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Peer-driven Intervention on PrEP

Primary Purpose

HIV Infections

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer-driven intervention
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring pre-exposure prophylaxis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Eligibility Criteria 18 years of age or older Assigned male at birth and currently identify as male Having sex with men in the past three months Not currently on PrEP English- or Spanish-speaking

Exclusion Criteria:

Age less than 18 years, No having sex with men in the past 3 months

Sites / Locations

  • The Miriam HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PDI group

Control group

Arm Description

In this group, participants will receive education about HIV and pre-exposure prophylaxis (PrEP) and be referred to our study by peer educators. Referred participants will have free PrEP counseling and receive referrals if interested. We will follow up at three and six months and check participants' PrEP status.

In the control group, participants do not receive any education from peers and will be directly recruited by research assistants from venues (e.g. gay bars, LGBTQ communities, LGBTQ events, and social media advertisements). Participants will receive PrEP counseling and referral if interested. We will follow up at three and six months and check participants' PrEP status.

Outcomes

Primary Outcome Measures

Pre-exposure prophylaxis (PrEP) uptake
Self-report PrEP uptake
Pre-exposure prophylaxis (PrEP) persistence
the length of time on PrEP
Pre-exposure prophylaxis (PrEP) adherence
Self-reported medication adherence

Secondary Outcome Measures

Full Information

First Posted
August 26, 2021
Last Updated
August 13, 2022
Sponsor
The Miriam Hospital
Collaborators
National Institute of Mental Health (NIMH), Rhode Island Public Health Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05161663
Brief Title
Peer-driven Intervention on PrEP
Official Title
Peer-driven Intervention Promoting PrEP Uptake Among African American and Hispanic/Latino MSM
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 6, 2022 (Actual)
Primary Completion Date
March 11, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Miriam Hospital
Collaborators
National Institute of Mental Health (NIMH), Rhode Island Public Health Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to develop an effective peer-driven intervention (PDI) approach and assess its feasibility and efficacy on pre-exposure prophylaxis (PrEP) uptake among men who have sex with men.
Detailed Description
This proposed study aims to assess the effect of a peer-driven intervention (PDI) on promoting pre-exposure prophylaxis (PrEP) uptake among African American (AA) and Hispanic/Latino men who have sex with men (MSM). PDI is based on respondent-driven sampling (RDS) or snowball sampling. PDI is a chain referral approach and includes both peer referral and peer education. Index peers will be purposefully sampled to reflect the diversity of our study population through local clinics, community organizations, and online. Index peers will receive a four-hour formal training about PrEP and HIV, educate members of their social network, and encourage them to initiate PrEP. Each index peers will be given three referral coupons. Referred peers will schedule a research visit to complete a short survey and then be referred to the local PrEP clinic if they are interested in starting PrEP. These referred individuals will also serve as index peers for the following wave of recruitment. We expect to achieve a robust sample of AA and H/L MSM within six waves of recruitment as peers will educate and recruit study participants through their social networks. Given the nature of RDS, the study design will include a concurrent non-randomized control group, which will be recruited using venue-based sampling (e.g. gay dance clubs, bars, and social organizations). This has been used in previous RDS studies as an appropriate study design and comparison group. We will identify appropriate venues that AA and H/L MSM frequent using one-to-one qualitative interviews in Specific Aim 1. Research staff will visit these venues at specific times to recruit AA and H/L MSM. MSM who are willing to participate in this study will receive PrEP and HIV education offered by research staff and complete a short survey during outreach. Individuals who are interested in PrEP uptake will be referred to the PrEP clinic. All study participants, regardless of PrEP status (initiated or not initiated), will be followed for six months. Each individual will complete three visits, including baseline, three-month, and six-month follow-ups. This study has two independent arms. Our primary outcome is PrEP uptake, which is defined as a binary variable (Yes vs. No). We will calculate the study power using the method for two independent proportions power analyses. Our local STD clinic data shows only 8% of AA and H/L MSM have used PrEP and we will assume that 8% of AA and H/L MSM recruited through venue-based sampling will initiate PrEP. We expect to observe at least a 14% increase in PrEP uptake in the PDI group. To have 80% of power (Type I error =0.05), we will recruit 100 participants (N=100, 50 AA, and 50 H/L MSM) in each group. PrEP uptake measured by receiving a prescription for the medication and filling a prescription at a pharmacy will be treated as time-to-event variables. We will perform survival analysis techniques (Kaplan-Meier models and Cox proportional hazards models) to assess the effect of the PDI on PrEP initiation. Self-reported PrEP adherence and drug concentration level (Yes vs. No) will be treated as binary variables and multivariate logistic regression will be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
pre-exposure prophylaxis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This peer-driven intervention (PDI), modified based on respondent-driven sampling (RDS) or snowball sampling, is a "chain referral" approach. Index peers will be purposefully selected to reflect the diversity of African American (AA) and Hispanic/Latino (H/L) men who have sex with men (MSM) and are required to take a formal training about pre-exposure prophylaxis (PrEP) and HIV. These index peers will educate members of their social networks and encourage them to initiate PrEP. Those referred peers will schedule an appointment to complete a short survey and will be referred to our PrEP clinic if they are interested in PrEP uptake. The referred peers will serve as index peers for the following wave of recruitment. It is expected to achieve a robust sample of AA and H/L within six waves of recruitment. This PDI approach is potential to engage AA and H/L who are most at risk of HIV acquisition in PrEP uptake and could contribute to reducing the concentrated HIV epidemic.
Masking
None (Open Label)
Masking Description
No mask
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PDI group
Arm Type
Experimental
Arm Description
In this group, participants will receive education about HIV and pre-exposure prophylaxis (PrEP) and be referred to our study by peer educators. Referred participants will have free PrEP counseling and receive referrals if interested. We will follow up at three and six months and check participants' PrEP status.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
In the control group, participants do not receive any education from peers and will be directly recruited by research assistants from venues (e.g. gay bars, LGBTQ communities, LGBTQ events, and social media advertisements). Participants will receive PrEP counseling and referral if interested. We will follow up at three and six months and check participants' PrEP status.
Intervention Type
Behavioral
Intervention Name(s)
Peer-driven intervention
Intervention Description
This peer-driven intervention (PDI), modified based on respondent-driven sampling (RDS) or snowball sampling, is a "chain referral" approach. Index peers will be purposefully selected to reflect the diversity of African American (AA) and Hispanic/Latino (H/L) men who have sex with men (MSM) and are required to take a formal training about pre-exposure prophylaxis (PrEP) and HIV. These index peers will educate members of their social networks and encourage them to initiate PrEP. Those referred peers will schedule an appointment to complete a short survey and will be referred to our PrEP clinic if they are interested in PrEP uptake. The referred peers will serve as index peers for the following wave of recruitment. It is expected to achieve a robust sample of AA and H/L within six waves of recruitment. This PDI approach is potential to engage AA and H/L who are most at risk of HIV acquisition in PrEP uptake and could contribute to reducing the concentrated HIV epidemic.
Primary Outcome Measure Information:
Title
Pre-exposure prophylaxis (PrEP) uptake
Description
Self-report PrEP uptake
Time Frame
0-6 months
Title
Pre-exposure prophylaxis (PrEP) persistence
Description
the length of time on PrEP
Time Frame
0-6 months
Title
Pre-exposure prophylaxis (PrEP) adherence
Description
Self-reported medication adherence
Time Frame
0-6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Eligibility Criteria 18 years of age or older Assigned male at birth and currently identify as male Having sex with men in the past three months Not currently on PrEP English- or Spanish-speaking Exclusion Criteria: Age less than 18 years, No having sex with men in the past 3 months
Facility Information:
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leslie M Simone
Phone
401-444-8696
Email
lvarone@lifespan.org
First Name & Middle Initial & Last Name & Degree
Jun Tao, Ph.D.

12. IPD Sharing Statement

Learn more about this trial

Peer-driven Intervention on PrEP

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