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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03004170
Other study ID # NIA-R01AG053081
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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