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Kenya HIV Self-Testing in PrEP Delivery

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ClinicalTrials.gov Identifier: NCT03593629
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : April 8, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Jared Baeten, University of Washington

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.

Condition or disease Intervention/treatment Phase
HIV-1-infection Combination Product: 6-month PrEP + blood-based HIV self-test Combination Product: 6-month PrEP + oral fluid HIV self-test Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 825 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: HIV Self-Testing to Improve the Efficiency of PrEP Delivery
Actual Study Start Date : May 28, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
No Intervention: Standard of Care
Participants receive standard of care for PrEP, including 3-months of PrEP supply and HIV testing at clinic every three months
Experimental: Blood-based HIV self-testing
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-month PrEP supply plus two blood-based HIV self-tests (Atomo Diagnostics Blood-Based HIV-1 Self-Testing Kit) for quarterly HIV testing.

Experimental: Oral fluid HIV self-testing
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 oral fluid HIV self-tests (OraQuick Oral Fluid-based HIV-1 Self-Testing Kit) for quarterly HIV testing.




Primary Outcome Measures :
  1. PrEP adherence [ Time Frame: 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.

  2. Persistence in refilling PrEP [ Time Frame: Month 6 ]
    The percentage of participants that return to clinic to refill their PrEP medication. An alternative measure of PrEP adherence.

  3. HIV-1 testing [ Time Frame: Month 6 ]
    Self-reported HIV-1 testing in the past 6 months


Secondary Outcome Measures :
  1. PrEP adherence [ Time Frame: 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.

  2. Persistence in refilling PrEP [ Time Frame: Month 12 ]
    The percentage of participants that return to clinic to refill their PrEP medication. An alternative measure of PrEP adherence.

  3. HIV-1 testing [ Time Frame: Month 12 ]
    Self-reported HIV-1 testing in the past 6 months


Other Outcome Measures:
  1. Recent abuse by a sexual partner [ Time Frame: Month 6 ]
    Self-reported verbal, physical or emotional abuse by a sexual partner

  2. Recent abuse by a sexual partner [ Time Frame: Month 12 ]
    Self-reported verbal, physical or emotional abuse by a sexual partner

  3. Prevalence of depression [ Time Frame: 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.

  4. Prevalence of depression [ Time Frame: Month 12 ]
    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.

  5. Participant's self-reported self-efficacy [ Time Frame: 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.

  6. Participant's self-reported self-efficacy [ Time Frame: Month 12 ]
    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.

  7. Number of sexual partners [ Time Frame: Month 6 ]
    Self-reported number of sexual partners in the past month

  8. Number of sexual partners [ Time Frame: Month 12 ]
    Self-reported number of sexual partners in the past month

  9. Inconsistent condom use [ Time Frame: 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.

  10. Inconsistent condom use [ Time Frame: Month 12 ]
    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.

  11. PrEP disclosure [ Time Frame: 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.

  12. PrEP disclosure [ Time Frame: Month 12 ]
    Participants report that at least one other person (besides one's main sexual partners in serodiscordant couples) is aware they are taking PrEP.

  13. HIV testing preferences [ Time Frame: 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

  14. HIV testing preferences [ Time Frame: Month 12 ]
    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

  15. HIV Incidence [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Based on self-representation of gender identity
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03593629


Contacts
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Contact: John E Kearney 253-632-1997 kearneje@uw.edu
Contact: Justice Quame-Amaglo 206-520-3866 quamaglo@uw.edu

Locations
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Kenya
Partners in Health Research and Development - Thika House Recruiting
Thika, Kenya
Contact: Kenneth Ngure, MPH, PhD    722 362219 ext 254    kngure@uw.edu   
Contact: Peter Mogere    707 177811 ext 254    patandi@pipsthika.org   
Sponsors and Collaborators
University of Washington
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Jared Baeten, MD, PhD University of Washington
Principal Investigator: Kenneth Ngure, PhD, MSc, MPH Jomo Kenyatta University of Agriculture and Technology
Study Director: Katrina Ortblad, ScD, MPH University of Washington

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jared Baeten, Professor, School of Medicine: Global Health; Dept. of Medicine, Allergy & Infectious Diseases, University of Washington
ClinicalTrials.gov Identifier: NCT03593629     History of Changes
Other Study ID Numbers: STUDY00003750
1R01MH113572 ( U.S. NIH Grant/Contract )
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Jared Baeten, University of Washington:
HIV
AIDS
PrEP
Truvada
Public Health
Global Health
Infectious Disease
Self-Testing
Kenya
Africa
Low and/or Middle Income Countries (LMIC)
Cost-Effectiveness