NCT00601237

Brief Summary

This study will develop and test the effectiveness of a cell phone-based text messaging program to encourage abstinence, monogamy, or condom use among black urban males in Philadelphia, Pennsylvania.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P25-P50 for not_applicable hiv-infections

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

April 3, 2015

Status Verified

April 1, 2015

Enrollment Period

4.6 years

First QC Date

January 23, 2008

Last Update Submit

April 1, 2015

Conditions

Keywords

HIV PreventionMobile PhoneTechnology-Based InterventionHIVHIV Seronegativity

Outcome Measures

Primary Outcomes (3)

  • Condom use

    Measured at baseline and Months 3 and 6

  • Abstinence

    Measured at baseline and Months 3 and 6

  • Monogamy

    Measured at baseline and Months 3 and 6

Secondary Outcomes (1)

  • Attitudes, norms, self-efficacy, and intentions to remain abstinent, remain monogamous, or use condoms

    Measured at baseline and Months 3 and 6

Study Arms (3)

A

EXPERIMENTAL

Participants will receive HIV-related text messages

Behavioral: HIV-related text messaging

B

ACTIVE COMPARATOR

Participants will receive nutrition-related text messages

Behavioral: Nutrition-related text messaging

C

NO INTERVENTION

Participants will attend a 90-minute focus group to develop messages for the cell-phone program

Interventions

Participants will receive up to 90 text messages related to abstinence, monogamy, and condom use over 3 months.

A

Participants will receive up to 30 text messages about nutrition and healthy eating over 3 months.

B

Eligibility Criteria

Age16 Years - 20 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Resident of Philadelphia
  • Self-identified black or African American
  • English-speaking
  • Cell phone user

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Motivational Educational Entertainment (MEE) Productions

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

  • Sheana Bull, PhD

    University of Colorado at Denver and Health Sciences

    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

January 23, 2008

First Posted

January 28, 2008

Study Start

October 1, 2008

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

April 3, 2015

Record last verified: 2015-04

Locations