Telephone-delivered Behavioral Interventions to Reduce Risky Sexual Behavior in HIV-positive Late Middle-age and Older Adults (MI)
Primary Purpose
Unsafe Sex
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
1-session of telephone-administered motivational interviewing
4-session telephone-administered motivational interviewing
Sponsored by
About this trial
This is an interventional treatment trial for Unsafe Sex focused on measuring Motivational Interviewing, Telephone, HIV, AIDS, Older Adults
Eligibility Criteria
Inclusion Criteria:
- HIV-positive
- English-speaking
- Access to a land line or cellular telephone
- Unprotected anal or vaginal intercourse in the past 3 months
Exclusion Criteria:
- Sexual partner of study participant
Sites / Locations
- Ohio University College of Osteopathic Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Standard of Care Control
1-session motivational interviewing
4-session motivational interviewing
Arm Description
Participants will receive standard sexual risk reduction services available to them through medical and community-based organizations
Participants will receive a single session of motivational interviewing delivered over the telephone
Participants will receive four weekly sessions of motivational interviewing delivered over the telephone.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Proportion of participants reporting 100% condom use for anal and vaginal sex in the past 3 months
Full Information
NCT ID
NCT01499706
First Posted
December 21, 2011
Last Updated
December 22, 2011
Sponsor
Ohio University College of Osteopathic Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01499706
Brief Title
Telephone-delivered Behavioral Interventions to Reduce Risky Sexual Behavior in HIV-positive Late Middle-age and Older Adults
Acronym
MI
Official Title
Phase I Clinical Trial of Telephone-delivered Motivational Interviewing to Reduce Sexual Risk Behavior in HIV-positive Persons 45-plus Years of Age
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio University College of Osteopathic Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
The number of late middle-age and older adults living with HIV/AIDS in the U.S. continues to rise. In fact, it is estimated that by 2014, 50% of all HIV-positive persons will be 50 years of age or older, due largely to a) better clinical care and the improved efficacy of highly active antiretroviral therapy that has extended the lives of many HIV-positive persons and b) an increase in the number of new HIV infections in older persons. Despite escalating HIV incidence and prevalence rates in older adults, and the fact that an estimated 13% to 30% of older persons living with HIV/AIDS continue to engage in risky sexual practices, few secondary risk reduction interventions have been contextualized to meet the unique needs of sexually active HIV-infected older adults. These unique needs include biological and libidinal changes associated with aging such as erectile dysfunction and the increased use of erectile dysfunction medications in older men, sexual partnerships with younger persons, survivor guilt over outliving romantic partners, and the impact of co-morbid chronic illnesses (e.g., diabetes, osteoporosis, cancer, hepatitis C) and associated medication and/or treatment side effects on perceptions of physical attractiveness.
Many HIV-positive older adults who would benefit from face-to-face sexual risk reduction interventions live with serious comorbid health conditions that complicate travel to medical and social service appointments, have significant confidentiality concerns, and are geographically isolated from traditional risk reduction resources. As such, face-to-face interventions are an unrealistic intervention modality for many members of this group. However, risk reduction interventions delivered using distance technologies, such as regular and cellular telephones, can reach many older adults living with HIV/AIDS.
In response to the lack of age-appropriate risk reduction interventions for HIV-infected older adults who engage in high-risk sex, and the potential of telephone technology to deliver cost-effective risk reduction interventions to this group, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unsafe Sex
Keywords
Motivational Interviewing, Telephone, HIV, AIDS, Older Adults
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care Control
Arm Type
No Intervention
Arm Description
Participants will receive standard sexual risk reduction services available to them through medical and community-based organizations
Arm Title
1-session motivational interviewing
Arm Type
Experimental
Arm Description
Participants will receive a single session of motivational interviewing delivered over the telephone
Arm Title
4-session motivational interviewing
Arm Type
Experimental
Arm Description
Participants will receive four weekly sessions of motivational interviewing delivered over the telephone.
Intervention Type
Behavioral
Intervention Name(s)
1-session of telephone-administered motivational interviewing
Intervention Description
Participants will receive a single session of telephone-delivered motivational interviewing to reduce sexual risk behavior.
Intervention Type
Behavioral
Intervention Name(s)
4-session telephone-administered motivational interviewing
Intervention Description
Participants will receive four weekly sessions of telephone-delivered motivational interviewing to reduce sexual risk behavior.
Primary Outcome Measure Information:
Title
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
Time Frame
baseline, 3-month follow-up
Title
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
Time Frame
baseline, 6-month follow-up
Secondary Outcome Measure Information:
Title
Proportion of participants reporting 100% condom use for anal and vaginal sex in the past 3 months
Time Frame
3-month follow-up, 6-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HIV-positive
English-speaking
Access to a land line or cellular telephone
Unprotected anal or vaginal intercourse in the past 3 months
Exclusion Criteria:
Sexual partner of study participant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Travis I Lovejoy, Ph.D., M.P.H.
Organizational Affiliation
Ohio University College of Osteopathic Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio University College of Osteopathic Medicine
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21809048
Citation
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.
Results Reference
result
Learn more about this trial
Telephone-delivered Behavioral Interventions to Reduce Risky Sexual Behavior in HIV-positive Late Middle-age and Older Adults
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