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

Not Applicable

• Conditions: HIV Seropositivity
• Interventions: Behavioral: Telephone-Administered Motivational Interviewing Plus Behavioral Skills Training; Behavioral: Telephone-Administered Coping Effectiveness Training

• Registration Number: NCT03004170
• Lead Sponsor: Oregon Health and Science University

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.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-20
• Study First Submitted QC: 2016-12-22
• Study First Posted: 2016-12-28
• Status Verified: 2021-04
• Primary Completion: 2021-04
• Last Update Submitted: 2021-04-08
• Last Update Posted: 2021-04-09
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 343

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tele-Motivational Interviewing Plus Behavioral Skills Training	Telephone-Administered 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.
Tele-Coping Effectiveness Training	Telephone-Administered 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.

Primary Outcome Measures

Name	Time	Method
Change in number of condomless sex acts from baseline to 12-month follow-up	Baseline, 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.

Secondary Outcome Measures

Name	Time	Method
Change in depressive symptom severity from baseline to 12-month follow-up	Baseline, 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.

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States