Social Networks and Prevention for HIV Care and Prevention (SNAP)

July 15, 2018 updated by: Carl Latkin, Johns Hopkins Bloomberg School of Public Health

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.

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

559

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Bloomberg School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • 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 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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Carl Latkin, PhD, Johns Hopkins Bloomberg School of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2011

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

February 26, 2013

First Submitted That Met QC Criteria

February 26, 2013

First Posted (Estimate)

February 28, 2013

Study Record Updates

Last Update Posted (Actual)

July 17, 2018

Last Update Submitted That Met QC Criteria

July 15, 2018

Last Verified

July 1, 2018

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)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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