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

Study Overview
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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

Intervention / Treatment
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* Behavioral: Telephone-Administered Motivational Interviewing Plus Behavioral Skills Training
* Behavioral: Telephone-Administered Coping Effectiveness Training


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tele-Motivational Interviewing Plus Behavioral Skills Training<br>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<br> <br> |
| Active Comparator: Tele-Coping Effectiveness Training<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Motivational Interviewing, Telephone, Telehealth, Risky Sex, Unprotected Sex, Condoms, Older Adults