Trial Outcomes & Findings for Innovations in HIV Testing (TI) (NCT NCT03271424)
NCT ID: NCT03271424
Last Updated: 2018-01-19
Results Overview
Qualitative Summaries for recruitment of peers/sex partners, issues related to privacy and spaces for testing, options for post-test counseling, optimizing return visits, and preferences for contact
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
95 participants
Primary outcome timeframe
6 months post study start
Results posted on
2018-01-19
Participant Flow
Participant milestones
| Measure |
In Clinic Observation-Both
10 young women and 10 young men were assigned and conducted BOTH of the HIV self-tests. Participants tried two different self-testing kits, one that is oral fluid based (saliva), Oraquick HIV Self Test, and one that is blood based via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test and Atomo HIV Self Test - Both
Oraquick HIV Self Test and Atomo HIV Self Test - Both: This is an oral swab in home HIV test and this is a blood finger prick in home HIV test.
|
Focus Group Discussions
Focus group discussions (FGD) with young women (n=2 FGDs) and young men (n=2 FGDs) in the study area to determine the best way to offer self-testing to study participants.
|
In Clinic Observation-Subject Choice
20 young women and 20 young men were assigned and conducted EITHER of the HIV self-tests. Investigators asked them to choose which test they would prefer to use, one that is oral fluid based (saliva), Oraquick HIV Self Test, or one that requires the use blood via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test - Choice; Atomo HIV Self Test - choice
Oraquick HIV Self Test - Choice: This is an oral swab in home HIV test.
Atomo HIV Self Test - Choice: This is a blood finger prick in home HIV test.
|
|---|---|---|---|
|
November 2015
STARTED
|
20
|
0
|
0
|
|
November 2015
COMPLETED
|
20
|
0
|
0
|
|
November 2015
NOT COMPLETED
|
0
|
0
|
0
|
|
December 2015
STARTED
|
0
|
35
|
0
|
|
December 2015
COMPLETED
|
0
|
35
|
0
|
|
December 2015
NOT COMPLETED
|
0
|
0
|
0
|
|
April-May 2016
STARTED
|
0
|
0
|
40
|
|
April-May 2016
COMPLETED
|
0
|
0
|
40
|
|
April-May 2016
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Innovations in HIV Testing (TI)
Baseline characteristics by cohort
| Measure |
Focus Group Discussions
n=35 Participants
Focus group discussions (FGD) with young women (n=2 FGDs) and young men (n=2 FGDs) in the study area to determine the best way to offer self-testing to study participants.
|
In Clinic Observation-Both
n=20 Participants
10 young women and 10 young men were assigned and conducted BOTH of the HIV self-tests. Participants tried two different self-testing kits, one that is oral fluid based (saliva), Oraquick HIV Self Test, and one that is blood based via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test and Atomo HIV Self Test - Both
Oraquick HIV Self Test and Atomo HIV Self Test - Both: This is an oral swab in home HIV test and this is a blood finger prick in home HIV test.
|
In Clinic Observation-Subject Choice
n=40 Participants
20 young women and 20 young men were assigned and conducted EITHER of the HIV self-tests. Investigators asked them to choose which test they would prefer to use, one that is oral fluid based (saliva), Oraquick HIV Self Test, or one that requires the use blood via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test - Choice; Atomo HIV Self Test - choice
Oraquick HIV Self Test - Choice: This is an oral swab in home HIV test.
Atomo HIV Self Test - Choice: This is a blood finger prick in home HIV test.
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
95 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
20 years
n=99 Participants
|
20 years
n=107 Participants
|
20 years
n=206 Participants
|
20 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
46 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
49 Participants
n=7 Participants
|
|
Region of Enrollment
South Africa
|
35 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
95 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 6 months post study startQualitative Summaries for recruitment of peers/sex partners, issues related to privacy and spaces for testing, options for post-test counseling, optimizing return visits, and preferences for contact
Outcome measures
| Measure |
Focus Group Discussions
n=35 Participants
Focus group discussions (FGD) with young women (n=2 FGDs) and young men (n=2 FGDs) in the study area to determine the best way to offer self-testing to study participants.
|
In Clinic Observation - Both (Atomo Results)
10 young women and 10 young men were assigned and conducted BOTH of the HIV self-tests. Participants tried two different self-testing kits, one that is oral fluid based (saliva), Oraquick HIV Self Test, and one that is blood based via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test and Atomo HIV Self Test - Both
Oraquick HIV Self Test and Atomo HIV Self Test - Both: This is an oral swab in home HIV test and this is a blood finger prick in home HIV test.
|
In Clinic Observation-Subject Choice (Oraquick Results)
20 young women and 20 young men conducted EITHER of the HIV self-tests. Investigators asked them to choose which test they would prefer to use, one that is oral fluid based (saliva), Oraquick HIV Self Test, or one that requires the use blood via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test - Choice; Atomo HIV Self Test - choice
Oraquick HIV Self Test - Choice: This is an oral swab in home HIV test.
Atomo HIV Self Test - Choice: This is a blood finger prick in home HIV test.
|
In Clinic Observation-Subject Choice (Atomo Results)
20 young women and 20 young men conducted EITHER of the HIV self-tests. Investigators asked them to choose which test they would prefer to use, one that is oral fluid based (saliva), Oraquick HIV Self Test, or one that requires the use blood via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test - Choice; Atomo HIV Self Test - choice
Oraquick HIV Self Test - Choice: This is an oral swab in home HIV test.
Atomo HIV Self Test - Choice: This is a blood finger prick in home HIV test.
|
|---|---|---|---|---|
|
Qualitative Summaries of Participant Experience in Focus Group Discussions
HIV Self Test (HST) Acceptability
|
100 number of times reported in FGD
|
—
|
—
|
—
|
|
Qualitative Summaries of Participant Experience in Focus Group Discussions
HST Context
|
7 number of times reported in FGD
|
—
|
—
|
—
|
|
Qualitative Summaries of Participant Experience in Focus Group Discussions
HST Kit Preference
|
26 number of times reported in FGD
|
—
|
—
|
—
|
|
Qualitative Summaries of Participant Experience in Focus Group Discussions
HST motivation
|
10 number of times reported in FGD
|
—
|
—
|
—
|
|
Qualitative Summaries of Participant Experience in Focus Group Discussions
HST Recommendations
|
29 number of times reported in FGD
|
—
|
—
|
—
|
|
Qualitative Summaries of Participant Experience in Focus Group Discussions
Supportive resources
|
12 number of times reported in FGD
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 month post study startFrequency counts of clarity of instructions, comfort using the test, confidence in test result, difficulty performing the test and reading results
Outcome measures
| Measure |
Focus Group Discussions
n=20 Participants
Focus group discussions (FGD) with young women (n=2 FGDs) and young men (n=2 FGDs) in the study area to determine the best way to offer self-testing to study participants.
|
In Clinic Observation - Both (Atomo Results)
n=20 Participants
10 young women and 10 young men were assigned and conducted BOTH of the HIV self-tests. Participants tried two different self-testing kits, one that is oral fluid based (saliva), Oraquick HIV Self Test, and one that is blood based via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test and Atomo HIV Self Test - Both
Oraquick HIV Self Test and Atomo HIV Self Test - Both: This is an oral swab in home HIV test and this is a blood finger prick in home HIV test.
|
In Clinic Observation-Subject Choice (Oraquick Results)
n=32 Participants
20 young women and 20 young men conducted EITHER of the HIV self-tests. Investigators asked them to choose which test they would prefer to use, one that is oral fluid based (saliva), Oraquick HIV Self Test, or one that requires the use blood via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test - Choice; Atomo HIV Self Test - choice
Oraquick HIV Self Test - Choice: This is an oral swab in home HIV test.
Atomo HIV Self Test - Choice: This is a blood finger prick in home HIV test.
|
In Clinic Observation-Subject Choice (Atomo Results)
n=8 Participants
20 young women and 20 young men conducted EITHER of the HIV self-tests. Investigators asked them to choose which test they would prefer to use, one that is oral fluid based (saliva), Oraquick HIV Self Test, or one that requires the use blood via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test - Choice; Atomo HIV Self Test - choice
Oraquick HIV Self Test - Choice: This is an oral swab in home HIV test.
Atomo HIV Self Test - Choice: This is a blood finger prick in home HIV test.
|
|---|---|---|---|---|
|
Quantitative Summaries of Participants Experience in Observation Sessions
Found Instructions Clear
|
19 Participants
|
19 Participants
|
30 Participants
|
8 Participants
|
|
Quantitative Summaries of Participants Experience in Observation Sessions
Were Very Comfortable Using the Test
|
16 Participants
|
14 Participants
|
24 Participants
|
6 Participants
|
|
Quantitative Summaries of Participants Experience in Observation Sessions
Very Easy to use the Test
|
18 Participants
|
13 Participants
|
27 Participants
|
7 Participants
|
|
Quantitative Summaries of Participants Experience in Observation Sessions
Very Easy to Interpret Results
|
18 Participants
|
18 Participants
|
31 Participants
|
8 Participants
|
Adverse Events
Focus Group Discussions
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
In Clinic Observation-Both
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
In Clinic Observation-Subject Choice
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. Audrey Pettifor
University of North Carolina Chapel Hill
Phone: 919-966-7439
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place