HIVNCT02503618
Understanding Substance Use and Incident HIV/STI Among Young Black MSM
An observational study of HIV and Substance Abuse, run by Emory University at 7 sites in United States.
Trial summary
The scientific purpose of this study is to look at how substance use may relate to human immunodeficiency virus (HIV) infection among young black men who have sex with men in Atlanta. Read more about this study
- Who is it for?
- Ages 18 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Substance Abuse
- How many people
- 469 participants
- Where
- 7 sitesUnited States
- Study dates
- Jul 2015to 18 Mar 2019
- Phase
- Observational
- 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 18 to 29 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Young black men who have sex with men in Atlanta, Georgia will be recruited in a variety of venues in Atlanta. If needed, there will be targeted recruitment via Facebook.
Who may be able to join
- male at birth
- currently identifies as male
- age ≥18 years and < 30 years at enrollment
- had anal sex with a man in lifetime
- has had any sex with a man in the past 3 months
- self-reported race is black/African American
Show all 11Show fewer
- lives in Atlanta area and plans to remain for 2 years
- is able to complete the survey instruments in English
- is willing to provide at least 2 means of contact
- is willing to be re-contacted for the return of HIV/STI testing results, and for other study reasons as necessary
- is not enrolled in an HIV prevention trial
Who cannot join
- self-reported multiple or non-Black/African American race(s)
- self-reported Hispanic ethnicity
- (for prospective follow-up) participant screens HIV-positive
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Grady Health System
Atlanta, Georgia, 30303
Grady Infectious Diseases Clinic (Ponce Clinic)
Atlanta, Georgia, 30308
The Ponce de Leon Center of the Grady Health System
Atlanta, Georgia, 30308
AID Atlanta
Atlanta, Georgia, 30309
Southside Medical Center
Atlanta, Georgia, 30315
Rollins School of Public Health
Atlanta, Georgia, 30322
SisterLove, Inc
Atlanta, Georgia, 30331
About this study
Official title: Understanding Substance Use and Incident HIV/STI Among Young Black Men Having Sex With Men (MSM)
The scientific purpose of this study is to look at how substance use may relate to human immunodeficiency virus (HIV) infection among young black men who have sex with men in Atlanta.
Read the detailed description
Young black men who have sex with men (YBMSM) are a critically at-risk population in the United States and Atlanta that faces extremely high incidence rates of HIV and other sexually transmitted infections (STIs). The understanding of what places this group of men at high risk is incomplete, and the role of substances in amplifying that risk is unclear. This study will fill a number of gaps about how substances and partnerships place YBMSM at increased HIV risk. The study includes several innovative aspects. First, the investigators are using a theoretical framework to understand multilevel associations between substance use and HIV risk behavior in YBMSM in the southeastern United States, a critically at-risk but understudied population. Second, the investigators are using a variety of enhanced measurement methods to understand these associations. The investigators are supplementing self-reported substance use with objective measures to enhance the sensitivity of classifying recent use. The investigators will analyze incident HIV/STI endpoints in addition to self-reported sexual behaviors. The investigators will use detailed, event-based and dyadic measures of substance use and its covariates, which will capture both sexual and non-sexual contexts of use. Although previous cohort studies have explored alcohol and drug use during sexual events among men who have sex with men (MSM), few studies have described both sexual and non-sexual patterns of, and motivations for, substance use among YBMSM, and none have incorporated longitudinal biomarkers of substance use and related these to incident infection outcomes. Finally, the investigators are using a mixed-methods approach to provide context to the quantitative findings. By recruiting subjects to a nested qualitative study within the larger cohort based on their interval-specific risks, the investigators will gain in-depth information regarding the emergence, persistence, and resolution of these complex relationships between substances and sexual risk behaviors among YBMSM and how these relationships emerge and are resolved over time.
- Conditions
- HIV, Substance Abuse
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV-negative YBMSM | Subjects are young black men who have sex with men in Atlanta, Georgia and are HIV-negative | |
| HIV-positive YBMSM | Subjects are young black men who have sex with men in Atlanta, Georgia and are HIV-positive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hazard ratio for HIV incidence and levels of alcohol, marijuana, cocaine, and ecstasy use
Prevalence of drug use and association between these factors and HIV seroconversion (hazard ratio)
Measured: 2 years
Incidence rates of biomarker-detected and self-reported alcohol, marijuana, cocaine, and ecstasy use
Measured: 2 years
Proportion of recent sex partners who are additionally substance-use partners
Measured: 2.5 years
Incidence rates of HIV
Total person-years will be calculated as the time from study entry to the estimated date of seroconversion.
Measured: 2 years
Secondary outcomes (3)
Event-level odds ratios between serodiscordant unprotected anal intercourse and self-reported alcohol, marijuana, cocaine, and ecstasy use
Measured: 2.5 years
Incidence rates of sexually transmitted infections (rectal gonorrhea, rectal chlamydia, urethral gonorrhea, urethral chlamydia, syphilis)
Total person-years will be calculated as the time from study entry to the estimated date of seroconversion.
Measured: 2 years
Rate ratios between sexually transmitted infection (STI) incidence and levels of biomarker-detected and self-reported alcohol, marijuana, cocaine, and ecstasy use
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startJul 2015
- Primary completion18 Mar 2019
- Study completion18 Mar 2019
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 HIVStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 469 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Patrick S Sullivan, Emory University
- Investigators
- Patrick S Sullivan, DVM, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503618
- Sponsor's protocol ID
- IRB00078950
- Other IDs
- 1R01DA038196-01
- Status last verified
- Jun 2019
- First submitted
- 17 Jul 2015
- Last updated
- 27 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Serota DP, Rosenberg ES, Thorne AL, Sullivan PS, Kelley CF. Lack of health insurance is associated with delays in PrEP initiation among young black men who have sex with men in Atlanta, US: a longitudinal cohort study. J Int AIDS Soc. 2019 Oct;22(10):e25399. doi: 10.1002/jia2.25399.
PubMed 31592575Serota DP, Rosenberg ES, Sullivan PS, Thorne AL, Rolle CM, Del Rio C, Cutro S, Luisi N, Siegler AJ, Sanchez TH, Kelley CF. Pre-exposure Prophylaxis Uptake and Discontinuation Among Young Black Men Who Have Sex With Men in Atlanta, Georgia: A Prospective Cohort Study. Clin Infect Dis. 2020 Jul 27;71(3):574-582. doi: 10.1093/cid/ciz894.
PubMed 31499518Serota DP, Rosenberg ES, Lockard AM, Rolle CM, Luisi N, Cutro S, Del Rio C, Siegler AJ, Sanchez TH, Sullivan PS, Kelley CF. Beyond the Biomedical: Preexposure Prophylaxis Failures in a Cohort of Young Black Men Who Have Sex With Men in Atlanta, Georgia. Clin Infect Dis. 2018 Aug 31;67(6):965-970. doi: 10.1093/cid/ciy297.
PubMed 29635415
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Substance Use and Incident HIV/STI Among Young Black Men Having Sex With Men (MSM)
- ClinicalTrials.gov ID
- NCT02503618
- Acronym / sponsor ID
- IRB00078950
- Conditions
- HIV, Substance Abuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 469 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2015
- Primary completion
- 18 Mar 2019 (actual)
- Study completion
- 18 Mar 2019 (actual)
- First posted
- 21 Jul 2015 (estimated)
- 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.
The scientific purpose of this study is to look at how substance use may relate to human immunodeficiency virus (HIV) infection among young black men who have sex with men in Atlanta.
Detailed description
Young black men who have sex with men (YBMSM) are a critically at-risk population in the United States and Atlanta that faces extremely high incidence rates of HIV and other sexually transmitted infections (STIs). The understanding of what places this group of men at high risk is incomplete, and the role of substances in amplifying that risk is unclear. This study will fill a number of gaps about how substances and partnerships place YBMSM at increased HIV risk. The study includes several innovative aspects. First, the investigators are using a theoretical framework to understand multilevel associations between substance use and HIV risk behavior in YBMSM in the southeastern United States, a critically at-risk but understudied population. Second, the investigators are using a variety of enhanced measurement methods to understand these associations. The investigators are supplementing self-reported substance use with objective measures to enhance the sensitivity of classifying recent use. The investigators will analyze incident HIV/STI endpoints in addition to self-reported sexual behaviors. The investigators will use detailed, event-based and dyadic measures of substance use and its covariates, which will capture both sexual and non-sexual contexts of use. Although previous cohort studies have explored alcohol and drug use during sexual events among men who have sex with men (MSM), few studies have described both sexual and non-sexual patterns of, and motivations for, substance use among YBMSM, and none have incorporated longitudinal biomarkers of substance use and related these to incident infection outcomes. Finally, the investigators are using a mixed-methods approach to provide context to the quantitative findings. By recruiting subjects to a nested qualitative study within the larger cohort based on their interval-specific risks, the investigators will gain in-depth information regarding the emergence, persistence, and resolution of these complex relationships between substances and sexual risk behaviors among YBMSM and how these relationships emerge and are resolved over time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV-negative YBMSM | – | –Subjects are young black men who have sex with men in Atlanta, Georgia and are HIV-negative |
| HIV-positive YBMSM | – | –Subjects are young black men who have sex with men in Atlanta, Georgia and are HIV-positive |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young black men who have sex with men in Atlanta, Georgia will be recruited in a variety of venues in Atlanta. If needed, there will be targeted recruitment via Facebook.
Key inclusion criteria (11 listed)
- male at birth
- currently identifies as male
- age ≥18 years and < 30 years at enrollment
- had anal sex with a man in lifetime
- has had any sex with a man in the past 3 months
Key exclusion criteria (3 listed)
- self-reported multiple or non-Black/African American race(s)
- self-reported Hispanic ethnicity
- (for prospective follow-up) participant screens HIV-positive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hazard ratio for HIV incidence and levels of alcohol, marijuana, cocaine, and ecstasy use
Time frame: 2 years
Prevalence of drug use and association between these factors and HIV seroconversion (hazard ratio)
Incidence rates of biomarker-detected and self-reported alcohol, marijuana, cocaine, and ecstasy use
Time frame: 2 years
Proportion of recent sex partners who are additionally substance-use partners
Time frame: 2.5 years
Incidence rates of HIV
Time frame: 2 years
Total person-years will be calculated as the time from study entry to the estimated date of seroconversion.
3 secondary outcomes
Event-level odds ratios between serodiscordant unprotected anal intercourse and self-reported alcohol, marijuana, cocaine, and ecstasy use
Time frame: 2.5 years
Incidence rates of sexually transmitted infections (rectal gonorrhea, rectal chlamydia, urethral gonorrhea, urethral chlamydia, syphilis)
Time frame: 2 years
Rate ratios between sexually transmitted infection (STI) incidence and levels of biomarker-detected and self-reported alcohol, marijuana, cocaine, and ecstasy use
Time frame: 2 years
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 27 Jun 2019.
- Derived from this study: PubMed 31592575Serota DP, Rosenberg ES, Thorne AL, Sullivan PS, Kelley CF. Lack of health insurance is associated with delays in PrEP initiation among young black men who have sex with men in Atlanta, US: a longitudinal cohort study. J Int AIDS Soc. 2019 Oct;22(10):e25399. doi: 10.1002/jia2.25399.
- Derived from this study: PubMed 31499518Serota DP, Rosenberg ES, Sullivan PS, Thorne AL, Rolle CM, Del Rio C, Cutro S, Luisi N, Siegler AJ, Sanchez TH, Kelley CF. Pre-exposure Prophylaxis Uptake and Discontinuation Among Young Black Men Who Have Sex With Men in Atlanta, Georgia: A Prospective Cohort Study. Clin Infect Dis. 2020 Jul 27;71(3):574-582. doi: 10.1093/cid/ciz894.
- Derived from this study: PubMed 29635415Serota DP, Rosenberg ES, Lockard AM, Rolle CM, Luisi N, Cutro S, Del Rio C, Siegler AJ, Sanchez TH, Sullivan PS, Kelley CF. Beyond the Biomedical: Preexposure Prophylaxis Failures in a Cohort of Young Black Men Who Have Sex With Men in Atlanta, Georgia. Clin Infect Dis. 2018 Aug 31;67(6):965-970. doi: 10.1093/cid/ciy297.
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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.
Patrick S Sullivan, DVM, PhD principal investigator
Emory University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Substance Abuse, run by Emory University at 7 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 11 inclusion and 3 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 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Hazard ratio for HIV incidence and levels of alcohol, marijuana, cocaine, and ecstasy use (time frame: 2 years). The study lists 4 primary outcomes in all. 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 NCT02503618, 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 27 Jun 2019.