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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH113572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | No Intervention | 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 | Experimental | Participants receive 6-months of PrEP supply and blood-based HIV self-tests for quarterly HIV testing. |
|
| Oral fluid HIV self-testing | Experimental | Participants receive 6-months of PrEP supply and oral fluid HIV self-tests for quarterly HIV testing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6-month PrEP + blood-based HIV self-test | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Month 6 |
| HIV-1 Testing | Self-reported HIV-1 testing in the past 6 months | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 12 |
| Persistence in Refilling PrEP |
| Measure | Description | Time Frame |
|---|---|---|
| Recent Abuse by a Sexual Partner | Self-reported verbal, physical or emotional abuse by a sexual partner | Month 6 |
| Recent Abuse by a Sexual Partner | Self-reported verbal, physical or emotional abuse by a sexual partner |
Inclusion Criteria:
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:
Based on self-representation of gender identity
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| Name | Affiliation | Role |
|---|---|---|
| Jared Baeten, MD, PhD | University of Washington | Principal Investigator |
| Kenneth Ngure, PhD, MPH | Jomo Kenyatta University of Agriculture and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Partners in Health Research and Development - Thika House | Thika | Kenya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40598383 | Derived | Mangale DI, Heitner J, Ortblad KF, Mogere P, Kiptinness C, Mugo NR, Baeten JM, Ngure K, Barnabas R. Opportunity for cost savings with a novel differentiated model of PrEP delivery: a comparative costing analysis of six-month PrEP supported by interim HIV self-testing and standard of care PrEP dispensing in Kenya. BMC Health Serv Res. 2025 Jul 1;25(1):865. doi: 10.1186/s12913-025-12891-7. | |
| 39448999 | Derived | Thuo N, Bardon AR, Mogere P, Kiptinness C, Casmir E, Wairimu N, Owidi E, Okello P, Mugo NR, Baeten JM, Ngure K, Ortblad KF. Acceptability of six-monthly PrEP dispensing supported with interim HIV self-testing to simplify PrEP delivery in Kenya: findings from qualitative research. BMC Health Serv Res. 2024 Oct 24;24(1):1281. doi: 10.1186/s12913-024-11521-y. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care | Participants receive standard of care for PrEP, including 3-months of PrEP supply and HIV testing at clinic every three months |
| FG001 | 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. |
| FG002 | HIV-positive Partners | Participants receive a baseline questionnaire, there are no outcomes related to this group. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care | Participants receive standard of care for PrEP, including 3-months of PrEP supply and HIV testing at clinic every three months |
| BG001 | Blood-based HIV Self-testing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Month 6 |
|
15 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care | Participants receive standard of care for PrEP, including 3-months of PrEP supply and HIV testing at clinic every three months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization, hysterectomy | Reproductive system and breast disorders | Non-systematic Assessment | Hysterectomy, dysfunctional uterine bleeding; unrelated to study medication |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Ngure | Jomo Kenyatta University of Agriculture and Technology and University of Washington | +254722362219 | kngure@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Apr 18, 2019 | Jul 29, 2022 | Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 28, 2022 | Jul 6, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| 6-month PrEP + oral fluid HIV self-test | Combination Product | 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. |
|
The percentage of participants that return to clinic to refill their PrEP medication. An alternative measure of PrEP adherence. |
| Month 12 |
| HIV-1 Testing | Self-reported HIV-1 testing in the past 6 months | Month 12 |
| 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. | 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. | 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. | 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. | Month 12 |
| Number of Sexual Partners | Self-reported number of sexual partners in the past month | Month 6 |
| Number of Sexual Partners | Self-reported number of sexual partners in the past month | 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. | 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. | 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. | 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. | 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 | 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 | 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. | Month 12 |
| 37318803 | Derived | Ortblad KF, Bardon AR, Mogere P, Kiptinness C, Gakuo S, Mbaire S, Thomas KK, Mugo NR, Baeten JM, Ngure K. Effect of 6-Month HIV Preexposure Prophylaxis Dispensing With Interim Self-testing on Preexposure Prophylaxis Continuation at 12 Months: A Randomized Noninferiority Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2318590. doi: 10.1001/jamanetworkopen.2023.18590. |
| 35777410 | Derived | Ngure K, Ortblad KF, Mogere P, Bardon AR, Thomas KK, Mangale D, Kiptinness C, Gakuo S, Mbaire S, Nyokabi J, Mugo NR, Baeten JM. Efficiency of 6-month PrEP dispensing with HIV self-testing in Kenya: an open-label, randomised, non-inferiority, implementation trial. Lancet HIV. 2022 Jul;9(7):e464-e473. doi: 10.1016/S2352-3018(22)00126-6. |
| 31272495 | Derived | Ortblad KF, Kearney JE, Mugwanya K, Irungu EM, Haberer JE, Barnabas RV, Donnell D, Mugo NR, Baeten JM, Ngure K. HIV-1 self-testing to improve the efficiency of pre-exposure prophylaxis delivery: a randomized trial in Kenya. Trials. 2019 Jul 4;20(1):396. doi: 10.1186/s13063-019-3521-2. |
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.
| BG002 | 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. |
| BG003 | HIV- Positive Partners | Participants receive a baseline questionnaire, there are no outcomes related to this group. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 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. |
|
|
|
| Primary | Persistence in Refilling PrEP | The percentage of participants that return to clinic to refill their PrEP medication. An alternative measure of PrEP adherence. | Posted | Count of Participants | Participants | Month 6 |
|
|
|
|
| Primary | HIV-1 Testing | Self-reported HIV-1 testing in the past 6 months | Posted | Count of Participants | Participants | Month 6 |
|
|
|
|
| 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. | Not Posted | Oct 2024 | Month 12 | Participants |
| Secondary | Persistence in Refilling PrEP | The percentage of participants that return to clinic to refill their PrEP medication. An alternative measure of PrEP adherence. | Not Posted | Oct 2024 | Month 12 | Participants |
| Secondary | HIV-1 Testing | Self-reported HIV-1 testing in the past 6 months | Not Posted | Oct 2024 | Month 12 | Participants |
| Other Pre-specified | Recent Abuse by a Sexual Partner | Self-reported verbal, physical or emotional abuse by a sexual partner | Not Posted | Oct 2024 | Month 6 | Participants |
| Other Pre-specified | Recent Abuse by a Sexual Partner | Self-reported verbal, physical or emotional abuse by a sexual partner | Not Posted | Oct 2024 | Month 12 | Participants |
| 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. | Not Posted | Oct 2024 | Month 6 | Participants |
| 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. | Not Posted | Oct 2024 | Month 12 | Participants |
| 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. | Not Posted | Oct 2024 | Month 6 | Participants |
| 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. | Not Posted | Oct 2024 | Month 12 | Participants |
| Other Pre-specified | Number of Sexual Partners | Self-reported number of sexual partners in the past month | Not Posted | Oct 2024 | Month 6 | Participants |
| Other Pre-specified | Number of Sexual Partners | Self-reported number of sexual partners in the past month | Not Posted | Oct 2024 | Month 12 | Participants |
| 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. | Not Posted | Oct 2024 | Month 6 | Participants |
| 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. | Not Posted | Oct 2024 | Month 12 | Participants |
| 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. | Not Posted | Oct 2024 | Month 6 | Participants |
| 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. | Not Posted | Oct 2024 | Month 12 | Participants |
| 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 | Not Posted | Oct 2024 | Month 6 | Participants |
| 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 | Not Posted | Oct 2024 | Month 12 | Participants |
| 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. | Posted | Count of Participants | Participants | Month 12 |
|
|
|
| 0 |
| 166 |
| 1 |
| 166 |
| 0 |
| 166 |
| EG001 | 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. | 0 | 166 | 2 | 166 | 0 | 166 |
| EG002 | HIV-positive Partners | Participants receive a baseline questionnaire, there are no outcomes related to this group. | 0 | 291 | 0 | 291 | 0 | 291 |
| EG003 | 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. | 0 | 163 | 2 | 163 | 0 | 163 |
|
| Hospitalization, Intrauterine fetal death | Reproductive system and breast disorders | Non-systematic Assessment | Hospitalization and induced delivery due to Intrauterine fetal death ; unrelated to study medication |
|
| Hospitalization, caesarian | Reproductive system and breast disorders | Non-systematic Assessment | Caesarian section; unrelated to study medication |
|
| Hospitalization, normal delivery | Reproductive system and breast disorders | Non-systematic Assessment | Normal delivery; unrelated to study medication |
|
| Hospitalization, ectopic pregnancy | Reproductive system and breast disorders | Non-systematic Assessment | Ectopic pregnancy; unrelated to study medication |
|
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|