HIV PreventionNCT03642314
HIV Self-testing in Implementation PrEP Study
A study testing HIV self test kit in people with HIV Prevention, run by Oswaldo Cruz Foundation.
Trial summary
This is a sub-study of an ongoing PrEP study ( HIV PrEP for men who have sex with men - MSM - and transgender women - TGW: a demonstrative project in Brazil, Peru and Mexico - ImPrEP). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- What is being tested?
- HIV self test kit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 876 participants
- Where
- No sites listed yet
- Study dates
- Sep 2018to Sep 2022
- Phase
- Interventional
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- individuals who were included in the ImPrEP Study
- performed at least 3 study visits,
- accepted to participate in this sub study,
- provide informed consent form
Who cannot join
- Individuals included into ImPrEP as a result of HIVST secondary distribution
Trial locations and contacts
No sites are listed yet.
About this study
Official title: ImPrEP Sub-study - HIV Self-Testing to Increase Combination Prevention Demand in the ImPrEP Project: an Adaptative Randomized Trial
This is a sub-study of an ongoing PrEP study ( HIV PrEP for men who have sex with men - MSM - and transgender women - TGW: a demonstrative project in Brazil, Peru and Mexico - ImPrEP). MSM/TGW enrolled to ImPrEP Study at the selected sites, who agree to participate in this HIV Self Test (HIVST) sub-study, will be 1:1 randomized at the third study visit either to receive 5 HIVST+voucher (intervention arm) or 5 vouchers alone (control arm) to secondarily distribute into their MSM/TGW network. All vouchers are numbered invitations for priority access to individualized HIV risk assessment and combination prevention services, including PrEP, at the ImPrEP sites. Study population comprises ImPrEP participants and their referred peers. Sample size is going to be determined at an interim analysis performed when each city has enrolled 70 participants. Trial participants will be at maximum 876 (438 intervention and 438 in the control arm) MSM and TGW included in the ImPrEP Study who received PrEP for at least 6 months in the sites from Rio de Janeiro and Lima. The study is designed as a multicenter, open, adaptative, randomized trial. The main study outcome is the voucher redemption proportion by arm.
- Conditions
- HIV Prevention
- Being tested
- HIV self test kit
- Keywords
- pre exposure prophylaxis, men who have sex with men
- Medical subject headings
- Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV self test kitDiagnostic test
Also called HIVST
HIVST receptor will be invited to priority access to PrEP sites
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Individuals receive 5 HIV Self Test kits + vouchers to secondarily distribute to MSM/TGW from their social/sexual networks. All vouchers are uniquely identified invitations for priority access to ImPrEP sites, valid to be redeemed by a 3 month period Receives: Diagnostic Test: HIV self test kit |
| Control | No intervention | Individuals receive 5 vouchers to secondarily distribute to MSM/TGW from their social/sexual networks. All vouchers are uniquely identified invitations for priority access to ImPrEP sites, valid to be redeemed by a 3 month period |
What is being measured
The primary outcome is the main question the study is designed to answer.
voucher redemption proportion by arm
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study startSep 2018 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionSep 2022 (estimated)
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 HIV PreventionStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 876 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oswaldo Cruz Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valdilea Veloso, PhD, Study chair, Oswaldo Cruz Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642314
- Sponsor's protocol ID
- HIV-ST
- Status last verified
- Aug 2018
- First submitted
- 20 Aug 2018
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoagland B, Torres TS, Konda K, Moreira RI, Leite IC, Cunha M, Campos K, Calvo G, Pimenta C, Benedetti M, Rocha C, Grangeiro JR, Bastos E, Nazer S, Palombo C, de Vasconcellos M, Caceres CF, Grinzstejn B, Veloso VG. HIV Self-testing and Coupons Distribution by Persons Using PrEP to Create Demand for Combination HIV Prevention Services Among Men Who Have Sex With Men and Transgender Women: A Randomized Clinical Trial in the Context of the ImPrEP Project. J Acquir Immune Defic Syndr. 2026 Aug 1;101(8):881-889. doi: 10.1097/QAI.0000000000003887.
PubMed 41983677
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ImPrEP Sub-study - HIV Self-Testing to Increase Combination Prevention Demand in the ImPrEP Project: an Adaptative Randomized Trial
- ClinicalTrials.gov ID
- NCT03642314
- Acronym / sponsor ID
- HIV-ST
- Conditions
- HIV Prevention
- Keywords
- pre exposure prophylaxis, men who have sex with men
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 876 participants (estimated)
- Lead sponsor
- Oswaldo Cruz FoundationUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 22 Aug 2018 (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.
This is a sub-study of an ongoing PrEP study ( HIV PrEP for men who have sex with men - MSM - and transgender women - TGW: a demonstrative project in Brazil, Peru and Mexico - ImPrEP). MSM/TGW enrolled to ImPrEP Study at the selected sites, who agree to participate in this HIV Self Test (HIVST) sub-study, will be 1:1 randomized at the third study visit either to receive 5 HIVST+voucher (intervention arm) or 5 vouchers alone (control arm) to secondarily distribute into their MSM/TGW network. All vouchers are numbered invitations for priority access to individualized HIV risk assessment and combination prevention services, including PrEP, at the ImPrEP sites. Study population comprises ImPrEP participants and their referred peers. Sample size is going to be determined at an interim analysis performed when each city has enrolled 70 participants. Trial participants will be at maximum 876 (438 intervention and 438 in the control arm) MSM and TGW included in the ImPrEP Study who received PrEP for at least 6 months in the sites from Rio de Janeiro and Lima. The study is designed as a multicenter, open, adaptative, randomized trial. The main study outcome is the voucher redemption proportion by arm.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Diagnostic Test: HIV self test kitIndividuals receive 5 HIV Self Test kits + vouchers to secondarily distribute to MSM/TGW from their social/sexual networks. All vouchers are uniquely identified invitations for priority access to ImPrEP sites, valid to be redeemed by a 3 month period |
| Control | No intervention | –Individuals receive 5 vouchers to secondarily distribute to MSM/TGW from their social/sexual networks. All vouchers are uniquely identified invitations for priority access to ImPrEP sites, valid to be redeemed by a 3 month period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- individuals who were included in the ImPrEP Study
- performed at least 3 study visits,
- accepted to participate in this sub study,
- provide informed consent form
Key exclusion criteria (1 listed)
- Individuals included into ImPrEP as a result of HIVST secondary distribution
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 |
|---|---|---|
| HIV self test kitAlso: HIVSTHIVST receptor will be invited to priority access to PrEP sites | Diagnostic test | Intervention |
Primary outcome
voucher redemption proportion by arm
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Derived from this study: PubMed 41983677Hoagland B, Torres TS, Konda K, Moreira RI, Leite IC, Cunha M, Campos K, Calvo G, Pimenta C, Benedetti M, Rocha C, Grangeiro JR, Bastos E, Nazer S, Palombo C, de Vasconcellos M, Caceres CF, Grinzstejn B, Veloso VG. HIV Self-testing and Coupons Distribution by Persons Using PrEP to Create Demand for Combination HIV Prevention Services Among Men Who Have Sex With Men and Transgender Women: A Randomized Clinical Trial in the Context of the ImPrEP Project. J Acquir Immune Defic Syndr. 2026 Aug 1;101(8):881-889. doi: 10.1097/QAI.0000000000003887.
- Individual participant dataSharing planned: No
Related trials for HIV Prevention
Active, not recruiting
Suubi4PrEP: Improving PrEP Access and Adherence Among Adolescent Girls and Young Women in Uganda
HIV Prevention
Not yet recruitingPhase 4
Starting HIV Prevention Medicine (PrEP) During an Emergency Department Visit With a Peer Navigator
HIV Prevention, Pre-Exposure Prophylaxis (PrEP)
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
Recruiting
Screen Smart: Using Digital Health to Improve HIV Screening and Prevention
HIV Infections
Active, not recruiting
IGHID 12230 - An Implementation Trial of an Experiential Brief Alcohol Intervention for HIV Prevention
HIV-1-infection, Unhealthy Alcohol Use
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.
Valdilea Veloso, PhD study chair
Oswaldo Cruz Foundation
Questions about this trial
What is this clinical trial studying?
A study testing HIV self test kit in people with HIV Prevention, run by Oswaldo Cruz Foundation.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valdilea Veloso, PhD (+552122707064, valdilea.veloso@ini.fiocruz.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
voucher redemption proportion by arm (time frame: 2 years). 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 NCT03642314, 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 22 Aug 2018.