IPrEP Men's Study: Expanding the Reach of Prevention for Men in Kisumu, Kenya
Status:
Not yet recruiting
Trial end date:
2022-03-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
N/A
Details
Lead Sponsor:
Columbia University
Collaborators:
Impact Research & Development Organization Research Foundation for Mental Hygiene, Inc.
Treatments:
Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Tenofovir