Effectiveness of a Cell Phone-Based Program for Abstinence and HIV Risk Prevention

April 1, 2015 updated by: University of Colorado, Denver

Text Messaging for Abstinence and HIV Risk Prevention: The 411 on Safe Text

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sexually transmitted diseases (STDs), including HIV infections, are most commonly spread through unprotected sexual intercourse. STDs are a primary health issue, especially among young ethnic minorities in the United States. The rate of STDs is significantly greater in urban areas where ethnic minorities, particularly African-American males, are commonly represented. Despite this information, safe sexual practices, including correct condom use, are not commonly followed among minority males. It is believed that educational outreach designed to motivate and inform on the correct use of condoms will be effective in encouraging safer sex practices. A cell phone-based text messaging program designed to promote safer sex practices may provide an effective and easy means of delivery of treatment. This study will develop and test the effectiveness of a cell phone-based text messaging program to sustain abstinence, monogamy, or condom use among black urban males in Philadelphia, Pennsylvania.

Participation in this study will be divided into two phases. In the first study phase, participants will partake in a 90-minute focus group to help develop text message content and plans for treatment delivery. The next study phase will be a pilot test of the program developed in the first phase. Participants will be assigned to receive text messages concerning either HIV prevention or general nutrition. Participants receiving the HIV prevention text messages will be sent up to 90 text messages related to abstinence, monogamy, and condom use over a 3-month period. Participants will also be able to join interactive phone activities related to HIV. Participants receiving the nutritional text messages will be sent up to 30 messages about nutrition and healthy eating over the same period of time. Participants will complete telephone surveys at baseline and Months 3 and 6. The surveys will assess measures of abstinence, monogamy and condom use attitudes, norms, self-efficacy, and risk behaviors.

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Motivational Educational Entertainment (MEE) Productions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Participants will receive HIV-related text messages
Behavioral: HIV-related text messaging
Participants will receive up to 90 text messages related to abstinence, monogamy, and condom use over 3 months.
Active Comparator: B
Participants will receive nutrition-related text messages
Behavioral: Nutrition-related text messaging
Participants will receive up to 30 text messages about nutrition and healthy eating over 3 months.
No Intervention: C
Participants will attend a 90-minute focus group to develop messages for the cell-phone program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Condom use
Time Frame: Measured at baseline and Months 3 and 6
Measured at baseline and Months 3 and 6
Abstinence
Time Frame: Measured at baseline and Months 3 and 6
Measured at baseline and Months 3 and 6
Monogamy
Time Frame: Measured at baseline and Months 3 and 6
Measured at baseline and Months 3 and 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Attitudes, norms, self-efficacy, and intentions to remain abstinent, remain monogamous, or use condoms
Time Frame: Measured at baseline and Months 3 and 6
Measured at baseline and Months 3 and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Sheana Bull, PhD, University of Colorado at Denver and Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

January 23, 2008

First Submitted That Met QC Criteria

January 25, 2008

First Posted (Estimate)

January 28, 2008

Study Record Updates

Last Update Posted (Estimate)

April 3, 2015

Last Update Submitted That Met QC Criteria

April 1, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-0463
  • DAHBR 9A-ASPA (National Institute of Mental Health)
  • R21MH083318 (U.S. NIH Grant/Contract)
  • COMIRB 07-0463

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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