Kenya HIV Self-Testing in PrEP Delivery

NCT03593629 | Completed Results DMC

• 2 other identifiers: STUDY000037501R01MH113572
• Study Type: interventional
• Target: 790
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV-1-infection

Keywords

HIV; AIDS; PrEP; Truvada; Public Health; Global Health; Infectious Disease; Self-Testing; Kenya; Africa; Low and/or Middle Income Countries (LMIC); Cost-Effectiveness

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• PrEP Adherence

  Month 12

• Persistence in Refilling PrEP

  Month 12

• HIV-1 Testing

  Month 12

Other Outcomes (15)

• Recent Abuse by a Sexual Partner

  Month 6

• Recent Abuse by a Sexual Partner

  Month 12

• Prevalence of Depression

  Month 6

Study Arms (3)

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.

Combination Product: 6-month PrEP + blood-based HIV self-test

Oral fluid HIV self-testing

EXPERIMENTAL

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

Interventions

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.

Blood-based HIV self-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.

Oral fluid HIV self-testing

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Based on self-representation of gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Partners in Health Research and Development - Thika House

Thika, Kenya

Location

Related Publications (5)

• 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.

  PMID: 40598383 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.

  PMID: 39448999 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.

  PMID: 37318803 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.

  PMID: 35777410 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.

  PMID: 31272495 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Communicable Diseases

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Kenneth Ngure
• Organization: Jomo Kenyatta University of Agriculture and Technology and University of Washington

kngure@uw.edu

+254722362219

Study Officials

• Jared Baeten, MD, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Kenneth Ngure, PhD, MPH

  Jomo Kenyatta University of Agriculture and Technology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine: Global Health; Dept. of Medicine, Allergy & Infectious Diseases

Study Record Dates

• First Submitted: June 2, 2018
• First Posted: July 20, 2018
• Study Start: May 28, 2018
• Primary Completion: December 10, 2020
• Study Completion: May 25, 2021
• Last Updated: June 4, 2024
• Results First Posted: September 27, 2022

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)