NCT01866046

Brief Summary

This is a developmental study evaluating a new rapid HIV testing and risk prevention intervention for residents of battered women's shelters who endorse risky sexual behaviors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2013

Typical duration for phase_1

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

January 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 31, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

1.7 years

First QC Date

May 28, 2013

Last Update Submit

March 24, 2015

Conditions

HIV Risk

Keywords

battered womenHIV riskSTI risk

Outcome Measures

Primary Outcomes (1)

  • number of unprotected sexual occasions

    Calendar assessment of number of unprotected sexual occasions

    up to 3 months post shelter

Study Arms (1)

RESPECT-IPV

EXPERIMENTAL

Rapid HIV testing and risk prevention intervention for victims of intimate partner violence

Behavioral: RESPECT-IPV

Interventions

RESPECT-IPVBEHAVIORAL

rapid HIV testing intervention and behavioral counseling session where identify risks and develop a risk reduction plan

RESPECT-IPV

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • intimate partner violence and at least one unprotected sexual occasion 3 months prior to entering shelter

You may not qualify if:

  • HIV positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Akron

Akron, Ohio, 44325, United States

Location

Related Publications (1)

  • Johnson DM, Johnson NL, Beckwith CG, Palmieri PA, Zlotnick C. Rapid Human Immunodeficiency Virus Testing and Risk Prevention in Residents of Battered Women's Shelters. Womens Health Issues. 2017 Jan-Feb;27(1):36-42. doi: 10.1016/j.whi.2016.10.007. Epub 2016 Nov 30.

    PMID: 27914861DERIVED

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 28, 2013

First Posted

May 31, 2013

Study Start

January 1, 2013

Primary Completion

October 1, 2014

Study Completion

March 1, 2015

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

US(1)