HIV-1-infection
Conditions
Keywords
HIV, AIDS, PrEP, Truvada, Public Health, Global Health, Infectious Disease, Self-Testing, Kenya, Africa, Low and/or Middle Income Countries (LMIC), Cost-Effectiveness
Brief summary
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.
Detailed description
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).
Interventions
COMBINATION_PRODUCT6-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.
COMBINATION_PRODUCT6-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.
Sponsors
National Institute of Mental Health (NIMH)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age ≥18 years HIV-1 uninfected based on negative HIV-1 rapid testing * Not currently enrolled in an HIV-1 prevention clinical trial * Taking PrEP and planning to continue * Willing to be randomized to either clinic based HIV-1 testing or HIV-1 self-testing * Note: Women who are pregnant at screening/enrollment are still eligible
Exclusion criteria
* Unable to provide written informed consent * Contraindication to use Tenofovir (TDF)+/- Emtricitabine (FTC)/ Lamivudine (3TC) For the HIV-1 serodiscordant couples, HIV-1 infected members of the couple will be enrolled for a single visit at baseline, if: * Age ≥18 * Able and willing to provide written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adherence to PrEP at 6 Months | Month 6 | 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. |
| Persistence in Refilling PrEP | Month 6 | The percentage of participants that return to clinic to refill their PrEP medication. An alternative measure of PrEP adherence. |
| HIV-1 Testing | Month 6 | Self-reported HIV-1 testing in the past 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Adherence | Month 12 | 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. |
| Persistence in Refilling PrEP | Month 12 | The percentage of participants that return to clinic to refill their PrEP medication. An alternative measure of PrEP adherence. |
| HIV-1 Testing | Month 12 | Self-reported HIV-1 testing in the past 6 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| HIV Testing Preferences | Month 6 | 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 |
| Recent Abuse by a Sexual Partner | Month 6 | Self-reported verbal, physical or emotional abuse by a sexual partner |
| Number of Participants That Test HIV-1 Positive Since Trial Enrollment | Month 12 | The proportion of participants (binary outcome) that test HIV-1 positive since trial enrollment. Genotypic HIV-1 resistance for seroconverters will additionally be measured. |
| Prevalence of Depression | Month 6 | 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. |
| Participant's Self-reported Self-efficacy | Month 6 | 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. |
| Number of Sexual Partners | Month 6 | Self-reported number of sexual partners in the past month |
| Inconsistent Condom Use | Month 6 | 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. |
| PrEP Disclosure | Month 6 | Participants report that at least one other person (besides one's main sexual partners in serodiscordant couples) is aware they are taking PrEP. |
Countries
Kenya
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Participants receive standard of care for PrEP, including 3-months of PrEP supply and HIV testing at clinic every three months | 166 |
| 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. | 166 |
| 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. | 163 |
| HIV- Positive Partners Participants receive a baseline questionnaire, there are no outcomes related to this group. | 291 |
| Total | 786 |
Baseline characteristics
| Characteristic | Blood-based HIV Self-testing | Oral Fluid HIV Self-testing | HIV- Positive Partners | Standard of Care | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 7 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 164 Participants | 161 Participants | 290 Participants | 163 Participants | 778 Participants |
| Age, Continuous | 32 years | 33 years | 35 years | 33 years | 33 years |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Region of Enrollment Kenya | 166 participants | 163 participants | 291 participants | 166 participants | 495 participants |
| Sex: Female, Male Female | 56 Participants | 54 Participants | 130 Participants | 55 Participants | 295 Participants |
| Sex: Female, Male Male | 110 Participants | 109 Participants | 161 Participants | 111 Participants | 491 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 166 | 0 / 166 | 0 / 291 | 0 / 163 |
| other Total, other adverse events | 0 / 166 | 0 / 166 | 0 / 291 | 0 / 163 |
| serious Total, serious adverse events | 1 / 166 | 2 / 166 | 0 / 291 | 2 / 163 |
Outcome results
Primary
HIV-1 Testing
Self-reported HIV-1 testing in the past 6 months
Time frame: Month 6
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | HIV-1 Testing | 140 Participants |
| Blood-based HIV Self-testing | HIV-1 Testing | 135 Participants |
| Oral Fluid HIV Self-testing | HIV-1 Testing | 139 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Number of Participants With Adherence to PrEP at 6 Months | 95 Participants |
| Blood-based HIV Self-testing | Number of Participants With Adherence to PrEP at 6 Months | 106 Participants |
| Oral Fluid HIV Self-testing | Number of Participants With Adherence to PrEP at 6 Months | 94 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Persistence in Refilling PrEP | 134 Participants |
| Blood-based HIV Self-testing | Persistence in Refilling PrEP | 127 Participants |
| Oral Fluid HIV Self-testing | Persistence in Refilling PrEP | 130 Participants |
Secondary
HIV-1 Testing
Self-reported HIV-1 testing in the past 6 months
Time frame: Month 12
Secondary
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
Secondary
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
Other Pre-specified
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
Other Pre-specified
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
Other Pre-specified
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
Other Pre-specified
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
Other Pre-specified
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Number of Participants That Test HIV-1 Positive Since Trial Enrollment | 0 Participants |
| Blood-based HIV Self-testing | Number of Participants That Test HIV-1 Positive Since Trial Enrollment | 0 Participants |
| Oral Fluid HIV Self-testing | Number of Participants That Test HIV-1 Positive Since Trial Enrollment | 0 Participants |
Other Pre-specified
Number of Sexual Partners
Self-reported number of sexual partners in the past month
Time frame: Month 6
Other Pre-specified
Number of Sexual Partners
Self-reported number of sexual partners in the past month
Time frame: Month 12
Other Pre-specified
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
Other Pre-specified
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
Other Pre-specified
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
Other Pre-specified
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
Other Pre-specified
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
Other Pre-specified
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
Other Pre-specified
Recent Abuse by a Sexual Partner
Self-reported verbal, physical or emotional abuse by a sexual partner
Time frame: Month 6
Other Pre-specified
Recent Abuse by a Sexual Partner
Self-reported verbal, physical or emotional abuse by a sexual partner
Time frame: Month 12