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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 ]
2. 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 :

1. 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	45 Years and older (Adult, Senior)
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
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