Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04898699
Status:
UNKNOWN
Last Update Posted:
2021-10-05
First Post:
2021-05-14
Brief Title:
IPrEP Mens Study Expanding the Reach of Prevention for Men in Kisumu Kenya
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
IPrEP A Combination HIV Prevention Strategy for Young Women at Risk for HIV in Kisumu Kenya IPrEP Mens Study Expanding the Reach of Prevention for Men in Kisumu Kenya
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
IPrEP Mens 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 emtricitabinetenofovir FTCTDF 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None