HIV/AIDSSTARNCT04121962
A Pilot Peer Mentor Intervention That Trains Black Men Who Have Sex With Men (BMSM) to Use and Promote Uptake of HIV/STI Self-Testing to Peers and Sex Partners: STAR Study (Self-Testing at Your Residence)
A study testing Peer Mentor and Website only in people with HIV/AIDS and Sexually Transmitted Diseases, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial summary
The objectives of the study are to assess the feasibility, reach and preliminary efficacy of a brief intervention that trains Black men who have sex with men [referred to as Index] (a) to use home-based testing for HIV and sexually transmitted infections and (b) promote home-based testing to their peers and sexual… Read more about this study
- Who is it for?
- Ages 17 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS, Sexually Transmitted Diseases
- What is being tested?
- Peer Mentor and Website only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2019to 11 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 17 to 60 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- self-report male sex
- condomless anal sex with >1 male in the prior 6 months
- self-report Black race
- aged 18 or older
- internet use at least once a week.
Who cannot join
- younger than 17
Trial locations and contacts
1 site in 1 country.
United States1 site
Lighthouse Studies @ Peer Point
Baltimore, Maryland, 21205
About this study
Official title: Pilot Peer Mentor Intervention to Train Black MSM to Use and Promote Home-based HIV and STI Testing
The objectives of the study are to assess the feasibility, reach and preliminary efficacy of a brief intervention that trains Black men who have sex with men [referred to as Index] (a) to use home-based testing for HIV and sexually transmitted infections and (b) promote home-based testing to their peers and sexual partners.
Read the detailed description
Sexually transmitted infections (STIs) increase one's risk of HIV infection, are serious co-infections that affect HIV clinical outcomes, and remain a risk for individuals using PrEP. Self-testing methods address barriers to clinic-based testing by offering convenience and privacy and have been shown to be well accepted by MSM. Therefore, use of self-testing is a potential approach through which to improve HIV and STI testing rates in MSM. Internet-based distribution (herein: web-based) of STI self-test kits enables an individual to request sampling kits via a website, mail biological specimens (e.g. urethral swabs) to a laboratory for testing, and view test results through a web-based account. Web-based self-HIV oral testing enables an individual to request a test kit, collect an oral specimen, and receive results within 20 minutes. Despite these potential benefits and reports of willingness to use free self-testing, uptake has been low due to barriers such as concerns about accuracy of the tests, apprehension to collect specimens, low risk perception, and the desire for counseling. In the proposed study, investigators will pilot test an intervention that address these barriers by training BMSM with information about the accuracy of the HIV rapid oral test kit, demonstrating how to properly collect specimens for HIV and STIs (gonorrhea, chlamydia and syphilis) self-testing, and providing resources for linkage to HIV and STI treatment and PrEP services. Study participants will utilize a secure website to request test kits.
- Conditions
- HIV/AIDS, Sexually Transmitted Diseases
- Being tested
- Peer Mentor, Website only
- Keywords
- Black MSM, Social network
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer MentorBehavioural
Participants will be trained to be Peer Mentors and promote home-based testing to their social network
Website onlyBehavioural
Participants will be given instructions on how to use the project website to request kits to test for HIV at home and collect specimens for lab testing.
| Study group | Role | What they receive |
|---|---|---|
| Peer Mentor | Experimental | Peer Mentor Training is 5 individual sessions with a 30 day check-in session. This condition is focused on training Index with communication skills to promote HIV and STI testing and treatment and pre-exposure prophalaxis (PrEP) to individuals in their social networks. Peer Mentor training is conducted by a one health educator. The sessions are held once a week and will last approximately 60 minutes. Receives: Behavioral: Peer Mentor |
| Control | Active comparator | Is one individual-based session which will be conducted by sending a video about the website of a health educator. Receives: Behavioral: Website only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Session Attendance
number of participants who completed 80%
Measured: 3 month
Number of Index Participants Who Requested Test Kits
Number of Index participants who requested test kits is reported
Measured: 3 months
Number of Participants Who Return Kits for Testing
Number of participants who returned kits to lab for testing is reported.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start6 May 2019
- Primary completion9 Mar 2022
- Study completion11 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Karin E Tobin, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121962
- Sponsor's protocol ID
- 1R34MH118178
- Other IDs
- IRB00009216
- Acronym
- STAR
- Status last verified
- May 2024
- First submitted
- 4 Oct 2019
- Last updated
- 20 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators will share data in a way that will protect participant confidentiality. Within 12 months of publication of the primary papers for this study, a dataset of aggregate values will be made available. Due to the highly sensitive nature of the data collected and the characteristics of this often stigmatized population, no client-level data will be shared until the entire cohort is accrued and completed, even that which is de-identified; this will reduce the risk of small numbers resulting in deductive identification.
Publications
Tobin KE, Heidari O, Winiker A, Pollock S, Rothwell MD, Alexander K, Owczarzak J, Latkin C. Peer Approaches to Improve HIV Care Cascade Outcomes: a Scoping Review Focused on Peer Behavioral Mechanisms. Curr HIV/AIDS Rep. 2022 Aug;19(4):251-264. doi: 10.1007/s11904-022-00611-3. Epub 2022 Jul 7.
PubMed 35798989
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Peer Mentor Intervention to Train Black MSM to Use and Promote Home-based HIV and STI Testing
- ClinicalTrials.gov ID
- NCT04121962
- Acronym / sponsor ID
- STAR / 1R34MH118178
- Conditions
- HIV/AIDS, Sexually Transmitted Diseases
- Keywords
- Black MSM, Social network
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 6 May 2019 (actual)
- Primary completion
- 9 Mar 2022 (actual)
- Study completion
- 11 Jul 2023 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Posted 20 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of the study are to assess the feasibility, reach and preliminary efficacy of a brief intervention that trains Black men who have sex with men [referred to as Index] (a) to use home-based testing for HIV and sexually transmitted infections and (b) promote home-based testing to their peers and sexual partners.
Detailed description
Sexually transmitted infections (STIs) increase one's risk of HIV infection, are serious co-infections that affect HIV clinical outcomes, and remain a risk for individuals using PrEP. Self-testing methods address barriers to clinic-based testing by offering convenience and privacy and have been shown to be well accepted by MSM. Therefore, use of self-testing is a potential approach through which to improve HIV and STI testing rates in MSM. Internet-based distribution (herein: web-based) of STI self-test kits enables an individual to request sampling kits via a website, mail biological specimens (e.g. urethral swabs) to a laboratory for testing, and view test results through a web-based account. Web-based self-HIV oral testing enables an individual to request a test kit, collect an oral specimen, and receive results within 20 minutes. Despite these potential benefits and reports of willingness to use free self-testing, uptake has been low due to barriers such as concerns about accuracy of the tests, apprehension to collect specimens, low risk perception, and the desire for counseling. In the proposed study, investigators will pilot test an intervention that address these barriers by training BMSM with information about the accuracy of the HIV rapid oral test kit, demonstrating how to properly collect specimens for HIV and STIs (gonorrhea, chlamydia and syphilis) self-testing, and providing resources for linkage to HIV and STI treatment and PrEP services. Study participants will utilize a secure website to request test kits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer Mentor | Experimental | Behavioral: Peer MentorPeer Mentor Training is 5 individual sessions with a 30 day check-in session. This condition is focused on training Index with communication skills to promote HIV and STI testing and treatment and pre-exposure prophalaxis (PrEP) to individuals in their social networks. Peer Mentor training is conducted by a one health educator. The sessions are held once a week and will last approximately 60 minutes. |
| Control | Active comparator | Behavioral: Website onlyIs one individual-based session which will be conducted by sending a video about the website of a health educator. |
Who may qualify
- Ages
- 17 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- self-report male sex
- condomless anal sex with >1 male in the prior 6 months
- self-report Black race
- aged 18 or older
- internet use at least once a week.
Key exclusion criteria (1 listed)
- younger than 17
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 |
|---|---|---|
| Peer MentorParticipants will be trained to be Peer Mentors and promote home-based testing to their social network | Behavioural | Peer Mentor |
| Website onlyParticipants will be given instructions on how to use the project website to request kits to test for HIV at home and collect specimens for lab testing. | Behavioural | Control |
Primary outcome
Session Attendance
Time frame: 3 month
number of participants who completed 80%
Number of Index Participants Who Requested Test Kits
Time frame: 3 months
Number of Index participants who requested test kits is reported
Number of Participants Who Return Kits for Testing
Time frame: 3 month
Number of participants who returned kits to lab for testing is reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35798989Tobin KE, Heidari O, Winiker A, Pollock S, Rothwell MD, Alexander K, Owczarzak J, Latkin C. Peer Approaches to Improve HIV Care Cascade Outcomes: a Scoping Review Focused on Peer Behavioral Mechanisms. Curr HIV/AIDS Rep. 2022 Aug;19(4):251-264. doi: 10.1007/s11904-022-00611-3. Epub 2022 Jul 7.
- Individual participant dataSharing planned: Yes. Investigators will share data in a way that will protect participant confidentiality. Within 12 months of publication of the primary papers for this study, a dataset of aggregate values will be made available. Due to the highly sensitive nature of the data collected and the characteristics of this often stigmatized population, no client-level data will be shared until the entire cohort is accrued and completed, even that which is de-identified; this will reduce the risk of small numbers resulting in deductive identification.
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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.
Karin E Tobin, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Mentor and Website only in people with HIV/AIDS and Sexually Transmitted Diseases, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
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 5 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: finished, as of the sponsor's last update on 20 May 2024. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Session Attendance (time frame: 3 month). The study lists 3 primary outcomes in all. 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 NCT04121962, 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 20 May 2024.