Telephone-delivered Behavioral Interventions to Reduce Risky Sexual Behavior in HIV-positive Late Middle-age and Older Adults
MI
Phase I Clinical Trial of Telephone-delivered Motivational Interviewing to Reduce Sexual Risk Behavior in HIV-positive Persons 45-plus Years of Age
1 other identifier
interventional
100
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2009
1 active site
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
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 21, 2011
CompletedFirst Posted
Study publicly available on registry
December 26, 2011
CompletedDecember 26, 2011
December 1, 2011
11 months
December 21, 2011
December 22, 2011
Conditions
Keywords
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 INTERVENTIONParticipants will receive standard sexual risk reduction services available to them through medical and community-based organizations
1-session motivational interviewing
EXPERIMENTALParticipants will receive a single session of motivational interviewing delivered over the telephone
4-session motivational interviewing
EXPERIMENTALParticipants will receive four weekly sessions of motivational interviewing delivered over the telephone.
Interventions
Participants will receive a single session of telephone-delivered motivational interviewing to reduce sexual risk behavior.
Participants will receive four weekly sessions of telephone-delivered motivational interviewing to reduce sexual risk behavior.
Eligibility Criteria
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
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.
PMID: 21809048RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Travis I Lovejoy, Ph.D., M.P.H.
Ohio University College of Osteopathic Medicine
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