HIVSNAPNCT01800721
Social Networks and Prevention for HIV Care and Prevention
A study testing SNAP in people with HIV, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial summary
The present study includes a randomized clinical trial of a peer health education intervention and a 12-month longitudinal study. The sample will include Black Men who have Sex with Men (MSM) who will be randomized into an experimental or control condition and then asked to recruit peer and risk network members for… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- SNAP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 559 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2011to Jul 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligibility criteria for indexes include: (a) sex with a male partner within the prior 90 days; (b) self-reported Black or African American race/ethnicity; (c) self-reported biological male sex at birth; (d) identify as male; (e) unprotected vaginal or anal sex within the prior 90 days; (f) age 18 or older; (g) willingness to attend intervention sessions; (h) willingness to discuss HIV prevention and encourage VCT among network members; (i) reside in Baltimore city or a surrounding counties; (j) not planning on moving from Baltimore city or a surrounding county within the next year; (k) not involved in a behavioral intervention for HIV prevention within the prior five years.
- Eligibility for network members for receiving VCT: (a) Provide a study coupon to verify that they were referred by an index participant and (b) age 18 or older.
- Eligibility criteria for network members enrolling in the longitudinal study: (a) age 18 or older; (b) recruited by index participant and engaged in VCT at our clinic; (c) was either a current sex partner of index (male or female)or a Black MSM peer (as operationalized as self-reported black or African American and reporting sex with a man in the prior 90 days) and (d) had one of the following risk behaviors in the prior 90 days: unprotected vaginal or anal sex, diagnosed STI, or had sex with 2 or more people.
Who cannot join
- Exclusion criteria for indexes include being previously enrolled in the study as a network participant.
- Exclusion criteria for network participants include being previously enrolled in the study as an index participant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
About this study
Official title: A Randomized Controlled Trial to Train Black MSM as Peer Health Educators for HIV Testing and Prevention
The present study includes a randomized clinical trial of a peer health education intervention and a 12-month longitudinal study. The sample will include Black Men who have Sex with Men (MSM) who will be randomized into an experimental or control condition and then asked to recruit peer and risk network members for HIV testing over a 3 month period. Some of the network members who are recruited for voluntary counseling and testing (VCT) will enroll into the longitudinal study for assessments only. Both index and network participants will be assessed at baseline, 6, and 12-months.
The specific aims of the proposed study are to:
- Train Black MSM (index participants in the experimental condition) to conduct peer health education, to promote VCT and HIV risk reduction among social network members, and to recruit social network members for VCT.
- Examine changes in HIV risk behaviors and VCT among index participants and their network members in the experimental intervention as compared to those in the control condition.
- Examine mediating effects of social environments (networks, social norms) on HIV risk behaviors and VCT, among indexes and network members.
- Examine mediating effects of individual level factors (substance use and depression) on HIV risk behaviors and VCT among indexes and network members.
Read the detailed description
The primary objective of this funded research is to conduct a randomized controlled trial of an experimental behavioral intervention that will train African American men who have sex with men (AA MSM) to 1) conduct peer health education, 2) to promote HIV risk reduction among their social network members, 3) promote HIV voluntary counseling and testing (VCT) among their social network members and 4) recruit social network members for VCT. Index participants are African American/Black men who have sex with men (MSM) who are randomized to either a peer education intervention or comparison condition. After the baseline is complete, index participants refer social network members (i.e. network participants) to the research clinic for HIV antibody testing. In addition, a subset of network participants participate in the longitudinal portion of the study.
- Conditions
- HIV
- Being tested
- SNAP, SNAP Control
- Keywords
- HIV, testing, Social Network, African American, MSM, Men who have sex with men
- Medical subject headings
- Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNAPBehavioural
Also called Peer Education Randomized Controlled Trial for Black MSM for VCT and Prevention
Behavioral: SNAP 7 group sessions, and 1 individual session
SNAP ControlBehavioural
Behavioral: SNAP control 7 group sessions
| Study group | Role | What they receive |
|---|---|---|
| Experimental Condition SNAP | Experimental | Behavioral Intervention SNAP HIV training and peer outreach
Participants learn skills for sexual health and peer outreach which includes talking with network members about HIV testing and prevention. Receives: Behavioral: SNAP |
| SNAP Control Condition | Active comparator | SNAP Control
Participants receive information on HIV/STDs as well as healthy eating and nutrition instruction. Receives: Behavioral: SNAP Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Sex Risk Behavior at 6 months
We will measures sex risk behavior by assessing the frequency of oral and anal sex; frequency and consistency of condom use; the number and types (e.g., main, casual, and exchange) of sex partners in the prior 90 days; and the gender, sexual preference, and HIV and drug use status of each partner.
Measured: 6 months
Change from Baseline in Sex Risk Behavior at 12 months
We will measures sex risk behavior by assessing the frequency of oral and anal sex; frequency and consistency of condom use; the number and types (e.g., main, casual, and exchange) of sex partners in the prior 90 days; and the gender, sexual preference, and HIV and drug use status of each partner.
Measured: 12months
Change from Baseline in HIV Testing Rates at 6 months
Measured: 6 months
Change from Baseline in HIV Testing Rates at 12 months
Measured: 12 months
Number of Network Members Recruited for HIV Testing
Measured: 3 Months
Secondary outcomes (2)
Change from Baseline in Drug Use at 6 months
Type of drug (e.g. cocaine, heroin, prescription drugs)and frequency of drug use
Measured: 6 months
Change from Baseline in Drug Use at 12 months
Type of drug (e.g. cocaine, heroin, prescription drugs)and frequency of drug use
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2013 (estimated)
- Study start30 Jul 2011
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 559 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Carl Latkin, Johns Hopkins Bloomberg School of Public Health
- Investigators
- Carl Latkin, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800721
- Sponsor's protocol ID
- 1R01DA031030
- Other IDs
- 1R01DA031030
- Acronym
- SNAP
- Status last verified
- Jul 2018
- First submitted
- 26 Feb 2013
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Train Black MSM as Peer Health Educators for HIV Testing and Prevention
- ClinicalTrials.gov ID
- NCT01800721
- Acronym / sponsor ID
- SNAP / 1R01DA031030
- Conditions
- HIV
- Keywords
- HIV, testing, Social Network, African American, MSM, Men who have sex with men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 559 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 30 Jul 2011 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 28 Feb 2013 (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 present study includes a randomized clinical trial of a peer health education intervention and a 12-month longitudinal study. The sample will include Black Men who have Sex with Men (MSM) who will be randomized into an experimental or control condition and then asked to recruit peer and risk network members for HIV testing over a 3 month period. Some of the network members who are recruited for voluntary counseling and testing (VCT) will enroll into the longitudinal study for assessments only. Both index and network participants will be assessed at baseline, 6, and 12-months.
The specific aims of the proposed study are to:
- Train Black MSM (index participants in the experimental condition) to conduct peer health education, to promote VCT and HIV risk reduction among social network members, and to recruit social network members for VCT.
- Examine changes in HIV risk behaviors and VCT among index participants and their network members in the experimental intervention as compared to those in the control condition.
- Examine mediating effects of social environments (networks, social norms) on HIV risk behaviors and VCT, among indexes and network members.
- Examine mediating effects of individual level factors (substance use and depression) on HIV risk behaviors and VCT among indexes and network members.
Detailed description
The primary objective of this funded research is to conduct a randomized controlled trial of an experimental behavioral intervention that will train African American men who have sex with men (AA MSM) to 1) conduct peer health education, 2) to promote HIV risk reduction among their social network members, 3) promote HIV voluntary counseling and testing (VCT) among their social network members and 4) recruit social network members for VCT. Index participants are African American/Black men who have sex with men (MSM) who are randomized to either a peer education intervention or comparison condition. After the baseline is complete, index participants refer social network members (i.e. network participants) to the research clinic for HIV antibody testing. In addition, a subset of network participants participate in the longitudinal portion of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Condition SNAP | Experimental | Behavioral: SNAPBehavioral Intervention SNAP HIV training and peer outreach Participants learn skills for sexual health and peer outreach which includes talking with network members about HIV testing and prevention. |
| SNAP Control Condition | Active comparator | Behavioral: SNAP ControlSNAP Control Participants receive information on HIV/STDs as well as healthy eating and nutrition instruction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Eligibility criteria for indexes include: (a) sex with a male partner within the prior 90 days; (b) self-reported Black or African American race/ethnicity; (c) self-reported biological male sex at birth; (d) identify as male; (e) unprotected vaginal or anal sex within the prior 90 days; (f) age 18 or older; (g) willingness to attend intervention sessions; (h) willingness to discuss HIV prevention and encourage VCT among network members; (i) reside in Baltimore city or a surrounding counties; (j) not planning on moving from Baltimore city or a surrounding county within the next year; (k) not involved in a behavioral intervention for HIV prevention within the prior five years.
- Eligibility for network members for receiving VCT: (a) Provide a study coupon to verify that they were referred by an index participant and (b) age 18 or older.
- Eligibility criteria for network members enrolling in the longitudinal study: (a) age 18 or older; (b) recruited by index participant and engaged in VCT at our clinic; (c) was either a current sex partner of index (male or female)or a Black MSM peer (as operationalized as self-reported black or African American and reporting sex with a man in the prior 90 days) and (d) had one of the following risk behaviors in the prior 90 days: unprotected vaginal or anal sex, diagnosed STI, or had sex with 2 or more people.
Key exclusion criteria (2 listed)
- Exclusion criteria for indexes include being previously enrolled in the study as a network participant.
- Exclusion criteria for network participants include being previously enrolled in the study as an index participant.
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 |
|---|---|---|
| SNAPAlso: Peer Education Randomized Controlled Trial for Black MSM for VCT and PreventionBehavioral: SNAP 7 group sessions, and 1 individual session | Behavioural | Experimental Condition SNAP |
| SNAP ControlBehavioral: SNAP control 7 group sessions | Behavioural | SNAP Control Condition |
Primary outcome
Change from Baseline in Sex Risk Behavior at 6 months
Time frame: 6 months
We will measures sex risk behavior by assessing the frequency of oral and anal sex; frequency and consistency of condom use; the number and types (e.g., main, casual, and exchange) of sex partners in the prior 90 days; and the gender, sexual preference, and HIV and drug use status of each partner.
Change from Baseline in Sex Risk Behavior at 12 months
Time frame: 12months
We will measures sex risk behavior by assessing the frequency of oral and anal sex; frequency and consistency of condom use; the number and types (e.g., main, casual, and exchange) of sex partners in the prior 90 days; and the gender, sexual preference, and HIV and drug use status of each partner.
Change from Baseline in HIV Testing Rates at 6 months
Time frame: 6 months
Change from Baseline in HIV Testing Rates at 12 months
Time frame: 12 months
Number of Network Members Recruited for HIV Testing
Time frame: 3 Months
2 secondary outcomes
Change from Baseline in Drug Use at 6 months
Time frame: 6 months
Change from Baseline in Drug Use at 12 months
Time frame: 12 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 17 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
Carl Latkin, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SNAP in people with HIV, run by Johns Hopkins Bloomberg School of Public Health at 1 site 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 3 inclusion and 2 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 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change from Baseline in Sex Risk Behavior at 6 months (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2018.