Social Networks and Prevention (SNAP)

This study is currently recruiting participants.
Verified February 2013 by Johns Hopkins Bloomberg School of Public Health
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01800721
First received: February 26, 2013
Last updated: March 4, 2013
Last verified: February 2013

February 26, 2013
March 4, 2013
July 2011
July 2014   (final data collection date for primary outcome measure)
  • Change from Baseline in Sex Risk Behavior at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change from Baseline in HIV Testing Rates at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of Network Members Recruited for HIV Testing [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01800721 on ClinicalTrials.gov Archive Site
  • Change from Baseline in Drug Use at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Type of drug (e.g. cocaine, heroin, prescription drugs)and frequency of drug use
  • Change from Baseline in Drug Use at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Type of drug (e.g. cocaine, heroin, prescription drugs)and frequency of drug use
Same as current
Not Provided
Not Provided
 
Social Networks and Prevention
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:

  1. 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.
  2. 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.
  3. Examine mediating effects of social environments (networks, social norms) on HIV risk behaviors and VCT, among indexes and network members.
  4. Examine mediating effects of individual level factors (substance use and depression) on HIV risk behaviors and VCT among indexes and network members.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV
Behavioral: Peer Education Randomized Controlled Trial for Black MSM for VCT and Prevention
Using a randomized clinical trial design, half of the index participants will be assigned to the intervention condition and half to the control condition. Index participants in the intervention condition will receive training in recruiting network members for testing and promoting norms of risk reduction within their networks. We propose 8 sessions in order to provide the Index Peer Health Educators with sufficient skill training to promote behavior change within the networks.
Other Name: SNAP
  • Experimental: Experimental condition
    The experimental condition is a training on sexual health and peer outreach which includes talking to network members about HIV testing and prevention. There will be 8 sessions which include: (1) a sexual health overview, short term goal setting, communication skills for recruiting networks for testing; (2) sexually transmitted infection (STI) overview, testing and condom use, recruiting networks for testing; (3) HIV overview, testing and condom use, recruiting networks for testing; (4) Alcohol use and risk, condom use practice; (5) Sexual risk reduction options and talking with partners; (6) Individual session: personalized risk reduction; (7) Recap and talking with providers; and (8) Sustainability of skills and graduation.
    Intervention: Behavioral: Peer Education Randomized Controlled Trial for Black MSM for VCT and Prevention
  • Active Comparator: Control Condition

    The control condition will receive equal attention. There will be 7 group sessions. The group sessions are focused on HIV education, nutrition and healthy eating. Session topics include:

    (1) Eating healthy overview, recruiting networks for testing; (2) Preparing healthy meals; (3) Cardiovascular health; (4) Strategies for improving cardiovascular health; (5) Diabetes; (6) Preparing healthy meals and healthy portions; and (7) Healthy food shopping, sustainability and graduation.

    Intervention: Behavioral: Peer Education Randomized Controlled Trial for Black MSM for VCT and Prevention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
900
Not Provided
July 2014   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
Yes
Not Provided
United States
 
NCT01800721
1 R01DA031030-01A1
Yes
Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
National Institute on Drug Abuse (NIDA)
Principal Investigator: Carl Latkin, PhD Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP