Social Networks and Prevention (SNAP)

This study is currently recruiting participants. (see Contacts and Locations)
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: April 22, 2014
Last verified: February 2013
  Purpose

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.

Condition Intervention Phase
HIV
Behavioral: SNAP
Behavioral: SNAP Control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial to Train Black MSM as Peer Health Educators for HIV Testing and Prevention

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 900
Study Start Date: July 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Behavioral: SNAP 7 group sessions, and 1 individual session
Other Name: Peer Education Randomized Controlled Trial for Black MSM for VCT and Prevention
Active Comparator: SNAP Control Condition

SNAP Control

Participants receive information on HIV/STDs as well as healthy eating and nutrition instruction.

Behavioral: SNAP Control
Behavioral: SNAP control 7 group sessions

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01800721

Locations
United States, Maryland
Johns Hopkins Bloomberg School of Public Health Recruiting
Baltimore, Maryland, United States, 21205
Contact: Carl Latkin, PhD    410-955-3972    clatkin@jhsph.edu   
Principal Investigator: Carl Latkin, PhD         
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Investigators
Principal Investigator: Carl Latkin, PhD Johns Hopkins Bloomberg School of Public Health
  More Information

No publications provided

Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01800721     History of Changes
Other Study ID Numbers: 1 R01DA031030, 1R01DA031030
Study First Received: February 26, 2013
Last Updated: April 22, 2014
Health Authority: United States: Federal Government

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
HIV
testing
Social Network
African American
MSM
Men who have sex with men

ClinicalTrials.gov processed this record on October 23, 2014