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

NCT03004170 | Unknown DMC

• 1 other identifier: NIA-R01AG053081
• Study Type: interventional
• Target: 343
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Seropositivity

Keywords

HIV; Motivational Interviewing; Telephone; Telehealth; Risky Sex; Unprotected Sex; Condoms; Older Adults

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in depressive symptom severity from baseline to 12-month follow-up

  Baseline, 12-month follow-up

Other Outcomes (1)

• Change in knowledge of HIV viral load from baseline to 12-month follow-up

  Baseline, 12-month follow-up

Study Arms (2)

Tele-Motivational Interviewing Plus Behavioral Skills Training

EXPERIMENTAL

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.

Behavioral: Telephone-Administered Motivational Interviewing Plus Behavioral Skills Training

Tele-Coping Effectiveness Training

ACTIVE COMPARATOR

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.

Behavioral: Telephone-Administered Coping Effectiveness Training

Interventions

Telephone-Administered Motivational Interviewing Plus Behavioral Skills Training BEHAVIORAL

Tele-Motivational Interviewing Plus Behavioral Skills Training

Telephone-Administered Coping Effectiveness Training BEHAVIORAL

Tele-Coping Effectiveness Training

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• University of Georgia: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (3)

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

  PMID: 1594721 RESULT

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

  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.

  PMID: 32474130 DERIVED

MeSH Terms

Conditions

HIV Seropositivity; Unsafe Sex

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Sexual Behavior; Behavior

Study Officials

• Travis Lovejoy, PhD, MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome Assessor is blind to participant condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: December 28, 2016
• Study Start: December 1, 2016
• Primary Completion: April 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 9, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)