HivNCT05769270
Development of a Telehealth-delivered Peer Navigation and Coping Skills Intervention to Increase PrEP Use in Young Black MSM
A study testing Peer Navigation and Coping Skills and Treatment as Usual in people with Hiv and Sexual Behavior, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This proposal seeks to adapt an existing peer navigation protocol (by adding coping skills and using telehealth) to be feasible, acceptable, and capable of supporting both PrEP uptake and P-E adherence for YBMSM ages 15-24. Read more about this study
- Who is it for?
- Ages 15 to 24 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hiv, Sexual Behavior
- What is being tested?
- Peer Navigation and Coping Skills and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 31 Mar 2024
- 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 15 to 24 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- HIV-negative (by self-report)
- Black race (of any ethnicity, by self-report)
- age 15-24
- sexually active
- identifies as male
- report HIV risk characterized by one or more of the following: 1) condomless anal or vaginal sex (receptive or penetrative) with a partner assigned male at birth (AMAB) of unknown HIV status in the last 6 months, 2) presence of rectal STI in the last 6 months, 3) condomless anal or vaginal sex with a known HIV-infected partner in the last 6 months (inclusive of partners who are undetectable), or 4) condomless anal or vaginal sex (receptive or penetrative) with casual partners assigned male at birth and endorsement of factors associated with not using PrEP based on my preliminary research with the MDPH (i.e., non-disclosure of same-sex behavior to provider, uninsured, history of incarceration, or lacking healthcare due to cost). For participants under the age of 18, condomless sex criteria can be met by having condomless oral sex.
Who cannot join
- Those unable to complete consent in English and those with significant mental health diagnoses (e.g., uncontrolled psychosis) that would likely interfere with participation will be excluded and referred for treatment or alternative resources as necessary.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Development and Pilot RCT of a Telehealth-delivered Peer Navigation and Coping Skills Intervention to Increase PrEP Use in Young Black Men Who Have Sex With Men
This proposal seeks to adapt an existing peer navigation protocol (by adding coping skills and using telehealth) to be feasible, acceptable, and capable of supporting both PrEP uptake and P-E adherence for YBMSM ages 15-24.
Read the detailed description
Young Black men who have sex with men (YBMSM) ages 15-24 are heavily affected by HIV transmission and, at current rates, nearly half of Black MSM in the US will be infected with HIV in their lifetime. MSM represented 42% of all HIV diagnoses in Massachusetts from 2015-2017 and rates among Black MSM were 7 times that of White MSM. Fortunately, PrEP is highly effective at preventing HIV if adhered to in a prevention-effective (P-E) manner, which involves daily or event-based dosing specifically during periods of risk of HIV exposure (i.e., P-E adherence). Unfortunately, initiation and adherence among YBMSM is lower than other racial and age groups. According to Social Action Theory, barriers among YBMSM can be conceptualized as multifactorial, consisting of contextual factors (e.g., mood/arousal factors, structural factors, and demographics) and self-change processes (social interaction processes, motivations, generative capabilities, and problem-solving skills). An effective intervention must address contextual and self-change processes to promote PrEP uptake and P-E adherence.
The use of navigators (i.e., health workers trained to support ongoing adherence) has shown promise in promoting both PrEP uptake and sustained use in Black MSM by addressing structural barriers; however, rates of PrEP discontinuation were high. An NICHD-funded U01 study (SMILE) conducted in Boston found that peer navigation was highly acceptable for youth with HIV. The current study will use the Boston site of SMILE's peer navigation protocol. Notably, SMILE did not include behavioral components. In addition to structural barriers, YBSM often face unique barriers such as medical mistrust and disclosure concerns that affect self-change processes and impede PrEP uptake and P-E adherence. Limited knowledge exists on how these factors may impede PrEP use; however, it is clear these barriers may be addressed using problem/emotion-focused coping strategies. Many PrEP interventions require office visits, which may limit participation to those willing and able to present to a research office. Despite prevalent economic stressors, more than 90% of YMSM of color in various studies have smartphones, thus telehealth and remote study procedures may facilitate participation by YBMSM at highest HIV risk. This proposal seeks to adapt peer navigation from SMILE (adding coping skills and using telehealth) to be feasible, acceptable, and capable of supporting both PrEP uptake and P-E adherence for YBMSM ages 15-24.
Aim 1: Obtain qualitative knowledge on experiences of YBMSM ages 15-24 and specify role of peer navigator in promoting PrEP uptake and P-E adherence. I will conduct ~30 in-depth interviews with YBMSM at various stages of the PrEP continuum (e.g., never used, former user, and currently using PrEP) using a semi-structured interview guide. Interviews will explore how contextual factors and self-change processes influence PrEP uptake and P-E adherence. It will specify the role of a peer navigator (e.g., meeting frequency, demographics of navigator, topics to discuss and how best to employ technology-based tools and strategies). The knowledge gained from these interviews will be used to inform intervention development in Aim 2.
Aim 2: Develop and iteratively refine the intervention in consultation with a Youth Advisory Board Intervention development will be guided by Aim 1 findings and the IDEAS framework (i.e., generating ideas for intervention strategies, developing an initial intervention, gathering user feedback, and creating a viable intervention). We will recruit ~20 YBMSM via online and in-person strategies to participate in an advisory board meeting quarterly (virtually or in-person) to provide feedback on the intervention. The intervention will be iteratively refined after each meeting resulting in a refined intervention manual for use in the Aim 3 trial.
Aim 3: Evaluate the telehealth-delivered peer navigation/coping skills intervention for feasibility and acceptability. We will have a short, 3-month run-in of the intervention with 2-4 sexually active YBMSM, without HIV, ages 15-24. After further refinement, we will conduct a small (N=60) RCT of the peer navigation/coping skills intervention vs. treatment as usual (TAU; PrEP/case management referrals). The primary outcomes will be feasibility and acceptability. Secondarily, we will examine group differences in PrEP uptake, P-E adherence (proportion of covered sexual episodes), and sustained use at 6 months among those with risk. Outcomes of this aim will be a feasible (>75% enrollment; >75% of sessions attended) and acceptable (per questionnaires and exit interviews) intervention that can be tested in a larger efficacy trial in the context of a future R01 grant.
- Conditions
- Hiv, Sexual Behavior
- Being tested
- Peer Navigation and Coping Skills, Treatment as Usual
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Navigation and Coping SkillsBehavioural
Participants will receive 6 sessions of peer navigation and coping skills
Treatment as UsualBehavioural
Participants will receive referrals for PrEP and services
| Study group | Role | What they receive |
|---|---|---|
| Peer Navigation and Coping Skills | Experimental | Participants will receive peer navigation and coping skills to increase PrEP use. Receives: Behavioral: Peer Navigation and Coping Skills; Behavioral: Treatment as Usual |
| Treatment as usual | Sham comparator | Participants will receive referrals to PrEP and services. Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP Use
Self-reported use of PrEP
Measured: 3 months
PrEP Adherence
Dried blood spots
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start1 Apr 2022
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Why it stopped: Investigator requested early termination of grant
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.
- More trials run by Massachusetts General HospitalThe 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
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fenway Community Health, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Calvin Fitch, PhD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769270
- Sponsor's protocol ID
- 2021P003220
- Other IDs
- 1K23MH129240
- Status last verified
- Jul 2024
- First submitted
- 2 Mar 2023
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Pilot RCT of a Telehealth-delivered Peer Navigation and Coping Skills Intervention to Increase PrEP Use in Young Black Men Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT05769270
- Acronym / sponsor ID
- 2021P003220
- Conditions
- Hiv, Sexual Behavior
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator requested early termination of grant
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Fenway Community Health, National Institute of Mental Health (NIMH)
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 15 Mar 2023 (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 proposal seeks to adapt an existing peer navigation protocol (by adding coping skills and using telehealth) to be feasible, acceptable, and capable of supporting both PrEP uptake and P-E adherence for YBMSM ages 15-24.
Detailed description
Young Black men who have sex with men (YBMSM) ages 15-24 are heavily affected by HIV transmission and, at current rates, nearly half of Black MSM in the US will be infected with HIV in their lifetime. MSM represented 42% of all HIV diagnoses in Massachusetts from 2015-2017 and rates among Black MSM were 7 times that of White MSM. Fortunately, PrEP is highly effective at preventing HIV if adhered to in a prevention-effective (P-E) manner, which involves daily or event-based dosing specifically during periods of risk of HIV exposure (i.e., P-E adherence). Unfortunately, initiation and adherence among YBMSM is lower than other racial and age groups. According to Social Action Theory, barriers among YBMSM can be conceptualized as multifactorial, consisting of contextual factors (e.g., mood/arousal factors, structural factors, and demographics) and self-change processes (social interaction processes, motivations, generative capabilities, and problem-solving skills). An effective intervention must address contextual and self-change processes to promote PrEP uptake and P-E adherence.
The use of navigators (i.e., health workers trained to support ongoing adherence) has shown promise in promoting both PrEP uptake and sustained use in Black MSM by addressing structural barriers; however, rates of PrEP discontinuation were high. An NICHD-funded U01 study (SMILE) conducted in Boston found that peer navigation was highly acceptable for youth with HIV. The current study will use the Boston site of SMILE's peer navigation protocol. Notably, SMILE did not include behavioral components. In addition to structural barriers, YBSM often face unique barriers such as medical mistrust and disclosure concerns that affect self-change processes and impede PrEP uptake and P-E adherence. Limited knowledge exists on how these factors may impede PrEP use; however, it is clear these barriers may be addressed using problem/emotion-focused coping strategies. Many PrEP interventions require office visits, which may limit participation to those willing and able to present to a research office. Despite prevalent economic stressors, more than 90% of YMSM of color in various studies have smartphones, thus telehealth and remote study procedures may facilitate participation by YBMSM at highest HIV risk. This proposal seeks to adapt peer navigation from SMILE (adding coping skills and using telehealth) to be feasible, acceptable, and capable of supporting both PrEP uptake and P-E adherence for YBMSM ages 15-24.
Aim 1: Obtain qualitative knowledge on experiences of YBMSM ages 15-24 and specify role of peer navigator in promoting PrEP uptake and P-E adherence. I will conduct ~30 in-depth interviews with YBMSM at various stages of the PrEP continuum (e.g., never used, former user, and currently using PrEP) using a semi-structured interview guide. Interviews will explore how contextual factors and self-change processes influence PrEP uptake and P-E adherence. It will specify the role of a peer navigator (e.g., meeting frequency, demographics of navigator, topics to discuss and how best to employ technology-based tools and strategies). The knowledge gained from these interviews will be used to inform intervention development in Aim 2.
Aim 2: Develop and iteratively refine the intervention in consultation with a Youth Advisory Board Intervention development will be guided by Aim 1 findings and the IDEAS framework (i.e., generating ideas for intervention strategies, developing an initial intervention, gathering user feedback, and creating a viable intervention). We will recruit ~20 YBMSM via online and in-person strategies to participate in an advisory board meeting quarterly (virtually or in-person) to provide feedback on the intervention. The intervention will be iteratively refined after each meeting resulting in a refined intervention manual for use in the Aim 3 trial.
Aim 3: Evaluate the telehealth-delivered peer navigation/coping skills intervention for feasibility and acceptability. We will have a short, 3-month run-in of the intervention with 2-4 sexually active YBMSM, without HIV, ages 15-24. After further refinement, we will conduct a small (N=60) RCT of the peer navigation/coping skills intervention vs. treatment as usual (TAU; PrEP/case management referrals). The primary outcomes will be feasibility and acceptability. Secondarily, we will examine group differences in PrEP uptake, P-E adherence (proportion of covered sexual episodes), and sustained use at 6 months among those with risk. Outcomes of this aim will be a feasible (>75% enrollment; >75% of sessions attended) and acceptable (per questionnaires and exit interviews) intervention that can be tested in a larger efficacy trial in the context of a future R01 grant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer Navigation and Coping Skills | Experimental | Behavioral: Peer Navigation and Coping Skills, Behavioral: Treatment as UsualParticipants will receive peer navigation and coping skills to increase PrEP use. |
| Treatment as usual | Sham comparator | Behavioral: Treatment as UsualParticipants will receive referrals to PrEP and services. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- HIV-negative (by self-report)
- Black race (of any ethnicity, by self-report)
- age 15-24
- sexually active
- identifies as male
Key exclusion criteria (1 listed)
- Those unable to complete consent in English and those with significant mental health diagnoses (e.g., uncontrolled psychosis) that would likely interfere with participation will be excluded and referred for treatment or alternative resources as necessary.
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 Navigation and Coping SkillsParticipants will receive 6 sessions of peer navigation and coping skills | Behavioural | Peer Navigation and Coping Skills |
| Treatment as UsualParticipants will receive referrals for PrEP and services | Behavioural | Peer Navigation and Coping Skills, Treatment as usual |
Primary outcome
PrEP Use
Time frame: 3 months
Self-reported use of PrEP
PrEP Adherence
Time frame: 6 months
Dried blood spots
Results and safety
The study was stopped early (reason given: Investigator requested early termination of grant). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: No
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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.
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 Navigation and Coping Skills and Treatment as Usual in people with Hiv and Sexual Behavior, run by Massachusetts General Hospital 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 6 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: stopped early, as of the sponsor's last update on 1 Aug 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Investigator requested early termination of grant). Results are not available in the source record.
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 Use (time frame: 3 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?
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 1 Aug 2024.