Social Networks and Prevention for HIV Care and Prevention

NCT01800721 | Completed DMC

• 1 other identifier: 1R01DA031030
• Study Type: interventional
• Target: 559
• Locations: 1 country
• Sites: 1

Brief 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 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. 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. 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. 3.Examine mediating effects of social environments (networks, social norms) on HIV risk behaviors and VCT, among indexes and network members.
4. 4.Examine mediating effects of individual level factors (substance use and depression) on HIV risk behaviors and VCT among indexes and network members.

Conditions

HIV

Keywords

HIV; testing; Social Network; African American; MSM; Men who have sex with men

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  12months

• Change from Baseline in HIV Testing Rates at 6 months

  6 months

• Change from Baseline in HIV Testing Rates at 12 months

  12 months

• Number of Network Members Recruited for HIV Testing

  3 Months

Secondary Outcomes (2)

• Change from Baseline in Drug Use at 6 months

  6 months

• Change from Baseline in Drug Use at 12 months

  12 months

Study Arms (2)

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.

Behavioral: SNAP

SNAP Control Condition

ACTIVE COMPARATOR

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

Behavioral: SNAP Control

Interventions

SNAP BEHAVIORAL

Behavioral: SNAP 7 group sessions, and 1 individual session

Also known as: Peer Education Randomized Controlled Trial for Black MSM for VCT and Prevention

Experimental Condition SNAP

SNAP Control BEHAVIORAL

Behavioral: SNAP control 7 group sessions

SNAP Control Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Homosexuality

Condition Hierarchy (Ancestors)

Sexuality; Sexual Behavior; Behavior

Study Officials

• Carl Latkin, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: February 28, 2013
• Study Start: July 30, 2011
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 17, 2018

Record last verified: 2018-07

Locations

US (1)