NCT05769270

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

2 years

First QC Date

March 2, 2023

Last Update Submit

July 30, 2024

Conditions

HivSexual Behavior

Outcome Measures

Primary Outcomes (2)

  • PrEP Use

    Self-reported use of PrEP

    3 months

  • PrEP Adherence

    Dried blood spots

    6 months

Study Arms (2)

Peer Navigation and Coping Skills

EXPERIMENTAL

Participants will receive peer navigation and coping skills to increase PrEP use.

Behavioral: Peer Navigation and Coping SkillsBehavioral: Treatment as Usual

Treatment as usual

SHAM COMPARATOR

Participants will receive referrals to PrEP and services.

Behavioral: Treatment as Usual

Interventions

Peer Navigation and Coping SkillsBEHAVIORAL

Participants will receive 6 sessions of peer navigation and coping skills

Peer Navigation and Coping Skills
Treatment as UsualBEHAVIORAL

Participants will receive referrals for PrEP and services

Peer Navigation and Coping SkillsTreatment as usual

Eligibility Criteria

Age15 Years - 24 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsCisgender or Transgender men or non-binary individuals assigned male at birth
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeSexual Behavior

Interventions

Coping SkillsTherapeutics

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Fellow

Study Record Dates

First Submitted

March 2, 2023

First Posted

March 15, 2023

Study Start

April 1, 2022

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

August 1, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)