- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01800721
Social Networks and Prevention for HIV Care and Prevention (SNAP)
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Johns Hopkins Bloomberg School of Public Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Condition SNAP
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. |
Behavioral: SNAP 7 group sessions, and 1 individual session
Other Names:
|
Active Comparator: SNAP Control Condition
SNAP Control Participants receive information on HIV/STDs as well as healthy eating and nutrition instruction. |
Behavioral: SNAP control 7 group sessions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
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.
|
12months
|
Change from Baseline in HIV Testing Rates at 6 months
Time Frame: 6 months
|
6 months
|
|
Change from Baseline in HIV Testing Rates at 12 months
Time Frame: 12 months
|
12 months
|
|
Number of Network Members Recruited for HIV Testing
Time Frame: 3 Months
|
3 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Drug Use at 6 months
Time Frame: 6 months
|
Type of drug (e.g.
cocaine, heroin, prescription drugs)and frequency of drug use
|
6 months
|
Change from Baseline in Drug Use at 12 months
Time Frame: 12 months
|
Type of drug (e.g.
cocaine, heroin, prescription drugs)and frequency of drug use
|
12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Carl Latkin, PhD, Johns Hopkins Bloomberg School of Public Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1R01DA031030 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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