Selective Exposure in HIV Prevention

This study is currently recruiting participants.
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

May 28, 2010
June 28, 2010
May 2010
April 2017   (final data collection date for primary outcome measure)
Enrollment [ Time Frame: 1 month ] [ Designated as safety issue: No ]
return rate for 2 upcoming sessions
Same as current
Complete list of historical versions of study NCT01152281 on ClinicalTrials.gov Archive Site
Perceptions of the counselor [ Time Frame: 0-10 minutes ] [ Designated as safety issue: No ]
Questionnaire measures of perceptions of the counseling session
Same as current
Not Provided
Not Provided
 
Selective Exposure in HIV Prevention
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.

  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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
HIV Infections
  • 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.
  • Other: Control
    Control messages to increase awareness of HIV risk
  • Active Comparator: Control with stories
    Basic awareness messages with stories of people living with AIDS
    Intervention: Other: Control
  • Experimental: Instrumental
    Instrumental messages with stories of people living with HIV
    Intervention: Other: Instrumental meta intervention
  • Experimental: Empowering
    Empowering messages with stories of people living with HIV
    Intervention: Other: Empowering meta-intervention
  • Experimental: Instrumental and Empowering
    Instrumental and empowering messages with stories of people living with HIV
    Interventions:
    • Other: Instrumental meta intervention
    • Other: Empowering meta-intervention
  • Active Comparator: Basic Control
    Basic awareness messages with stories of people who are not infected with HIV
    Intervention: Other: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
760
April 2017
April 2017   (final data collection date for primary outcome measure)

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
Both
18 Years to 35 Years
No
Contact: Dolores Albarracin, PhD 217 244 7019 dalbarra@illinois.edu
Contact: Marta Durantini, PhD mrdurant@illinois.edu
United States
 
NCT01152281
selectiveexposure
Yes
Dolores Albarracin, Professor, University of Illinois
University of Illinois at Urbana-Champaign
Duval County Health Department
Principal Investigator: Dolores Albarracin, PhD University of Illinois at Urbana-Champaign
University of Illinois at Urbana-Champaign
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP