Human Immunodeficiency VirusSNAPNCT03823209
Increasing PrEP Use in High-Risk Social Networks of African-American MSM in Underserved Low-Risk Cities
A study testing Social Network and Brief HIV Prevention Counseling in people with Human Immunodeficiency Virus, run by Medical College of Wisconsin at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, men only
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Social Network and Brief HIV Prevention Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Jan 2019to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
AIDS TaskForce of Greater Cleveland
Cleveland, Ohio, 44113
Medical College of Wisconsin
Milwaukee, Wisconsin, 53202
About this study
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.
Read the 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.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Social Network, Brief HIV Prevention Counseling
- Keywords
- Pre-exposure prophylaxis (PrEP)
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social NetworkBehavioural
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 CounselingBehavioural
Participants will receive brief (15-minute) counseling on how to prevent HIV infection.
| Study group | Role | What they receive |
|---|---|---|
| Social Network Approach | Experimental | 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. Receives: Behavioral: Social Network; Behavioral: Brief HIV Prevention Counseling |
| Comparison | Active comparator | Participants will receive brief HIV counseling at baseline visit. Receives: Behavioral: Brief HIV Prevention Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-report of pre-exposure prophylaxis (PrEP) use
Change in self-reported PrEP use
Measured: 6 and 15 months
Secondary outcomes (5)
Pre-Exposure Prophylaxis (PrEP) Knowledge
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.
Measured: 6 and 15 months
Pre-Exposure Prophylaxis Attitudes
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.
Measured: 6 and 15 months
Pre-Exposure Prophylaxis Norm Perceptions
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.
Measured: 6 and 15 months
Pre-Exposure Prophylaxis Intentions
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.
Measured: 6 and 15 months
Pre-Exposure Prophylaxis Self-Efficacy
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.
Measured: 6 and 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start24 Jan 2019
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Kelly, Medical College of Wisconsin
- Investigators
- Jeffrey A. Kelly, PhD, Principal investigator, Medical College of WisconsinYuri A. Amirkhanian, PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823209
- Sponsor's protocol ID
- PRO00029359
- Acronym
- SNAP
- Status last verified
- Jul 2026
- First submitted
- 24 Jan 2019
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31658194Quinn 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.
PubMed 32016815Kelly 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.
PubMed 32167374
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing PrEP Use in High-Risk Social Networks of African-American MSM in Underserved Low-Risk Cities
- ClinicalTrials.gov ID
- NCT03823209
- Acronym / sponsor ID
- SNAP / PRO00029359
- Conditions
- Human Immunodeficiency Virus
- Keywords
- Pre-exposure prophylaxis (PrEP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social Network Approach | Experimental | Behavioral: Social Network, Behavioral: Brief HIV Prevention CounselingParticipants 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 | Active comparator | Behavioral: Brief HIV Prevention CounselingParticipants will receive brief HIV counseling at baseline visit. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social NetworkLeaders 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. | Behavioural | Social Network Approach |
| Brief HIV Prevention CounselingParticipants will receive brief (15-minute) counseling on how to prevent HIV infection. | Behavioural | Comparison, Social Network Approach |
Primary outcome
Self-report of pre-exposure prophylaxis (PrEP) use
Time frame: 6 and 15 months
Change in self-reported PrEP use
5 secondary outcomes
Pre-Exposure Prophylaxis (PrEP) Knowledge
Time frame: 6 and 15 months
Pre-Exposure Prophylaxis Attitudes
Time frame: 6 and 15 months
Pre-Exposure Prophylaxis Norm Perceptions
Time frame: 6 and 15 months
Pre-Exposure Prophylaxis Intentions
Time frame: 6 and 15 months
Pre-Exposure Prophylaxis Self-Efficacy
Time frame: 6 and 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Results publication: PubMed 31658194Kelly 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.
- Results publication: PubMed 32016815Quinn 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.
- Results publication: PubMed 32167374Kelly 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey A. Kelly, PhD principal investigator
Medical College of Wisconsin
Yuri A. Amirkhanian, PhD principal investigator
Medical College of Wisconsin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Network and Brief HIV Prevention Counseling in people with Human Immunodeficiency Virus, run by Medical College of Wisconsin at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-report of pre-exposure prophylaxis (PrEP) use (time frame: 6 and 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03823209, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.