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

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.

Study Overview

• Status: Completed
• Conditions: Unsafe Sex
• Intervention / Treatment: Behavioral: 1-session of telephone-administered motivational interviewing; Behavioral: 4-session telephone-administered motivational interviewing

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: December 21, 2011
• First Submitted That Met QC Criteria: December 22, 2011
• First Posted (Estimate): December 26, 2011

Study Record Updates

• Last Update Posted (Estimate): December 26, 2011
• Last Update Submitted That Met QC Criteria: December 22, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Motivational Interviewing; HIV; Older Adults; AIDS; Telephone
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; HIV Seropositivity
• Other Study ID Numbers: OUCOM-MI-1