HIVEarly Phase 1NCT04898699
IPrEP Men's Study: Expanding the Reach of Prevention for Men in Kisumu, Kenya
A Early Phase 1 study testing UrSure Rapid Urine Tenofovir Test, OraQuick Rapid HIV Self-test kit and Tenofovir (300mg)/Emtricitabine(200mg) [Truvada®] in people with HIV, run by Columbia University at 1 site in Kenya.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- UrSure Rapid Urine Tenofovir Test, OraQuick Rapid HIV Self-test kit and Tenofovir (300mg)/Emtricitabine(200mg) [Truvada®]
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteKenya
- Study dates
- 24 Nov 2021to 19 Jul 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Kenya1 site
Impact Research, Training & Healthcare Services (IRTHS) Centre
Kisumu, Nyanza
About this study
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
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.
Read more
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.
- Conditions
- HIV
- Being tested
- UrSure Rapid Urine Tenofovir Test, OraQuick Rapid HIV Self-test kit, Tenofovir (300mg)/Emtricitabine(200mg) [Truvada®], 2-way text message reminders, HIV risk-reduction counseling
- Keywords
- HIV, Pre-exposure prophylaxis, Kenya, Male clients, Female sex workers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UrSure Rapid Urine Tenofovir TestDevice
A point of care urine immunoassay to measure PrEP drug levels for adherence in participant urine samples over the preceding seven days will be done at all follow-up visits. At enrollment, study staff will explain the use of this experimental measurement of PrEP drug level in urine samples. Participants will receive results of the test at the same study visit during which it is performed.
OraQuick Rapid HIV Self-test kitDevice
Participants will be provided with HIV self-testing kits to use at their discretion and, in case of multi-month dispensing, prior to start of new bottle of PrEP medication, in between study visits. HIV self-testing kits will be provided to confirm their HIV-negative status and make a connection between PrEP use and protection against HIV. Participants will receive detailed, interactive training on HIVST with pictorial elements, including instructions to contact study staff immediately in event of a reactive test for confirmation as per Kenya guidelines.
Tenofovir (300mg)/Emtricitabine(200mg) [Truvada®]Drug
Information will be provided regarding dosing of PrEP medications, importance of daily adherence, importance of frequent HIV testing, and signs and symptoms of drug toxicity, acute HIV infection and STIs. An initial one-month supply (30 pills) of FTC/TDF will be given to all PrEP study participants. At the one-month study assessment, a two-month supply of daily oral FTC/TDF will be given to each participant, after HIV testing, assessment for acute HIV infection and review of side effects and adherence, following national guidelines and procedures for PrEP services. At Month 3 assessment, a three-month supply of oral FTC/TDF will be given.
2-way text message remindersBehavioural
All participants will receive weekly SMS visit reminders to support PrEP adherence. Participants will be asked at study enrollment for a primary contact telephone number and an alternate number for contact. Participants without cell phones will be provided an inexpensive cell phone (although cell phone ownership is very high in Kenya). Participants will receive a discrete weekly SMS text (or voice message if participant is illiterate) to encourage healthy behaviors, use of HIV self-test kit, study engagement and PrEP adherence. Messages will be a general message that the participant has selected and will not have any information identifying the participant as part of the study or describing the purpose of the study. An example text is "Remember to look after yourself today, See you tomorrow." Participants will be requested to respond to the message with any questions, concerns or messages that they have for the study staff.
HIV risk-reduction counselingBehavioural
All study participants will be provided with brief interactive counseling at each study visit, tailored to the results of their urine assay.
| Study group | Role | What they receive |
|---|---|---|
| PrEP+ | Experimental | 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. Receives: Device: UrSure Rapid Urine Tenofovir Test; Device: OraQuick Rapid HIV Self-test kit; Drug: Tenofovir (300mg)/Emtricitabine(200mg) [Truvada®]; Behavioral: 2-way text message reminders; Behavioral: HIV risk-reduction counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP adherence
Percentage of participants with plasma tenofovir concentration of >40 ng/mL (consistent with daily adherence)
Measured: 6-month visit
Secondary outcomes (2)
Detectable ARV levels at 3 and 6 months
Percentage of participants with detectable ARV (i.e, plasma tenofovir concentration of >0.31 ng/ml) at 3- and 6-month visit
Measured: 3- and 6- month visit
Self-reported adherence
Percentage of those who self-report daily adherence in the past 7 days (no doses missed)
Measured: 1-, 3- and 6- month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start24 Nov 2021
- Primary completion19 Jul 2022
- Study completion19 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Impact Research & Development Organization, Research Foundation for Mental Hygiene, Inc., National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Wafaa M. El-Sadr, MD, Principal investigator, ICAP at Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898699
- Sponsor's protocol ID
- AAAT6103
- Other IDs
- R01MH110051-04S1
- Status last verified
- Feb 2026
- First submitted
- 14 May 2021
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 36332953
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04898699
- Acronym / sponsor ID
- AAAT6103
- Conditions
- HIV
- Keywords
- HIV, Pre-exposure prophylaxis, Kenya, Male clients, Female sex workers
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Impact Research & Development Organization, Research Foundation for Mental Hygiene, Inc., National Institute of Mental Health (NIMH)
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 19 Jul 2022 (actual)
- Study completion
- 19 Jul 2022 (actual)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PrEP+ | Experimental | Device: UrSure Rapid Urine Tenofovir Test, Device: OraQuick Rapid HIV Self-test kit, Drug: Tenofovir (300mg)/Emtricitabine(200mg) [Truvada®], Behavioral: 2-way text message reminders, Behavioral: HIV risk-reduction counselingPrEP+ 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UrSure Rapid Urine Tenofovir TestA point of care urine immunoassay to measure PrEP drug levels for adherence in participant urine samples over the preceding seven days will be done at all follow-up visits. At enrollment, study staff will explain the use of this experimental measurement of PrEP drug level in urine samples. Participants will receive results of the test at the same study visit during which it is performed. | Device | PrEP+ |
| OraQuick Rapid HIV Self-test kitParticipants will be provided with HIV self-testing kits to use at their discretion and, in case of multi-month dispensing, prior to start of new bottle of PrEP medication, in between study visits. HIV self-testing kits will be provided to confirm their HIV-negative status and make a connection between PrEP use and protection against HIV. Participants will receive detailed, interactive training on HIVST with pictorial elements, including instructions to contact study staff immediately in event of a reactive test for confirmation as per Kenya guidelines. | Device | PrEP+ |
| Tenofovir (300mg)/Emtricitabine(200mg) [Truvada®]Information will be provided regarding dosing of PrEP medications, importance of daily adherence, importance of frequent HIV testing, and signs and symptoms of drug toxicity, acute HIV infection and STIs. An initial one-month supply (30 pills) of FTC/TDF will be given to all PrEP study participants. At the one-month study assessment, a two-month supply of daily oral FTC/TDF will be given to each participant, after HIV testing, assessment for acute HIV infection and review of side effects and adherence, following national guidelines and procedures for PrEP services. At Month 3 assessment, a three-month supply of oral FTC/TDF will be given. | Drug | PrEP+ |
| 2-way text message remindersAll participants will receive weekly SMS visit reminders to support PrEP adherence. Participants will be asked at study enrollment for a primary contact telephone number and an alternate number for contact. Participants without cell phones will be provided an inexpensive cell phone (although cell phone ownership is very high in Kenya). Participants will receive a discrete weekly SMS text (or voice message if participant is illiterate) to encourage healthy behaviors, use of HIV self-test kit, study engagement and PrEP adherence. Messages will be a general message that the participant has selected and will not have any information identifying the participant as part of the study or describing the purpose of the study. An example text is "Remember to look after yourself today, See you tomorrow." Participants will be requested to respond to the message with any questions, concerns or messages that they have for the study staff. | Behavioural | PrEP+ |
| HIV risk-reduction counselingAll study participants will be provided with brief interactive counseling at each study visit, tailored to the results of their urine assay. | Behavioural | PrEP+ |
Primary outcome
PrEP adherence
Time frame: 6-month visit
Percentage of participants with plasma tenofovir concentration of >40 ng/mL (consistent with daily adherence)
2 secondary outcomes
Detectable ARV levels at 3 and 6 months
Time frame: 3- and 6- month visit
Self-reported adherence
Time frame: 1-, 3- and 6- month visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Derived from this study: PubMed 36332953Mantell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wafaa M. El-Sadr, MD principal investigator
ICAP at Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing UrSure Rapid Urine Tenofovir Test, OraQuick Rapid HIV Self-test kit and Tenofovir (300mg)/Emtricitabine(200mg) [Truvada®] in people with HIV, run by Columbia University at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP adherence (time frame: 6-month visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04898699, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.