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

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Primary Purpose

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Telephone-Administered Motivational Interviewing Plus Behavioral Skills Training

Telephone-Administered Coping Effectiveness Training

About this trial

This is an interventional treatment trial for HIV Seropositivity focused on measuring HIV, Motivational Interviewing, Telephone, Telehealth, Risky Sex, Unprotected Sex, Condoms, Older Adults

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Oregon Health & Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tele-Motivational Interviewing Plus Behavioral Skills Training

Tele-Coping Effectiveness Training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03004170

First Posted

December 20, 2016

Last Updated

April 8, 2021

Sponsor

Oregon Health and Science University

Collaborators

University of Georgia

1. Study Identification

Unique Protocol Identification Number

NCT03004170

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

December 2016 (Actual)

Primary Completion Date

April 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oregon Health and Science University

Collaborators

University of Georgia

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Seropositivity

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

Outcome Assessor is blind to participant condition.

Allocation

Randomized

Enrollment

343 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tele-Motivational Interviewing Plus Behavioral Skills Training

Arm Type

Experimental

Arm Description

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.

Arm Title

Tele-Coping Effectiveness Training

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Telephone-Administered Motivational Interviewing Plus Behavioral Skills Training

Intervention Type

Behavioral

Intervention Name(s)

Telephone-Administered Coping Effectiveness Training

Primary Outcome Measure Information:

Title

Change in number of condomless sex acts from baseline to 12-month follow-up

Description

Self-reported condomless anal and/or vaginal sex acts with HIV-negative or unknown HIV serostatus sex partners based on the Timeline Followback Interview.

Time Frame

Baseline, 12-month follow-up

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Baseline, 12-month follow-up

Other Pre-specified Outcome Measures:

Title

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

Description

Self-reported knowledge of one's HIV viral load status (i.e., test result and date of most recent viral load test)

Time Frame

Baseline, 12-month follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Travis Lovejoy, PhD, MPH

Organizational Affiliation

Oregon Health and Science University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oregon Health & Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Raw de-identified data will be made publicly available to the scientific community upon request after the trial is complete and data have been published. Data requests should be directed to the study principal investigator.

Citations:

PubMed Identifier

1594721

Citation

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

Results Reference

result

Citation

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

Results Reference

result

PubMed Identifier

32474130

Citation

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.

Results Reference

derived

HIV Seropositivity

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial