Clinical trial NCT03004170: Telephone Counseling to Enhance the Quality and Safety of Romantic and Sexual Relationships in People Living and Aging With HIV
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV Seropositivity
Keywords: HIV
Motivational Interviewing
Telephone
Telehealth
Risky Sex
Unprotected Sex
Condoms
Older Adults
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: University of Georgia
First posted: 2016-12-28
Enrollment: 343
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if a brief behavioral intervention delivered over the telephone is effective at reducing occasions of condomless sex in persons living and aging with HIV.

Detailed description: Estimated rates of condomless anal and vaginal intercourse among HIV-positive older adults remain high. Brief motivational interventions delivered face-to-face have demonstrated efficacy at reducing condomless sex in HIV-positive persons. However, these interventions are not contextualized to the unique sexual health needs of HIV-positive older adults. Further, many HIV-positive older adults have difficulty accessing face-to-face services due to transportation, stigma, and other barriers. Telehealth interventions represent one delivery approach that overcomes such barriers.

Eligibility criteria: Inclusion Criteria:

* English speaking
* Have access to a landline or cellular telephone
* Be 50 years of age or older at some point during study participation
* Report engaging in one or more occasions of condomless anal and/or vaginal intercourse with an HIV-negative or unknown HIV serostatus sex partner in the 3 months prior to study enrollment. An exception to this criterion is participants whose HIV viral load is undetectable and whose only condomless sex is in the context of a monogamous sexual relationship with an HIV-negative partner.

Exclusion Criteria:

* Active suicidal ideation as determined by the Patient Health Questionnaire 9-item Depression Module

Primary outcomes:
measure: Change in number of condomless sex acts from baseline to 12-month follow-up
timeFrame: Baseline, 12-month follow-up
Secondary outcomes:
measure: Change in depressive symptom severity from baseline to 12-month follow-up
timeFrame: Baseline, 12-month follow-up
Other outcomes:
measure: Change in knowledge of HIV viral load from baseline to 12-month follow-up
timeFrame: Baseline, 12-month follow-up
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Travis Lovejoy, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fisher JD, Fisher WA. Changing AIDS-risk behavior. Psychol Bull. 1992 May;111(3):455-74. doi: 10.1037/0033-2909.111.3.455.
citation: Lazarus RS, Susan Folkman. Stress, appraisal, and coping. New York, NY: Springer; 1984.
citation: Kahler J, Heckman TG, Shen Y, Huckans MS, Feldstein Ewing SW, Parsons JT, Phelps A, Sutton M, Holloway J, Lovejoy TI. Randomized controlled trial protocol for project BRIDGE: A telephone-administered motivational interviewing intervention targeting risky sexual behavior in older people living with HIV. Contemp Clin Trials. 2020 Aug;95:106047. doi: 10.1016/j.cct.2020.106047. Epub 2020 May 28.