Increasing PrEP Use in High-Risk Social Networks of African-American MSM in Underserved Low-Risk Cities
- Conditions
- Human Immunodeficiency Virus
- Interventions
- Behavioral: Social NetworkBehavioral: Brief HIV Prevention Counseling
- Registration Number
- NCT03823209
- Lead Sponsor
- Medical College of Wisconsin
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 500
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Social Network Approach Social Network 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. Comparison Brief HIV Prevention Counseling Participants will receive brief HIV counseling at baseline visit. Social Network Approach Brief HIV Prevention Counseling 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.
- Primary Outcome Measures
Name Time Method Self-report of pre-exposure prophylaxis (PrEP) use 6 and 15 months Change in self-reported PrEP use
- Secondary Outcome Measures
Name Time Method Pre-Exposure Prophylaxis (PrEP) Knowledge 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.Pre-Exposure Prophylaxis Norm Perceptions 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.Pre-Exposure Prophylaxis Attitudes 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.Pre-Exposure Prophylaxis Intentions 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.Pre-Exposure Prophylaxis Self-Efficacy 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.
Trial Locations
- Locations (2)
AIDS TaskForce of Greater Cleveland
🇺🇸Cleveland, Ohio, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States