ClinicalTrials.gg
Status unknownNCT03004170Updated Apr 9, 2021

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

An interventional study of Telephone-Administered Motivational Interviewing Plus Behavioral Skills Training and Telephone-Administered Coping Effectiveness Training in HIV Seropositivity, sponsored by Oregon Health and Science University. Status unknown at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2021-04-09.

Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
343
Allocation
Randomized
Ages
50 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • HIV Seropositivity

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Keywords

  • HIV
  • Motivational Interviewing
  • Telephone
  • Telehealth
  • Risky Sex
  • Unprotected Sex
  • Condoms
  • Older Adults
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In context

HIV Seropositivity

215 studies on the registry are indexed under HIV Seropositivity; 10 are open to participants now.

This study's enrollment of 343 is above the median of 89 across 144 interventional studies indexed under HIV Seropositivity.

Browse HIV Seropositivity studies →

Lead sponsor

Oregon Health and Science University is the lead sponsor of 694 studies on the registry; 133 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 39 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
343 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Telephone-Administered Motivational Interviewing Plus Behavioral Skills Training

  • Active comparator
    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.

    Behavioral: Telephone-Administered Coping Effectiveness Training

Interventions

  • BehavioralTelephone-Administered Motivational Interviewing Plus Behavioral Skills Training
  • BehavioralTelephone-Administered Coping Effectiveness Training
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What researchers measure

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.

    Time frame: Baseline, 12-month follow-up

Secondary outcomes

  1. 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.

    Time frame: Baseline, 12-month follow-up

Other outcomes

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

    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

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Study locations

1 site
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
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References and documents

Publications

  • Fisher JD, Fisher WA. Changing AIDS-risk behavior. Psychol Bull. 1992 May;111(3):455-74. doi: 10.1037/0033-2909.111.3.455. PubMed 1594721 ↗
  • Lazarus RS, Susan Folkman. Stress, appraisal, and coping. New York, NY: Springer; 1984.
  • 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. PubMed 32474130 ↗

Individual participant data

Plan to share: Yes — 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.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03004170
Collaborators
University of Georgia
Responsible party
Travis Lovejoy (Associate Professor of Psychiatry, Oregon Health and Science University) — Principal investigator
First posted
Dec 28, 2016
Start date
Dec 2016
Primary completion
Apr 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Apr 9, 2021

Study contacts

Travis Lovejoy, PhD, MPH
principal investigator · Oregon Health and Science University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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