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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Travis Lovejoy, Ph.D., M.P.H., Ohio University College of Osteopathic Medicine
ClinicalTrials.gov Identifier:
NCT01499706
First received: December 21, 2011
Last updated: December 22, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
Unsafe Sex
Behavioral: 1-session of telephone-administered motivational interviewing
Behavioral: 4-session telephone-administered motivational interviewing
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ohio University College of Osteopathic Medicine:

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: November 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
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
Study First Received: December 21, 2011
Last Updated: December 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio University College of Osteopathic Medicine:
Motivational Interviewing
Telephone
HIV
AIDS
Older Adults

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on September 16, 2014