Trial Outcomes & Findings for Kenya HIV Self-Testing in PrEP Delivery (NCT NCT03593629)
NCT ID: NCT03593629
Last Updated: 2024-06-04
Results Overview
Laboratory tests will be conducted to measure adherence to PrEP medication by testing drug levels in the collected blood specimen. The detection of PrEP in blood will be considered as adherent to PrEP.
COMPLETED
NA
790 participants
Month 6
2024-06-04
Participant Flow
Participant milestones
| Measure |
Standard of Care
Participants receive standard of care for PrEP, including 3-months of PrEP supply and HIV testing at clinic every three months
|
Blood-based HIV Self-testing
Participants receive 6-months of PrEP supply and blood-based HIV self-tests for quarterly HIV testing.
6-month PrEP + blood-based HIV self-test: Participants receive 6-month PrEP supply plus two blood-based HIV self-tests (Atomo Diagnostics Blood-Based HIV-1 Self-Testing Kit) for quarterly HIV testing.
|
HIV-positive Partners
Participants receive a baseline questionnaire, there are no outcomes related to this group.
|
Oral Fluid HIV Self-testing
Participants receive 6-months of PrEP supply and oral fluid HIV self-tests for quarterly HIV testing.
6-month PrEP + oral fluid HIV self-test: Participants receive 6-month PrEP supply plus two oral fluid HIV self-tests (OraQuick Oral Fluid-based HIV-1 Self-Testing Kit) for quarterly HIV testing.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
166
|
166
|
291
|
163
|
|
Overall Study
COMPLETED
|
166
|
166
|
291
|
163
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard of Care
n=166 Participants
Participants receive standard of care for PrEP, including 3-months of PrEP supply and HIV testing at clinic every three months
|
Blood-based HIV Self-testing
n=166 Participants
Participants receive 6-months of PrEP supply and blood-based HIV self-tests for quarterly HIV testing.
6-month PrEP + blood-based HIV self-test: Participants receive 6-month PrEP supply plus two blood-based HIV self-tests (Atomo Diagnostics Blood-Based HIV-1 Self-Testing Kit) for quarterly HIV testing.
|
Oral Fluid HIV Self-testing
n=163 Participants
Participants receive 6-months of PrEP supply and oral fluid HIV self-tests for quarterly HIV testing.
6-month PrEP + oral fluid HIV self-test: Participants receive 6-month PrEP supply plus two oral fluid HIV self-tests (OraQuick Oral Fluid-based HIV-1 Self-Testing Kit) for quarterly HIV testing.
|
HIV- Positive Partners
n=291 Participants
Participants receive a baseline questionnaire, there are no outcomes related to this group.
|
Total
n=786 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=166 Participants
|
2 Participants
n=166 Participants
|
2 Participants
n=163 Participants
|
1 Participants
n=291 Participants
|
7 Participants
n=786 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
163 Participants
n=166 Participants
|
164 Participants
n=166 Participants
|
161 Participants
n=163 Participants
|
290 Participants
n=291 Participants
|
778 Participants
n=786 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=166 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=291 Participants
|
1 Participants
n=786 Participants
|
|
Age, Continuous
|
33 years
n=166 Participants
|
32 years
n=166 Participants
|
33 years
n=163 Participants
|
35 years
n=291 Participants
|
33 years
n=786 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=166 Participants
|
56 Participants
n=166 Participants
|
54 Participants
n=163 Participants
|
130 Participants
n=291 Participants
|
295 Participants
n=786 Participants
|
|
Sex: Female, Male
Male
|
111 Participants
n=166 Participants
|
110 Participants
n=166 Participants
|
109 Participants
n=163 Participants
|
161 Participants
n=291 Participants
|
491 Participants
n=786 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Kenya
|
166 participants
n=166 Participants
|
166 participants
n=166 Participants
|
163 participants
n=163 Participants
|
291 participants
n=291 Participants
|
495 participants
n=786 Participants
|
PRIMARY outcome
Timeframe: Month 6Laboratory tests will be conducted to measure adherence to PrEP medication by testing drug levels in the collected blood specimen. The detection of PrEP in blood will be considered as adherent to PrEP.
Outcome measures
| Measure |
Standard of Care
n=166 Participants
Participants receive standard of care for PrEP, including 3-months of PrEP supply and HIV testing at clinic every three months
|
Blood-based HIV Self-testing
n=166 Participants
Participants receive 6-months of PrEP supply and blood-based HIV self-tests for quarterly HIV testing.
6-month PrEP + blood-based HIV self-test: Participants receive 6-month PrEP supply plus two blood-based HIV self-tests (Atomo Diagnostics Blood-Based HIV-1 Self-Testing Kit) for quarterly HIV testing.
|
Oral Fluid HIV Self-testing
n=163 Participants
Participants receive 6-months of PrEP supply and oral fluid HIV self-tests for quarterly HIV testing.
6-month PrEP + oral fluid HIV self-test: Participants receive 6-month PrEP supply plus two oral fluid HIV self-tests (OraQuick Oral Fluid-based HIV-1 Self-Testing Kit) for quarterly HIV testing.
|
|---|---|---|---|
|
Number of Participants With Adherence to PrEP at 6 Months
|
95 Participants
|
106 Participants
|
94 Participants
|
PRIMARY outcome
Timeframe: Month 6The percentage of participants that return to clinic to refill their PrEP medication. An alternative measure of PrEP adherence.
Outcome measures
| Measure |
Standard of Care
n=166 Participants
Participants receive standard of care for PrEP, including 3-months of PrEP supply and HIV testing at clinic every three months
|
Blood-based HIV Self-testing
n=166 Participants
Participants receive 6-months of PrEP supply and blood-based HIV self-tests for quarterly HIV testing.
6-month PrEP + blood-based HIV self-test: Participants receive 6-month PrEP supply plus two blood-based HIV self-tests (Atomo Diagnostics Blood-Based HIV-1 Self-Testing Kit) for quarterly HIV testing.
|
Oral Fluid HIV Self-testing
n=163 Participants
Participants receive 6-months of PrEP supply and oral fluid HIV self-tests for quarterly HIV testing.
6-month PrEP + oral fluid HIV self-test: Participants receive 6-month PrEP supply plus two oral fluid HIV self-tests (OraQuick Oral Fluid-based HIV-1 Self-Testing Kit) for quarterly HIV testing.
|
|---|---|---|---|
|
Persistence in Refilling PrEP
|
134 Participants
|
127 Participants
|
130 Participants
|
PRIMARY outcome
Timeframe: Month 6Self-reported HIV-1 testing in the past 6 months
Outcome measures
| Measure |
Standard of Care
n=166 Participants
Participants receive standard of care for PrEP, including 3-months of PrEP supply and HIV testing at clinic every three months
|
Blood-based HIV Self-testing
n=166 Participants
Participants receive 6-months of PrEP supply and blood-based HIV self-tests for quarterly HIV testing.
6-month PrEP + blood-based HIV self-test: Participants receive 6-month PrEP supply plus two blood-based HIV self-tests (Atomo Diagnostics Blood-Based HIV-1 Self-Testing Kit) for quarterly HIV testing.
|
Oral Fluid HIV Self-testing
n=163 Participants
Participants receive 6-months of PrEP supply and oral fluid HIV self-tests for quarterly HIV testing.
6-month PrEP + oral fluid HIV self-test: Participants receive 6-month PrEP supply plus two oral fluid HIV self-tests (OraQuick Oral Fluid-based HIV-1 Self-Testing Kit) for quarterly HIV testing.
|
|---|---|---|---|
|
HIV-1 Testing
|
140 Participants
|
135 Participants
|
139 Participants
|
SECONDARY outcome
Timeframe: Month 12Laboratory tests will be conducted to measure adherence to PrEP medication by testing drug levels in the collected blood specimen. The detection of PrEP in blood will be considered as adherent to PrEP.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 12The percentage of participants that return to clinic to refill their PrEP medication. An alternative measure of PrEP adherence.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 12Self-reported HIV-1 testing in the past 6 months
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6Self-reported verbal, physical or emotional abuse by a sexual partner
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 12Self-reported verbal, physical or emotional abuse by a sexual partner
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6The Patient Health Questionnaire-9 item (PHQ-9) depression scale. A 0-27 point scale where scores 10 or greater can be categorized as likely depression.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 12The Patient Health Questionnaire-9 item (PHQ-9) depression scale. A 0-27 point scale where scores 10 or greater can be categorized as likely depression.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6Measured using the General Self-Efficacy Scale (GSE), which is correlated to emotion, optimism, work satisfaction, to measure self-efficacy. The scale ranges from 10-40 points - higher scores indicate more self-efficacy.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 12Measured using the General Self-Efficacy Scale (GSE), which is correlated to emotion, optimism, work satisfaction, to measure self-efficacy. The scale ranges from 10-40 points - higher scores indicate more self-efficacy.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6Self-reported number of sexual partners in the past month
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 12Self-reported number of sexual partners in the past month
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6Participants were asked how many times they had sexual intercourse in the past month and how many times a condom was used. If condoms were not used at every time, condom use was categorized as inconsistent.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 12Participants were asked how many times they had sexual intercourse in the past month and how many times a condom was used. If condoms were not used at every time, condom use was categorized as inconsistent.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6Participants report that at least one other person (besides one's main sexual partners in serodiscordant couples) is aware they are taking PrEP.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 12Participants report that at least one other person (besides one's main sexual partners in serodiscordant couples) is aware they are taking PrEP.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6Participants report their preference for HIV testing from the following options: blood-based HIV self-testing, oral HIV self-testing, testing for HIV at a standard healthcare facility
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 12Participants report their preference for HIV testing from the following options: blood-based HIV self-testing, oral HIV self-testing, testing for HIV at a standard healthcare facility
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 12The proportion of participants (binary outcome) that test HIV-1 positive since trial enrollment. Genotypic HIV-1 resistance for seroconverters will additionally be measured.
Outcome measures
| Measure |
Standard of Care
n=166 Participants
Participants receive standard of care for PrEP, including 3-months of PrEP supply and HIV testing at clinic every three months
|
Blood-based HIV Self-testing
n=166 Participants
Participants receive 6-months of PrEP supply and blood-based HIV self-tests for quarterly HIV testing.
6-month PrEP + blood-based HIV self-test: Participants receive 6-month PrEP supply plus two blood-based HIV self-tests (Atomo Diagnostics Blood-Based HIV-1 Self-Testing Kit) for quarterly HIV testing.
|
Oral Fluid HIV Self-testing
n=163 Participants
Participants receive 6-months of PrEP supply and oral fluid HIV self-tests for quarterly HIV testing.
6-month PrEP + oral fluid HIV self-test: Participants receive 6-month PrEP supply plus two oral fluid HIV self-tests (OraQuick Oral Fluid-based HIV-1 Self-Testing Kit) for quarterly HIV testing.
|
|---|---|---|---|
|
Number of Participants That Test HIV-1 Positive Since Trial Enrollment
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Standard of Care
Blood-based HIV Self-testing
HIV-positive Partners
Oral Fluid HIV Self-testing
Serious adverse events
| Measure |
Standard of Care
n=166 participants at risk
Participants receive standard of care for PrEP, including 3-months of PrEP supply and HIV testing at clinic every three months
|
Blood-based HIV Self-testing
n=166 participants at risk
Participants receive 6-months of PrEP supply and blood-based HIV self-tests for quarterly HIV testing.
6-month PrEP + blood-based HIV self-test: Participants receive 6-month PrEP supply plus two blood-based HIV self-tests (Atomo Diagnostics Blood-Based HIV-1 Self-Testing Kit) for quarterly HIV testing.
|
HIV-positive Partners
n=291 participants at risk
Participants receive a baseline questionnaire, there are no outcomes related to this group.
|
Oral Fluid HIV Self-testing
n=163 participants at risk
Participants receive 6-months of PrEP supply and oral fluid HIV self-tests for quarterly HIV testing.
6-month PrEP + oral fluid HIV self-test: Participants receive 6-month PrEP supply plus two oral fluid HIV self-tests (OraQuick Oral Fluid-based HIV-1 Self-Testing Kit) for quarterly HIV testing.
|
|---|---|---|---|---|
|
Reproductive system and breast disorders
Hospitalization, hysterectomy
|
0.00%
0/166 • 15 months
|
0.00%
0/166 • 15 months
|
0.00%
0/291 • 15 months
|
0.61%
1/163 • 15 months
|
|
Reproductive system and breast disorders
Hospitalization, Intrauterine fetal death
|
0.00%
0/166 • 15 months
|
0.60%
1/166 • 15 months
|
0.00%
0/291 • 15 months
|
0.00%
0/163 • 15 months
|
|
Reproductive system and breast disorders
Hospitalization, caesarian
|
0.60%
1/166 • 15 months
|
0.00%
0/166 • 15 months
|
0.00%
0/291 • 15 months
|
0.00%
0/163 • 15 months
|
|
Reproductive system and breast disorders
Hospitalization, normal delivery
|
0.00%
0/166 • 15 months
|
0.60%
1/166 • 15 months
|
0.00%
0/291 • 15 months
|
0.00%
0/163 • 15 months
|
|
Reproductive system and breast disorders
Hospitalization, ectopic pregnancy
|
0.00%
0/166 • 15 months
|
0.00%
0/166 • 15 months
|
0.00%
0/291 • 15 months
|
0.61%
1/163 • 15 months
|
Other adverse events
Adverse event data not reported
Additional Information
Kenneth Ngure
Jomo Kenyatta University of Agriculture and Technology and University of Washington
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place