Telephone Counseling to Enhance the Quality and Safety of Romantic and Sexual Relationships in People Living and Aging With HIV

HIV Seropositivity Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03004170
• Other study ID #: NIA-R01AG053081
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2021

Study information

• Verified date: April 2021
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 343
• Est. completion date: December 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Seropositivity

Intervention

Behavioral:
• Telephone-Administered Motivational Interviewing Plus Behavioral Skills Training

• Telephone-Administered Coping Effectiveness Training

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	University of Georgia

Country where clinical trial is conducted

United States, 

References & Publications (2)

Fisher JD, Fisher WA. Changing AIDS-risk behavior. Psychol Bull. 1992 May;111(3):455-74. Review. — View Citation

Lazarus RS, Susan Folkman. Stress, appraisal, and coping. New York, NY: Springer; 1984.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in knowledge of HIV viral load from baseline to 12-month follow-up	Self-reported knowledge of one's HIV viral load status (i.e., test result and date of most recent viral load test)	Baseline, 12-month follow-up
Primary	Change in number of condomless sex acts from baseline to 12-month follow-up	Self-reported condomless anal and/or vaginal sex acts with HIV-negative or unknown HIV serostatus sex partners based on the Timeline Followback Interview.	Baseline, 12-month follow-up
Secondary	Change in depressive symptom severity from baseline to 12-month follow-up	Self-reported depressive symptom severity using the Patient Health Questionnaire 9-item Depression Module (PHQ-9). This outcome will be assessed among the approximately one-third of participants who report mild levels of depression at study enrollment.	Baseline, 12-month follow-up