HIV TestingTRUSTNCT04210271
Testing an Intervention to Increase HIV Self-Testing Among Young, Black MSM
A study testing Buddy self-testing condition in people with HIV Testing, run by New York Blood Center.
Trial summary
The investigators propose a study to design and test a brief intervention to increase uptake of consistent HIV self-testing among YBMSM using a novel and culturally-relevant "buddy system" approach. Read more about this study
- Who is it for?
- Ages 18 to 34 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Testing
- What is being tested?
- Buddy self-testing condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Dec 2018
- 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 to 34 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- biological male at birth
- between 18 and 34 years of age
- self-identify Black, African American, Caribbean Black, African Black, multiethnic Black OR Latino/Hispanic
- reside in the NYC metropolitan area
- not HIV-infected (self-report)
- report insertive or receptive anal intercourse with another man in the past year
Show all 9Show fewer
- ability to communicate in English
- provide informed consent for the study.
- willing to participate in the study with a friend or buddy.
Who cannot join
- currently enrolled in any other HIV research study involving HIV testing or an HIV vaccine trial
About this study
The investigators propose a study to design and test a brief intervention to increase uptake of consistent HIV self-testing among YBMSM using a novel and culturally-relevant "buddy system" approach. In the model, peer educators train pairs of YBMSM (or "buddies") to initiate self-testing and support each other in consistent self-testing (past 3 months) and sexual and AOD use risk reduction.
The specific aims of this developmental R01 study are:
- To conduct qualitative formative research to adapt couples testing for self-testing with a buddy;
- To assess the preliminary efficacy of the intervention to increase the proportion of YBMSM who self-test regularly over 12 months using a 2-arm randomized, controlled study design.
Read the detailed description
Increasing HIV testing rates among young, Black men who have sex with men (YBMSM) is critical to reducing the disproportionate disease burden in the Black community. MSM comprised almost two-thirds of new HIV diagnoses in the United States (US) in 2010. We propose a study to design and test a brief intervention to increase uptake of consistent HIV self-testing among YBMSM using a novel and culturally-relevant "buddy system" approach. In our model, peer educators train pairs of YBMSM (or "buddies") to initiate self-testing and support each other in consistent self-testing (past 3 months) and sexual and AOD use risk reduction. We propose a study to design and test a brief intervention to increase uptake of consistent HIV self-testing among YBMSM using a novel and culturally-relevant "buddy system" approach. In the model, peer educators train pairs of YBMSM (or "buddies") to initiate self-testing and support each other in consistent self-testing (past 3 months) and sexual and AOD use risk reduction.
The specific aims of this developmental R01 study are:
- To conduct qualitative formative research to adapt couples testing for self-testing with a buddy;
- To assess the preliminary efficacy of the intervention to increase the proportion of YBMSM who self-test regularly (i.e., past three months) over 12 months using a 2-arm randomized, controlled study design.
The investigators will achieve the aims of the study in three phases, recruiting YBMSM using web- and app-based approaches. In Phase 1, the investigators conducted 30 in-depth interviews to identify barriers to, facilitators of, perceptions of and preferences for regular HIV self-testing, describe how AOD use and sexual behavior influence HIV self-testing behaviors, and assess participant perspectives on the proposed buddy intervention. In Phase 2, based on the formative research, the investigators adapted couples testing, integrating enhanced motivational interviewing techniques to create a brief, peer educator-delivered, face-to-face intervention. In Phase 3, for which the investigators currently seek IRB approval, the investigators will use web- and app-based, face-to-face and word-of-mouth approaches to recruit 376 HIV-negative, BMSM aged 18 to 34 who will be randomized as pairs to either the intervention arm (HIV testing together, HIV self-testing screening information and skills training; free test kits on demand; tailored booster messages) or the control arm (HIV testing separately, generic health screening information; free test kits on demand) and followed for 12 months to estimate the intervention's efficacy in increasing regular HIV self-testing according to self-report. If demonstrated to be efficacious, this innovative and efficient approach can be adapted easily for widespread distribution, with the potential to diffuse along naturally occurring, social networks among YBMSM.
- Conditions
- HIV Testing
- Being tested
- Buddy self-testing condition, Control self-screening condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buddy self-testing conditionBehavioural
Control self-screening conditionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| HIV Self-testing | Experimental | brief intervention to teach and support consistent self-testing with a friend Receives: Behavioral: Buddy self-testing condition |
| Generic Self-screening | Active comparator | time and attention control providing basic self-screening education on a range of health outcomes Receives: Behavioral: Control self-screening condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consistent HIV self-testing
One or more HIV self-test in past three months
Measured: 12 months
Consistent HIV testing
One or more HIV test (any type) in past three months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study startJun 2016
- Primary completionDec 2018
- Study completionDec 2018
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 TestingStudies 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
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Blood Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210271
- Sponsor's protocol ID
- 648283
- Acronym
- TRUST
- Status last verified
- Dec 2019
- First submitted
- 29 Jan 2018
- Last updated
- 24 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Frye V, Nandi V, Paige MQ, McCrossin J, Lucy D, Gwadz M, Sullivan PS, Hoover DR, Wilton L; TRUST Study Team. TRUST: Assessing the Efficacy of an Intervention to Increase HIV Self-Testing Among Young Black Men Who have Sex with Men (MSM) and Transwomen. AIDS Behav. 2021 Apr;25(4):1219-1235. doi: 10.1007/s10461-020-03091-x. Epub 2020 Nov 15.
PubMed 33190178
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing an Intervention to Increase HIV Self-Testing Among Young, Black MSM
- ClinicalTrials.gov ID
- NCT04210271
- Acronym / sponsor ID
- TRUST / 648283
- Conditions
- HIV Testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- New York Blood CenterUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 24 Dec 2019 (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.
The investigators propose a study to design and test a brief intervention to increase uptake of consistent HIV self-testing among YBMSM using a novel and culturally-relevant "buddy system" approach. In the model, peer educators train pairs of YBMSM (or "buddies") to initiate self-testing and support each other in consistent self-testing (past 3 months) and sexual and AOD use risk reduction.
The specific aims of this developmental R01 study are:
- To conduct qualitative formative research to adapt couples testing for self-testing with a buddy;
- To assess the preliminary efficacy of the intervention to increase the proportion of YBMSM who self-test regularly over 12 months using a 2-arm randomized, controlled study design.
Detailed description
Increasing HIV testing rates among young, Black men who have sex with men (YBMSM) is critical to reducing the disproportionate disease burden in the Black community. MSM comprised almost two-thirds of new HIV diagnoses in the United States (US) in 2010. We propose a study to design and test a brief intervention to increase uptake of consistent HIV self-testing among YBMSM using a novel and culturally-relevant "buddy system" approach. In our model, peer educators train pairs of YBMSM (or "buddies") to initiate self-testing and support each other in consistent self-testing (past 3 months) and sexual and AOD use risk reduction. We propose a study to design and test a brief intervention to increase uptake of consistent HIV self-testing among YBMSM using a novel and culturally-relevant "buddy system" approach. In the model, peer educators train pairs of YBMSM (or "buddies") to initiate self-testing and support each other in consistent self-testing (past 3 months) and sexual and AOD use risk reduction.
The specific aims of this developmental R01 study are:
- To conduct qualitative formative research to adapt couples testing for self-testing with a buddy;
- To assess the preliminary efficacy of the intervention to increase the proportion of YBMSM who self-test regularly (i.e., past three months) over 12 months using a 2-arm randomized, controlled study design.
The investigators will achieve the aims of the study in three phases, recruiting YBMSM using web- and app-based approaches. In Phase 1, the investigators conducted 30 in-depth interviews to identify barriers to, facilitators of, perceptions of and preferences for regular HIV self-testing, describe how AOD use and sexual behavior influence HIV self-testing behaviors, and assess participant perspectives on the proposed buddy intervention. In Phase 2, based on the formative research, the investigators adapted couples testing, integrating enhanced motivational interviewing techniques to create a brief, peer educator-delivered, face-to-face intervention. In Phase 3, for which the investigators currently seek IRB approval, the investigators will use web- and app-based, face-to-face and word-of-mouth approaches to recruit 376 HIV-negative, BMSM aged 18 to 34 who will be randomized as pairs to either the intervention arm (HIV testing together, HIV self-testing screening information and skills training; free test kits on demand; tailored booster messages) or the control arm (HIV testing separately, generic health screening information; free test kits on demand) and followed for 12 months to estimate the intervention's efficacy in increasing regular HIV self-testing according to self-report. If demonstrated to be efficacious, this innovative and efficient approach can be adapted easily for widespread distribution, with the potential to diffuse along naturally occurring, social networks among YBMSM.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV Self-testing | Experimental | Behavioral: Buddy self-testing conditionbrief intervention to teach and support consistent self-testing with a friend |
| Generic Self-screening | Active comparator | Behavioral: Control self-screening conditiontime and attention control providing basic self-screening education on a range of health outcomes |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- biological male at birth
- between 18 and 34 years of age
- self-identify Black, African American, Caribbean Black, African Black, multiethnic Black OR Latino/Hispanic
- reside in the NYC metropolitan area
- not HIV-infected (self-report)
Key exclusion criteria (1 listed)
- currently enrolled in any other HIV research study involving HIV testing or an HIV vaccine trial
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 |
|---|---|---|
| Buddy self-testing condition | Behavioural | HIV Self-testing |
| Control self-screening condition | Behavioural | Generic Self-screening |
Primary outcome
Consistent HIV self-testing
Time frame: 12 months
One or more HIV self-test in past three months
Consistent HIV testing
Time frame: 12 months
One or more HIV test (any type) in past three months
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 24 Dec 2019.
- Derived from this study: PubMed 33190178Frye V, Nandi V, Paige MQ, McCrossin J, Lucy D, Gwadz M, Sullivan PS, Hoover DR, Wilton L; TRUST Study Team. TRUST: Assessing the Efficacy of an Intervention to Increase HIV Self-Testing Among Young Black Men Who have Sex with Men (MSM) and Transwomen. AIDS Behav. 2021 Apr;25(4):1219-1235. doi: 10.1007/s10461-020-03091-x. Epub 2020 Nov 15.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Buddy self-testing condition in people with HIV Testing, run by New York Blood Center.
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 9 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 24 Dec 2019. 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?
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?
Consistent HIV self-testing (time frame: 12 months). The study lists 2 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 NCT04210271, 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 24 Dec 2019.