Selective Exposure in HIV Prevention

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01152281
• Other study ID #: selectiveexposure
• Status: Completed
• Phase: Phase 2
• First received: May 28, 2010
• Last updated: January 12, 2018
• Start date: May 2010
• Est. completion date: April 30, 2017

Study information

• Verified date: June 2010
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 722
• Est. completion date: April 30, 2017
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• Maximal Control
30 min video with stories of people with HIV. Content describes general health and emotional benefits of counseling.
• Instrumental and Empowering
Mix of Instrumental and empowering messages with stories of people living with HIV
• Minimal Control
Control messages to increase awareness of HIV risk
• Instrumental
Instrumental messages with stories of people living with HIV
• Empowering
Empowering messages with stories of people living with HIV

Locations

Country	Name	City	State
United States	Duval County Health Department	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign	Duval County Health Department

Country where clinical trial is conducted

United States, 

References & Publications (1)

Albarracín 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. Epub 2016 Oct 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment	return rate for 2 upcoming sessions	1 month
Secondary	Perceptions of the counselor	Questionnaire measures of perceptions of the counseling session	0-10 minutes