NCT01499706

Brief Summary

The number of late middle-age and older adults living with HIV/AIDS in the U.S. continues to rise due largely to

  • better clinical care and the improved efficacy of highly active antiretroviral therapy that has extended the lives of many HIV-positive persons
  • an increase in the number of new HIV infections in older persons. This study tested the efficacy of 1- and 4-session telephone-administered behavioral sexual risk reduction interventions for HIV-positive adults 45-plus years of age who engage in risky sexual behaviors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2009

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

November 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 26, 2011

Completed
Last Updated

December 26, 2011

Status Verified

December 1, 2011

Enrollment Period

11 months

First QC Date

December 21, 2011

Last Update Submit

December 22, 2011

Conditions

Keywords

Motivational InterviewingTelephoneHIVAIDSOlder Adults

Outcome Measures

Primary Outcomes (2)

  • Change in self-reported number of non-condom-protected anal and vaginal sex acts in the past 3 months from baseline to 3-month follow-up

    baseline, 3-month follow-up

  • Change in self-reported number of non-condom-protected anal and vaginal sex acts in the past 3 months from baseline to 6-month follow-up

    baseline, 6-month follow-up

Secondary Outcomes (1)

  • Proportion of participants reporting 100% condom use for anal and vaginal sex in the past 3 months

    3-month follow-up, 6-month follow-up

Study Arms (3)

Standard of Care Control

NO INTERVENTION

Participants will receive standard sexual risk reduction services available to them through medical and community-based organizations

1-session motivational interviewing

EXPERIMENTAL

Participants will receive a single session of motivational interviewing delivered over the telephone

Behavioral: 1-session of telephone-administered motivational interviewing

4-session motivational interviewing

EXPERIMENTAL

Participants will receive four weekly sessions of motivational interviewing delivered over the telephone.

Behavioral: 4-session telephone-administered motivational interviewing

Interventions

Participants will receive a single session of telephone-delivered motivational interviewing to reduce sexual risk behavior.

1-session motivational interviewing

Participants will receive four weekly sessions of telephone-delivered motivational interviewing to reduce sexual risk behavior.

4-session motivational interviewing

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV-positive
  • English-speaking
  • Access to a land line or cellular telephone
  • Unprotected anal or vaginal intercourse in the past 3 months

You may not qualify if:

  • Sexual partner of study participant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio University College of Osteopathic Medicine

Athens, Ohio, 45701, United States

Location

Related Publications (1)

  • Lovejoy TI, Heckman TG, Suhr JA, Anderson T, Heckman BD, France CR. Telephone-administered motivational interviewing reduces risky sexual behavior in HIV-positive late middle-age and older adults: a pilot randomized controlled trial. AIDS Behav. 2011 Nov;15(8):1623-34. doi: 10.1007/s10461-011-0016-x.

MeSH Terms

Conditions

Unsafe SexAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Sexual BehaviorBehaviorHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Travis I Lovejoy, Ph.D., M.P.H.

    Ohio University College of Osteopathic Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Health Psychology Fellow

Study Record Dates

First Submitted

December 21, 2011

First Posted

December 26, 2011

Study Start

November 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

December 26, 2011

Record last verified: 2011-12

Locations