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

December 21, 2011
December 22, 2011
November 2009
October 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01499706 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Telephone-delivered Behavioral Interventions to Reduce Risky Sexual Behavior in HIV-positive Late Middle-age and Older Adults
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Unsafe Sex
  • Behavioral: 1-session of telephone-administered motivational interviewing
    Participants will receive a single session of telephone-delivered motivational interviewing to reduce sexual risk behavior.
  • Behavioral: 4-session telephone-administered motivational interviewing
    Participants will receive four weekly sessions of telephone-delivered motivational interviewing to reduce sexual risk behavior.
  • 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
    Intervention: Behavioral: 1-session of telephone-administered motivational interviewing
  • Experimental: 4-session motivational interviewing
    Participants will receive four weekly sessions of motivational interviewing delivered over the telephone.
    Intervention: Behavioral: 4-session telephone-administered motivational interviewing
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
October 2010
October 2010   (final data collection date for primary outcome measure)

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
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01499706
OUCOM-MI-1
Yes
Travis Lovejoy, Ph.D., M.P.H., Ohio University College of Osteopathic Medicine
Ohio University College of Osteopathic Medicine
Not Provided
Principal Investigator: Travis I Lovejoy, Ph.D., M.P.H. Ohio University College of Osteopathic Medicine
Ohio University College of Osteopathic Medicine
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP