NCT00886561

Brief Summary

This pilot study will test the efficacy of a behavioral intervention in reducing HIV related risk behaviors among sex workers in Yerevan, Armenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 23, 2009

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

1 year

First QC Date

April 22, 2009

Last Update Submit

November 21, 2013

Conditions

HIV PreventionHIV Infections

Keywords

HIV prevention, female sex workersHIV seronegativity

Outcome Measures

Primary Outcomes (1)

  • Consistent condom use

    3 and 6 months post intervention

Secondary Outcomes (1)

  • Condom application

    3 and 6 months post intervention

Study Arms (2)

HIV risk reduction intervention

EXPERIMENTAL

Behavioral intervention designed to reduce HIV risk behaviors and enhance enhance HIV-preventive behaviors among female sex workers (FSWs) in Armenia

Behavioral: HIV risk reduction intervention

Wait list control

ACTIVE COMPARATOR

Will receive behavioral intervention after completion of study upon request.

Behavioral: HIV risk reduction intervention

Interventions

HIV risk reduction interventionBEHAVIORAL

Education intervention designed to reduce HIV risk behaviors and enhance HIV prevention behaviors among female sex workers in Armenia

HIV risk reduction interventionWait list control

Eligibility Criteria

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

You may qualify if:

  • years and older
  • traded sex for money in the past 7 days
  • cognitive ability to participate in assessment and intervention

You may not qualify if:

  • younger than 18 years of age
  • did not trade sex for money in the past 7 days
  • cognitively unable to participate in assessment and intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hope and Help NGO

Yerevan, Yerevan, Armenia

Location

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

  • Ralph J DiClemente, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 22, 2009

First Posted

April 23, 2009

Study Start

July 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations

AR(1)