test the hypothesis that a norming intervention can increase test uptake, the investigators will compare testing uptake among the intervention households and control households using cluster-adjusted chi-squared tests of proportion and by fitting mixed effects logistic regression models with two levels (household, contact). The effect of the intervention will then be evaluated by comparing adjusted slope differences in the primary outcomes (test uptake) between the intervention and the control arms, using random intercept mixed logit models to account for clustering by household.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

612 participants

Primary outcome timeframe

up to 8 weeks

Results posted on

2024-02-14

Participant Flow

208 index participants were randomized to be contacted for either Social Support or Standard of Care were identified and randomized to be approached in the community. Presented are the totals that agreed to participate in terms of the number of index participants that consented to participants and then added household contacts that consented to also participate.

Participant milestones

Participant milestones
Measure
Social Support
CHWs will offer HIV testing to the individual nominated by the index patient as most likely to test. If this person is not present, CHWs will decide which contact should be offered testing first. CHWs will use a prosocial script for HIV testing: "Knowing your status sets a good example for your household." CHWs will follow an "opt-out" strategy: "This test kit is approved by the Ministry of Health and used in KCCA health facilities. I am going to offer you a free HIV test now, is that okay?". If the initial household contact who is offered HIV testing agrees to test, the CHW will ask if he/she is willing to share his/her decision to test with other members of the household: "Would you like to share your decision to test with the others? Sharing is completely optional. However, learning that someone else in their household decided to test sometimes gives people the strength to test themselves. Sharing your decision might help another person find the strength to test." Social Support: The intervention to be evaluated in this study is a multidimensional, socio-behavioral "Norming" intervention. The various components of this intervention are designed to harness household dynamics and prosocial inclinations to encourage individuals to accept the HIV testing invitation. Each component is briefly described in the arm description.
Standard of Care
As a control for the socio-behavioral intervention, the control arm will lack the socio-behavioral intervention components. The order of testing invitation will be decided by the CHW; and CHWs will be trained at baseline to provide standard, opt-in framing of test offers, without any mention of asking contacts to share their testing decision with other household contacts. Oral HIV kits will also be used in control households.
Overall Study
STARTED
364
248
Overall Study
Index Patients
79
61
Overall Study
Household Contacts
285
187
Overall Study
COMPLETED
364
248
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Social Support: Household Contacts
n=285 Participants
CHWs will offer HIV testing to the individual nominated by the index patient as most likely to test. If this person is not present, CHWs will decide which contact should be offered testing first. CHWs will use a prosocial script for HIV testing: "Knowing your status sets a good example for your household." CHWs will follow an "opt-out" strategy: "This test kit is approved by the Ministry of Health and used in KCCA health facilities. I am going to offer you a free HIV test now, is that okay?". If the initial household contact who is offered HIV testing agrees to test, the CHW will ask if he/she is willing to share his/her decision to test with other members of the household: "Would you like to share your decision to test with the others? Sharing is completely optional. However, learning that someone else in their household decided to test sometimes gives people the strength to test themselves. Sharing your decision might help another person find the strength to test." Social Support: The intervention to be evaluated in this study is a multidimensional, socio-behavioral "Norming" intervention. The various components of this intervention are designed to harness household dynamics and prosocial inclinations to encourage individuals to accept the HIV testing invitation. Each component is briefly described in the arm description.
Social Support: Index Participants
n=79 Participants
Social Support: The intervention to be evaluated in this study is a multidimensional, socio-behavioral "Norming" intervention. The various components of this intervention are designed to harness household dynamics and prosocial inclinations to encourage individuals to accept the HIV testing invitation. Each component is briefly described in the arm description.
Standard of Care: Household Contacts
n=187 Participants
As a control for the socio-behavioral intervention, the control arm will lack the socio-behavioral intervention components. The order of testing invitation will be decided by the CHW; and CHWs will be trained at baseline to provide standard, opt-in framing of test offers, without any mention of asking contacts to share their testing decision with other household contacts. Oral HIV kits will also be used in control households.
Standard of Care: Index Participants
n=61 Participants
As a control for the socio-behavioral intervention, the control arm will lack the socio-behavioral intervention components. The order of testing invitation will be decided by the CHW; and CHWs will be trained at baseline to provide standard, opt-in framing of test offers, without any mention of asking contacts to share their testing decision with other household contacts. Oral HIV kits will also be used in control households.
Total
n=612 Participants
Total of all reporting groups
Age, Continuous
29.6 years
STANDARD_DEVIATION 12.7 • n=285 Participants
31.3 years
STANDARD_DEVIATION 16.9 • n=79 Participants
31.4 years
STANDARD_DEVIATION 14.4 • n=187 Participants
28.6 years
STANDARD_DEVIATION 18.5 • n=61 Participants
30.3 years
STANDARD_DEVIATION 13.4 • n=612 Participants
Sex: Female, Male
Female
187 Participants
n=285 Participants
35 Participants
n=79 Participants
122 Participants
n=187 Participants
22 Participants
n=61 Participants
366 Participants
n=612 Participants
Sex: Female, Male
Male
98 Participants
n=285 Participants
44 Participants
n=79 Participants
65 Participants
n=187 Participants
39 Participants
n=61 Participants
246 Participants
n=612 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
Uganda
285 participants
n=285 Participants • Count of Index Participants
79 participants
n=79 Participants • Count of Index Participants
187 participants
n=187 Participants • Count of Index Participants
61 participants
n=61 Participants • Count of Index Participants
612 participants
n=612 Participants • Count of Index Participants
HIV Status
Not Known to be Living with HIV
224 Participants
n=285 Participants
50 Participants
n=79 Participants
152 Participants
n=187 Participants
49 Participants
n=61 Participants
475 Participants
n=612 Participants
HIV Status
Unknown/Never Tested
61 Participants
n=285 Participants
0 Participants
n=79 Participants
35 Participants
n=187 Participants
0 Participants
n=61 Participants
96 Participants
n=612 Participants
HIV Status
Person Living with HIV
0 Participants
n=285 Participants
29 Participants
n=79 Participants
0 Participants
n=187 Participants
12 Participants
n=61 Participants
41 Participants
n=612 Participants
Education Level
No Formal Education
13 Participants
n=285 Participants • Education data collected only for Household Contacts
7 Participants
n=187 Participants • Education data collected only for Household Contacts
20 Participants
n=472 Participants • Education data collected only for Household Contacts
Education Level
Level 1-4
22 Participants
n=285 Participants • Education data collected only for Household Contacts
15 Participants
n=187 Participants • Education data collected only for Household Contacts
37 Participants
n=472 Participants • Education data collected only for Household Contacts
Education Level
Level 5-7
66 Participants
n=285 Participants • Education data collected only for Household Contacts
50 Participants
n=187 Participants • Education data collected only for Household Contacts
116 Participants
n=472 Participants • Education data collected only for Household Contacts
Education Level
O-Level
104 Participants
n=285 Participants • Education data collected only for Household Contacts
66 Participants
n=187 Participants • Education data collected only for Household Contacts
170 Participants
n=472 Participants • Education data collected only for Household Contacts
Education Level
A-Level
38 Participants
n=285 Participants • Education data collected only for Household Contacts
18 Participants
n=187 Participants • Education data collected only for Household Contacts
56 Participants
n=472 Participants • Education data collected only for Household Contacts
Education Level
Vocational
5 Participants
n=285 Participants • Education data collected only for Household Contacts
5 Participants
n=187 Participants • Education data collected only for Household Contacts
10 Participants
n=472 Participants • Education data collected only for Household Contacts
Education Level
Tertiary/University
31 Participants
n=285 Participants • Education data collected only for Household Contacts
24 Participants
n=187 Participants • Education data collected only for Household Contacts
55 Participants
n=472 Participants • Education data collected only for Household Contacts
Education Level
Post-Graduate
6 Participants
n=285 Participants • Education data collected only for Household Contacts
2 Participants
n=187 Participants • Education data collected only for Household Contacts
8 Participants
n=472 Participants • Education data collected only for Household Contacts

PRIMARY outcome

Timeframe: up to 8 weeks

Population: Household Contacts

To test the hypothesis that a norming intervention can increase test uptake, the investigators will compare testing uptake among the intervention households and control households using cluster-adjusted chi-squared tests of proportion and by fitting mixed effects logistic regression models with two levels (household, contact). The effect of the intervention will then be evaluated by comparing adjusted slope differences in the primary outcomes (test uptake) between the intervention and the control arms, using random intercept mixed logit models to account for clustering by household.

Outcome measures

Outcome measures
Measure
Social Support: Household Contacts
n=285 Participants
CHWs will offer HIV testing to the individual nominated by the index patient as most likely to test. If this person is not present, CHWs will decide which contact should be offered testing first. CHWs will use a prosocial script for HIV testing: "Knowing your status sets a good example for your household." CHWs will follow an "opt-out" strategy: "This test kit is approved by the Ministry of Health and used in KCCA health facilities. I am going to offer you a free HIV test now, is that okay?". If the initial household contact who is offered HIV testing agrees to test, the CHW will ask if he/she is willing to share his/her decision to test with other members of the household: "Would you like to share your decision to test with the others? Sharing is completely optional. However, learning that someone else in their household decided to test sometimes gives people the strength to test themselves. Sharing your decision might help another person find the strength to test." Social Support: The intervention to be evaluated in this study is a multidimensional, socio-behavioral "Norming" intervention. The various components of this intervention are designed to harness household dynamics and prosocial inclinations to encourage individuals to accept the HIV testing invitation. Each component is briefly described in the arm description.
Standard of Care: Household Contacts
n=187 Participants
As a control for the socio-behavioral intervention, the control arm will lack the socio-behavioral intervention components. The order of testing invitation will be decided by the CHW; and CHWs will be trained at baseline to provide standard, opt-in framing of test offers, without any mention of asking contacts to share their testing decision with other household contacts. Oral HIV kits will also be used in control households.
Proportion of Contacts Accepting HIV Testing
279 Participants
172 Participants

SECONDARY outcome

Timeframe: Baseline to End of Interview (Up to 8 hours)

Population: Household Contacts

Change in HIV Stigma will be evaluated by measuring the change in HIV-TB stigma as measured by the Van Rie paired HIV-TB Stigma Scales (adapted for use in Uganda) using multilevel models. The investigators will use mixed effects Poisson regression models to evaluate changes in HIV stigma measured after the household visit among a two-stage,stratified random sample of participants. Van Rie Perceived TB and HIV Stigma scales adapted and validated in the Ugandan context are used. Scores range from 0 to 100 (standardized scale). Higher values represent higher levels of perceived stigma. The timeframe has been updated to reflect changes in follow up due to COVID-19 restrictions.

Outcome measures

Outcome measures
Measure
Social Support: Household Contacts
n=285 Participants
CHWs will offer HIV testing to the individual nominated by the index patient as most likely to test. If this person is not present, CHWs will decide which contact should be offered testing first. CHWs will use a prosocial script for HIV testing: "Knowing your status sets a good example for your household." CHWs will follow an "opt-out" strategy: "This test kit is approved by the Ministry of Health and used in KCCA health facilities. I am going to offer you a free HIV test now, is that okay?". If the initial household contact who is offered HIV testing agrees to test, the CHW will ask if he/she is willing to share his/her decision to test with other members of the household: "Would you like to share your decision to test with the others? Sharing is completely optional. However, learning that someone else in their household decided to test sometimes gives people the strength to test themselves. Sharing your decision might help another person find the strength to test." Social Support: The intervention to be evaluated in this study is a multidimensional, socio-behavioral "Norming" intervention. The various components of this intervention are designed to harness household dynamics and prosocial inclinations to encourage individuals to accept the HIV testing invitation. Each component is briefly described in the arm description.
Standard of Care: Household Contacts
n=187 Participants
As a control for the socio-behavioral intervention, the control arm will lack the socio-behavioral intervention components. The order of testing invitation will be decided by the CHW; and CHWs will be trained at baseline to provide standard, opt-in framing of test offers, without any mention of asking contacts to share their testing decision with other household contacts. Oral HIV kits will also be used in control households.
Change in Score of Perceived HIV Stigma
2.57 score on a scale
Standard Deviation 24.9
-0.21 score on a scale
Standard Deviation 18.6

SECONDARY outcome

Timeframe: Baseline to End of Interview (Up to 8 hours)

Population: Household Contacts

Change in TB Stigma will be evaluated by measuring the change in perceived TB stigma as measured by the Van Rie paired HIV-TB Stigma Scales (adapted for use in Uganda) using multilevel models. The investigators will use mixed effects Poisson regression models to evaluate changes in TB stigma measured after the household visit among a two-stage,stratified random sample of participants. Van Rie Perceived TB and HIV Stigma scales adapted and validated in the Ugandan context are used. Scores range from 0 to 100 (standardized scale). Higher values represent higher levels of perceived stigma. The timeframe has been updated to reflect changes in follow up due to COVID-19 restrictions.

Outcome measures

Outcome measures
Measure
Social Support: Household Contacts
n=285 Participants
CHWs will offer HIV testing to the individual nominated by the index patient as most likely to test. If this person is not present, CHWs will decide which contact should be offered testing first. CHWs will use a prosocial script for HIV testing: "Knowing your status sets a good example for your household." CHWs will follow an "opt-out" strategy: "This test kit is approved by the Ministry of Health and used in KCCA health facilities. I am going to offer you a free HIV test now, is that okay?". If the initial household contact who is offered HIV testing agrees to test, the CHW will ask if he/she is willing to share his/her decision to test with other members of the household: "Would you like to share your decision to test with the others? Sharing is completely optional. However, learning that someone else in their household decided to test sometimes gives people the strength to test themselves. Sharing your decision might help another person find the strength to test." Social Support: The intervention to be evaluated in this study is a multidimensional, socio-behavioral "Norming" intervention. The various components of this intervention are designed to harness household dynamics and prosocial inclinations to encourage individuals to accept the HIV testing invitation. Each component is briefly described in the arm description.
Standard of Care: Household Contacts
n=187 Participants
As a control for the socio-behavioral intervention, the control arm will lack the socio-behavioral intervention components. The order of testing invitation will be decided by the CHW; and CHWs will be trained at baseline to provide standard, opt-in framing of test offers, without any mention of asking contacts to share their testing decision with other household contacts. Oral HIV kits will also be used in control households.
Change in Score of Perceived TB Stigma
0.47 score on a scale
Standard Deviation 20.8
-2.52 score on a scale
Standard Deviation 17.8

SECONDARY outcome

Timeframe: Baseline to Immediately post intervention (up to 8 hours)

Population: Household Contacts

The investigators will conduct a causal mediation analysis to determine the degree to which the effects of the intervention on HIV stigma explain the improvement in HIV test uptake using observed-variable structural equation modeling. HIV stigma will be measured using the Van Rie paired HIV-TB Stigma Scales (adapted for use in Uganda) and standardized scores (0 to 100) will be utilized. Higher score represents higher levels of perceived stigma.

Outcome measures

Outcome measures
Measure
Social Support: Household Contacts
n=285 Participants
CHWs will offer HIV testing to the individual nominated by the index patient as most likely to test. If this person is not present, CHWs will decide which contact should be offered testing first. CHWs will use a prosocial script for HIV testing: "Knowing your status sets a good example for your household." CHWs will follow an "opt-out" strategy: "This test kit is approved by the Ministry of Health and used in KCCA health facilities. I am going to offer you a free HIV test now, is that okay?". If the initial household contact who is offered HIV testing agrees to test, the CHW will ask if he/she is willing to share his/her decision to test with other members of the household: "Would you like to share your decision to test with the others? Sharing is completely optional. However, learning that someone else in their household decided to test sometimes gives people the strength to test themselves. Sharing your decision might help another person find the strength to test." Social Support: The intervention to be evaluated in this study is a multidimensional, socio-behavioral "Norming" intervention. The various components of this intervention are designed to harness household dynamics and prosocial inclinations to encourage individuals to accept the HIV testing invitation. Each component is briefly described in the arm description.
Standard of Care: Household Contacts
n=187 Participants
As a control for the socio-behavioral intervention, the control arm will lack the socio-behavioral intervention components. The order of testing invitation will be decided by the CHW; and CHWs will be trained at baseline to provide standard, opt-in framing of test offers, without any mention of asking contacts to share their testing decision with other household contacts. Oral HIV kits will also be used in control households.
Change in Effects of Perceived HIV Stigma on HIV Test Uptake
2.59 units on a scale
Standard Deviation 24.75
-0.17 units on a scale
Standard Deviation 20.09

SECONDARY outcome

Timeframe: Baseline to End of Interview (Up to 8 hours)

Population: Household Contacts

The investigators will conduct a causal mediation analysis to determine the degree to which the effects of the intervention on TB stigma explain the improvement in HIV test uptake using observed-variable structural equation modeling. TB stigma will be measured using the Van Rie paired HIV-TB Stigma Scales (adapted for use in Uganda) and standardized scores (0 to 100) will be utilized. Higher score represents higher levels of perceived stigma.

Outcome measures

Outcome measures
Measure
Social Support: Household Contacts
n=285 Participants
CHWs will offer HIV testing to the individual nominated by the index patient as most likely to test. If this person is not present, CHWs will decide which contact should be offered testing first. CHWs will use a prosocial script for HIV testing: "Knowing your status sets a good example for your household." CHWs will follow an "opt-out" strategy: "This test kit is approved by the Ministry of Health and used in KCCA health facilities. I am going to offer you a free HIV test now, is that okay?". If the initial household contact who is offered HIV testing agrees to test, the CHW will ask if he/she is willing to share his/her decision to test with other members of the household: "Would you like to share your decision to test with the others? Sharing is completely optional. However, learning that someone else in their household decided to test sometimes gives people the strength to test themselves. Sharing your decision might help another person find the strength to test." Social Support: The intervention to be evaluated in this study is a multidimensional, socio-behavioral "Norming" intervention. The various components of this intervention are designed to harness household dynamics and prosocial inclinations to encourage individuals to accept the HIV testing invitation. Each component is briefly described in the arm description.
Standard of Care: Household Contacts
n=187 Participants
As a control for the socio-behavioral intervention, the control arm will lack the socio-behavioral intervention components. The order of testing invitation will be decided by the CHW; and CHWs will be trained at baseline to provide standard, opt-in framing of test offers, without any mention of asking contacts to share their testing decision with other household contacts. Oral HIV kits will also be used in control households.
Change in Effects of Perceived TB Stigma on HIV Test Uptake
-0.46 units on a scale
Standard Deviation 21.12
-2.34 units on a scale
Standard Deviation 16.82

SECONDARY outcome

Timeframe: up to 8 weeks

Population: Household Contacts

The investigators will measure the proportion of testing preference predictions made by the index patient about their household contacts that were accurate, that is, the proportion of household members who accepted the HIV test among those nominated by the index patient as being most likely to accept the HIV test. The proportion of first testers who accepted the HIV test in the intervention arm will be compared to the proportion of first testers who took the HIV test in the control arm.

Outcome measures

Outcome measures
Measure
Social Support: Household Contacts
n=59 Participants
CHWs will offer HIV testing to the individual nominated by the index patient as most likely to test. If this person is not present, CHWs will decide which contact should be offered testing first. CHWs will use a prosocial script for HIV testing: "Knowing your status sets a good example for your household." CHWs will follow an "opt-out" strategy: "This test kit is approved by the Ministry of Health and used in KCCA health facilities. I am going to offer you a free HIV test now, is that okay?". If the initial household contact who is offered HIV testing agrees to test, the CHW will ask if he/she is willing to share his/her decision to test with other members of the household: "Would you like to share your decision to test with the others? Sharing is completely optional. However, learning that someone else in their household decided to test sometimes gives people the strength to test themselves. Sharing your decision might help another person find the strength to test." Social Support: The intervention to be evaluated in this study is a multidimensional, socio-behavioral "Norming" intervention. The various components of this intervention are designed to harness household dynamics and prosocial inclinations to encourage individuals to accept the HIV testing invitation. Each component is briefly described in the arm description.
Standard of Care: Household Contacts
n=33 Participants
As a control for the socio-behavioral intervention, the control arm will lack the socio-behavioral intervention components. The order of testing invitation will be decided by the CHW; and CHWs will be trained at baseline to provide standard, opt-in framing of test offers, without any mention of asking contacts to share their testing decision with other household contacts. Oral HIV kits will also be used in control households.
Proportion of Index Patient Nominated Household Members Who Accept HIV Test
58 Participants
33 Participants

SECONDARY outcome

Timeframe: up to 8 weeks

Population: Household Contacts

The investigators will estimate in the intervention arm the effect of first testers' decision to disclose on subsequent testers' decisions to test in the intervention arm using a logistic regression model. This will be assessed with relative risk of first testers' decision to disclose testing decision on subsequent household members decision to test for HIV.

Outcome measures

Outcome measures
Measure
Social Support: Household Contacts
n=285 Participants
CHWs will offer HIV testing to the individual nominated by the index patient as most likely to test. If this person is not present, CHWs will decide which contact should be offered testing first. CHWs will use a prosocial script for HIV testing: "Knowing your status sets a good example for your household." CHWs will follow an "opt-out" strategy: "This test kit is approved by the Ministry of Health and used in KCCA health facilities. I am going to offer you a free HIV test now, is that okay?". If the initial household contact who is offered HIV testing agrees to test, the CHW will ask if he/she is willing to share his/her decision to test with other members of the household: "Would you like to share your decision to test with the others? Sharing is completely optional. However, learning that someone else in their household decided to test sometimes gives people the strength to test themselves. Sharing your decision might help another person find the strength to test." Social Support: The intervention to be evaluated in this study is a multidimensional, socio-behavioral "Norming" intervention. The various components of this intervention are designed to harness household dynamics and prosocial inclinations to encourage individuals to accept the HIV testing invitation. Each component is briefly described in the arm description.
Standard of Care: Household Contacts
As a control for the socio-behavioral intervention, the control arm will lack the socio-behavioral intervention components. The order of testing invitation will be decided by the CHW; and CHWs will be trained at baseline to provide standard, opt-in framing of test offers, without any mention of asking contacts to share their testing decision with other household contacts. Oral HIV kits will also be used in control households.
Number of Social Support Household Contacts Deciding to Test for HIV
196 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 8 weeks

Population: Only includes contacts who provided a nomination for social influence within the household (subset of all household contacts)

The investigators will assess the concordance of index patients' perceptions of their household contacts' influence on health decisions within the household with the perceptions of the rest of their household. To do so, the investigators will measure the number of participants that provide social influence nominations that align with nominations by the household contacts in the intervention arm.

Outcome measures

Outcome measures
Measure
Social Support: Household Contacts
n=246 Participants
CHWs will offer HIV testing to the individual nominated by the index patient as most likely to test. If this person is not present, CHWs will decide which contact should be offered testing first. CHWs will use a prosocial script for HIV testing: "Knowing your status sets a good example for your household." CHWs will follow an "opt-out" strategy: "This test kit is approved by the Ministry of Health and used in KCCA health facilities. I am going to offer you a free HIV test now, is that okay?". If the initial household contact who is offered HIV testing agrees to test, the CHW will ask if he/she is willing to share his/her decision to test with other members of the household: "Would you like to share your decision to test with the others? Sharing is completely optional. However, learning that someone else in their household decided to test sometimes gives people the strength to test themselves. Sharing your decision might help another person find the strength to test." Social Support: The intervention to be evaluated in this study is a multidimensional, socio-behavioral "Norming" intervention. The various components of this intervention are designed to harness household dynamics and prosocial inclinations to encourage individuals to accept the HIV testing invitation. Each component is briefly described in the arm description.
Standard of Care: Household Contacts
n=152 Participants
As a control for the socio-behavioral intervention, the control arm will lack the socio-behavioral intervention components. The order of testing invitation will be decided by the CHW; and CHWs will be trained at baseline to provide standard, opt-in framing of test offers, without any mention of asking contacts to share their testing decision with other household contacts. Oral HIV kits will also be used in control households.
Count of Social Influence Nominations (Participants) by the Index Patient That Align With Nominations by the Household Contacts
148 Participants
59 Participants

Adverse Events

Social Support: Index Participants

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Social Support: Household Contacts

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Standard of Care: Index Participants

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Standard of Care: Household Contacts

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

Dr. J. Lucian Davis

Yale School of Public Health

Phone: 203-785-3665

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place