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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03004170
Enrollment
343
Registered
2016-12-28
Start date
2016-12-31
Completion date
2021-12-31
Last updated
2021-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Seropositivity

Keywords

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

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.

Interventions

BEHAVIORALTelephone-Administered Motivational Interviewing Plus Behavioral Skills Training
BEHAVIORALTelephone-Administered Coping Effectiveness Training

Sponsors

University of Georgia
CollaboratorOTHER
Oregon Health and Science University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcome Assessor is blind to participant condition.

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in number of condomless sex acts from baseline to 12-month follow-upBaseline, 12-month follow-upSelf-reported condomless anal and/or vaginal sex acts with HIV-negative or unknown HIV serostatus sex partners based on the Timeline Followback Interview.

Secondary

MeasureTime frameDescription
Change in depressive symptom severity from baseline to 12-month follow-upBaseline, 12-month follow-upSelf-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.

Other

MeasureTime frameDescription
Change in knowledge of HIV viral load from baseline to 12-month follow-upBaseline, 12-month follow-upSelf-reported knowledge of one's HIV viral load status (i.e., test result and date of most recent viral load test)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026