IPrEP Men's Study: Expanding the Reach of Prevention for Men in Kisumu, Kenya

Columbia University

Status: Unknown

Conditions: HIV

Treatments: Behavioral: HIV risk-reduction counseling; Device: UrSure Rapid Urine Tenofovir Test; Drug: Tenofovir (300mg)/Emtricitabine(200mg) [Truvada®]; Behavioral: 2-way text message reminders; Device: OraQuick Rapid HIV Self-test kit

Study type: Interventional

Funder types: Other

Identifiers

NCT04898699

AAAT6103

Details and patient eligibility

About

IPrEP Men's Study is a prospective cohort study enrolling male clients (MC) of female sex workers (FSW) in Kisumu, Kenya. HIV-negative MC participants will be offered oral PrEP (emtricitabine/tenofovir [FTC/TDF]) combined with two adherence self-management interventions: (1) real-time feedback from point of care urine drug-level assay, (2) HIV self-testing (HIVST) and (3) 2-way text message reminders.

Potential MC participants will be recruited from pre-specified community-based venues ("hotspots") or through referral by FSW using convenience sampling. Potential participants will be prescreened for age; residence and intent to stay in Kisumu for study duration, and having exchanged money, goods, or services for sex with a woman in the past three months. Individuals who meet prescreening eligibility criteria will be invited to the study site to undergo informed consenting process. Consenting individuals will complete a baseline questionnaire and undergo HIV counseling and testing as per national guidelines. Participants found to be HIV-positive will receive appropriate post-test counseling, including referral for immediate HIV treatment initiation at local health facility. Participants with negative HIV test results will complete eligibility screening for PrEP as per national guidelines. Eligible individuals will be prescribed once-daily oral PrEP, undergo HIV risk-reduction counseling session and receive HIVST kits for use between study visits. Participants who are not eligible for PrEP will be compensated for the visit and informed that they will not have further study follow-up. Enrollment will end when 120 HIV-negative MC eligible and willing to start PrEP are enrolled into the cohort.

Study participants will have a baseline visit, will be followed for a total of 6 months and attend 3 study visits over this period (1 month, 3 months and 6 months). At each follow-up visit, participants will undergo HIV rapid testing; screening for adverse events, sexually transmitted infections and acute HIV infection; a focused clinical exam, urine and blood specimen collection; receive HIV risk-reduction counseling (as per national guidelines), PrEP prescription refills and tailored adherence self-management counseling and HIVST kits; and complete study questionnaires.

This trial will be conducted in Kisumu County, Kenya.

Enrollment: 120 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Report no previous diagnosis of HIV infection
• Report being >18 years of age
• Report living or working in study area
• Report intention to stay in study area for 6 months
• Report exchanging sex for money, goods or services with a woman in past 3 months
• Report no current or recent (within the past 3 months) PrEP use
• Able to provide informed consent and complete study procedures in English, Kiswahili or Dholuo
• Willingness to participate and adhere to study interventions according to eligibility

Exclusion criteria

• Ineligible for PrEP according to Guidelines on Use of Antiretroviral Drugs for Treating and Preventing HIV Infection in Kenya - 2018 Edition (National AIDS and STI Control Program, 2018)
• Unable to provide informed consent for study procedures
• Any medical, psychiatric, or social condition, occupational or other responsibility that, in the judgment of the study team, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

PrEP+

Experimental group

Description:

PrEP+ is an experimental pre-exposure prophylaxis (PrEP)-focused prevention strategy providing daily oral tenofovir/emtricitabine (TDF/FTC) in combination with two adherence self-management interventions: (1) real-time feedback from point-of-care urine drug-level assay, (2) HIV self-testing and (3) 2-way text message reminders in addition to standard of care HIV risk-reduction counseling among male clients (MC) of female sex workers in Kisumu, Kenya.

Treatment:

Drug: Tenofovir (300mg)/Emtricitabine(200mg) [Truvada®]

Device: UrSure Rapid Urine Tenofovir Test

Device: OraQuick Rapid HIV Self-test kit

Behavioral: 2-way text message reminders

Behavioral: HIV risk-reduction counseling