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



Status:Not yet recruiting
Conditions:HIV / AIDS, HIV / AIDS, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:16 - Any
Updated:2/1/2019
Start Date:January 24, 2019
End Date:July 2022
Contact:Jeffrey A. Kelly, Ph.D.
Email:cairdirector@mcw.edu
Phone:414-955-7700

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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.

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.

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
We found this trial at
2
sites
Cleveland, Ohio 44113
Principal Investigator: Tracy Jones
Phone: 216-621-0766
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Jeffrey A. Kelly, PhD
Phone: 414-955-7732
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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