HIVNCT05499962
SNS and PrEP Initiation and Adherence in Black SMM
A study testing Social Networking Strategies in people with HIV, run by Us Helping Us, People Into Living, Inc. at 1 site in United States.
Trial summary
Specific Aim 1. Conduct 18 focus groups among Black gay, bisexual and other sexual minority men (SMM; n=72-90) in the Washington, DC area of different age groups (18-24, 25-34, 35+) and various pre-exposure prophylaxis (PrEP) use profiles (i.e., PrEP naïve, current PrEP users, and discontinued PrEP; two per age-group… 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?
- Social Networking Strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to Dec 2023
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age of 18 years or above
- Black or African American race
- Cisgender male identity
- Gay, bisexual or a male who has sex with other males
- Residence in the greater Washington, DC area (includes District of Columbia, Prince George's County, MD and Montgomery County, MD)
- Current PrEP use
- Confirmed HIV-negative status.
Who cannot join
- Being younger than 18 years of age ;
- Cisgender or transgender female identity
- Males having sex with women exclusively
- Being unable to speak or read English
- Reside outside of the defined greater Washington, DC area
- Being unable or unwilling to provide written informed consent
- Being unable to comply with the requirements of the protocol (e.g. persons with mental health conditions, persons who are intoxicated or incoherent for other reasons)
- Being a member of other vulnerable populations: pregnant women, children or wards of the state.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Us Helping Us, People Into Living, Inc.
Washington D.C., District of Columbia, 20010-1646
Dianne Murphy, 202-446-1100, dmurphy@uhupil.org
Alexa Euceda, MPH, 202.446.1100, aeuceda@uhupil.org
About this study
Official title: PrEP Initiation and Adherence Among Black SMM: A Social Network-Level Intervention
Specific Aim 1. Conduct 18 focus groups among Black gay, bisexual and other sexual minority men (SMM; n=72-90) in the Washington, DC area of different age groups (18-24, 25-34, 35+) and various pre-exposure prophylaxis (PrEP) use profiles (i.e., PrEP naïve, current PrEP users, and discontinued PrEP; two per age-group and PrEP use profile) to understand intervention feasibility, acceptability and appropriateness, how the intervention can address experienced and perceived socio-structural barriers, and increase PrEP initiation and adherence among Black SMM in the Washington, District of Columbia (DC) area.
Specific Aim 2. Implement an iterative open-phase pilot of an SNS intervention to increase PrEP initiation among human immunodeficiency virus (HIV)-negative Black SMM, aged 18 years and above, in the Washington, DC area. Recruit 30 PrEP-using Black SMM, including those who use substances, as Recruiters to identify and refer Network Associates to PrEP services. The pilot will occur in six blocks of up to 5 Recruiters to further develop all intervention procedures and enhance the social networking strategy (SNS) intervention's feasibility and acceptability.
Read the detailed description
The first 12 months (Phase 1: Formative Research) will be an intervention development/adaptation phase. Using a community-based participatory approach (n=18 age- and PrEP use profile-specific focus groups, of at least 4-5 participants each, totaling 72-90), participants will be asked about the social network dynamics and characteristics (e.g., influential network members, communication about PrEP as an HIV prevention method) that influenced their decision to initiate PrEP. Among participants with no PrEP use, they will be asked about the acceptability and feasibility of talking with PrEP-using Black SMM within their respective social network to support initiation along with preferences for relevant PrEP-related information from peers.
The following 12 months (Phase 2: Open-phase Pilot Study) will involve conducting an open pilot of the SNS intervention, in up to six batches of up to 5 participants (n=30), allowing for further intervention refinement. This will allow us to demonstrate participant feasibility and acceptance, which includes the ability to recruit network members, feasibility of intervention delivery, and changes in participant behaviors. It will allow for further evaluation of the feasibility of all study procedures, and refinement of intervention manual. Therefore, the expected outcome is a culturally relevant SNS intervention to increase PrEP initiation among Black SMM through PrEP-using social network members.
- Conditions
- HIV
- Being tested
- Social Networking Strategies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Networking StrategiesBehavioural
Assess whether PrEP-using Black SMM can serve as an Interventionist to get their social and sexual network members to uptake and adhere to PrEP
| Study group | Role | What they receive |
|---|---|---|
| PrEP-using Black SMM as Recruiters | Other | Recruit 30 PrEP-using Black SMM, including those who use substances, as Recruiters to identify and refer Network Associates to PrEP services. The pilot will occur in six blocks of up to 5 Recruiters to further develop all intervention procedures and enhance the SNS intervention's feasibility and acceptability. Receives: Behavioral: Social Networking Strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention as measured by Weiner et al., 2017.
Assess the feasibility of intervention delivery method (i.e., PrEP-using SMM as the Interventionist/Recruiter).
Measured: During the peer-based debriefing sessions that occurs before a Recruiter is dismissed from the open-phase pilot.
Acceptability of Intervention as measured by Weiner et al., 2017.
Assess the feasibility of intervention delivery method (i.e., PrEP-using SMM as the Interventionist/Recruiter).
Measured: During the peer-based debriefing sessions that occurs before a Recruiter is dismissed from the open-phase pilot.
Secondary outcomes (3)
Recruited Network Members
Proportion of Recruiters who recruit Network Associates
Measured: Immediately after PrEP-using SMM enroll as an Interventionist (i.e., Recruiter)
Network members on PrEP
Number of Network Associates recruited
Measured: Immediately after PrEP-using SMM enroll as an Interventionist (i.e., Recruiter)
Comfortability of the Intervention as measured by an adaptation of Weiner et al., 2017.
Extent to which Network Associates were comfortable with the intervention modality
Measured: During the peer-based debriefing sessions that occurs before a Recruiter is dismissed from the open-phase pilot.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start1 Mar 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Recruit 30 PrEP-using Black SMM, including those who use substances, as Recruiters to identify and refer Network Associates to PrEP services. The pilot will occur in six blocks of up to 5 Recruiters to further develop all intervention procedures and enhance the SNS intervention's feasibility and acceptability.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Us Helping Us, People Into Living, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DeMarc A. Hickson, PhD, Us Helping Us, People Into Living, Inc.
- Investigators
- DeMarc A Hickson, PhD, Principal investigator, Executive Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499962
- Sponsor's protocol ID
- 21-USHE-104
- Status last verified
- Sep 2023
- First submitted
- 9 Aug 2022
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PrEP Initiation and Adherence Among Black SMM: A Social Network-Level Intervention
- ClinicalTrials.gov ID
- NCT05499962
- Acronym / sponsor ID
- 21-USHE-104
- Conditions
- HIV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Us Helping Us, People Into Living, Inc.University, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 12 Aug 2022 (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.
Specific Aim 1. Conduct 18 focus groups among Black gay, bisexual and other sexual minority men (SMM; n=72-90) in the Washington, DC area of different age groups (18-24, 25-34, 35+) and various pre-exposure prophylaxis (PrEP) use profiles (i.e., PrEP naïve, current PrEP users, and discontinued PrEP; two per age-group and PrEP use profile) to understand intervention feasibility, acceptability and appropriateness, how the intervention can address experienced and perceived socio-structural barriers, and increase PrEP initiation and adherence among Black SMM in the Washington, District of Columbia (DC) area.
Specific Aim 2. Implement an iterative open-phase pilot of an SNS intervention to increase PrEP initiation among human immunodeficiency virus (HIV)-negative Black SMM, aged 18 years and above, in the Washington, DC area. Recruit 30 PrEP-using Black SMM, including those who use substances, as Recruiters to identify and refer Network Associates to PrEP services. The pilot will occur in six blocks of up to 5 Recruiters to further develop all intervention procedures and enhance the social networking strategy (SNS) intervention's feasibility and acceptability.
Detailed description
The first 12 months (Phase 1: Formative Research) will be an intervention development/adaptation phase. Using a community-based participatory approach (n=18 age- and PrEP use profile-specific focus groups, of at least 4-5 participants each, totaling 72-90), participants will be asked about the social network dynamics and characteristics (e.g., influential network members, communication about PrEP as an HIV prevention method) that influenced their decision to initiate PrEP. Among participants with no PrEP use, they will be asked about the acceptability and feasibility of talking with PrEP-using Black SMM within their respective social network to support initiation along with preferences for relevant PrEP-related information from peers.
The following 12 months (Phase 2: Open-phase Pilot Study) will involve conducting an open pilot of the SNS intervention, in up to six batches of up to 5 participants (n=30), allowing for further intervention refinement. This will allow us to demonstrate participant feasibility and acceptance, which includes the ability to recruit network members, feasibility of intervention delivery, and changes in participant behaviors. It will allow for further evaluation of the feasibility of all study procedures, and refinement of intervention manual. Therefore, the expected outcome is a culturally relevant SNS intervention to increase PrEP initiation among Black SMM through PrEP-using social network members.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Recruit 30 PrEP-using Black SMM, including those who use substances, as Recruiters to identify and refer Network Associates to PrEP services. The pilot will occur in six blocks of up to 5 Recruiters to further develop all intervention procedures and enhance the SNS intervention's feasibility and acceptability.
| Arm | Type | Receives |
|---|---|---|
| PrEP-using Black SMM as Recruiters | Other | Behavioral: Social Networking StrategiesRecruit 30 PrEP-using Black SMM, including those who use substances, as Recruiters to identify and refer Network Associates to PrEP services. The pilot will occur in six blocks of up to 5 Recruiters to further develop all intervention procedures and enhance the SNS intervention's feasibility and acceptability. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age of 18 years or above
- Black or African American race
- Cisgender male identity
- Gay, bisexual or a male who has sex with other males
- Residence in the greater Washington, DC area (includes District of Columbia, Prince George's County, MD and Montgomery County, MD)
Key exclusion criteria (8 listed)
- Being younger than 18 years of age ;
- Cisgender or transgender female identity
- Males having sex with women exclusively
- Being unable to speak or read English
- Reside outside of the defined greater Washington, DC area
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 |
|---|---|---|
| Social Networking StrategiesAssess whether PrEP-using Black SMM can serve as an Interventionist to get their social and sexual network members to uptake and adhere to PrEP | Behavioural | PrEP-using Black SMM as Recruiters |
Primary outcome
Feasibility of Intervention as measured by Weiner et al., 2017.
Time frame: During the peer-based debriefing sessions that occurs before a Recruiter is dismissed from the open-phase pilot.
Assess the feasibility of intervention delivery method (i.e., PrEP-using SMM as the Interventionist/Recruiter).
Acceptability of Intervention as measured by Weiner et al., 2017.
Time frame: During the peer-based debriefing sessions that occurs before a Recruiter is dismissed from the open-phase pilot.
Assess the feasibility of intervention delivery method (i.e., PrEP-using SMM as the Interventionist/Recruiter).
3 secondary outcomes
Recruited Network Members
Time frame: Immediately after PrEP-using SMM enroll as an Interventionist (i.e., Recruiter)
Network members on PrEP
Time frame: Immediately after PrEP-using SMM enroll as an Interventionist (i.e., Recruiter)
Comfortability of the Intervention as measured by an adaptation of Weiner et al., 2017.
Time frame: During the peer-based debriefing sessions that occurs before a Recruiter is dismissed from the open-phase pilot.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
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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.
DeMarc A Hickson, PhD principal investigator
Executive Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Networking Strategies in people with HIV, run by Us Helping Us, People Into Living, Inc. 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 7 inclusion and 8 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 15 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DeMarc A Hickson, PhD (678.613.9827, dhickson@uhupil.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Intervention as measured by Weiner et al., 2017. (time frame: During the peer-based debriefing sessions that occurs before a Recruiter is dismissed from the open-phase pilot.). 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?
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 15 Sep 2023.