HIV SeropositivityNCT03004170
Telephone Counseling to Enhance the Quality and Safety of Romantic and Sexual Relationships in People Living and Aging With HIV
A study testing Telephone-Administered Motivational Interviewing Plus Behavioral Skills Training and Telephone-Administered Coping Effectiveness Training in people with HIV Seropositivity, run by Oregon Health and Science University at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- HIV Seropositivity
- What is being tested?
- Telephone-Administered Motivational Interviewing Plus Behavioral Skills Training and Telephone-Administered Coping Effectiveness Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 343 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Active suicidal ideation as determined by the Patient Health Questionnaire 9-item Depression Module
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
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.
- Conditions
- HIV Seropositivity
- Being tested
- Telephone-Administered Motivational Interviewing Plus Behavioral Skills Training, Telephone-Administered Coping Effectiveness Training
- Keywords
- HIV, Motivational Interviewing, Telephone, Telehealth, Risky Sex, Unprotected Sex, Condoms, Older Adults
- Medical subject headings
- HIV Seropositivity, Unsafe Sex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone-Administered Motivational Interviewing Plus Behavioral Skills TrainingBehavioural
Telephone-Administered Coping Effectiveness TrainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Telephone-Administered Coping Effectiveness Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionApr 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV SeropositivityStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Georgia
- Responsible party
- Principal investigator, Travis Lovejoy, Oregon Health and Science University
- Investigators
- Travis Lovejoy, PhD, MPH, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004170
- Sponsor's protocol ID
- NIA-R01AG053081
- Status last verified
- Apr 2021
- First submitted
- 20 Dec 2016
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- 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.
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 1594721Lazarus 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone Counseling to Enhance the Quality and Safety of Romantic and Sexual Relationships in People Living and Aging With HIV
- ClinicalTrials.gov ID
- NCT03004170
- Acronym / sponsor ID
- NIA-R01AG053081
- Conditions
- HIV Seropositivity
- Keywords
- HIV, Motivational Interviewing, Telephone, Telehealth, Risky Sex, Unprotected Sex, Condoms, Older Adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 343 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- University of Georgia
- Study start
- Dec 2016 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 28 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-Motivational Interviewing Plus Behavioral Skills Training | Experimental | Behavioral: Telephone-Administered Motivational Interviewing Plus Behavioral Skills TrainingThe 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 | Active comparator | Behavioral: Telephone-Administered Coping Effectiveness TrainingThe 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Active suicidal ideation as determined by the Patient Health Questionnaire 9-item Depression Module
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone-Administered Motivational Interviewing Plus Behavioral Skills Training | Behavioural | Tele-Motivational Interviewing Plus Behavioral Skills Training |
| Telephone-Administered Coping Effectiveness Training | Behavioural | Tele-Coping Effectiveness Training |
Primary outcome
Change in number of condomless sex acts from baseline to 12-month follow-up
Time frame: 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.
1 secondary outcome
Change in depressive symptom severity from baseline to 12-month follow-up
Time frame: Baseline, 12-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
- Results publication: PubMed 1594721Fisher JD, Fisher WA. Changing AIDS-risk behavior. Psychol Bull. 1992 May;111(3):455-74. doi: 10.1037/0033-2909.111.3.455.
- Results publicationLazarus RS, Susan Folkman. Stress, appraisal, and coping. New York, NY: Springer; 1984.
- Derived from this study: PubMed 32474130Kahler 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.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Travis Lovejoy, PhD, MPH principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone-Administered Motivational Interviewing Plus Behavioral Skills Training and Telephone-Administered Coping Effectiveness Training in people with HIV Seropositivity, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of condomless sex acts from baseline to 12-month follow-up (time frame: Baseline, 12-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03004170, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2021.