Selective Exposure in HIV Prevention
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

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. 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.
    

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.
    

Intervention name(s): Maximal Control; Instrumental and Empowering; Minimal Control; Instrumental; Empowering
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): 30 min video with stories of people with HIV. Content describes general health and emotional benefits of counseling.; Mix of Instrumental and empowering messages with stories of people living with HIV; Control messages to increase awareness of HIV risk; Instrumental messages with stories of people living with HIV; Empowering messages with stories of people living with HIV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: retention; attrition; empowering; reactance; motivational; goals; Basic control; Control with stories of people with AIDS; Instrumental; Instrumental and Empowering