NCT03433053

Brief Summary

The goals of this study are to:

  1. 1.Develop a HIV test message tailored for African American women. A generic non-tailored message will be developed as well for comparison. A third group will be included that will not be exposed to any message at all.
  2. 2.Test the effectiveness of both messages on reported future intentions to get tested for HIV and HIV test behavior at 3 month follow up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
141

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 14, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

October 24, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2019

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

8 months

First QC Date

February 7, 2018

Last Update Submit

July 3, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • HIV Test Intentions

    Difference in future HIV test intentions between the tailored message group and the control group as measured by a follow up questionnaire, with higher scores indicating greater intention to be tested for HIV

    Three month follow up

Study Arms (2)

Control

PLACEBO COMPARATOR

Participants will be exposed to a generic HIV testing message.

Behavioral: Control

Experiment

EXPERIMENTAL

Participants will be exposed to a targeted HIV testing message, developed specifically for African American women.

Behavioral: HIV Testing Message Intervention

Interventions

The Health Belief Model will be utilized as the primary theoretical framework in guiding the development of a tailored HIV testing message for young African American women in this intervention. Two conditions will be developed and compared as outlined below. Condition 1 participants will be exposed to an HIV testing message inclusive of culturally tailored information that addresses both culturally specific barriers and facilitators of HIV testing (as identified in Study 1). The message will be brief (will take less than 3 minutes to present/read).

Experiment
ControlBEHAVIORAL

Condition 2 (generic message) participants will be exposed to a simple HIV educational message only, consisting of HIV statistics for women in the United States, information on how HIV is transmitted, where to get tested, and the benefits of HIV testing. The statistics on HIV and where to get tested will be taken directly from the CDC's website. The message will be brief (will take less than 3 minutes to present/read).

Control

Eligibility Criteria

Age18 Years - 24 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Self-identified Black or African American women

You may not qualify if:

  • Women who have never had sex, are married, or are pregnant/attempting to become pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Faye Belgrave, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2018

First Posted

February 14, 2018

Study Start

October 24, 2018

Primary Completion

June 24, 2019

Study Completion

June 24, 2019

Last Updated

July 5, 2019

Record last verified: 2019-07

Locations