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Selective Exposure in HIV Prevention

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2010 by University of Illinois at Urbana-Champaign
Sponsor:
Collaborator:
Duval County Health Department
Information provided by:
University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier:
NCT01152281
First received: May 28, 2010
Last updated: June 28, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
HIV Infections
Other: Instrumental meta intervention
Other: Empowering meta-intervention
Other: Control
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: Study to Test Meta-intervention to Increase Retention in HIV Prevention Counseling

Resource links provided by NLM:


Further study details as provided by University of Illinois at Urbana-Champaign:

Primary Outcome Measures:
  • Enrollment [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    return rate for 2 upcoming sessions


Secondary Outcome Measures:
  • Perceptions of the counselor [ Time Frame: 0-10 minutes ] [ Designated as safety issue: No ]
    Questionnaire measures of perceptions of the counseling session


Estimated Enrollment: 760
Study Start Date: May 2010
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control with stories
Basic awareness messages with stories of people living with AIDS
Other: Control
Control messages to increase awareness of HIV risk
Experimental: Instrumental
Instrumental messages with stories of people living with HIV
Other: Instrumental meta intervention
30 min video with stories of people with HIV. Content describes general health and emotional benefits of counseling.
Experimental: Empowering
Empowering messages with stories of people living with HIV
Other: Empowering meta-intervention
Empowering 30 min video with stories of people living with AIDS. Emphasizes individual control over behavior change.
Experimental: Instrumental and Empowering
Instrumental and empowering messages with stories of people living with HIV
Other: Instrumental meta intervention
30 min video with stories of people with HIV. Content describes general health and emotional benefits of counseling.
Other: Empowering meta-intervention
Empowering 30 min video with stories of people living with AIDS. Emphasizes individual control over behavior change.
Active Comparator: Basic Control
Basic awareness messages with stories of people who are not infected with HIV
Other: Control
Control messages to increase awareness of HIV risk

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.
  9. 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.
  10. 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.
  11. All participants will be fully debriefed. Non-attendees will be called and debriefed either by phone or in person based on their preferences.
  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Trying to get pregnant
  • HIV positive
  • with contaminant knowledge about the study
  • planning to leave the area
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01152281

Contacts
Contact: Dolores Albarracin, PhD 217 244 7019 dalbarra@illinois.edu
Contact: Marta Durantini, PhD mrdurant@illinois.edu

Locations
United States, Florida
Duval County Health Department Recruiting
Jacksonville, Florida, United States, 32211
Principal Investigator: William Livingood, PhD         
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
Duval County Health Department
Investigators
Principal Investigator: Dolores Albarracin, PhD University of Illinois at Urbana-Champaign
  More Information

No publications provided

Responsible Party: Dolores Albarracin, Professor, University of Illinois
ClinicalTrials.gov Identifier: NCT01152281     History of Changes
Other Study ID Numbers: selectiveexposure
Study First Received: May 28, 2010
Last Updated: June 28, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Illinois at Urbana-Champaign:
retention
attrition
empowering
reactance
motivational
goals
Basic control
Control with stories of people with AIDS
Instrumental
Empowering
Instrumental and Empowering

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 24, 2014