An interventional study of 6-month PrEP + blood-based HIV self-test and 6-month PrEP + oral fluid HIV self-test in HIV-1-infection, sponsored by University of Washington. Completed at 1 site in Kenya. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-04.
Sponsored by University of Washington · Not applicable, Interventional, and Health services research
In a three-arm, randomized trial, the investigators will test the use of HIV-1 self-testing to decrease the frequency and burden of clinic visits for PrEP while resulting in equivalent PrEP adherence and HIV testing.
Guidelines recommend HIV-1 testing quarterly for individuals on PrEP. Clinic-based HIV testing every three months is costly for both clinics and participants. The investigators propose using HIV self-testing to replace quarterly clinic-based HIV testing for participants on PrEP, eliminating half of clinic visits and saving staffing and participant costs. The investigators want to understand the effect that reduced clinic contact frequency (resulting from HIV self-testing) has on PrEP adherence or completion of HIV-1 testing, overall and in subgroups.
The investigators will enroll roughly 495 eligible individuals on PrEP: 165 men and 165 women in HIV-1 serodiscordant couples and 165 women at risk of HIV-1 infection (priority populations for PrEP delivery in Kenya and more generally in Africa).
In this study, participants will be randomly assigned in a 2:1 fashion to either six-monthly clinic visits or quarterly clinic visits. Participants randomized to six-monthly clinic visits will receive a 6-month supply of PrEP and either two blood-based HIV self-tests (blood-based HIV self-testing arm) or two oral fluid HIV self-tests (oral fluid HIV self-testing arm). Participants randomized to quarterly clinic visits will receive a 3-month supply of PrEP and get tested for HIV by a healthcare professional at the clinic (standard of care arm)
Study outcomes, measured at Months 6 and 12, include PrEP adherence (defined as the detection of PrEP in dried blood spots as well as persistence in refilling PrEP), HIV-1 testing, and safety (including side effects and social harm).
University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
For the HIV-1 serodiscordant couples, HIV-1 infected members of the couple will be enrolled for a single visit at baseline, if:
Participants receive standard of care for PrEP, including 3-months of PrEP supply and HIV testing at clinic every three months
Participants receive 6-months of PrEP supply and blood-based HIV self-tests for quarterly HIV testing.
Combination Product: 6-month PrEP + blood-based HIV self-test
Participants receive 6-months of PrEP supply and oral fluid HIV self-tests for quarterly HIV testing.
Combination Product: 6-month PrEP + oral fluid 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.
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
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.
Time frame: Month 6
Persistence in Refilling PrEP
The percentage of participants that return to clinic to refill their PrEP medication. An alternative measure of PrEP adherence.
Time frame: Month 6
HIV-1 Testing
Self-reported HIV-1 testing in the past 6 months
Time frame: Month 6
PrEP Adherence
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.
Time frame: Month 12
Persistence in Refilling PrEP
The percentage of participants that return to clinic to refill their PrEP medication. An alternative measure of PrEP adherence.
Time frame: Month 12
HIV-1 Testing
Self-reported HIV-1 testing in the past 6 months
Time frame: Month 12
Recent Abuse by a Sexual Partner
Self-reported verbal, physical or emotional abuse by a sexual partner
Time frame: Month 6
Recent Abuse by a Sexual Partner
Self-reported verbal, physical or emotional abuse by a sexual partner
Time frame: Month 12
Prevalence of Depression
The 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.
Time frame: Month 6
Prevalence of Depression
The 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.
Time frame: Month 12
Participant's Self-reported Self-efficacy
Measured 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.
Time frame: Month 6
Participant's Self-reported Self-efficacy
Measured 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.
Time frame: Month 12
Number of Sexual Partners
Self-reported number of sexual partners in the past month
Time frame: Month 6
Number of Sexual Partners
Self-reported number of sexual partners in the past month
Time frame: Month 12
Inconsistent Condom Use
Participants 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.
Time frame: Month 6
Inconsistent Condom Use
Participants 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.
Time frame: Month 12
PrEP Disclosure
Participants report that at least one other person (besides one's main sexual partners in serodiscordant couples) is aware they are taking PrEP.
Time frame: Month 6
PrEP Disclosure
Participants report that at least one other person (besides one's main sexual partners in serodiscordant couples) is aware they are taking PrEP.
Time frame: Month 12
HIV Testing Preferences
Participants 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
Time frame: Month 6
HIV Testing Preferences
Participants 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
Time frame: Month 12
Number of Participants That Test HIV-1 Positive Since Trial Enrollment
The proportion of participants (binary outcome) that test HIV-1 positive since trial enrollment. Genotypic HIV-1 resistance for seroconverters will additionally be measured.
Time frame: Month 12
| Milestone | Standard of Care | Blood-based HIV Self-testing | HIV-positive Partners | Oral Fluid HIV Self-testing |
|---|---|---|---|---|
| Started | 166 | 166 | 291 | 163 |
| Completed | 166 | 166 | 291 | 163 |
| Not completed | 0 | 0 | 0 | 0 |
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.
| Participants | Standard of Care | Blood-based HIV Self-testing | Oral Fluid HIV Self-testing |
|---|---|---|---|
| Number of Participants With Adherence to PrEP at 6 Months | 95 | 106 | 94 |
The percentage of participants that return to clinic to refill their PrEP medication. An alternative measure of PrEP adherence.
| Participants | Standard of Care | Blood-based HIV Self-testing | Oral Fluid HIV Self-testing |
|---|---|---|---|
| Persistence in Refilling PrEP | 134 | 127 | 130 |
Self-reported HIV-1 testing in the past 6 months
| Participants | Standard of Care | Blood-based HIV Self-testing | Oral Fluid HIV Self-testing |
|---|---|---|---|
| HIV-1 Testing | 140 | 135 | 139 |
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.
Results for this outcome have not been posted.
The percentage of participants that return to clinic to refill their PrEP medication. An alternative measure of PrEP adherence.
Results for this outcome have not been posted.
Self-reported HIV-1 testing in the past 6 months
Results for this outcome have not been posted.
Self-reported verbal, physical or emotional abuse by a sexual partner
Results for this outcome have not been posted.
Self-reported verbal, physical or emotional abuse by a sexual partner
Results for this outcome have not been posted.
The 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.
Results for this outcome have not been posted.
The 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.
Results for this outcome have not been posted.
Measured 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.
Results for this outcome have not been posted.
Measured 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.
Results for this outcome have not been posted.
Self-reported number of sexual partners in the past month
Results for this outcome have not been posted.
Self-reported number of sexual partners in the past month
Results for this outcome have not been posted.
Participants 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.
Results for this outcome have not been posted.
Participants 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.
Results for this outcome have not been posted.
Participants report that at least one other person (besides one's main sexual partners in serodiscordant couples) is aware they are taking PrEP.
Results for this outcome have not been posted.
Participants report that at least one other person (besides one's main sexual partners in serodiscordant couples) is aware they are taking PrEP.
Results for this outcome have not been posted.
Participants 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
Results for this outcome have not been posted.
Participants 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
Results for this outcome have not been posted.
The proportion of participants (binary outcome) that test HIV-1 positive since trial enrollment. Genotypic HIV-1 resistance for seroconverters will additionally be measured.
| Participants | Standard of Care | Blood-based HIV Self-testing | Oral Fluid HIV Self-testing |
|---|---|---|---|
| Number of Participants That Test HIV-1 Positive Since Trial Enrollment | 0 | 0 | 0 |
Collected over 15 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard of Care | 0/166 (0%) | 1/166 (0.6%) | 0/166 (0%) |
| Blood-based HIV Self-testing | 0/166 (0%) | 2/166 (1.2%) | 0/166 (0%) |
| HIV-positive Partners | 0/291 (0%) | 0/291 (0%) | 0/291 (0%) |
| Oral Fluid HIV Self-testing | 0/163 (0%) | 2/163 (1.2%) | 0/163 (0%) |
| Event | Standard of Care | Blood-based HIV Self-testing | HIV-positive Partners | Oral Fluid HIV Self-testing |
|---|---|---|---|---|
| Hospitalization, hysterectomyReproductive system and breast disorders | 0/166 | 0/166 | 0/291 | 1/163 |
| Hospitalization, ectopic pregnancyReproductive system and breast disorders | 0/166 | 0/166 | 0/291 | 1/163 |
| Hospitalization, Intrauterine fetal deathReproductive system and breast disorders | 0/166 | 1/166 | 0/291 | 0/163 |
| Hospitalization, caesarianReproductive system and breast disorders | 1/166 | 0/166 | 0/291 | 0/163 |
| Hospitalization, normal deliveryReproductive system and breast disorders | 0/166 | 1/166 | 0/291 | 0/163 |
| Age, Categorical(Participants) | Standard of Care | Blood-based HIV Self-testing | Oral Fluid HIV Self-testing | HIV- Positive Partners | Total |
|---|---|---|---|---|---|
| <=18 years | 2 | 2 | 2 | 1 | 7 |
| Between 18 and 65 years | 163 | 164 | 161 | 290 | 778 |
| >=65 years | 1 | 0 | 0 | 0 | 1 |
| Age, Continuous(years) | Standard of Care | Blood-based HIV Self-testing | Oral Fluid HIV Self-testing | HIV- Positive Partners | Total |
|---|---|---|---|---|---|
| Median | 33 (28 to 40) | 32 (27 to 39) | 33 (28 to 40) | 35 (28 to 43) | 33 (28 to 40) |
| Sex: Female, Male(Participants) | Standard of Care | Blood-based HIV Self-testing | Oral Fluid HIV Self-testing | HIV- Positive Partners | Total |
|---|---|---|---|---|---|
| Female | 55 | 56 | 54 | 130 | 295 |
| Male | 111 | 110 | 109 | 161 | 491 |
| Race and Ethnicity Not Collected(Participants) | Standard of Care | Blood-based HIV Self-testing | Oral Fluid HIV Self-testing | HIV- Positive Partners | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
| Region of Enrollment(participants) | Standard of Care | Blood-based HIV Self-testing | Oral Fluid HIV Self-testing | HIV- Positive Partners | Total |
|---|---|---|---|---|---|
| Kenya | 166 | 166 | 163 | 291 | 495 |
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