NCT00164398

Brief Summary

The purpose is to encourage Provider participants to evaluate high risk HIV transmission behaviors and offer prevention messages to their HIV+ patients which will, in turn, reduce rates of unprotected anal and/or vaginal sex with partners of known HIV sero-negativity or unknown HIV serostatus. It is hypothesized that patients of providers participating in the HIP intervention will report higher reduction in sexual risk practices, when compared to the patients of the providers who were randomized into the control condition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2 hiv-infections

Timeline
Completed

Started Jun 2004

Typical duration for phase_2 hiv-infections

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

Study Start

First participant enrolled

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

September 11, 2012

Status Verified

September 1, 2012

Enrollment Period

2.3 years

First QC Date

September 9, 2005

Last Update Submit

September 10, 2012

Conditions

Keywords

HIV

Outcome Measures

Primary Outcomes (1)

  • Self-reported, unprotected (without condoms) anal or vaginal sex with HIV-negative and unknown-status persons.

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provider participants: (1) licensed MD, NP or PA on staff at the participating institution; (2) has a minimum panel of 5 HIV+ patients; (3) sees patients at least one-half day per week in the clinical setting; (4) is willing to participate in all intervention training sessions; and (5) is willing and able to provide full informed consent.
  • HIV+ patient participants:(1) report at least 1 encounter of unprotected anal or vaginal sex with known HIV- or unknown serostatus partner in the preceding six months; (2) patient's Primary Provider is enrolled as a participant in the study; (3) age 18 years or older; and (4) willing and able to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco - CAPS

San Francisco, California, 94105, United States

Location

Related Publications (1)

  • Rose CD, Courtenay-Quirk C, Knight K, Shade SB, Vittinghoff E, Gomez C, Lum PJ, Bacon O, Colfax G. HIV intervention for providers study: a randomized controlled trial of a clinician-delivered HIV risk-reduction intervention for HIV-positive people. J Acquir Immune Defic Syndr. 2010 Dec 15;55(5):572-81. doi: 10.1097/QAI.0b013e3181ee4c62.

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Dogan Eroglu, PhD.

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

June 1, 2004

Primary Completion

October 1, 2006

Study Completion

September 1, 2008

Last Updated

September 11, 2012

Record last verified: 2012-09

Locations