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Completed

NCT Number: NCT03593629

Kenya HIV Self-Testing in PrEP Delivery

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.

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Key information

Conditions

HIV-1-infection Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Disease Attributes Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Partners in Health Research and Development - Thika House

Thika, Kenya

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Number of Participants With Adherence to PrEP at 6 Months

    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 outcomes

  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 outcomes

  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. Number of Participants That Test HIV-1 Positive Since Trial Enrollment

    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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

HIV Self-Testing to Improve the Efficiency of PrEP Delivery

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jul 20, 2018
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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