Clinical trial NCT04898699: IPrEP Men's Study: Expanding the Reach of Prevention for Men in Kisumu, Kenya
Official title: IPrEP: A Combination HIV Prevention Strategy for Young Women at Risk for HIV in Kisumu, Kenya IPrEP Men's Study: Expanding the Reach of Prevention for Men in Kisumu, Kenya
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV
Keywords: HIV
Pre-exposure prophylaxis
Kenya
Male clients
Female sex workers
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Impact Research & Development Organization
name: Research Foundation for Mental Hygiene, Inc.
First posted: 2021-05-24
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: PrEP adherence
timeFrame: 6-month visit
Secondary outcomes:
measure: Detectable ARV levels at 3 and 6 months
timeFrame: 3- and 6- month visit
measure: Self-reported adherence
timeFrame: 1-, 3- and 6- month visit
Other outcomes:
Locations:
Study officials:
affiliation: ICAP at Columbia University
name: Wafaa M. El-Sadr, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mantell J, Franks J, Zerbe A, Lamb MR, Reed DM, Omollo D, Lahuerta M, Naitore D, El-Sadr WM, Agot K. MPrEP+ study protocol: a prospective cohort study assessing the feasibility and acceptability of an HIV pre-exposure prophylaxis (PrEP) strategy for male clients of female sex workers in Kisumu, Kenya. BMJ Open. 2022 Nov 4;12(11):e064037. doi: 10.1136/bmjopen-2022-064037.