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

NCT ID: NCT03004170

Last Updated: 2021-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

343 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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HIV Seropositivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Outcome Assessor is blind to participant condition.

Study Groups

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Tele-Motivational Interviewing Plus Behavioral Skills Training

The Telephone-Administered Motivational Interviewing Plus Behavioral Skills Training (teleMI+BST) intervention comprises 5 sessions lasting approximately 45-50 minutes each. Sessions occur in weeks 3, 4, 8, and 12 post-enrollment, with a follow-up booster session in week 24. The Information-Motivation-Behavioral Skills (IMB) Model (Fisher \& Fisher, 1992) provides the theoretical framework for behavior change mechanisms of teleMI+BST. The IMB posits that knowledge about condom use practices, condom use motivation, and acquisition and application of requisite condom use skills lead to engagement in condom-protected sex. The focus of this intervention is to help participants process ambivalence about engaging in condomless sex acts that risk HIV transmission.

Group Type EXPERIMENTAL

Telephone-Administered Motivational Interviewing Plus Behavioral Skills Training

Intervention Type BEHAVIORAL

Tele-Coping Effectiveness Training

The Telephone-Administered Coping Effectiveness Training (teleCET) intervention is the attention-equivalent comparator and also comprises 5 sessions lasting approximately 45-50 minutes each. The teleCET intervention is based on the Lazarus and Folkman Transactional Model of Stress and Coping (Lazarus \& Folkman, 1984) and uses cognitive-behavioral principles to: (a) appraise stressor severity, (b) develop problem- and emotion-focused coping skills, (c) determine the match between coping strategies and stressor controllability, and (d) optimize coping through use of social support resources.

Group Type ACTIVE_COMPARATOR

Telephone-Administered Coping Effectiveness Training

Intervention Type BEHAVIORAL

Interventions

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Telephone-Administered Motivational Interviewing Plus Behavioral Skills Training

Intervention Type BEHAVIORAL

Telephone-Administered Coping Effectiveness Training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Georgia

OTHER

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Travis Lovejoy

Associate Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Travis Lovejoy, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

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United States

References

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Fisher JD, Fisher WA. Changing AIDS-risk behavior. Psychol Bull. 1992 May;111(3):455-74. doi: 10.1037/0033-2909.111.3.455.

Reference Type RESULT
PMID: 1594721 (View on PubMed)

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

Reference Type RESULT

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.

Reference Type DERIVED
PMID: 32474130 (View on PubMed)

Other Identifiers

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NIA-R01AG053081

Identifier Type: -

Identifier Source: org_study_id

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