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Increasing PrEP Use in High-Risk Social Networks of African-American MSM in Underserved Low-Risk Cities (SNAP)

Primary Purpose

Human Immunodeficiency Virus

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Network
Brief HIV Prevention Counseling
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Immunodeficiency Virus focused on measuring Pre-exposure prophylaxis (PrEP)

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

INDIVIDUALS:

  1. Age 16 or older
  2. For the seed only, self-report of HIV-negative serostatus or unknown serostatus
  3. Except for the seed, being named as a friend by an already-enrolled participant
  4. Male at birth
  5. Sex with at least one male partner in the past 12 months

NETWORKS

  1. More than 49% of the seed's eligible friends agree to participate
  2. More than 49% of all network members self-report they are HIV-negative at baseline

Exclusion Criteria:

INDIVIDUALS:

  1. Age 15 or younger
  2. For the seed only, self-report of HIV-positive serostatus
  3. Except for the seed, not being named as a friend by an already-enrolled participant
  4. Not male at birth
  5. No report of sex with at least one male partner in the past 12 months

NETWORKS

  1. Less than 50% of the seed's eligible friends agree to participate
  2. Less than 50% of all network members self-report they are HIV-negative at baseline

Sites / Locations

  • AIDS TaskForce of Greater Cleveland
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Social Network Approach

Comparison

Arm Description

Participants will receive brief HIV counseling at baseline visit. Leaders of social networks will be determined using data from participants. These leaders will then be invited to attend a 5-session small-group training that will teach them how to communicate the benefits of PrEP to their social network members. All social network members will be asked about intervention exposure at 6- and 15-month followups.

Participants will receive brief HIV counseling at baseline visit.

Outcomes

Primary Outcome Measures

Self-report of pre-exposure prophylaxis (PrEP) use
Change in self-reported PrEP use

Secondary Outcome Measures

Pre-Exposure Prophylaxis (PrEP) Knowledge
PrEP Knowledge: 13 items in scale, items are added to determine score, with higher scores indicating greater knowledge Scale taken from Walsh, J.L. (2018). Applying the Information-Motivation-Behavioral Skills Model to Understand PrEP Intentions and Use Among Men Who Have Sex with Men. AIDS and Behavior.
Pre-Exposure Prophylaxis Attitudes
PrEP Attitudes: 5 items in scale, items are averaged to determine score, with higher scores indicating more positive attitudes Scale taken from Walsh, J.L. (2018). Applying the Information-Motivation-Behavioral Skills Model to Understand PrEP Intentions and Use Among Men Who Have Sex with Men. AIDS and Behavior.
Pre-Exposure Prophylaxis Norm Perceptions
PrEP Norm Perceptions: 6 items in scale, items are averaged to determine score, with higher scores indicating more favorable norms Scale taken from Walsh, J.L. (2018). Applying the Information-Motivation-Behavioral Skills Model to Understand PrEP Intentions and Use Among Men Who Have Sex with Men. AIDS and Behavior.
Pre-Exposure Prophylaxis Intentions
PrEP Intentions: 3 items in scale, items are averaged to determine score, with higher scores indicating greater intentions to use PrEP Scale taken from Walsh, J.L. (2018). Applying the Information-Motivation-Behavioral Skills Model to Understand PrEP Intentions and Use Among Men Who Have Sex with Men. AIDS and Behavior.
Pre-Exposure Prophylaxis Self-Efficacy
PrEP Self-Efficacy: 8 items in scale, items are averaged to determine score, with higher scores indicating greater self-efficacy for PrEP use. Scale taken from Walsh, J.L. (2018). Applying the Information-Motivation-Behavioral Skills Model to Understand PrEP Intentions and Use Among Men Who Have Sex with Men. AIDS and Behavior.

Full Information

First Posted
January 24, 2019
Last Updated
August 1, 2022
Sponsor
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT03823209
Brief Title
Increasing PrEP Use in High-Risk Social Networks of African-American MSM in Underserved Low-Risk Cities
Acronym
SNAP
Official Title
Increasing PrEP Use in High-Risk Social Networks of African-American MSM in Underserved Low-Risk Cities
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 24, 2019 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin

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
This study evaluates the use of a social-network approach to encourage African-American men who have sex with men (AAMSM) to adopt pre-exposure prophylaxis (PrEP) to prevent HIV infection. Thirty-six networks of AAMSM will be recruited in Milwaukee, WI, and Cleveland, OH. Half of these networks will have their leaders trained to endorse PrEP to their social network members, and the other half will be given brief HIV prevention counseling.
Detailed Description
Pre-exposure prophylaxis (PrEP) regimens greatly reduce the likelihood that high-risk uninfected men who have sex with men (MSM) will contract HIV infection. Although this protective benefit has been unequivocally established in clinical trials, the number of high-risk men on PrEP remains far below the threshold needed to substantially reduce HIV incidence. This is especially true outside of the country's largest cities. Novel approaches are needed to increase PrEP use among high-risk racial minority MSM in these neglected cities. This study will recruit 36 sociocentric social networks of high-risk young racial minority MSM, 18 networks per city (total n=36 networks x 14 anticipated recruited members per network = 504 participants). Participants will complete measures assessing baseline PrEP use; knowledge, attitudes, perceived norms, intentions, and stage of readiness for PrEP; sexual risk practices and substance use; and prior or current ART use. Participants will also complete measures used to identify each network's leaders. Networks will be randomized in equal numbers in each city to comparison or intervention conditions. All study participants will receive individual baseline counseling about risk reduction and PrEP, with referral offered to clinics prescribing PrEP. Members of the 18 experimental condition networks will also receive the social network PrEP intervention being tested in the study. In it, cadres of leaders in each network-selected based on their leadership position within the network and their own openness to PrEP-will attend a 5-session intervention that trains, engages, and supports network leaders in communicating to friends accurate information about PrEP and its availability; corrects PrEP misconceptions and negative stereotypes; endorses PrEP use and its benefits; and strengthens friends' attitudes, intentions, perceived peer norms, and self-efficacy regarding PrEP as a personal HIV protective strategy. Two additional booster sessions spaced monthly will support maintenance of leaders' efforts in talking with friends in their network about the benefits of PrEP, as well as where and how to access it. At 6- and 15-month followup points, all study participants will complete the same behavioral measures that were administered at baseline, as well as measures of intervention exposure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus
Keywords
Pre-exposure prophylaxis (PrEP)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Social Network Approach
Arm Type
Experimental
Arm Description
Participants will receive brief HIV counseling at baseline visit. Leaders of social networks will be determined using data from participants. These leaders will then be invited to attend a 5-session small-group training that will teach them how to communicate the benefits of PrEP to their social network members. All social network members will be asked about intervention exposure at 6- and 15-month followups.
Arm Title
Comparison
Arm Type
Active Comparator
Arm Description
Participants will receive brief HIV counseling at baseline visit.
Intervention Type
Behavioral
Intervention Name(s)
Social Network
Intervention Description
Leaders of social networks will be statistically determined. Over 5 small-group training sessions, these leaders will be trained to communicate to their social network members accurate information about PrEP and its availability; correct PrEP misconceptions and negative stereotypes; endorse PrEP use and its benefits; and strengthen friends' attitudes, intentions, perceived peer norms, and self-efficacy regarding PrEP as a personal HIV protective strategy.
Intervention Type
Behavioral
Intervention Name(s)
Brief HIV Prevention Counseling
Intervention Description
Participants will receive brief (15-minute) counseling on how to prevent HIV infection.
Primary Outcome Measure Information:
Title
Self-report of pre-exposure prophylaxis (PrEP) use
Description
Change in self-reported PrEP use
Time Frame
6 and 15 months
Secondary Outcome Measure Information:
Title
Pre-Exposure Prophylaxis (PrEP) Knowledge
Description
PrEP Knowledge: 13 items in scale, items are added to determine score, with higher scores indicating greater knowledge Scale taken from Walsh, J.L. (2018). Applying the Information-Motivation-Behavioral Skills Model to Understand PrEP Intentions and Use Among Men Who Have Sex with Men. AIDS and Behavior.
Time Frame
6 and 15 months
Title
Pre-Exposure Prophylaxis Attitudes
Description
PrEP Attitudes: 5 items in scale, items are averaged to determine score, with higher scores indicating more positive attitudes Scale taken from Walsh, J.L. (2018). Applying the Information-Motivation-Behavioral Skills Model to Understand PrEP Intentions and Use Among Men Who Have Sex with Men. AIDS and Behavior.
Time Frame
6 and 15 months
Title
Pre-Exposure Prophylaxis Norm Perceptions
Description
PrEP Norm Perceptions: 6 items in scale, items are averaged to determine score, with higher scores indicating more favorable norms Scale taken from Walsh, J.L. (2018). Applying the Information-Motivation-Behavioral Skills Model to Understand PrEP Intentions and Use Among Men Who Have Sex with Men. AIDS and Behavior.
Time Frame
6 and 15 months
Title
Pre-Exposure Prophylaxis Intentions
Description
PrEP Intentions: 3 items in scale, items are averaged to determine score, with higher scores indicating greater intentions to use PrEP Scale taken from Walsh, J.L. (2018). Applying the Information-Motivation-Behavioral Skills Model to Understand PrEP Intentions and Use Among Men Who Have Sex with Men. AIDS and Behavior.
Time Frame
6 and 15 months
Title
Pre-Exposure Prophylaxis Self-Efficacy
Description
PrEP Self-Efficacy: 8 items in scale, items are averaged to determine score, with higher scores indicating greater self-efficacy for PrEP use. Scale taken from Walsh, J.L. (2018). Applying the Information-Motivation-Behavioral Skills Model to Understand PrEP Intentions and Use Among Men Who Have Sex with Men. AIDS and Behavior.
Time Frame
6 and 15 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: INDIVIDUALS: Age 16 or older For the seed only, self-report of HIV-negative serostatus or unknown serostatus Except for the seed, being named as a friend by an already-enrolled participant Male at birth Sex with at least one male partner in the past 12 months NETWORKS More than 49% of the seed's eligible friends agree to participate More than 49% of all network members self-report they are HIV-negative at baseline Exclusion Criteria: INDIVIDUALS: Age 15 or younger For the seed only, self-report of HIV-positive serostatus Except for the seed, not being named as a friend by an already-enrolled participant Not male at birth No report of sex with at least one male partner in the past 12 months NETWORKS Less than 50% of the seed's eligible friends agree to participate Less than 50% of all network members self-report they are HIV-negative at baseline
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey A. Kelly, PhD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yuri A. Amirkhanian, PhD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
AIDS TaskForce of Greater Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44113
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31658194
Citation
Kelly JA. Ten Things We Need to Do to Achieve the Goals of the End the HIV Epidemic Plan for America. J Acquir Immune Defic Syndr. 2019 Dec 1;82 Suppl 2(2):S94-S98. doi: 10.1097/QAI.0000000000002166.
Results Reference
result
PubMed Identifier
32016815
Citation
Quinn KG, Christenson E, Spector A, Amirkhanian Y, Kelly JA. The Influence of Peers on PrEP Perceptions and Use Among Young Black Gay, Bisexual, and Other Men Who Have Sex with Men: A Qualitative Examination. Arch Sex Behav. 2020 Aug;49(6):2129-2143. doi: 10.1007/s10508-019-01593-x. Epub 2020 Feb 3.
Results Reference
result
PubMed Identifier
32167374
Citation
Kelly JA, Amirkhanian YA, Walsh JL, Brown KD, Quinn KG, Petroll AE, Pearson BM, Rosado AN, Ertl T. Social network intervention to increase pre-exposure prophylaxis (PrEP) awareness, interest, and use among African American men who have sex with men. AIDS Care. 2020 May;32(sup2):40-46. doi: 10.1080/09540121.2020.1739207. Epub 2020 Mar 13.
Results Reference
result

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Increasing PrEP Use in High-Risk Social Networks of African-American MSM in Underserved Low-Risk Cities

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