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HIV InfectionsPhase 2NCT01152281

Selective Exposure in HIV Prevention

A Phase 2 study testing Instrumental and Empowering, Instrumental and Empowering in people with HIV Infections, run by University of Illinois at Urbana-Champaign at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Unfortunately, people most at risk for HIV are the least likely to enroll and remain in prevention programs. In our past work, we have learned how to increase enrollment in such programs among this group. Read more about this study

Who is it for?
Ages 18 to 35 years
Conditions the study is for
HIV Infections
What is being tested?
Instrumental and Empowering, Instrumental and Empowering
Could I receive a placebo?
No, everyone receives an active treatment
How many people
722 participants
Where
1 siteUnited States
Study dates
May 2010to 30 Apr 2017
Phase
Phase 2
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 18 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Sexually active,
  • Low condom use,
  • Low intention to use condom

Who cannot join

  • Trying to get pregnant
  • HIV positive
  • with contaminant knowledge about the study
  • planning to leave the area

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duval County Health Department

    Jacksonville, Florida, 32211

Other trials in United States

About this study

Official title: Study to Test Meta-intervention to Increase Retention in HIV Prevention Counseling

Unfortunately, people most at risk for HIV are the least likely to enroll and remain in prevention programs. In our past work, we have learned how to increase enrollment in such programs among this group. We have identified and addressed previously ignored gender-specific and client self-validation issues that conventional interventions often leave not only uncontrolled, but often biased against participation. The present work will extend these methods from enrollment to retention.

We intend to recruit a sample of 656 at-risk participants through our collaboration with the Duval County, FL Health Department for our randomized, double-blind trial. Our study will investigate if a meta-intervention video designed for empowering participants as agents of their own change can increase the number of attended sessions relative to a control condition without such a video. This trial will also determine if a meta-intervention video addressing various emotional/social and instrumental benefits of an HIV-prevention-counseling intervention can also increase the number of attended sessions. These two factors will be crossed, and their effects on retention will be estimated for different genders and ethnicities. Effects on clients' attention to the return sessions as reported by the counselor will also be explored among participants who return.

We will also conduct mediator analyses for investigating if the meta-intervention has mediating influences on corresponding expectations about the return counseling session. As the inclusion of meta-cognitive measures can alter the efficacy of the intervention, half of the sample will receive measures immediately (0-10 minutes) after exposure to the meta-intervention, before attendance to the next session is registered. The other half will not complete these measures.

Read the detailed description
  1. After the Informed Consent is signed, the research assistant supervises administration of the baseline questionnaire via ACASI. In ACASI, the questions are seen on the computer screen and heard through earphones simultaneously. This technique has been shown to enhance the accuracy of any reported non-normative behavior by the relative privacy and anonymity it affords. It is expected to take about 30 minutes.
  2. Participants are seen for one-on-one HIV counseling for approximately 20 minutes by counselors briefed to the study according to the protocol described in the attached document "Scripts Florida Study.doc" (hereinafter "the Scripts document").
  3. After the counseling session, participants will watch a 20-minute video delivering one of the experimental or control meta-intervention messages, which are more fully described in the Scripts document.
  4. The self-reporting of expectations and intentions that we need to elicit at this point may have a confounding effect on the retention that the study hopes to measure. Therefore, half of the participants will skip the next step and half will complete it, to allow us to assess the actual effect of this self-report measure on retention while studying if these measures mediate retention.
  5. The half of the participants reporting expectations will report their expectations and intentions for further counseling, via a 10-minute ACASI questionnaire. The questionnaire is designed to distinguish the dimensions of social/emotional, instrumental and empowering expectations.
  6. At the end of the first 70-80 minute session, the counselor schedules the follow-up appointments.
  7. Customary phone reminders are issued two days before each 20-minute follow-up session, as is routine for medical and counseling appointments.
  8. The study counselor does the following at each follow-up session:
  • Records the participant's attendance or absence on the Counselor's Questionnaire.
  • For attending participants, the study counselor rates their attention to the counseling on the Counselor's Questionnaire.
  • The RA in charge of video presentation rates attention to the videos.
  • At the end of the second session, the study counselor double-checks the third appointment with the participant, and reschedules if necessary.
  1. A detailed description of the two follow-up sessions is found in the attached document titled "Counselor Guidelines (2nd and 3rd sessions). The questions and statements therein will be delivered and answered verbally.
  2. At the end of the third session, participants who did not answer the questionnaire in Step 5 will answer a similar questionnaire about their reactions to the meta-intervention video.
  3. All participants will be fully debriefed. Non-attendees will be called and debriefed either by phone or in person based on their preferences.
Conditions
HIV Infections
Being tested
Maximal Control, Instrumental and Empowering, Minimal Control, Instrumental, Empowering
Keywords
retention, attrition, empowering, reactance, motivational, goals, Basic control, Control with stories of people with AIDS, Instrumental, Instrumental and Empowering
Medical subject headings
HIV Infections, Tooth Wear

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Maximal ControlBehavioural

    30 min video with stories of people with HIV. Content describes general health and emotional benefits of counseling.

  • Instrumental and EmpoweringBehavioural

    Mix of Instrumental and empowering messages with stories of people living with HIV

  • Minimal ControlBehavioural

    Control messages to increase awareness of HIV risk

  • InstrumentalBehavioural

    Instrumental messages with stories of people living with HIV

  • EmpoweringBehavioural

    Empowering messages with stories of people living with HIV

Study groups in NCT01152281
Study groupRoleWhat they receive
Maximal ControlActive comparatorBasic awareness messages with stories of people living with AIDS
Receives: Behavioral: Maximal Control
InstrumentalExperimentalInstrumental messages with stories of people living with HIV
Receives: Behavioral: Instrumental
EmpoweringExperimentalEmpowering messages with stories of people living with HIV
Receives: Behavioral: Empowering
Instrumental and EmpoweringExperimentalInstrumental and empowering messages with stories of people living with HIV
Receives: Behavioral: Instrumental and Empowering
Minimal ControlActive comparatorBasic awareness messages with stories of people who are not infected with HIV
Receives: Behavioral: Minimal Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Enrollment

    return rate for 2 upcoming sessions

    Measured: 1 month

Secondary outcomes (1)

  1. Perceptions of the counselor

    Questionnaire measures of perceptions of the counseling session

    Measured: 0-10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2010 (estimated)
  2. Study startMay 2010
  3. Primary completion30 Apr 2017
  4. Study completion30 Apr 2017

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
722 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01152281
Sponsor's protocol ID
selectiveexposure
Status last verified
Jun 2010
First submitted
28 May 2010
Last updated
17 Jan 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Albarracin D, Wilson K, Durantini MR, Sunderrajan A, Livingood W. A meta-intervention to increase completion of an HIV-prevention intervention: Results from a randomized controlled trial in the state of Florida. J Consult Clin Psychol. 2016 Dec;84(12):1052-1065. doi: 10.1037/ccp0000139. Epub 2016 Oct 27.

    PubMed 27786499

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Instrumental and Empowering, Instrumental and Empowering in people with HIV Infections, run by University of Illinois at Urbana-Champaign 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 17 Jan 2018. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Enrollment (time frame: 1 month). 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 NCT01152281, which also lists 1 linked publication.

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 17 Jan 2018.

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Selective Exposure in HIV Prevention (NCT01152281) | AzTrials