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

Medical College of Wisconsin

Status: Active, not recruiting

Conditions: Human Immunodeficiency Virus

Treatments: Behavioral: Social Network; Behavioral: Brief HIV Prevention Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT03823209

PRO00029359

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: Male

Ages: 16+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups

Social Network Approach

Experimental group

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.

Treatment:

Behavioral: Brief HIV Prevention Counseling

Behavioral: Social Network

Comparison

Active Comparator group

Description:

Participants will receive brief HIV counseling at baseline visit.

Treatment:

Behavioral: Brief HIV Prevention Counseling