NCT01457066

Brief Summary

The goal of this proposal is to culturally adapt and tailor an existing, theory-based intervention, using state-of-the-art methods designed to maximize cultural sensitivity, feasibility and acceptability to HIV+ Latino MSM, and to test it in a small randomized controlled trial (n=60 intervention; n=60 control).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P75+ for phase_1 hiv

Timeline
Completed

Started Dec 2012

Typical duration for phase_1 hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2011

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

1.5 years

First QC Date

October 19, 2011

Last Update Submit

May 26, 2015

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

  • Retention in care

    Retention in care will be assessed through the following measures: HIV medical care visits, ART use, self-reported adherence, acute care utilization, viral load, and health-related quality of life

    Six month follow up

Secondary Outcomes (1)

  • Intermediate outcome variables

    Six month follow up

Study Arms (2)

Intervention

EXPERIMENTAL

This group will receive the peer navigator intervention.

Behavioral: Peer Navigator Intervention

Control

NO INTERVENTION

This group will receive usual care.

Interventions

Peer Navigator InterventionBEHAVIORAL

Peer navigators will teach HIV retention and linkage skills and knowledge using group-based as well as one-on-one, peer-based learning approaches.

Intervention

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AltaMed

Los Angeles, California, 90023, United States

Location

Study Officials

  • William E Cunningham, MD, MPH

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

October 19, 2011

First Posted

October 21, 2011

Study Start

December 1, 2012

Primary Completion

June 1, 2014

Study Completion

September 1, 2014

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

US(1)