Clinical trial NCT03823209: Increasing PrEP Use in High-Risk Social Networks of African-American MSM in Underserved Low-Risk Cities
Official title: Increasing PrEP Use in High-Risk Social Networks of African-American MSM in Underserved Low-Risk Cities
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Human Immunodeficiency Virus
Keywords: Pre-exposure prophylaxis (PrEP)
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 500
Sex: MALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Self-report of pre-exposure prophylaxis (PrEP) use
timeFrame: 6 and 15 months
Secondary outcomes:
measure: Pre-Exposure Prophylaxis (PrEP) Knowledge
timeFrame: 6 and 15 months
measure: Pre-Exposure Prophylaxis Attitudes
timeFrame: 6 and 15 months
measure: Pre-Exposure Prophylaxis Norm Perceptions
timeFrame: 6 and 15 months
measure: Pre-Exposure Prophylaxis Intentions
timeFrame: 6 and 15 months
measure: Pre-Exposure Prophylaxis Self-Efficacy
timeFrame: 6 and 15 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: AIDS TaskForce of Greater Cleveland
state: Ohio
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Jeffrey A. Kelly, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical College of Wisconsin
name: Yuri A. Amirkhanian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.