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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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
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

Other trials in United States

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 groups in NCT05769270
Study groupRoleWhat they receive
Peer Navigation and Coping SkillsExperimentalParticipants will receive peer navigation and coping skills to increase PrEP use.
Receives: Behavioral: Peer Navigation and Coping Skills; Behavioral: Treatment as Usual
Treatment as usualSham comparatorParticipants 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.

  1. PrEP Use

    Self-reported use of PrEP

    Measured: 3 months

  2. 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.

  1. First posted15 Mar 2023
  2. Study start1 Apr 2022
  3. Primary completion31 Mar 2024
  4. Study completion31 Mar 2024

Why it stopped: Investigator requested early termination of grant

Resources

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)
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

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.

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