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Completed

NCT Number: NCT03823209

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

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.

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Key information

Age range

16 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

AIDS TaskForce of Greater Cleveland, Cleveland, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Social Network

Behavioral

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.

Brief HIV Prevention Counseling

Behavioral

Participants will receive brief (15-minute) counseling on how to prevent HIV infection.

Primary outcomes

  1. Self-report of pre-exposure prophylaxis (PrEP) use

    Time frame: 6 and 15 months

    Change in self-reported PrEP use

Secondary outcomes

  1. Pre-Exposure Prophylaxis (PrEP) Knowledge

    Time frame: 6 and 15 months

    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.

  2. Pre-Exposure Prophylaxis Attitudes

    Time frame: 6 and 15 months

    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.

  3. Pre-Exposure Prophylaxis Norm Perceptions

    Time frame: 6 and 15 months

    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.

  4. Pre-Exposure Prophylaxis Intentions

    Time frame: 6 and 15 months

    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.

  5. Pre-Exposure Prophylaxis Self-Efficacy

    Time frame: 6 and 15 months

    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.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Acronym: SNAP

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jan 30, 2019
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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