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

Unsafe Sex Clinical Trial

— MI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01499706
• Other study ID #: OUCOM-MI-1
• Status: Completed
• Phase: Phase 1
• First received: December 21, 2011
• Last updated: December 22, 2011
• Start date: November 2009
• Est. completion date: October 2010

Study information

• Verified date: December 2011
• Source: Ohio University College of Osteopathic Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Unsafe Sex

Intervention

Behavioral:
• 1-session of telephone-administered motivational interviewing
Participants will receive a single session of telephone-delivered motivational interviewing to reduce sexual risk behavior.
• 4-session telephone-administered motivational interviewing
Participants will receive four weekly sessions of telephone-delivered motivational interviewing to reduce sexual risk behavior.

Locations

Country	Name	City	State
United States	Ohio University College of Osteopathic Medicine	Athens	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio University College of Osteopathic Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

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; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No