A Comprehensive Approach to Secondary HIV Prevention and Care Among Positives (P&T)

The goal of this study is to conduct an HIV prevention intervention to train HIV seropositive drug users to be peer health educators.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Behavioral: Prevention & Testing Control; Behavioral: Prevention & Testing

Detailed Description

The primary objective of this funded research is to conduct an HIV prevention intervention to train HIV seropositive drug users to be peer health educators to: (1) recruit their high risk social network members for voluntary HIV counseling and testing (VCT) at the research clinic, (2) promote risk reduction among social network members, and (3) promote engagement in HIV care by encouraging HIV seropositive network members to schedule and keep HIV primary care appointments. There will be four types of participants in the Full Trial: 1) Index, 2) Testing Network 3) Longitudinal Network and 4) HIV positive network participants. This longitudinal study includes baseline, 6-months, and 12-month assessments

• Study Type: Interventional
• Enrollment (Actual): 632
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Lighhouse Studies @ Peer Point

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Index

1. 18 years old or older
2. documentation of HIV positive status
3. report one of following risk behaviors in past 90 days: sharing injection equipment, use of crack cocaine, or unprotected vaginal or anal sex

Testing network

1. 18 or older
2. provided testing coupon provided by an index participant

Longitudinal network participant-

1. tested HIV negative at the Lighthouse via redeeming a testing coupon
2. reported interacting with index who gave the coupon at least weekly
3. report one of following risk behaviors in the prior 90 days: sharing injection equipment, use of crack cocaine, or unprotected vaginal or anal sex

Positive Networks

1. HIV positive
2. report one of following risk behaviors in the prior 90 days: sharing injection equipment, use of crack cocaine, or unprotected vaginal or anal sex

Exclusion Criteria:

Index- already enrolled in the study as a Network participant

Testing network- already enrolled in the study as a Network participant

Longitudinal network- a) already enrolled in the study as a Network participant b) already enrolled in the study as a Index participant

Positive network- a) already enrolled in the study as a Network participant b) already enrolled in the study as a Index participant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Prevention & Testing Control; The comparison condition is focused on basic HIV risk reduction , safety and preventing drug overdose.	Behavioral: Prevention & Testing Control; 7 group sessions
Experimental: Prevention & Testing Intervention; The intervention condition is training on peer outreach skills which includes talking to HIV positive social network members about HIV care, medication adherence and HIV risk reduction.	Behavioral: Prevention & Testing; 6 group sessions, 1 individual session, and 1 dyad session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change in HIV medication adherence	6 month
change in frequency in attending HIV medical appointments	6 month

Secondary Outcome Measures

Outcome Measure	Time Frame
change in sharing injection equipment	6 month
change in condom use	6 month

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2012
• Primary Completion (Actual): January 31, 2017
• Study Completion (Actual): January 31, 2017

Study Registration Dates

• First Submitted: August 20, 2013
• First Submitted That Met QC Criteria: August 30, 2013
• First Posted (Estimate): September 5, 2013

Study Record Updates

• Last Update Posted (Actual): July 9, 2018
• Last Update Submitted That Met QC Criteria: July 6, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: HIV, drug use
• Other Study ID Numbers: R01DA032217 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED