NCT01152281

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
722

participants targeted

Target at P75+ for phase_2 hiv-infections

Timeline
Completed

Started May 2010

Longer than P75 for phase_2 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 29, 2010

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
Last Updated

January 17, 2018

Status Verified

June 1, 2010

Enrollment Period

7 years

First QC Date

May 28, 2010

Last Update Submit

January 12, 2018

Conditions

Keywords

retentionattritionempoweringreactancemotivationalgoalsBasic controlControl with stories of people with AIDSInstrumentalInstrumental and Empowering

Outcome Measures

Primary Outcomes (1)

  • Enrollment

    return rate for 2 upcoming sessions

    1 month

Secondary Outcomes (1)

  • Perceptions of the counselor

    0-10 minutes

Study Arms (5)

Maximal Control

ACTIVE COMPARATOR

Basic awareness messages with stories of people living with AIDS

Behavioral: Maximal Control

Instrumental

EXPERIMENTAL

Instrumental messages with stories of people living with HIV

Behavioral: Instrumental

Empowering

EXPERIMENTAL

Empowering messages with stories of people living with HIV

Behavioral: Empowering

Instrumental and Empowering

EXPERIMENTAL

Instrumental and empowering messages with stories of people living with HIV

Behavioral: Instrumental and Empowering

Minimal Control

ACTIVE COMPARATOR

Basic awareness messages with stories of people who are not infected with HIV

Behavioral: Minimal Control

Interventions

Maximal ControlBEHAVIORAL

30 min video with stories of people with HIV. Content describes general health and emotional benefits of counseling.

Maximal Control

Mix of Instrumental and empowering messages with stories of people living with HIV

Instrumental and Empowering
Minimal ControlBEHAVIORAL

Control messages to increase awareness of HIV risk

Minimal Control
InstrumentalBEHAVIORAL

Instrumental messages with stories of people living with HIV

Instrumental
EmpoweringBEHAVIORAL

Empowering messages with stories of people living with HIV

Empowering

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Trying to get pregnant
  • HIV positive
  • with contaminant knowledge about the study
  • planning to leave the area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duval County Health Department

Jacksonville, Florida, 32211, United States

Location

Related Publications (1)

  • Albarracin 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. doi: 10.1037/ccp0000139. Epub 2016 Oct 27.

    PMID: 27786499BACKGROUND

MeSH Terms

Conditions

HIV InfectionsTooth Wear

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesTooth DiseasesStomatognathic Diseases

Study Officials

  • Dolores Albarracin, PhD

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 28, 2010

First Posted

June 29, 2010

Study Start

May 1, 2010

Primary Completion

April 30, 2017

Study Completion

April 30, 2017

Last Updated

January 17, 2018

Record last verified: 2010-06

Locations