Telephone-delivered Behavioral Interventions to Reduce Risky Sexual Behavior in HIV-positive Late Middle-age and Older Adults (MI)

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ClinicalTrials.gov Identifier: NCT01499706

Recruitment Status : Completed

First Posted : December 26, 2011

Last Update Posted : December 26, 2011

Sponsor:

Information provided by (Responsible Party):

Travis Lovejoy, Ph.D., M.P.H., Ohio University College of Osteopathic Medicine

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.

Condition or disease	Intervention/treatment	Phase
Unsafe Sex	Behavioral: 1-session of telephone-administered motivational interviewing Behavioral: 4-session telephone-administered motivational interviewing	Phase 1

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	100 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	November 2009
Actual Primary Completion Date :	October 2010
Actual Study Completion Date :	October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Standard of Care Control Participants will receive standard sexual risk reduction services available to them through medical and community-based organizations
Experimental: 1-session motivational interviewing Participants will receive a single session of motivational interviewing delivered over the telephone	Behavioral: 1-session of telephone-administered motivational interviewing Participants will receive a single session of telephone-delivered motivational interviewing to reduce sexual risk behavior.
Experimental: 4-session motivational interviewing Participants will receive four weekly sessions of motivational interviewing delivered over the telephone.	Behavioral: 4-session telephone-administered motivational interviewing Participants will receive four weekly sessions of telephone-delivered motivational interviewing to reduce sexual risk behavior.

Outcome Measures

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 [ Time Frame: 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 [ Time Frame: baseline, 6-month follow-up ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	45 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01499706

Locations


United States, Ohio
Ohio University College of Osteopathic Medicine
Athens, Ohio, United States, 45701

Sponsors and Collaborators

Ohio University College of Osteopathic Medicine

Investigators


Principal Investigator:	Travis I Lovejoy, Ph.D., M.P.H.	Ohio University College of Osteopathic Medicine

More Information

Publications of Results:

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.


Responsible Party:	Travis Lovejoy, Ph.D., M.P.H., Health Psychology Fellow, Ohio University College of Osteopathic Medicine
ClinicalTrials.gov Identifier:	NCT01499706 History of Changes
Other Study ID Numbers:	OUCOM-MI-1
First Posted:	December 26, 2011 Key Record Dates
Last Update Posted:	December 26, 2011
Last Verified:	December 2011

Keywords provided by Travis Lovejoy, Ph.D., M.P.H., Ohio University College of Osteopathic Medicine:


Motivational Interviewing Telephone HIV AIDS Older Adults

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