Selective Exposure in HIV Prevention

January 12, 2018 updated by: Dolores Albarracin, University of Illinois at Urbana-Champaign

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

722

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32211
        • Duval County Health Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Maximal Control
Basic awareness messages with stories of people living with AIDS
Behavioral: Maximal Control
30 min video with stories of people with HIV. Content describes general health and emotional benefits of counseling.
Experimental: Instrumental
Instrumental messages with stories of people living with HIV
Behavioral: Instrumental
Instrumental messages with stories of people living with HIV
Experimental: Empowering
Empowering messages with stories of people living with HIV
Behavioral: Empowering
Empowering messages with stories of people living with HIV
Experimental: Instrumental and Empowering
Instrumental and empowering messages with stories of people living with HIV
Behavioral: Instrumental and Empowering
Mix of Instrumental and empowering messages with stories of people living with HIV
Active Comparator: Minimal Control
Basic awareness messages with stories of people who are not infected with HIV
Behavioral: Minimal Control
Control messages to increase awareness of HIV risk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enrollment
Time Frame: 1 month
return rate for 2 upcoming sessions
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceptions of the counselor
Time Frame: 0-10 minutes
Questionnaire measures of perceptions of the counseling session
0-10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Urbana-Champaign

Collaborators

Duval County Health Department

Investigators

  • Principal Investigator: Dolores Albarracin, PhD, University of Illinois at Urbana-Champaign

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

April 30, 2017

Study Completion (Actual)

April 30, 2017

Study Registration Dates

First Submitted

May 28, 2010

First Submitted That Met QC Criteria

June 28, 2010

First Posted (Estimate)

June 29, 2010

Study Record Updates

Last Update Posted (Actual)

January 17, 2018

Last Update Submitted That Met QC Criteria

January 12, 2018

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • selectiveexposure

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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